-17% of people achieved SVR with pegylated-interferon and ribavirin alone in the control arm-
-Safety and tolerability results were consistent with prior Phase 3 studies-
-Completion of rolling New Drug Application submission on track for the fourth quarter 2010-
CAMBRIDGE, Mass., Sep 07, 2010 (BUSINESS WIRE) -- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that 65% of people overall achieved a sustained viral response (SVR or viral cure) with a telaprevir-based regimen in the pivotal Phase 3 REALIZE study, as compared to 17% of people in the control arm who received pegylated-interferon and ribavirin alone. REALIZE enrolled three groups of patients with genotype 1 hepatitis C who had undergone at least one prior treatment course with pegylated-interferon and ribavirin but did not achieve SVR: (1) those who relapsed, (2) those who achieved a partial response and (3) those who had almost no response, known as a null response. REALIZE is the only Phase 3 hepatitis C study to date of an investigational direct-acting antiviral therapy that was designed to evaluate all major subgroups of people whose prior treatment was unsuccessful, including those who had a null response. The safety and tolerability results were consistent with results from the other two Phase 3 studies of telaprevir. The REALIZE study was conducted by Vertex's collaborator, Tibotec.
"The REALIZE data represent a major milestone in the development of new treatments for hepatitis C, as patients who received telaprevir-based therapy had a viral cure rate almost four times greater than the cure rate in those treated with available medicines," said Stefan Zeuzem, M.D., Professor of Medicine and Chief of the Department of Medicine at the JW Goethe University Hospital, Frankfurt, Germany and Principal Investigator of the trial. "These results may provide hope to people who have not been cured and who are in need of new treatment options, including those with advanced liver disease."
"Along with results from ADVANCE and ILLUMINATE, the REALIZE data provide us with a strong understanding of telaprevir's potential role in helping many people with hepatitis C achieve a cure, regardless of their treatment history," said Robert Kauffman, M.D., Ph.D., Senior Vice President and Chief Medical Officer for Vertex. "With these data, we look forward to completing our rolling New Drug Application submission for telaprevir later this year."
Overview of SVR Results
The primary endpoint of the study was SVR in each of the two telaprevir arms compared to the control arm, as well as across the three subgroups of people included in the study. One of the telaprevir treatment arms was designed to evaluate, for the first time, whether there was any further improvement in viral cure rates when delaying the start of telaprevir by four weeks, during which time patients received four weeks of pegylated-interferon and ribavirin alone, compared to a simultaneous start. The SVR rates between these two arms were similar and there was no clinical benefit to the telaprevir delayed start treatment arm in any of the subgroups of patients. The table below combines the two telaprevir arms compared to the control.
Telaprevir- based Treatment Arms+
Relapsers (n=354)
86%*
(n=245/286)
Partial Responders (n=124)
57%*
(n=55/97)
Null Responders (n=184)
31%*
(n=46/147)
Overall (ITT) (n=662)
65%*
(n=346/530)
Pooled Analysis: 78% (n=300/383)**
Control Arm++
Relapsers (n=354)24%
(n=16/68)
Partial Responders (n=124)
15%
(n=4/27)
Null Responders (n=184)
5%
(n=2/37)
Overall (ITT) (n=662)
17%
(n=22/132)
Pooled Analysis: 21% (n = 20/95)**
* Combined endpoint analysis: The SVR rates observed in the overall combined telaprevir-based arms were statistically significant when compared with the control arm (p < 0.0001). Additionally, the SVR rates observed in each of the three groups of patients evaluated were statistically significant when compared with the control arm (relapsers and partial responders (p<0.0001) and null responders (p<0.001)).
+ Reflects SVR rates from the combined telaprevir-based treatment groups. There were two telaprevir-based treatment groups:
1. 12 weeks of telaprevir (750 mg, q8h), pegylated-interferon (Peg-IFN) & ribavirin (RBV), followed by 36 weeks of Peg-IFN & RBV alone or
2. 4 weeks of Peg-IFN & RBV alone followed by 12 weeks of telaprevir (750 mg, q8h), Peg-IFN & RBV, followed by 32 weeks of Peg-IFN & RBV alone
++12 weeks of placebo, Peg-IFN & RBV, followed by 36 weeks of Peg-IFN and RBV alone
**Supplemental analysis
Null Responder: Defined as a person who achieved a less than 2 log10 reduction in HCV RNA at week 12 of a prior course of therapy.
Relapser: Defined as a person whose hepatitis C virus was undetectable at the completion of at least 42 weeks of a prior course of therapy but whose virus became detectable during the follow-up period.
Partial Responder: Defined as a person who achieved at least a 2 log10 reduction at week 12, but whose hepatitis C virus never became undetectable by week 24 of a prior course of therapy.
Backgrounders on hepatitis C treatment response and the REALIZE study (including trial design diagram) can be found at http://investors.vrtx.com/press.cfm
SVR rates for the telaprevir simultaneous start arm and the delayed start arm were 64% and 66%, respectively, overall, based on an intent-to-treat (ITT) analysis. For the primary analysis, the SVR rates for the telaprevir simultaneous start arm, delayed start arm and control arm, respectively, were 83%, 88% and 24% in relapsers (p<0.0001); 59%, 54% and 15% in partial responders, (p<0.0001); and 29%, 33% and 5% in null responders, (p<0.001).
Safety & Tolerability Results
The safety and tolerability results of the telaprevir-based regimens in the REALIZE study were consistent with results reported from the Phase 3 ADVANCE and ILLUMINATE studies. The most common adverse events, reported in any treatment arm during the telaprevir dosing periods and up to week 16 to account for the telaprevir delayed start arm in order of frequency, were fatigue, pruritis, headache, rash, flu-like symptoms, nausea and anemia, with the majority being mild to moderate. Of these, fatigue, pruritis, rash, flu-like symptoms, nausea and anemia were more common in the telaprevir-based treatment arms compared to control. Adverse events leading to discontinuation of all study drugs during the telaprevir dosing period and up to week 16 occurred in 4% of people in the combined telaprevir arms and 3% in the control arm during the same period. Discontinuation of all drugs due to anemia and rash during the telaprevir dosing period and up to week 16 occurred in 0.6% and 0.4% of patients, respectively, in the combined telaprevir arms, while discontinuation of all three drugs due to rash and anemia did not occur in the control arm during the same period. As in ADVANCE and ILLUMINATE, the use of erythropoiesis-stimulating agents (ESAs) was not allowed in this study.
Telaprevir is an investigational, oral inhibitor of HCV protease, an enzyme essential for viral replication, and is being developed by Vertex Pharmaceuticals in collaboration with Tibotec Pharmaceuticals and Mitsubishi Tanabe Pharma. With results from the three Phase 3 studies of telaprevir - ADVANCE, ILLUMINATE and REALIZE - Vertex is on track to complete its rolling New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2010.
Patient Demographics
REALIZE enrolled people with hepatitis C who did not achieve a viral cure after receiving at least one course of prior treatment with pegylated-interferon and ribavirin. Patients in the study were enrolled based on their response to prior treatment: 53% were prior relapsers, 19% were prior partial responders and 28% were prior null responders. In this study, 26% of patients overall had cirrhosis and 89% of patients overall had a high viral load (HCV RNA greater-than or equal to 800,000 IU/mL) when entering the study. Specifically in the null responder population, there were an even greater number of people with cirrhosis (33%) and high viral load (95%). Approximately 50% of patients were genotype 1a and 50% were genotype 1b.
About the Study
REALIZE was a pivotal Phase 3, randomized, double-blind, placebo-controlled study conducted in 662 people at more than 100 international clinical trial sites with the majority in Europe and North America. The study was designed to evaluate the efficacy, safety and tolerability of telaprevir-based regimens in people infected with genotype 1 chronic hepatitis C who did not achieve a viral cure after at least one prior treatment with interferon-based therapy. There were two telaprevir-based arms (simultaneous and delayed start) and one control arm. Patients were randomized 2:2:1 to the two telaprevir arms and the control arm, respectively.
The primary endpoint of the REALIZE study was SVR, defined as the proportion of people who had undetectable HCV RNA (<25IU/mL undetectable by Roche COBAS Taqman HCV test) 24 weeks after the end of all treatment. REALIZE was designed to compare the SVR rates for each of the telaprevir-based regimens with the control arm, separately for the prior response subgroups of relapsers and non-responders (null and partial responders), and then for the two subgroups of non-responders. The secondary endpoint was to evaluate the safety and tolerability of telaprevir in combination with pegylated-interferon and ribavirin.
As in all Phase 3 studies of telaprevir, patients received no more than 12 weeks of telaprevir given in combination with pegylated interferon and ribavirin. In REALIZE, the telaprevir arms included 12 weeks of telaprevir in combination with pegylated-interferon and ribavirin with 36 weeks of pegylated-interferon and ribavirin alone for a total of 48 weeks of treatment.
About the Telaprevir Development Program
To date, more than 2,500 people with hepatitis C have received telaprevir-based therapy as part of Phase 2 studies and the Phase 3 ADVANCE, ILLUMINATE and REALIZE studies. Together, these studies enrolled people with genotype 1 hepatitis C who had not been treated for their disease previously as well as people who had been treated before but did not achieve a viral cure.
Vertex retains commercial rights to telaprevir in North America. Tibotec has rights to commercialize telaprevir in Europe, South America, Australia, the Middle East and certain other countries. Mitsubishi Tanabe Pharma has rights to commercialize telaprevir in Japan and certain Far East countries.
About Hepatitis C
Hepatitis C is a liver disease caused by the hepatitis C virus, which is found in the blood of people with the disease.2 According to a 2010 report from the Institute of Medicine, up to 3.9 million people in the United States have chronic hepatitis C and 75% of those infected are unaware of their infection.3 Approximately 60 percent of genotype 1 patients who undergo an initial 48-week regimen with pegylated-interferon and ribavirin, the currently approved treatment regimen, do not achieve SVR, 4,5,6 or viral cure.1
Hepatitis C is spread through direct contact with the blood of infected people.2 Though many people with hepatitis C may not experience symptoms, others may have symptoms such as fatigue, fever, jaundice and abdominal pain.2 Chronic hepatitis C can lead to serious and life-threatening liver problems, including liver damage, cirrhosis, liver failure or liver cancer.2 If treatment is not successful and a person does not achieve a viral cure, they remain at risk for progressive liver disease.7,8,9,10,11 In the United States, hepatitis C is the leading cause of liver transplantations and is reported to contribute to 4,600 to 12,000 deaths annually.8 The majority of people with hepatitis C were born between 1946 and 1964, accounting for two of every three people with chronic hepatitis C.11 By 2029, total annual medical costs in the U.S. for people with hepatitis C are expected to more than double, from $30 billion in 2009 to approximately $85 billion.11
Additional resources for media, including a hepatitis C backgrounder and glossary of common terms, are available at: http://investors.vrtx.com/press.cfm
About Vertex
Vertex Pharmaceuticals Incorporated is a global biotechnology company committed to the discovery and development of breakthrough small molecule drugs for serious diseases. The Company's strategy is to commercialize its products both independently and in collaboration with major pharmaceutical companies. Vertex's product pipeline is focused on viral diseases, cystic fibrosis, inflammation, autoimmune diseases, epilepsy, cancer and pain.
Vertex co-discovered the HIV protease inhibitor, Lexiva, with GlaxoSmithKline.
Lexiva is a registered trademark of the GlaxoSmithKline group of companies.
References:
1Ghany, m.G., Strader, d.B., Thomas, d.L., Seeff, Leondard B. Diagnosis, Management and Treatment of Hepatitis C; An Update. 2009. Hepatology. 2009;49 (4):1-40.
2 Centers for Disease Control and Prevention. Hepatitis C Fact Sheet: CDC Viral Hepatitis. Available at: http://www.cdc.gov/hepatitis/HCV/PDFs/HepCGeneralFactSheet.pdf. Accessed May 25, 2010.
3 Institute of Medicine. Hepatitis and Liver Cancer: A National Strategy for Prevention and Control of Hepatitis B and C. Available at http://www.iom.edu/Reports/2010/Hepatitis-and-Liver-Cancer-A-National-Strategy-for-Prevention-and-Control-of-Hepatitis-B-and-C.aspx. Accessed May 25, 2010.
4 Manns MP, McHutchison JG, Gordon SC, et al. Peginterferon alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis C: a randomised trial. Lancet. 2001;358:958-965.
5 Fried MW, Shiffman ML, Reddy KR, et al. Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection. N Engl J Med. 2002;347:975-982.
6 McHutchison JG, Lawitz EJ, Shiffman ML, et al; IDEAL Study Team. Peginterferon alfa-2b or alfa-2a with ribavirin for treatment of hepatitis C infection. N Engl J Med. 2009;361:580-593.
7 Morgan T.R, Ghany MG, Kim HY, Snow KK, Lindsay K, Lok AS. Outcome of sustained virological responders and non-responders in the Hepatitis C Antiviral Long-Term Treatment Against Cirrhosis (HALT-C) trial. Hepatology. 2008;50(Suppl 4):357A (Abstract 115).
8 Davis GL, Alter MJ, El-Serag H, Poynard T, Jennings LW. Aging of hepatitis C virus (HCV)-infected persons in the United States: A multiple cohort model of HCV prevalence and disease progression. Gastroenterology. 2010;138: 513-521
9 Volk, Michael I., Tocco, Rachel, Saini, Sameer, Lok, Anna S.F. Public Health Impact of Antiviral Therapy for Hepatitis C in the United States. Hepatology.2009;50(6):1750-1755.
10 Veldt, B.J., Heathcote, J., Wedmeyer, H. Sustained virologic response and clinical outcomes in patients with chronic hepatitis C and advanced fibrosis. Annals of Internal Medicine. 2007; 147: 677-684.
11 Pyenson, B., Fitch, K., Iwasaki, K. Consequences of Hepatitis C Virus (HCV): Costs of a Baby Boomer Epidemic of Liver Disease. Milliman, Inc. This report was commissioned by Vertex Pharmaceuticals, Inc. May, 2009.
Special Note Regarding Forward-looking Statements
This press release contains forward-looking statements, including statements regarding (i) the Company being on track to complete the NDA for telaprevir in the fourth quarter of 2010 and (ii) the REALIZE data providing the Company with a strong understanding of telaprevir's potential role in helping many people with hepatitis C achieve a cure, regardless of their treatment history. While the Company believes the forward-looking statements contained in this press release are accurate, there are a number of factors that could cause actual events or results to differ materially from those indicated by such forward-looking statements. Those risks and uncertainties include, among other things, that the Company could experience unforeseen delays in submitting the NDA for telaprevir and/or obtaining approval to market telaprevir; that there may be varying interpretations of the data from the telaprevir clinical trials; that future outcomes from clinical trials of telaprevir may not be favorable; and that future scientific, clinical, competitive or other market factors may adversely affect the potential for telaprevir-based combination therapy and the other risks listed under Risk Factors in Vertex's annual report and quarterly reports filed with the Securities and Exchange Commission and available through the Company's website at http://www.vrtx.com/. The Company disclaims any obligation to update the information contained in this press release as new information becomes available.
Investor Conference Call Today at 4:30 p.m. ET
Vertex Pharmaceuticals will host a conference call and webcast today, September 7, at 4:30 p.m. ET. This call and webcast will be broadcast via the Internet at www.vrtx.com/finances. It is suggested that webcast participants go to the web site at least 10 minutes in advance of the call to ensure that they can access the slides. The link to the webcast is available on the Events & Presentations button. To listen to the call on the telephone, dial (888) 634-7543 (U.S. and Canada) or (719) 457-2573 (International) and use conference ID number ID 5433422. Vertex is also providing a podcast MP3 file available for download on the Vertex website at http://www.vrtx.com/.
The call will be available for replay via telephone commencing September 8, 2010 at 8:00 p.m. ET running through September 22, 2010 at 5:00 p.m. ET. To listen to the replay dial (888) 203-1112 (U.S. and Canada) or (719) 457-0820 (International) and use conference ID number 5433422. Following the live webcast, an archived version will be available on Vertex's website until 5:00 p.m. on September 15, 2010.
New York City Investor and Analyst Webcast Tomorrow, September 8, at 8:00 a.m. ET
Vertex Pharmaceuticals will also webcast its investor and analyst meeting from New York City on Wednesday, September 8, 2010 at 8:00 a.m. ET. This webcast will be broadcast via the Internet at www.vrtx.com/finances. The link to the webcast is available on the Events & Presentations button. The New York City webcast will not be available via telephone. It is suggested that webcast participants go to the web site at least 10 minutes in advance of the call to ensure that they can access the slides.
(VRTX-GEN)
Photos/Multimedia Gallery Available: http://www.businesswire.com/cgi-bin/mmg.cgi?eid=6419968&lang=en
SOURCE: Vertex Pharmaceuticals Incorporated
Vertex Pharmaceuticals Incorporated
Media:
Zachry Barber, 617-444-6992
or
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or
Investors:Michael Partridge, 617-444-6108
or
Lora Pike, 617-444-6755
or
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Copyright Business Wire 2010
Source
September 7, 2010
September 6, 2010
15 Tips for Managing Interferon-Ribavirin Side Effects
Posted on: Sep 6, 2010
Many people abandon this challenging HCV treatment mid-course. Here are 15 ways to help manage the side effects of Hepatitis C combination therapy, to help patients' likelihood of completing the extremely challenging treatment. Share this article among patients contemplating and/or already undergoing chemotherapy for Hepatitis C, so they can help increase their likelihood of conquering the virus.
by Nicole Cutler, L.Ac.
Although it affects an estimated four to five million Americans, there is still no easy formula to eliminate the Hepatitis C virus (HCV). At best, infected individuals have a 50 percent chance of triumphing over the virus by enduring standard combination therapy, a notoriously challenging treatment with pegylated interferon and ribavirin medications. Most experts believe that the success rate of these drugs would be much higher without the burden of their potentially serious side effects. In cooperation with a physician, those with HCV who can manage standard combination therapy’s side effects are more likely to complete the drug regimen at full strength – and thus have a better chance of ridding the virus from their body.
Especially apparent in the first several weeks of treatment, the side effects of these drugs range from mild to severe. Managing these effects can be simple, involving lifestyle modifications, logical home remedies and taking some routine medications. Beyond these basics, working with a knowledgeable physician is important for customizing a plan to help someone manage their side effects.
The side effects from interferon and ribavirin therapy often lead to lowered dosages or even discontinuation of these drugs. Physicians agree that the more a dosage is reduced, the less of a chance the therapy has at successfully killing HCV. However, dose reduction or discontinuation of interferon or ribavirin may be indicated immediately if severe side effects develop.
Fifteen suggestions to discuss with your physician for managing the most common side effects of combination therapy are outlined below:
1. Getting a full night’s sleep helps the body recover from physical and emotional stressors. Being fully rested lessens the side effects of fatigue, headache, fever, myalgia (muscle pain), irritability and insomnia.
2. Keeping hydrated is helpful to counteract the drying properties of combination therapy. Keeping hydrated is advised to improve fatigue, headache, fever, myalgia and dry mouth.
3. Eating well-balanced meals helps the body bounce back from fatigue, headache, fever and myalgia.
4. Engaging in regular exercise keeps your circulation going and thus helps prevent fatigue, headache, fever and myalgia.
5. Taking a hot bath or using hot packs is recognized for helping relieve myalgia.
6. Taking acetaminophen (Tylenol) or NSAIDS can reduce fatigue, headaches, fever, myalgias or liver pain. However, dosage and safety considerations must be confirmed by your doctor since these drugs may place an additional burden on the liver.
7. Include ginger in your day by drinking it in tea, ale or snacking on ginger baked goods to relieve nausea.
8. Taking ribavirin with food and eating small, frequent meals helps ease ribavirin-related nausea.
9. Prochlorperazine (compazine) may stop nausea but should only be done under a physician’s guidance.
10. Avoiding stimulants like caffeine at night can reduce insomnia and irritability.
11. Practicing relaxation techniques, such as taking a deep breath and counting to ten, can significantly help reduce irritability.
12. Taking selective serotonin reuptake inhibitors (SSRIs) have been proven effective in treating the depression associated with interferon therapy for certain individuals. The additional side effects of SSRIs and treatment guidelines must be carefully evaluated by your physician.
13. Sharing feelings with friends, family or a support group can help many people cope with the irritability and depression often accompanying HCV therapy.
14. Being gentle with your hair can help minimize hair loss. This includes not pulling on or braiding the hair, avoiding vigorous combing or brushing and only using natural (not harsh) hair products.
15. Avoiding hot or spicy foods minimizes mouth irritation. For those dealing with the side effects of a dry mouth or mouth sores, avoiding these types of foods is a must.
Some of these tips for managing side effects are easily accomplished at home while others require collaboration with your physician. However it is accomplished, reducing side effect severity helps people endure a full course of combination therapy, a feat that increases their odds of eliminating the Hepatitis C virus.
References:
http://www.clevelandclinic.org/, Managing Side Effects of Hepatitis C Treatment, The Cleveland Clinic Department of Patient Education and Health Information, 2008.
http://www.hepatitis.va.gov/, Clinical Manual: Interferon and Ribavirin Treatment Side Effects, United States Department of Veteran Affairs, 2008.
http://www.hepcawareness.net.au/, Treatment Side Effects, Australian Hepatitis Council, 2008.
Source
Many people abandon this challenging HCV treatment mid-course. Here are 15 ways to help manage the side effects of Hepatitis C combination therapy, to help patients' likelihood of completing the extremely challenging treatment. Share this article among patients contemplating and/or already undergoing chemotherapy for Hepatitis C, so they can help increase their likelihood of conquering the virus.
by Nicole Cutler, L.Ac.
Although it affects an estimated four to five million Americans, there is still no easy formula to eliminate the Hepatitis C virus (HCV). At best, infected individuals have a 50 percent chance of triumphing over the virus by enduring standard combination therapy, a notoriously challenging treatment with pegylated interferon and ribavirin medications. Most experts believe that the success rate of these drugs would be much higher without the burden of their potentially serious side effects. In cooperation with a physician, those with HCV who can manage standard combination therapy’s side effects are more likely to complete the drug regimen at full strength – and thus have a better chance of ridding the virus from their body.
Especially apparent in the first several weeks of treatment, the side effects of these drugs range from mild to severe. Managing these effects can be simple, involving lifestyle modifications, logical home remedies and taking some routine medications. Beyond these basics, working with a knowledgeable physician is important for customizing a plan to help someone manage their side effects.
The side effects from interferon and ribavirin therapy often lead to lowered dosages or even discontinuation of these drugs. Physicians agree that the more a dosage is reduced, the less of a chance the therapy has at successfully killing HCV. However, dose reduction or discontinuation of interferon or ribavirin may be indicated immediately if severe side effects develop.
Fifteen suggestions to discuss with your physician for managing the most common side effects of combination therapy are outlined below:
1. Getting a full night’s sleep helps the body recover from physical and emotional stressors. Being fully rested lessens the side effects of fatigue, headache, fever, myalgia (muscle pain), irritability and insomnia.
2. Keeping hydrated is helpful to counteract the drying properties of combination therapy. Keeping hydrated is advised to improve fatigue, headache, fever, myalgia and dry mouth.
3. Eating well-balanced meals helps the body bounce back from fatigue, headache, fever and myalgia.
4. Engaging in regular exercise keeps your circulation going and thus helps prevent fatigue, headache, fever and myalgia.
5. Taking a hot bath or using hot packs is recognized for helping relieve myalgia.
6. Taking acetaminophen (Tylenol) or NSAIDS can reduce fatigue, headaches, fever, myalgias or liver pain. However, dosage and safety considerations must be confirmed by your doctor since these drugs may place an additional burden on the liver.
7. Include ginger in your day by drinking it in tea, ale or snacking on ginger baked goods to relieve nausea.
8. Taking ribavirin with food and eating small, frequent meals helps ease ribavirin-related nausea.
9. Prochlorperazine (compazine) may stop nausea but should only be done under a physician’s guidance.
10. Avoiding stimulants like caffeine at night can reduce insomnia and irritability.
11. Practicing relaxation techniques, such as taking a deep breath and counting to ten, can significantly help reduce irritability.
12. Taking selective serotonin reuptake inhibitors (SSRIs) have been proven effective in treating the depression associated with interferon therapy for certain individuals. The additional side effects of SSRIs and treatment guidelines must be carefully evaluated by your physician.
13. Sharing feelings with friends, family or a support group can help many people cope with the irritability and depression often accompanying HCV therapy.
14. Being gentle with your hair can help minimize hair loss. This includes not pulling on or braiding the hair, avoiding vigorous combing or brushing and only using natural (not harsh) hair products.
15. Avoiding hot or spicy foods minimizes mouth irritation. For those dealing with the side effects of a dry mouth or mouth sores, avoiding these types of foods is a must.
Some of these tips for managing side effects are easily accomplished at home while others require collaboration with your physician. However it is accomplished, reducing side effect severity helps people endure a full course of combination therapy, a feat that increases their odds of eliminating the Hepatitis C virus.
References:
http://www.clevelandclinic.org/, Managing Side Effects of Hepatitis C Treatment, The Cleveland Clinic Department of Patient Education and Health Information, 2008.
http://www.hepatitis.va.gov/, Clinical Manual: Interferon and Ribavirin Treatment Side Effects, United States Department of Veteran Affairs, 2008.
http://www.hepcawareness.net.au/, Treatment Side Effects, Australian Hepatitis Council, 2008.
Source
September 3, 2010
H.I.V. Prevention Gel Hits Snag: Money
Joao Silva for The New York Times
Volunteers who took part in a trial of a microbicide listened to results in Vulindlela, Kwazulu-Natal Province, South Africa.
JOHANNESBURG — When scientists celebrated the announcement in July that a vaginal microbicide had finally been found that significantly reduced H.I.V. infections in women, there was still a prosaic — though essential — piece of the puzzle missing: money.
Donors have not committed enough money for even one of the two studies needed to confirm a promising South African trial of the microbicide and get it into women’s hands. Only about $58 million of the $100 million needed for follow-up research has been pledged, according to Unaids, the United Nations AIDS agency. Experts say shifting global health priorities and tight finances in the West are making it hard to raise the rest.
Advocates say any delay could be deadly. Most of the 22 million people infected with H.I.V. in sub-Saharan Africa are women, and about a million women on the continent are infected each year. If subsequent studies find the gel effective, women could use it to protect themselves even when men refuse to use condoms.
“We have to keep our eye on the prize,” said Dr. Catherine Hankins, chief scientific adviser to Unaids. “It’s in reach. We have to close the funding gap and get the gel to women.”
Dozens of scientists and public health experts at a conference here last week agreed on the research needed to speed the microbicide to widespread use. They called for two more trials in southern Africa and steps to promote and distribute the vaginal gel, infused with the antiviral drug tenofovir, through family planning programs.
The original study of the gel found that women who used it before and after sex were 39 percent less likely over all to contract H.I.V. than those who used a placebo. Those who used the gel most regularly cut their odds of infection by 54 percent.
Researchers have tried for two decades to find a microbicide to fight H.I.V. transmission. So far, the American and South African governments have come up with a vast majority of the additional research money, while Britain’s Department for International Development, a major supporter of microbicide research, has committed nothing.
Participants in the conference said an agency official said the British government’s priorities were shifting away from AIDS and toward maternal and child health, malaria and tuberculosis.
“H.I.V./AIDS is perceived to be very expensive research, and there’s a sentiment in the U.K. that it’s time to shift priorities,” said Tim Farley, a World Health Organization scientist who attended the conference.
The British agency was noncommittal in a statement, saying that future spending “will be made based on impact on poverty eradication on the ground.”
Researchers also worry that the Bill and Melinda Gates Foundation, the most important philanthropic supporter, has not committed major financing for the additional studies on the gel. Dr. Stefano Bertozzi, who heads the foundation’s AIDS programs, said the gel — with a solid study showing its effectiveness — was just the kind of project that rich countries could justify to taxpayers. “It should be an easy case for South Africa, ourselves and others to make,” Dr. Bertozzi said.
He said the foundation was excited about the results, but tried to focus on riskier, longer-term research. The foundation has committed more than $250 million to microbicide research.
The hope is that two additional studies would provide the evidence to adopt the gel on a large scale. Three rigorous studies have established that male circumcision reduces a man’s risk of H.I.V. infection by at least half, and governments across Africa are beginning to offer it.
For the microbicide, researchers plan to lead one of the confirmatory studies in South Africa, where an estimated 5.7 million people are infected, more than in any other nation. Scientists would conduct the second study in five southern African nations.
Experts say investing in AIDS prevention is fiscally far preferable to the costs for lifelong treatment. Mead Over, a health economist at the Center for Global Development, says that providing antiretroviral therapy to the five million people with AIDS in Africa already receiving it will cost $72 billion over the next four decades. That amount rises to $225 billion if the number of people on treatment continues to grow.
“Donors should not be nickel and diming this research because by spending only $100 million they have a prospect of saving billions of dollars in treatment costs,” Mr. Over said.
Advocates make the case on humanitarian grounds.
“We see every day women getting infected by H.I.V.,” said Nomfundo Eland of the Treatment Action Campaign, an advocacy group here. “The sooner we can get a method in the control of women the better.”
Source
Week 4 Rapid Virological Response Predicts Sustained Response to Interferon-based Hepatitis C Treatment
SUMMARY: Rapid virological response (RVR), or undetectable plasma hepatitis C virus (HCV) RNA at 4 weeks after starting treatment with pegylated interferon plus ribavirin, has been confirmed as a good indicator of which patients will go on to achieve sustained virological response (SVR) at 6 months after completion of therapy, according to a review article published in the June 2010 issue of Alimentary Pharmacology and Therapeutics.
By Liz Highleyman
Standard treatment for chronic hepatitis C using pegylated interferon (Pegasys or PegIntron) plus ribavirin produces sustained response -- considered to be a cure -- about half the time, with HCV genotypes 2 and 3 (treated for 24 week) showing better response rates than hard-to-treat genotypes 1 or 4 (treated for 48 weeks).
Treatment is expensive and can cause difficult side effects, however, so it is useful to have an early indicator to enable patients to stop treatment that likely will not turn out to be successful.
F. Fred Poordad from Cedars-Sinai Medical Center in Los Angeles and colleagues collected data from previous published clinical trial reports in order to evaluate the predictive value of RVR as an indicator of SVR and viral relapse.
Results
Investigator affiliation: Hepatology and Liver Transplantation, Cedars-Sinai Medical Center, Los Angeles, CA.
9/3/10
Reference
FF Poordad. Review article: the role of rapid virological response in determining treatment duration for chronic hepatitis C. Alimentary Pharmacology and Therapeutics 31(12): 1251-1267 (Abstract). June 2010.
Source
By Liz Highleyman
Standard treatment for chronic hepatitis C using pegylated interferon (Pegasys or PegIntron) plus ribavirin produces sustained response -- considered to be a cure -- about half the time, with HCV genotypes 2 and 3 (treated for 24 week) showing better response rates than hard-to-treat genotypes 1 or 4 (treated for 48 weeks).
Treatment is expensive and can cause difficult side effects, however, so it is useful to have an early indicator to enable patients to stop treatment that likely will not turn out to be successful.
F. Fred Poordad from Cedars-Sinai Medical Center in Los Angeles and colleagues collected data from previous published clinical trial reports in order to evaluate the predictive value of RVR as an indicator of SVR and viral relapse.
Results
- Data supported a 24-week regimen for HCV genotype 1 patients who achieved RVR.
- The positive predictive value -- or how often RVR accurately predicted SVR -- was 77.8% for patients treated for 24 weeks versus 85.7% for those treated for 48 weeks, not a significant difference.
- However, lack of RVR among genotype 1 patients "should not be viewed as a criterion for extending treatment duration beyond 48 weeks."
- Negative predictive values -- or how often lack of RVR predicted failure to achieve SVR -- were 60.9% for genotype 1 patients treated for 48 weeks and 52.7% for those treated for 72 weeks, not a significant improvement with longer therapy.
- Among people with HCV genotypes 2 or 3, RVR also had a high positive predictive value.
- Negative predictive value, however, varied according to treatment duration, indicating that a 24-week regimen is warranted for genotype 2 or 3 patients who did not achieve RVR.
Investigator affiliation: Hepatology and Liver Transplantation, Cedars-Sinai Medical Center, Los Angeles, CA.
9/3/10
Reference
FF Poordad. Review article: the role of rapid virological response in determining treatment duration for chronic hepatitis C. Alimentary Pharmacology and Therapeutics 31(12): 1251-1267 (Abstract). June 2010.
Source
First Medical Marijuana Ad on TV (Video)
Friday, September 3rd, 2010 at 6:20 am
In Sacramento, California, the first medical marijuana ad was aired on television. The local Fox affiliate, KTXL, FOX40, aired the 30 second ad on Monday for CannaCare. The commercial (see video below) features testimonials for patients as the text ‘crawl’ describes how cannabis can relieve symptoms of illnesses such as hypertension, diabetes, HIV, hepatitis C and others. The commercial is believed to be the first in the United States for medical marijuana. CannaCare is not a medical marijuana dispensary, which are the places patients go to purchase cannabis.
The acting general manager of KTXL, Mike Armstrong, defends the station’s decision to run the ad during it’s 10pm local news broadcast. “It is a matter of record within the medical community that medical marijuana can have positive results in helping relieve nausea and vomiting among cancer patients receiving chemotherapy and increasing appetites among AIDS patients.”
CannaCare is a medical marijuana advocacy group. They do NOT sell marijuana! They primarily offer patients and the general public information on the medical use of marijuana as well as the legal details regard state and community laws. CannaCare does provide information on growing and cultivating marijuana, plus a list of suppliers of growing equipment.
Based in Seattle, CannaCare has branches in several states that have adopted medical marijuana laws. The TV ad does not use the term ‘marijuana’ at all during it, instead calling the product cannabis. Medical Marijuana relieves diseases such as AIDS/HIV, MS, diabetes, as well as chronic pain from arthritis. It’s benefits to assisting cancer patients ravaged by the side effects of chemotherapy are well documented.
KTXL, the Fox affiliate in Sacramento, has broken ground airing the first medical marijuana ad in the nation. There is no word yet if CannaCare intends to expand the ad campaign to include other states that allow the use of cannabis. Watch the commercial yourself (below) and decide for yourself if it will destroy Western Civilization.
Related Articles:
Fox Affiliate Airs Nation’s ‘First’ TV ad For Medical Marijuana
Medical Marijuana Hits the Small Screen
CannaCare Home Page
Source
Why DNA Vaccines May Be Commercially Viable
By: Jim Nelson Friday, September 03, 2010 11:13 AM
In the early 1990s, DNA vaccines for the treatment and prevention of diseases first emerged. Excitement about this technology was matched only by unrealistic expectations regarding the timeline to market. Interest was driven, however, by the real potential of the technology. For the first time, unvaccinatable targets like HIV and hepatitis C were in the bull's-eye. Traditional vaccine technology, using live or inactivated viruses, simply did not provide a viable way to provoke a protective immune response against these diseases.
Moreover, DNA vaccines could be used against diseases other than their historical target, viruses. Early on, it dawned on researchers that this new generation of vaccines could be used to train the immune system to attack cancers and a wide range of other malignancies that act like foreign invaders inside the body.
Conventional vaccines work by having the body's immune system recognize unique antigenic proteins that are part of the virus, triggering an immune response against the invader. The elegance of DNA vaccines is that, rather than introducing into the body an actual virus, only the antigen that would be recognized as foreign is introduced. Scientists realized that they could turn cells in the body into protein-manufacturing plants. By isolating the DNA responsible for producing ONLY the foreign antigenic protein associated with a specific virus, they could get around various issues associated with live or weakened viruses.
Big Pharma companies like Merck, Wyeth and GlaxoSmithKline as well as national labs and academic research facilities poured billions into a "first wave" attempt at producing commercially viable DNA vaccines. Problems delivering the DNA vaccines in a way that provoked a sufficient immune response soon dampened their enthusiasm.
Two basic problems prevented the development of truly effective DNA vaccines. The first was an immature understanding of genetics. In those days, researchers were only beginning to learn how to optimize the DNA sequences to produce antigens with maximum impact. Additionally, there was the familiar "delivery" problem. Cells didn't absorb enough of the DNA plasmids to become effective antigen factories. Since the amount of antigens produced by the body was therefore low, the immune response was insufficient to form the basis of viable drugs.
As a result, early DNA vaccine trials in humans were disappointing. The flow of research dollars slowed. Behind the scenes, however, determined scientists in dedicated startups never lost confidence in the core science. As importantly, alliances were formed and diverse discoveries merged. In recent years, their work has finally begun to bear fruit. I have been aware of this fact for some time. Until now, however, I hadn't identified a company that fits in the Breakthrough Technology Alert portfolio.
But thanks to a series of mergers, a single company holds all the talent and IP needed to deliver on the breakthrough potential of DNA vaccine technology. In fact, they appear to have solved the problems faced by early DNA vaccine researchers.
Source
In the early 1990s, DNA vaccines for the treatment and prevention of diseases first emerged. Excitement about this technology was matched only by unrealistic expectations regarding the timeline to market. Interest was driven, however, by the real potential of the technology. For the first time, unvaccinatable targets like HIV and hepatitis C were in the bull's-eye. Traditional vaccine technology, using live or inactivated viruses, simply did not provide a viable way to provoke a protective immune response against these diseases.
Moreover, DNA vaccines could be used against diseases other than their historical target, viruses. Early on, it dawned on researchers that this new generation of vaccines could be used to train the immune system to attack cancers and a wide range of other malignancies that act like foreign invaders inside the body.
Conventional vaccines work by having the body's immune system recognize unique antigenic proteins that are part of the virus, triggering an immune response against the invader. The elegance of DNA vaccines is that, rather than introducing into the body an actual virus, only the antigen that would be recognized as foreign is introduced. Scientists realized that they could turn cells in the body into protein-manufacturing plants. By isolating the DNA responsible for producing ONLY the foreign antigenic protein associated with a specific virus, they could get around various issues associated with live or weakened viruses.
Big Pharma companies like Merck, Wyeth and GlaxoSmithKline as well as national labs and academic research facilities poured billions into a "first wave" attempt at producing commercially viable DNA vaccines. Problems delivering the DNA vaccines in a way that provoked a sufficient immune response soon dampened their enthusiasm.
Two basic problems prevented the development of truly effective DNA vaccines. The first was an immature understanding of genetics. In those days, researchers were only beginning to learn how to optimize the DNA sequences to produce antigens with maximum impact. Additionally, there was the familiar "delivery" problem. Cells didn't absorb enough of the DNA plasmids to become effective antigen factories. Since the amount of antigens produced by the body was therefore low, the immune response was insufficient to form the basis of viable drugs.
As a result, early DNA vaccine trials in humans were disappointing. The flow of research dollars slowed. Behind the scenes, however, determined scientists in dedicated startups never lost confidence in the core science. As importantly, alliances were formed and diverse discoveries merged. In recent years, their work has finally begun to bear fruit. I have been aware of this fact for some time. Until now, however, I hadn't identified a company that fits in the Breakthrough Technology Alert portfolio.
But thanks to a series of mergers, a single company holds all the talent and IP needed to deliver on the breakthrough potential of DNA vaccine technology. In fact, they appear to have solved the problems faced by early DNA vaccine researchers.
Source
Cardiff trial for new hepatitis C drug 'successful'
2 September 2010 Last updated at 10:52 ET
Scientists say the first human clinical trials on a new drug to treat infections caused by the Hepatitis C virus have been successfully completed.
The oral medication INX-189, prepared at Cardiff University's Welsh School of Pharmacy in 2008, could now become an approved medicine, the school said.
Around 170m people worldwide have the condition which can cause liver cancer, cirrhosis and death.
Prof Chris McGuigan said the Cardiff trial showed "the drug is safe".
Hepatitis C is the leading cause of liver transplantation in western countries, explained Prof McGuigan, the academic lead on the trials.
The current treatment involves two drugs - ribavirin and interferon, which has to be given as an injection.
Side effects are often severe and lead to patients failing to complete the treatment.
But Prof McGuigan said the INX-189 trials process, though still at a very early stage, represented a significant development.
"Successfully completing phase 1a demonstrates that the drug is safe, with no drug-related side effects at all in a single dose of 100mg," he said.
He said the study, which began in May, had also confirmed that one single dose of the drug a day was most likely to be enough in treating the virus.
Second trial
In 2008, laboratory tests showed INX-189 killed 90% of the virus at very low concentration, making it the most potent compound of its kind developed to date.
The licence to INX-189 is owned by US pharmaceutical company Inhibitex, which has been working with the Cardiff team.
The company has announced it is looking forward to a second trial to evaluate the compound's effectiveness in Hepatitis C patients.
Cardiff University and Inhibitex filed a patent on INX-189 earlier this year.
It has been cleared for human clinical trials by the Food and Drug Administration in the US.
Source
Scientists say the first human clinical trials on a new drug to treat infections caused by the Hepatitis C virus have been successfully completed.
The oral medication INX-189, prepared at Cardiff University's Welsh School of Pharmacy in 2008, could now become an approved medicine, the school said.
Around 170m people worldwide have the condition which can cause liver cancer, cirrhosis and death.
Prof Chris McGuigan said the Cardiff trial showed "the drug is safe".
Hepatitis C is the leading cause of liver transplantation in western countries, explained Prof McGuigan, the academic lead on the trials.
The current treatment involves two drugs - ribavirin and interferon, which has to be given as an injection.
Side effects are often severe and lead to patients failing to complete the treatment.
But Prof McGuigan said the INX-189 trials process, though still at a very early stage, represented a significant development.
"Successfully completing phase 1a demonstrates that the drug is safe, with no drug-related side effects at all in a single dose of 100mg," he said.
He said the study, which began in May, had also confirmed that one single dose of the drug a day was most likely to be enough in treating the virus.
Second trial
In 2008, laboratory tests showed INX-189 killed 90% of the virus at very low concentration, making it the most potent compound of its kind developed to date.
The licence to INX-189 is owned by US pharmaceutical company Inhibitex, which has been working with the Cardiff team.
The company has announced it is looking forward to a second trial to evaluate the compound's effectiveness in Hepatitis C patients.
Cardiff University and Inhibitex filed a patent on INX-189 earlier this year.
It has been cleared for human clinical trials by the Food and Drug Administration in the US.
Source
New Partnership forms to Address the Hepatitis B and C Epidemic in Europe
LUXEMBOURG, September 2, 2010 /PRNewswire/ -- At least 23 million European Union (EU) citizens are currently living with hepatitis B or hepatitis C[i]. In a direct response to the health burden this presents and the recent recognition by the WHO of the seriousness of hepatitis as a global health issue, a unique Partnership comprising key international public and private stakeholders has formed to drive the first EU-wide initiative on hepatitis B and C.
The new Partnership will work to achieve the formation of a European-wide strategy on the communication, prevention and management of viral hepatitis as a healthcare priority. As a first step towards this, the Partnership will host the Hepatitis B and C Summit Conference on 14-15th October 2010, where the latest research and advances will be presented and used to inform and drive future EU strategies and action plans in this neglected disease area. New studies will assess the impact of mobility of populations and patient self-help programmes in relation to the hepatitis epidemic.
Professor Angelos Hatzakis of Athens University Medical School and one of the co-chairs of the Partnership Steering Group said: "The burden and challenges associated with viral hepatitis across Europe require the active and concerted involvement of a broad range of stakeholders. Patients, specialists, primary health care providers, epidemiologists, policy makers, those responsible for health budgets, the general public, advocates, donors and the pharmaceutical sector should all work together to deliver the results so needed for these urgent diseases."
The new Partnership involves the European Association for the Study of Liver Disease (EASL) and the European Liver Patient Association (ELPA). Other contributors include the Viral Hepatitis Prevention Board (VHPB), the World Hepatitis Alliance (WHA) and the European Centre for Disease Prevention and Control (ECDC). The conference is supported by the European Commission's Directorate-General for Health and Consumer Protection (DG SANCO) and is being held under the auspices of the current EU Belgian presidency.
Nadine Piorkowsky, President of the European Liver Patients Association (ELPA) and co-chair of the Partnership Steering Group stated: "The development and implementation of specific policies to prevent, diagnose and control hepatitis B and C are long overdue as the burden of these diseases has significantly increased for the last ten years. This conference constitutes an important step forward as we will bring all the latest research to the table with a view to collectively evaluating the findings. The aim of this conference will be to present EU Member States with concrete policy recommendations on hepatitis B and C that can be implemented in their future health programmes."
References
[i] WHO Europe Region. Hepatitis Fact and Figures.
http://www.euro.who.int/en/what-we-do/health-topics/diseases-and-conditions/hepatitis/facts-and-figures.
Accessed 20.08.10
(Due to the length of this URL, it may be necessary to copy and paste this hyperlink into your Internet browser's URL address field. Remove the space if one exists.)
Notes to editors
Contact details
For more information on attending the event and to arrange interviews, journalists should contact our press office:
Isabelle Scali
+44-207-331-2324
Isabelle.scali@cohnwolfe.com
For more details on the conference and the full list of members of the Steering Group visit: http://www.hepsummit2010.org/
Distributed by PR Newswire on behalf of Hepatitis B and C Summit Conference
Source
The new Partnership will work to achieve the formation of a European-wide strategy on the communication, prevention and management of viral hepatitis as a healthcare priority. As a first step towards this, the Partnership will host the Hepatitis B and C Summit Conference on 14-15th October 2010, where the latest research and advances will be presented and used to inform and drive future EU strategies and action plans in this neglected disease area. New studies will assess the impact of mobility of populations and patient self-help programmes in relation to the hepatitis epidemic.
Professor Angelos Hatzakis of Athens University Medical School and one of the co-chairs of the Partnership Steering Group said: "The burden and challenges associated with viral hepatitis across Europe require the active and concerted involvement of a broad range of stakeholders. Patients, specialists, primary health care providers, epidemiologists, policy makers, those responsible for health budgets, the general public, advocates, donors and the pharmaceutical sector should all work together to deliver the results so needed for these urgent diseases."
The new Partnership involves the European Association for the Study of Liver Disease (EASL) and the European Liver Patient Association (ELPA). Other contributors include the Viral Hepatitis Prevention Board (VHPB), the World Hepatitis Alliance (WHA) and the European Centre for Disease Prevention and Control (ECDC). The conference is supported by the European Commission's Directorate-General for Health and Consumer Protection (DG SANCO) and is being held under the auspices of the current EU Belgian presidency.
Nadine Piorkowsky, President of the European Liver Patients Association (ELPA) and co-chair of the Partnership Steering Group stated: "The development and implementation of specific policies to prevent, diagnose and control hepatitis B and C are long overdue as the burden of these diseases has significantly increased for the last ten years. This conference constitutes an important step forward as we will bring all the latest research to the table with a view to collectively evaluating the findings. The aim of this conference will be to present EU Member States with concrete policy recommendations on hepatitis B and C that can be implemented in their future health programmes."
References
[i] WHO Europe Region. Hepatitis Fact and Figures.
http://www.euro.who.int/en/what-we-do/health-topics/diseases-and-conditions/hepatitis/facts-and-figures.
Accessed 20.08.10
(Due to the length of this URL, it may be necessary to copy and paste this hyperlink into your Internet browser's URL address field. Remove the space if one exists.)
Notes to editors
Contact details
For more information on attending the event and to arrange interviews, journalists should contact our press office:
Isabelle Scali
+44-207-331-2324
Isabelle.scali@cohnwolfe.com
For more details on the conference and the full list of members of the Steering Group visit: http://www.hepsummit2010.org/
Distributed by PR Newswire on behalf of Hepatitis B and C Summit Conference
Source
Prevalence and risk factors of hepatitis B and C viruses among haemodialysis patients in Gaza strip, Palestine
The prevalence of hepatitis B virus (HBV) and hepatitis C virus (HCV) and its associated risk factors among haemodialysis (HD) patients in Gaza strip was investigated using serological and molecular techniques.
Results: The overall prevalence of HBV among the four HD centers was 8.1%. The main risk factors were HD center (p=0.05), history of blood transfusion (p<0.01), and treatment abroad (p=0.01).
The overall prevalence of HCV among the four HD centers was 22%. The main risk factors were HD center (p<0.01), time duration on HD (p<0.01), history of blood transfusion (p<0.01), treatment abroad (p<0.01), and history of blood transfusion abroad (p<0.01).
Serum aminotransferases levels decreased in HD patients compared with normal population but still there was a direct association between the activity of liver enzymes and both HBV (p<0.01) and HCV (p<0.01) infection.
Conclusion: The much higher prevalence of Hepatitis viruses among HD patients compared to the normal population of Gaza strip indicates a causative relation between HD and hepatitis viruses transmission. Therefore extremely careful observation of preventive infection control measures is essential to limit Hepatitis viruses'transmission in HD centers.
Author: Abed El-kader El-OttolAbdelraouf ElmanamaBasim Ayesh
Credits/Source: Virology Journal 2010, 7:210
Published on: 2010-09-01
Source
Results: The overall prevalence of HBV among the four HD centers was 8.1%. The main risk factors were HD center (p=0.05), history of blood transfusion (p<0.01), and treatment abroad (p=0.01).
The overall prevalence of HCV among the four HD centers was 22%. The main risk factors were HD center (p<0.01), time duration on HD (p<0.01), history of blood transfusion (p<0.01), treatment abroad (p<0.01), and history of blood transfusion abroad (p<0.01).
Serum aminotransferases levels decreased in HD patients compared with normal population but still there was a direct association between the activity of liver enzymes and both HBV (p<0.01) and HCV (p<0.01) infection.
Conclusion: The much higher prevalence of Hepatitis viruses among HD patients compared to the normal population of Gaza strip indicates a causative relation between HD and hepatitis viruses transmission. Therefore extremely careful observation of preventive infection control measures is essential to limit Hepatitis viruses'transmission in HD centers.
Author: Abed El-kader El-OttolAbdelraouf ElmanamaBasim Ayesh
Credits/Source: Virology Journal 2010, 7:210
Published on: 2010-09-01
Source
Will Aging Chimps Get to Retire, or Face Medical Research?
Sinbad, thought to be at least 35, is now at a sanctuary in Florida.
By DAN FROSCH
Published: September 1, 2010
ALAMOGORDO, N.M. — Flo the chimpanzee bounds about her enclosure, hurls a rubber ball then stares quizzically at the New Mexico green chili pepper that will be her morning snack.
It has been a long time since Flo was on exhibit at the Memphis Zoo, even longer since she learned to smoke cigarettes during a stint with the circus. Most recently, she was a research chimpanzee here in New Mexico, part of an expansive biomedical testing program for hepatitis C and H.I.V.
At the moment, though, she is out of a job — but perhaps not for long.
Flo and the 185 other chimpanzees who live at the Alamogordo Primate Facility at Holloman Air Force Base have not been research subjects for nearly a decade — part of an agreement between the National Institutes of Health and the military, which prohibits using the animals for biomedical tests on the base.
But recently, the health institute decided it wanted to use the chimp colony for medical research again, primarily to help develop the elusive hepatitis C vaccine. This past June, the institute began shipping some of the animals by special trucks to the Southwest National Primate Research Center in San Antonio and plans on moving the remaining chimpanzees by the end of 2011.
The move has spurred outrage among animal rights advocates, primate experts and politicians, who say the chimpanzees — many of them middle-aged and elderly — should get to live out the rest of their lives in peace after years of invasive research. It has also cast a fresh light on the debate over the tipping point between science and ethics, with everyone from the legendary primatologist Dr. Jane Goodall to Gov. Bill Richardson of New Mexico weighing in.
“These chimpanzees have given up their freedom, if not their natural environment, their bodies, their health, their children to research,” said Laura Bonar, program director for Animal Protection of New Mexico, which wants the government to turn the Alamogordo facility into a retirement sanctuary for the chimps. “And at the end of their lives, we can give them something back.”
For the health institute, though, the Alamogordo chimpanzees represent an invaluable resource. As per the agreement with the Air Force, biomedical research cannot be conducted on the animals. That agreement was forged after the institute acquired the chimpanzees from the Coulston Foundation, an infamous New Mexico research laboratory that was found by federal officials to have abused and neglected the animals.
In 2001, the institute gave the private Charles River Laboratories a 10-year contract to provide medical care to the chimps, most of whom have been infected or exposed to hepatitis C and H.I.V. through prior research.
These days, chimps like Flo, who at 53 is the oldest of the Alamogordo colony, spend their days living in small groups in geodesic domes: foraging for food, swinging from structures and whooping greetings at visitors and one another.
Harold Watson, who heads the chimpanzee research program for the National Center for Research Resources, said that with the end of the contract, it only makes sense to use the chimps for their original purpose. The research — which will most likely entail drawing periodic blood samples, liver biopsies and in some cases inoculations of hepatitis C — will be carefully monitored, he said.
“I think people envision pictures of monkeys with electrodes in their heads,” Dr. Watson said. “This is not what we’re talking about.”
The history of primate research, however, has been long and controversial. Because of their genetic closeness to humans, chimpanzees are considered well-suited for studies of how various infectious diseases or psychological environments might affect mankind.
But some have questioned whether that research has yielded any substantive breakthroughs, and the United States is currently the only developed country that continues large-scale confinement of chimps in laboratories, according to the Humane Society of the United States. Supporters of the research say the animals have been critical in the development of hepatitis A and B vaccines.
Pending Congressional legislation known as the Great Ape Protection Act would retire about 500 federally owned chimpanzees currently in laboratories to permanent sanctuary. The Alamogordo colony traces its lineage to the Air Force’s space chimp experiments in the late 1950s. A decade later, the toxicologist Frederick Coulston set out to build the world’s largest captive colony of chimpanzees for research, in New Mexico. His foundation’s tenure was marred by charges of severe mistreatment.
That legacy still haunts the health institute, which got 288 of the chimpanzees around 2001 and has tried to distance itself from the Coulston Foundation.
John Gluck, a professor emeritus of psychology at the University of New Mexico, who has visited the Alamogordo colony at least four times since the 1970s, is worried what a move to Texas would mean for the animals’ physical and mental health, particularly given “the tremendous price” paid by most of the chimpanzees while research subjects of the Coulston Foundation, he said.
“N.I.H., in general, is a place I respect,” Dr. Gluck said. “But it seems to me that they’ve lost both their ethical and scientific compass here.”
Governor Richardson has also urged the institute to reconsider, and Dr. Goodall wrote to the institute that the chimpanzees “will surely suffer considerable physical and emotional distress from this plan.”
Dr. Lon Lammey, the director of the Alamogordo primate facility for Charles River, the private contractor, disputed the notion that the move would be harmful, and said he was “confident the animals would continue to receive optimal medical care.”
Despite the mounting pressure, the institute has shown little sign of changing its plan.
Some 15 miles from the base, a separate group of 82 chimpanzees are also waiting to be moved, but to a lush Florida sanctuary run by Save the Chimps, a rescue group.
The animals were part of a larger group handed over to the rescue organization by the Coulston Foundation after its demise and have gradually been moved to Florida over the past few years. Save the Chimps wants the institute to permanently retire the rest of the Alamogordo chimpanzees to a sanctuary as well.
At the old Coulston facility, which has been transformed into a temporary sanctuary itself, a 13-year-old chimp named JJ clutched a bundle of security blankets while readying for lunch. As a worker placed bushels of fruit in the enclosures, the chimpanzees began to yelp in unison, their cries carrying across the high desert.
Source
September 1, 2010
Hepatitis B virus infection and risk of non-Hodgkin lymphoma in South Korea: a cohort study
The Lancet Oncology, Volume 11, Issue 9, Pages 827 - 834, September 2010
doi:10.1016/S1470-2045(10)70167-4 Cite or Link Using DOI
Published Online: 04 August 2010
Original Text
Eric A Engels MD a, Eo Rin Cho PhD b, Prof Sun Ha Jee PhD c
Summary
Background
Hepatitis B virus (HBV) infection is common throughout Asia and Africa. Whether chronic HBV infection increases risk of non-Hodgkin lymphoma (NHL) is unclear. We aimed to assess the association between chronic HBV infection and subsequent development of NHL in a South Korean cohort.
Methods
The Korean Cancer Prevention Study is a cohort study of South Korean workers and their dependants enrolled during 1992—95. From this cohort, we excluded individuals who died before Jan 1, 1993, who had cancer at or before the initial visit, who had missing information about weight, height, alanine aminotransferase or aspartate aminotransferase concentrations, or alcohol use, or who had evidence of HIV or HCV infection. Of 1 284 586 eligible participants, 603 585 had baseline data for serum hepatitis B surface antigen (HBsAg) status and were included in our study. We regarded HBsAg positivity at baseline as evidence of chronic HBV infection. Participants were followed up from baseline until Dec 31, 2006. We used national databases of inpatient and outpatient diagnoses and mortality records to ascertain occurrence of haematological malignancies. We assessed incidence of NHL overall and of NHL subtypes, malignant immunoproliferation, Hodgkin's lymphoma, multiple myeloma, and various leukaemias. We used Cox regression to evaluate associations with HBsAg status, adjusting for sex, age, and enrolment year.
Findings
53 045 (9%) of 603 585 participants tested positive for HBsAg at baseline. Subsequently, 133 HBsAg-positive and 905 HBsAg-negative individuals developed NHL. HBsAg-positive participants had an increased risk of NHL overall compared with those who were HBsAg-negative (incidence 19·4 vs 12·3 per 100 000 person-years; hazard ratio [HR] 1·74, 95% CI 1·45—2·09, adjusted for sex, age at baseline, and enrolment year). Among NHL subtypes, HBsAg positivity was associated with increased risk of diffuse large B-cell lymphoma (n=325, incidence 6·86 vs 3·79 per 100 000 person-years; adjusted HR 2·01, 1·48—2·75) and other or unknown subtypes (n=591, incidence 10·5 vs 7·07 per 100 000 person-years; adjusted HR 1·65, 1·29—2·11), compared with HBsAg negativity. Increased risk was also recorded for malignant immunoproliferation (n=14, incidence 0·44 vs 0·15 per 100 000 person-years; adjusted HR 3·79, 1·05—13·7). Risk of these malignancies was consistently raised in HBsAg-positive participants throughout 14 years of follow-up. HBsAg positivity was not associated with follicular or T-cell NHL, Hodgkin's lymphoma, multiple myeloma, or various leukaemias.
Interpretation
During extended follow-up, HBsAg-positive individuals had an increased risk of NHL, suggesting that chronic HBV infection promotes lymphomagenesis.
Funding
Korean Seoul City Research and the National Research and Development Program for Cancer Control, Ministry for Health, Welfare and Family Affairs, Republic of Korea; US National Cancer Institute.
a Division of Cancer Epidemiology and Genetics, National Cancer Institute, Rockville, MD, USA
b Institute of Human Genomic Study, College of Medicine, Korea University, Seoul, South Korea
c Department of Epidemiology, Institute for Health Promotion, Graduate School of Public Health, Seoul, South Korea
Correspondence to: Prof Sun Ha Jee, Department of Epidemiology and Health Promotion, Graduate School of Public Health, Yonsei University, Seoul, South Korea
Source
doi:10.1016/S1470-2045(10)70167-4 Cite or Link Using DOI
Published Online: 04 August 2010
Original Text
Eric A Engels MD a, Eo Rin Cho PhD b, Prof Sun Ha Jee PhD c
Summary
Background
Hepatitis B virus (HBV) infection is common throughout Asia and Africa. Whether chronic HBV infection increases risk of non-Hodgkin lymphoma (NHL) is unclear. We aimed to assess the association between chronic HBV infection and subsequent development of NHL in a South Korean cohort.
Methods
The Korean Cancer Prevention Study is a cohort study of South Korean workers and their dependants enrolled during 1992—95. From this cohort, we excluded individuals who died before Jan 1, 1993, who had cancer at or before the initial visit, who had missing information about weight, height, alanine aminotransferase or aspartate aminotransferase concentrations, or alcohol use, or who had evidence of HIV or HCV infection. Of 1 284 586 eligible participants, 603 585 had baseline data for serum hepatitis B surface antigen (HBsAg) status and were included in our study. We regarded HBsAg positivity at baseline as evidence of chronic HBV infection. Participants were followed up from baseline until Dec 31, 2006. We used national databases of inpatient and outpatient diagnoses and mortality records to ascertain occurrence of haematological malignancies. We assessed incidence of NHL overall and of NHL subtypes, malignant immunoproliferation, Hodgkin's lymphoma, multiple myeloma, and various leukaemias. We used Cox regression to evaluate associations with HBsAg status, adjusting for sex, age, and enrolment year.
Findings
53 045 (9%) of 603 585 participants tested positive for HBsAg at baseline. Subsequently, 133 HBsAg-positive and 905 HBsAg-negative individuals developed NHL. HBsAg-positive participants had an increased risk of NHL overall compared with those who were HBsAg-negative (incidence 19·4 vs 12·3 per 100 000 person-years; hazard ratio [HR] 1·74, 95% CI 1·45—2·09, adjusted for sex, age at baseline, and enrolment year). Among NHL subtypes, HBsAg positivity was associated with increased risk of diffuse large B-cell lymphoma (n=325, incidence 6·86 vs 3·79 per 100 000 person-years; adjusted HR 2·01, 1·48—2·75) and other or unknown subtypes (n=591, incidence 10·5 vs 7·07 per 100 000 person-years; adjusted HR 1·65, 1·29—2·11), compared with HBsAg negativity. Increased risk was also recorded for malignant immunoproliferation (n=14, incidence 0·44 vs 0·15 per 100 000 person-years; adjusted HR 3·79, 1·05—13·7). Risk of these malignancies was consistently raised in HBsAg-positive participants throughout 14 years of follow-up. HBsAg positivity was not associated with follicular or T-cell NHL, Hodgkin's lymphoma, multiple myeloma, or various leukaemias.
Interpretation
During extended follow-up, HBsAg-positive individuals had an increased risk of NHL, suggesting that chronic HBV infection promotes lymphomagenesis.
Funding
Korean Seoul City Research and the National Research and Development Program for Cancer Control, Ministry for Health, Welfare and Family Affairs, Republic of Korea; US National Cancer Institute.
a Division of Cancer Epidemiology and Genetics, National Cancer Institute, Rockville, MD, USA
b Institute of Human Genomic Study, College of Medicine, Korea University, Seoul, South Korea
c Department of Epidemiology, Institute for Health Promotion, Graduate School of Public Health, Seoul, South Korea
Correspondence to: Prof Sun Ha Jee, Department of Epidemiology and Health Promotion, Graduate School of Public Health, Yonsei University, Seoul, South Korea
Source
HCV Outside the Body: How Well Does It Survive on Surfaces, in Syringes, and in the Lab?
—Liz Highleyman
HCV Advocate
The hepatitis C virus (HCV) is relatively hardy compared with some other viruses, which has implications for transmission and prevention. HCV may survive outside the body for days in dried blood on surfaces, or for months in a liquid medium under favorable conditions. Paradoxically, however, HCV has proven difficult to maintain in laboratory cell cultures, which has hampered research on potential treatments.
Survival in the Lab
Due to the difficulty of maintaining viable HCV in the laboratory, researchers have relied on “replicon” models of a specific strain of HCV (JFH-1 genotype 2a) in a liver cancer cell line. But this year researchers from Massachusetts Institute of Technology and Rockefeller University finally found a way to sustain viral replication in healthy liver cells for up to three weeks.
As described in the February 16, 2010 Proceedings of the National Academy of Sciences, Sangeeta Bhatia and colleagues developed a way to maintain healthy hepatocytes, or liver cells, for four to six weeks by precisely arranging them on a specially patterned plate and mixing them with fibroblast cells that support their growth. The liver cells could then be infected with HCV for two to three weeks, giving time to study response to candidate drugs. The HCV strain used for this research came from a Japanese patient with fulminant hepatitis; the researchers hope to modify their system to maintain a genotype 1 HCV strain, the most common type in the U.S. and the hardest to treat.
Survival on Surfaces
According to the U.S. Centers for Disease Control and Prevention (CDC), HCV can survive on environmental surfaces at room temperature for at least 16 hours but no longer than four days. The more fragile HIV virus, in contrast, only lives on surfaces for a few hours, while influenza viruses may survive for several hours up to about a day.
The CDC estimate is based on a study by Kris Krawczynski and colleagues, presented at the 2003 American Society for the Study of Liver Diseases (AASLD) meeting and published in the May 2007 issue of Infection Control and Hospital Epidemiology. The researchers examined the stability of genotype 1a HCV in dried blood plasma from an infected chimpanzee.
Plasma samples were dried in test tubes overnight (for about 16 hours) then either rehydrated immediately using sterile water and stored at -70ºC (about -160ºF, the temperature of biomedical research freezers), or put in a controlled environment chamber with 42% humidity at 25ºC (77ºF, room temperature) for four or seven days before rehydration. The rehydrated virus was then injected into a different chimp to see whether it remained infectious.
HCV RNA (genetic material) was detectable in plasma dried overnight and stored for seven days, though viral load decreased by 1 log, or ten-fold, compared with the original plasma sample. The test chimpanzee injected with virus dried overnight developed detectable HCV RNA and elevated alanine aminotransferase (ALT), became HCV antibody positive, and had detectable HCV antigen in liver cells. Injection of rehydrated virus stored for four or seven days, however, did not lead to infection. The researchers therefore concluded that HCV could remain infectious on surfaces outside the body somewhere between 16 hours and four days.
Viability outside the body, however, can vary widely depending on conditions. Viruses survive longer on hard surfaces such as stainless steel and less time on soft surfaces like fabric. HCV can live longer at cooler temperatures and prefers humidity to dry conditions.
Survival in Liquid
HCV survives longer in liquids than it does when dried on surfaces. In one recent study, described in the June 15, 2010 Journal of Infectious Diseases, Sandra Ciesek from Hannover Medical School in Germany and colleagues looked at the environmental stability and infectivity of HCV grown in a laboratory cell culture, as well as its susceptibility to chemical disinfectants. The researchers measured changes in viral load and introduced recovered HCV RNA into cultured Huh7.5 liver cancer cells to test for infectiousness.
In a liquid environment, HCV was detectable for up to five months at lower temperatures. However, the researchers noted that the risk of HCV infection may not accurately be reflected by measuring HCV RNA levels, because viral infectivity and viral load were not directly correlated. Further, they found that various alcohols and commercially available antiseptics reduced HCV to undetectable levels, though diluting hand disinfectants reduced their virucidal activity.
In another study published in the February 2010 Virology Journal, Hongshuo Song from Peking University and colleges found that JFH-1 cell culture-derived HCV could survive in liquid culture medium for two days at 37ºC (98ºF, body temperature) and 16 days at 25ºC, but was relatively stable at 4ºC (about 40º, average refrigerator temperature) without major loss of infectivity for at least six weeks.
This cell culture-derived HCV was vulnerable to heat; infectious virus could be inactivated in four minutes at 65ºC (about 150ºF) or eight minutes at 60ºC (140ºF), but this took 40 minutes at 56ºC (about 130ºF). Ultraviolet light efficiently inactivated HCV within two minutes. Exposures to formaldehyde and various detergents destroyed infectious HCV effectively in both culture medium and human serum.
HCV’s ability to live for a prolonged period in liquid blood underlies its transmission via nasal drug use (HCV RNA was detected on 5% of straws from hepatitis C patients who “snorted air”—simulating drug use—in one recent study), tattooing, sharing personal care equipment such as razors, childbirth, certain sexual activities, and re-use of medical equipment in healthcare settings.
Epidemiologic studies show that hepatitis C prevalence is higher among people who have undergone various medical procedures including kidney dialysis, indicating that HCV can spread from one patient to another via contaminated equipment if proper infection control practices are not followed. In 2008, for example, several patients at a Las Vegas endoscopy clinic contracted hepatitis C when clinicians gave multiple people injections from the same vials of anesthesia medication.
Survival in Syringes
HCV survival in blood in syringes is a key concern, given that sharing needles for drug injection is the most common route of hepatitis C transmission. In a presentation at the 17th Conference on Retroviruses and Opportunistic Infections in February, Elijah Paintsil from Yale University School of Medicine reported findings from a laboratory study looking at how long HCV can live in syringes.
The researchers first filled syringes with HCV-infected blood and depressed the plunger, simulating what happens when a user “boots,” or draws blood up into a syringe to mix with drugs and then reinjects it. Either immediately or after storing for up to two months at various temperatures, the team flushed out the syringes and attempted to grow recovered virus in genotype 2 HCV in cell cultures. They analyzed both low-volume (2 microliter) insulin syringes with permanently attached needles and high-volume (32 microliter) tuberculin syringes with detachable needles.
In the low-volume syringes, the likelihood of finding infectious HCV declined rapidly, with no viable virus recovered after one day of storage at 37ºC or three days at 22ºC (72ºF). At 4ºC, viable virus could be detected in two-thirds of syringes after one day of storage, about 25% after three days, and about 5% after seven days.
But in high-volume syringes, infectious HCV could still be recovered from nearly all syringes stored at 4ºC for seven days, from about half of those stored for 35 days, and from about 10% even after 63 days. At higher temperatures of 22ºC or 37ºC, viable HCV could still be recovered from a small percentage of syringes after two months.
The longer survival of HCV in syringes helps explain why HCV transmission occurs ten times more often than HIV transmission from accidental needle sticks, and why harm reduction measures such as needle exchange have reduced HIV incidence more than new HCV incidence.
At an accompanying press conference Paintsil said that while it might be advisable for needle exchange programs to offer smaller insulin syringes, some individuals (for example, transgender people who inject hormones) want larger syringes, and the most important thing is to provide enough so that people never have to share.
Understanding how long HCV can survive outside the body can inform practices to reduce the risk of viral transmission. According to Krawczynski and colleagues, “The potential for HCV to survive in the environment re-emphasizes the importance of cleaning and disinfection procedures, safe therapeutic injection practices, and harm reduction counseling and services for injection drug users.”
Source
HCV Advocate
The hepatitis C virus (HCV) is relatively hardy compared with some other viruses, which has implications for transmission and prevention. HCV may survive outside the body for days in dried blood on surfaces, or for months in a liquid medium under favorable conditions. Paradoxically, however, HCV has proven difficult to maintain in laboratory cell cultures, which has hampered research on potential treatments.
Survival in the Lab
Due to the difficulty of maintaining viable HCV in the laboratory, researchers have relied on “replicon” models of a specific strain of HCV (JFH-1 genotype 2a) in a liver cancer cell line. But this year researchers from Massachusetts Institute of Technology and Rockefeller University finally found a way to sustain viral replication in healthy liver cells for up to three weeks.
As described in the February 16, 2010 Proceedings of the National Academy of Sciences, Sangeeta Bhatia and colleagues developed a way to maintain healthy hepatocytes, or liver cells, for four to six weeks by precisely arranging them on a specially patterned plate and mixing them with fibroblast cells that support their growth. The liver cells could then be infected with HCV for two to three weeks, giving time to study response to candidate drugs. The HCV strain used for this research came from a Japanese patient with fulminant hepatitis; the researchers hope to modify their system to maintain a genotype 1 HCV strain, the most common type in the U.S. and the hardest to treat.
Survival on Surfaces
According to the U.S. Centers for Disease Control and Prevention (CDC), HCV can survive on environmental surfaces at room temperature for at least 16 hours but no longer than four days. The more fragile HIV virus, in contrast, only lives on surfaces for a few hours, while influenza viruses may survive for several hours up to about a day.
The CDC estimate is based on a study by Kris Krawczynski and colleagues, presented at the 2003 American Society for the Study of Liver Diseases (AASLD) meeting and published in the May 2007 issue of Infection Control and Hospital Epidemiology. The researchers examined the stability of genotype 1a HCV in dried blood plasma from an infected chimpanzee.
Plasma samples were dried in test tubes overnight (for about 16 hours) then either rehydrated immediately using sterile water and stored at -70ºC (about -160ºF, the temperature of biomedical research freezers), or put in a controlled environment chamber with 42% humidity at 25ºC (77ºF, room temperature) for four or seven days before rehydration. The rehydrated virus was then injected into a different chimp to see whether it remained infectious.
HCV RNA (genetic material) was detectable in plasma dried overnight and stored for seven days, though viral load decreased by 1 log, or ten-fold, compared with the original plasma sample. The test chimpanzee injected with virus dried overnight developed detectable HCV RNA and elevated alanine aminotransferase (ALT), became HCV antibody positive, and had detectable HCV antigen in liver cells. Injection of rehydrated virus stored for four or seven days, however, did not lead to infection. The researchers therefore concluded that HCV could remain infectious on surfaces outside the body somewhere between 16 hours and four days.
Viability outside the body, however, can vary widely depending on conditions. Viruses survive longer on hard surfaces such as stainless steel and less time on soft surfaces like fabric. HCV can live longer at cooler temperatures and prefers humidity to dry conditions.
Survival in Liquid
HCV survives longer in liquids than it does when dried on surfaces. In one recent study, described in the June 15, 2010 Journal of Infectious Diseases, Sandra Ciesek from Hannover Medical School in Germany and colleagues looked at the environmental stability and infectivity of HCV grown in a laboratory cell culture, as well as its susceptibility to chemical disinfectants. The researchers measured changes in viral load and introduced recovered HCV RNA into cultured Huh7.5 liver cancer cells to test for infectiousness.
In a liquid environment, HCV was detectable for up to five months at lower temperatures. However, the researchers noted that the risk of HCV infection may not accurately be reflected by measuring HCV RNA levels, because viral infectivity and viral load were not directly correlated. Further, they found that various alcohols and commercially available antiseptics reduced HCV to undetectable levels, though diluting hand disinfectants reduced their virucidal activity.
In another study published in the February 2010 Virology Journal, Hongshuo Song from Peking University and colleges found that JFH-1 cell culture-derived HCV could survive in liquid culture medium for two days at 37ºC (98ºF, body temperature) and 16 days at 25ºC, but was relatively stable at 4ºC (about 40º, average refrigerator temperature) without major loss of infectivity for at least six weeks.
This cell culture-derived HCV was vulnerable to heat; infectious virus could be inactivated in four minutes at 65ºC (about 150ºF) or eight minutes at 60ºC (140ºF), but this took 40 minutes at 56ºC (about 130ºF). Ultraviolet light efficiently inactivated HCV within two minutes. Exposures to formaldehyde and various detergents destroyed infectious HCV effectively in both culture medium and human serum.
HCV’s ability to live for a prolonged period in liquid blood underlies its transmission via nasal drug use (HCV RNA was detected on 5% of straws from hepatitis C patients who “snorted air”—simulating drug use—in one recent study), tattooing, sharing personal care equipment such as razors, childbirth, certain sexual activities, and re-use of medical equipment in healthcare settings.
Epidemiologic studies show that hepatitis C prevalence is higher among people who have undergone various medical procedures including kidney dialysis, indicating that HCV can spread from one patient to another via contaminated equipment if proper infection control practices are not followed. In 2008, for example, several patients at a Las Vegas endoscopy clinic contracted hepatitis C when clinicians gave multiple people injections from the same vials of anesthesia medication.
Survival in Syringes
HCV survival in blood in syringes is a key concern, given that sharing needles for drug injection is the most common route of hepatitis C transmission. In a presentation at the 17th Conference on Retroviruses and Opportunistic Infections in February, Elijah Paintsil from Yale University School of Medicine reported findings from a laboratory study looking at how long HCV can live in syringes.
The researchers first filled syringes with HCV-infected blood and depressed the plunger, simulating what happens when a user “boots,” or draws blood up into a syringe to mix with drugs and then reinjects it. Either immediately or after storing for up to two months at various temperatures, the team flushed out the syringes and attempted to grow recovered virus in genotype 2 HCV in cell cultures. They analyzed both low-volume (2 microliter) insulin syringes with permanently attached needles and high-volume (32 microliter) tuberculin syringes with detachable needles.
In the low-volume syringes, the likelihood of finding infectious HCV declined rapidly, with no viable virus recovered after one day of storage at 37ºC or three days at 22ºC (72ºF). At 4ºC, viable virus could be detected in two-thirds of syringes after one day of storage, about 25% after three days, and about 5% after seven days.
But in high-volume syringes, infectious HCV could still be recovered from nearly all syringes stored at 4ºC for seven days, from about half of those stored for 35 days, and from about 10% even after 63 days. At higher temperatures of 22ºC or 37ºC, viable HCV could still be recovered from a small percentage of syringes after two months.
The longer survival of HCV in syringes helps explain why HCV transmission occurs ten times more often than HIV transmission from accidental needle sticks, and why harm reduction measures such as needle exchange have reduced HIV incidence more than new HCV incidence.
At an accompanying press conference Paintsil said that while it might be advisable for needle exchange programs to offer smaller insulin syringes, some individuals (for example, transgender people who inject hormones) want larger syringes, and the most important thing is to provide enough so that people never have to share.
Understanding how long HCV can survive outside the body can inform practices to reduce the risk of viral transmission. According to Krawczynski and colleagues, “The potential for HCV to survive in the environment re-emphasizes the importance of cleaning and disinfection procedures, safe therapeutic injection practices, and harm reduction counseling and services for injection drug users.”
Source
Meta-Analysis of Hepatitis C Virus Vaccine Efficacy in Chimpanzees Indicates an Importance for Structural Proteins.
Gastroenterology. 2010 Sep;139(3):965-974. Epub 2010 Jun 2.
Dahari H, Feinstone SM, Major ME.
Department of Medicine, University of Illinois at Chicago, Chicago, Illinois.
Abstract
BACKGROUND & AIMS: Studies in patients and chimpanzees that spontaneously cleared hepatitis C virus (HCV) infections demonstrated that natural immunity to the virus is induced during primary infections and that this immunity can be cross protective. These discoveries led to optimism about prophylactic HCV vaccines, and several studies were performed in chimpanzees, although most included fewer than 6 animals. To draw meaningful conclusions about the efficacy of HCV vaccines in chimpanzees, we performed statistical analyses of data from previously published studies from different groups.
METHODS: We performed a meta-analysis that compared parameters among naïve (n = 63), vaccinated (n = 53), and rechallenged (n = 36) animals, including peak RNA titer postchallenge, time points of peak RNA titer, duration of viremia, and proportion of persistent infections.
RESULTS: Each vaccination study induced immune responses that were effective in rapidly controlling HCV replication. Levels of induced T-cell responses did not indicate vaccine success. There was no reduction in the rate of HCV persistence in vaccinated animals, compared with naïve animals, when nonstructural proteins were included in the vaccine. Vaccines that contained only structural proteins had clearance rates that were significantly higher than vaccines that contained nonstructural components (P = .015).
CONCLUSIONS: The inclusion of nonstructural proteins in HCV vaccines might be detrimental to protective immune responses, and/or structural proteins might activate T-cell responses that mediate viral clearance.
PMID: 20621699 [PubMed - as supplied by publisher]
Source
Dahari H, Feinstone SM, Major ME.
Department of Medicine, University of Illinois at Chicago, Chicago, Illinois.
Abstract
BACKGROUND & AIMS: Studies in patients and chimpanzees that spontaneously cleared hepatitis C virus (HCV) infections demonstrated that natural immunity to the virus is induced during primary infections and that this immunity can be cross protective. These discoveries led to optimism about prophylactic HCV vaccines, and several studies were performed in chimpanzees, although most included fewer than 6 animals. To draw meaningful conclusions about the efficacy of HCV vaccines in chimpanzees, we performed statistical analyses of data from previously published studies from different groups.
METHODS: We performed a meta-analysis that compared parameters among naïve (n = 63), vaccinated (n = 53), and rechallenged (n = 36) animals, including peak RNA titer postchallenge, time points of peak RNA titer, duration of viremia, and proportion of persistent infections.
RESULTS: Each vaccination study induced immune responses that were effective in rapidly controlling HCV replication. Levels of induced T-cell responses did not indicate vaccine success. There was no reduction in the rate of HCV persistence in vaccinated animals, compared with naïve animals, when nonstructural proteins were included in the vaccine. Vaccines that contained only structural proteins had clearance rates that were significantly higher than vaccines that contained nonstructural components (P = .015).
CONCLUSIONS: The inclusion of nonstructural proteins in HCV vaccines might be detrimental to protective immune responses, and/or structural proteins might activate T-cell responses that mediate viral clearance.
PMID: 20621699 [PubMed - as supplied by publisher]
Source
Hepatitis C care quality condemned by MPs
1 September, 2010
Wide variations in hepatitis C treatment are contributing to a 60% rise in the number of people dying from liver disease over the past decade, MPs have warned.
Although hepatitis C’s exact contribution to rising mortality is difficult to calculate, the report from the All-Party Parliamentary Hepatology Group said it was certainly “underestimated” because so few people are diagnosed andcondemned the wide variation in the quality of patient services in NHS hospitals.
Liver disease is the fifth biggest killer after heart disease, cancer, stroke and lung disorders, and the number of deaths is rising by about 8% per year. It killed more than 10,000 people in the UK in 2008. Common causes include alcoholism, but hepatitis C is a growing contributory factor, according to MPs.
Many of the 250,000 to 466,000 people living with hepatitis C in the UK currently have no idea they have the disease because it can remain symptomless for many years. Around 13,000 people are newly infected every year but only about a third receive treatment which has been shown to cure half of cases, said the report. Success rates with treatment varies widely between hospitals, from just 10% of patients treated to 100%.
Furthermore, the UK’s use of hepatitis C drugs is the second lowest out of 14 comparable countries.
The report, In The Dark, pointed to a “worrying shortage of basic monitoring in hepatitis C services, such as numbers of patients referred, numbers offered treatment, numbers initiating treatment and treatment results”.
This has a negative impact on local and national planning of services while some hospitals refuse to treat drug-users, contrary to national guidance.
The number of people living with cirrhosis of the liver caused by hepatitis C is expected to rise by more than a third to 10,960 by 2015.
Source
Wide variations in hepatitis C treatment are contributing to a 60% rise in the number of people dying from liver disease over the past decade, MPs have warned.
Although hepatitis C’s exact contribution to rising mortality is difficult to calculate, the report from the All-Party Parliamentary Hepatology Group said it was certainly “underestimated” because so few people are diagnosed andcondemned the wide variation in the quality of patient services in NHS hospitals.
Liver disease is the fifth biggest killer after heart disease, cancer, stroke and lung disorders, and the number of deaths is rising by about 8% per year. It killed more than 10,000 people in the UK in 2008. Common causes include alcoholism, but hepatitis C is a growing contributory factor, according to MPs.
Many of the 250,000 to 466,000 people living with hepatitis C in the UK currently have no idea they have the disease because it can remain symptomless for many years. Around 13,000 people are newly infected every year but only about a third receive treatment which has been shown to cure half of cases, said the report. Success rates with treatment varies widely between hospitals, from just 10% of patients treated to 100%.
Furthermore, the UK’s use of hepatitis C drugs is the second lowest out of 14 comparable countries.
The report, In The Dark, pointed to a “worrying shortage of basic monitoring in hepatitis C services, such as numbers of patients referred, numbers offered treatment, numbers initiating treatment and treatment results”.
This has a negative impact on local and national planning of services while some hospitals refuse to treat drug-users, contrary to national guidance.
The number of people living with cirrhosis of the liver caused by hepatitis C is expected to rise by more than a third to 10,960 by 2015.
Source
Inhibitex Successfully Completes Phase 1a Trial of INX-189
Sept. 1, 2010, 7:00 a.m. EDT
Proof-of-Concept Trial in Patients with Chronic Hepatitis C Planned for Q4 2010
ATLANTA, Sep 01, 2010 (BUSINESS WIRE) -- Inhibitex, Inc. /quotes/comstock/15*!inhx/quotes/nls/inhx (INHX 1.59, +0.17, +11.97%) , announced today that it has successfully completed a Phase1a, first-in-man, single ascending dose trial of INX-189, its nucleotide polymerase inhibitor in development for the treatment of chronic hepatitis C (HCV) infections. In this trial, 42 healthy volunteers received either a single oral dose of INX-189, ranging from 3 mg to 100 mg, or placebo. The Company plans to present detailed results from this trial during a future scientific meeting. Preliminary data from the trial are as follows:
-- INX-189 was generally well tolerated at all dose levels;
-- No drug-related serious adverse events;
-- No dose-related trends in frequency or type of adverse events; adverse events occurring in more than one subject were headache and nasal congestion;
-- No grade II or higher laboratory abnormality adverse events or clinically significant changes in ECGs; and
-- Pharmacokinetic data supports INX-189's potential for once daily (QD) dosing.
"We are encouraged with the initial safety and pharmacokinetic profile of INX-189 in this first-in-man trial," stated Dr. Joseph Patti, Senior Vice President and Chief Scientific Officer of Inhibitex, Inc. "Based upon the pharmacokinetics observed in this study, we continue to believe that INX-189 has the potential to demonstrate antiviral activity with a low once-daily dose, and we look forward to assessing its ability to reduce HCV RNA viral loads in patients with chronic hepatitis C in a Phase 1b multiple ascending dose trial we plan to start in the fourth quarter."
About Inhibitex
Inhibitex, Inc., headquartered in Alpharetta, Georgia, is a biopharmaceutical company focused on developing products to prevent and treat serious infectious diseases. The Company's pipeline includes FV-100, which is in Phase II clinical development for the treatment of shingles, and INX-189, a nucleotide polymerase inhibitor in development for the treatment of chronic hepatitis C infections. The Company also has additional HCV nucleotide polymerase inhibitors in preclinical development and has licensed the use of its proprietary MSCRAMM(R) protein platform to Pfizer for the development of staphylococcal vaccines. For additional information about the Company, please visit http://www.inhibitex.com/.
Safe Harbor Statement
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. All statements, other than historical facts included in this press release, including statements regarding the Company's plans to present detailed results from the Phase 1a trial during a future medical meeting and its intention to initiate a Phase 1b multiple ascending dose trial in the fourth quarter of 2010 are forward looking statements. These intentions, expectations, or results may not be achieved in the future and various important factors could cause actual results or events to differ materially from the forward-looking statements that the Company makes, including the risk of: either the Company, the FDA, a data and safety monitoring board, or an investigational review board delaying, suspending or terminating the clinical development of INX-189 for a lack of safety or antiviral activity, manufacturing-related issues, questions or issues regarding the design of the planned Phase 1b clinical study of INX-189, or any other reasons; the Company obtaining, maintaining and protecting the intellectual property incorporated into and supporting the commercial viability of INX-189; and other cautionary statements contained elsewhere herein and in its Annual Report on Form 10-K for the year ended December 31, 2009, as filed with the Securities and Exchange Commission, or SEC, on March 26, 2010, and its Quarterly Report on Form 10-Q for the quarter ended June 30, 2010, as filed with the SEC on August 12, 2010. Given these uncertainties, you should not place undue reliance on these forward-looking statements, which apply only as of the date of this press release.
There may be events in the future that the Company is unable to predict accurately, or over which it has no control. The Company's business, financial condition, results of operations and prospects may change. The Company may not update these forward-looking statements, even though its situation may change in the future, unless it has obligations under the Federal securities laws to update and disclose material developments related to previously disclosed information. The Company qualifies all of the information contained in this press release, and particularly its forward-looking statements, by these cautionary statements.
Inhibitex(R) and MSCRAMM(R) are registered trademarks of Inhibitex, Inc.
SOURCE: Inhibitex, Inc.
Inhibitex, Inc.
Russell H. Plumb
Chief Executive Officer
678-746-1136
rplumb@inhibitex.com
or
Lee M. Stern, CFA
The Trout Group
646-378-2922
lstern@troutgroup.com
Source
Proof-of-Concept Trial in Patients with Chronic Hepatitis C Planned for Q4 2010
ATLANTA, Sep 01, 2010 (BUSINESS WIRE) -- Inhibitex, Inc. /quotes/comstock/15*!inhx/quotes/nls/inhx (INHX 1.59, +0.17, +11.97%) , announced today that it has successfully completed a Phase1a, first-in-man, single ascending dose trial of INX-189, its nucleotide polymerase inhibitor in development for the treatment of chronic hepatitis C (HCV) infections. In this trial, 42 healthy volunteers received either a single oral dose of INX-189, ranging from 3 mg to 100 mg, or placebo. The Company plans to present detailed results from this trial during a future scientific meeting. Preliminary data from the trial are as follows:
-- INX-189 was generally well tolerated at all dose levels;
-- No drug-related serious adverse events;
-- No dose-related trends in frequency or type of adverse events; adverse events occurring in more than one subject were headache and nasal congestion;
-- No grade II or higher laboratory abnormality adverse events or clinically significant changes in ECGs; and
-- Pharmacokinetic data supports INX-189's potential for once daily (QD) dosing.
"We are encouraged with the initial safety and pharmacokinetic profile of INX-189 in this first-in-man trial," stated Dr. Joseph Patti, Senior Vice President and Chief Scientific Officer of Inhibitex, Inc. "Based upon the pharmacokinetics observed in this study, we continue to believe that INX-189 has the potential to demonstrate antiviral activity with a low once-daily dose, and we look forward to assessing its ability to reduce HCV RNA viral loads in patients with chronic hepatitis C in a Phase 1b multiple ascending dose trial we plan to start in the fourth quarter."
About Inhibitex
Inhibitex, Inc., headquartered in Alpharetta, Georgia, is a biopharmaceutical company focused on developing products to prevent and treat serious infectious diseases. The Company's pipeline includes FV-100, which is in Phase II clinical development for the treatment of shingles, and INX-189, a nucleotide polymerase inhibitor in development for the treatment of chronic hepatitis C infections. The Company also has additional HCV nucleotide polymerase inhibitors in preclinical development and has licensed the use of its proprietary MSCRAMM(R) protein platform to Pfizer for the development of staphylococcal vaccines. For additional information about the Company, please visit http://www.inhibitex.com/.
Safe Harbor Statement
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. All statements, other than historical facts included in this press release, including statements regarding the Company's plans to present detailed results from the Phase 1a trial during a future medical meeting and its intention to initiate a Phase 1b multiple ascending dose trial in the fourth quarter of 2010 are forward looking statements. These intentions, expectations, or results may not be achieved in the future and various important factors could cause actual results or events to differ materially from the forward-looking statements that the Company makes, including the risk of: either the Company, the FDA, a data and safety monitoring board, or an investigational review board delaying, suspending or terminating the clinical development of INX-189 for a lack of safety or antiviral activity, manufacturing-related issues, questions or issues regarding the design of the planned Phase 1b clinical study of INX-189, or any other reasons; the Company obtaining, maintaining and protecting the intellectual property incorporated into and supporting the commercial viability of INX-189; and other cautionary statements contained elsewhere herein and in its Annual Report on Form 10-K for the year ended December 31, 2009, as filed with the Securities and Exchange Commission, or SEC, on March 26, 2010, and its Quarterly Report on Form 10-Q for the quarter ended June 30, 2010, as filed with the SEC on August 12, 2010. Given these uncertainties, you should not place undue reliance on these forward-looking statements, which apply only as of the date of this press release.
There may be events in the future that the Company is unable to predict accurately, or over which it has no control. The Company's business, financial condition, results of operations and prospects may change. The Company may not update these forward-looking statements, even though its situation may change in the future, unless it has obligations under the Federal securities laws to update and disclose material developments related to previously disclosed information. The Company qualifies all of the information contained in this press release, and particularly its forward-looking statements, by these cautionary statements.
Inhibitex(R) and MSCRAMM(R) are registered trademarks of Inhibitex, Inc.
SOURCE: Inhibitex, Inc.
Inhibitex, Inc.
Russell H. Plumb
Chief Executive Officer
678-746-1136
rplumb@inhibitex.com
or
Lee M. Stern, CFA
The Trout Group
646-378-2922
lstern@troutgroup.com
Source
Unilife Corporation Secures FDA 510k Clearance for the Unitract™ 1mL Tuberculin Syringe
US-made Unitract™ 1mL syringes also approved in Australia and Europe
Unitract™ 1mL syringes attain five-year shelf life expiration date
LEWISBERRY, Pa., Sept. 1 /PRNewswire-FirstCall/ -- Unilife Corporation ("Unilife" or "Company") (Nasdaq: UNIS, ASX: UNS), today announced that its Unitract™ Tuberculin (TB) Syringe has received 510(k) market clearance from the U.S. Food and Drug Administration (FDA).
The Unitract™ TB syringe is a variant of the Unitract™ 1mL Insulin Syringe for which Unilife secured FDA clearance earlier this year. Unlike insulin syringes which are primarily used by people with diabetes, TB syringes are used for the administration of a range of therapeutic drugs and vaccines within acute-care hospitals and other healthcare facilities.
The Unitract™ range of 1mL syringes is the world's first and only known syringe that allows operators to control the speed of passive (automatic) needle retraction directly from the patient's body into the barrel of the syringe where it is locked in place. The products are well positioned to help prevent the transmission of blood-borne diseases such as HIV and hepatitis C via needlestick injuries, aerosol dispersal and syringe reuse. Primary target markets of the products include healthcare facilities, pharmaceutical companies and patients who self-administer prescription medication. Production of the Unitract™ 1mL syringe is occurring at Unilife's FDA-registered manufacturing facility in Lewisberry, Pennsylvania.
Mr. Alan Shortall, Chief Executive Officer of Unilife, stated, "U.S. FDA 510k market clearance for our Unitract™ TB syringe marks an important step in our company's efforts to bring a complete line of safety syringes to market, as it is our second product to receive this clearance. With TB syringes most commonly used within acute-care hospitals and other healthcare facilities, FDA clearance of our Unitract™ TB syringe significantly broadens our capacity to market our unique products across the U.S. and other key international markets."
Unilife has also recently secured its EC certification to apply the CE Mark to its Unitract™ 1mL syringes manufactured at its Lewisberry facility, allowing the sale and distribution of these products within the European Union and Australia.
The Company also expects to complete studies required to attain a five-year shelf life expiration date for its full range of Unitract™ 1mL syringes in September. The inclusion of a five-year expiry date on medical device packaging is considered to be the gold-standard within the industry, and should help to finalize discussions with a number of interested U.S. healthcare distributors in the near future.
About Unilife Corporation
Unilife Corporation is a U.S.-based medical device company focused on the design, development, manufacture and supply of a proprietary range of retractable syringes. Primary target customers for Unilife products include pharmaceutical manufacturers, suppliers of medical equipment to healthcare facilities and patients who self-administer prescription medication. These patent-protected syringes incorporate automatic and fully-integrated safety features which are designed to protect those at risk of needlestick injuries and unsafe injection practices. Unilife is ISO 13485 certified and has FDA-registered medical device manufacturing facilities in Pennsylvania.
This press release contains forward-looking statements. All statements that address operating performance, events or developments that we expect or anticipate will occur in the future are forward-looking statements. These forward-looking statements are based on management's beliefs and assumptions and on information currently available to our management. Our management believes that these forward-looking statements are reasonable as and when made. However, you should not place undue reliance on any such forward-looking statements because such statements speak only as of the date when made. We do not undertake any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. In addition, forward-looking statements are subject to certain risks and uncertainties that could cause actual results, events and developments to differ materially from our historical experience and our present expectations or projections. These risks and uncertainties include, but are not limited to, those described in "Item 1A. Risk Factors" and elsewhere in our registration statement on Form 10 and those described from time to time in our periodic reports which we file with the Securities and Exchange Commission.
General: UNIS-G
Investor Contacts (US):
Todd Fromer / Garth Russell,
KCSA Strategic Communications
Phone + 1 212-682-6300
Stuart Fine
Carpe DM Inc
Phone + 1 908 469 1788
Investor Contacts (Australia)
Jeff Carter
Unilife Corporation
Phone + 61 2 8346 6500
SOURCE Unilife Corporation
RELATED LINKS
http://www.unilife.com/
Source
Unitract™ 1mL syringes attain five-year shelf life expiration date
LEWISBERRY, Pa., Sept. 1 /PRNewswire-FirstCall/ -- Unilife Corporation ("Unilife" or "Company") (Nasdaq: UNIS, ASX: UNS), today announced that its Unitract™ Tuberculin (TB) Syringe has received 510(k) market clearance from the U.S. Food and Drug Administration (FDA).
The Unitract™ TB syringe is a variant of the Unitract™ 1mL Insulin Syringe for which Unilife secured FDA clearance earlier this year. Unlike insulin syringes which are primarily used by people with diabetes, TB syringes are used for the administration of a range of therapeutic drugs and vaccines within acute-care hospitals and other healthcare facilities.
The Unitract™ range of 1mL syringes is the world's first and only known syringe that allows operators to control the speed of passive (automatic) needle retraction directly from the patient's body into the barrel of the syringe where it is locked in place. The products are well positioned to help prevent the transmission of blood-borne diseases such as HIV and hepatitis C via needlestick injuries, aerosol dispersal and syringe reuse. Primary target markets of the products include healthcare facilities, pharmaceutical companies and patients who self-administer prescription medication. Production of the Unitract™ 1mL syringe is occurring at Unilife's FDA-registered manufacturing facility in Lewisberry, Pennsylvania.
Mr. Alan Shortall, Chief Executive Officer of Unilife, stated, "U.S. FDA 510k market clearance for our Unitract™ TB syringe marks an important step in our company's efforts to bring a complete line of safety syringes to market, as it is our second product to receive this clearance. With TB syringes most commonly used within acute-care hospitals and other healthcare facilities, FDA clearance of our Unitract™ TB syringe significantly broadens our capacity to market our unique products across the U.S. and other key international markets."
Unilife has also recently secured its EC certification to apply the CE Mark to its Unitract™ 1mL syringes manufactured at its Lewisberry facility, allowing the sale and distribution of these products within the European Union and Australia.
The Company also expects to complete studies required to attain a five-year shelf life expiration date for its full range of Unitract™ 1mL syringes in September. The inclusion of a five-year expiry date on medical device packaging is considered to be the gold-standard within the industry, and should help to finalize discussions with a number of interested U.S. healthcare distributors in the near future.
About Unilife Corporation
Unilife Corporation is a U.S.-based medical device company focused on the design, development, manufacture and supply of a proprietary range of retractable syringes. Primary target customers for Unilife products include pharmaceutical manufacturers, suppliers of medical equipment to healthcare facilities and patients who self-administer prescription medication. These patent-protected syringes incorporate automatic and fully-integrated safety features which are designed to protect those at risk of needlestick injuries and unsafe injection practices. Unilife is ISO 13485 certified and has FDA-registered medical device manufacturing facilities in Pennsylvania.
This press release contains forward-looking statements. All statements that address operating performance, events or developments that we expect or anticipate will occur in the future are forward-looking statements. These forward-looking statements are based on management's beliefs and assumptions and on information currently available to our management. Our management believes that these forward-looking statements are reasonable as and when made. However, you should not place undue reliance on any such forward-looking statements because such statements speak only as of the date when made. We do not undertake any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. In addition, forward-looking statements are subject to certain risks and uncertainties that could cause actual results, events and developments to differ materially from our historical experience and our present expectations or projections. These risks and uncertainties include, but are not limited to, those described in "Item 1A. Risk Factors" and elsewhere in our registration statement on Form 10 and those described from time to time in our periodic reports which we file with the Securities and Exchange Commission.
General: UNIS-G
Investor Contacts (US):
Todd Fromer / Garth Russell,
KCSA Strategic Communications
Phone + 1 212-682-6300
Stuart Fine
Carpe DM Inc
Phone + 1 908 469 1788
Investor Contacts (Australia)
Jeff Carter
Unilife Corporation
Phone + 61 2 8346 6500
SOURCE Unilife Corporation
RELATED LINKS
http://www.unilife.com/
Source
Assessing the STIRR Model of Best Practices for Blood-Borne Infections of Clients With Severe Mental Illness
Psychiatr Serv 61:885-891, September 2010
doi: 10.1176/appi.ps.61.9.885
© 2010 American Psychiatric Association
Stanley D. Rosenberg, Ph.D., Richard W. Goldberg, Ph.D., Lisa B. Dixon, M.D., M.P.H., George L. Wolford, Ph.D., Eric P. Slade, Ph.D., Seth Himelhoch, M.D., M.P.H., Gerard Gallucci, M.D., Wendy Potts, M.S., Stephanie Tapscott, M.S. and Christopher J. Welsh, M.D.
Dr. Rosenberg is affiliated with the Departments of Psychiatry and of Community and Family Medicine, Dartmouth Medical School, 1 Medical Center Dr., Lebanon, NH 03756 (e-mail: stanley.rosenberg@dartmouth.edu). Dr. Goldberg, Dr. Dixon, Dr. Slade, Dr. Himelhoch, Ms. Potts, Ms. Tapscott, and Dr. Welsh are with the Department of Psychiatry, University of Maryland University College, Baltimore. Dr. Wolford is with the Department of Psychological and Brain Sciences, Dartmouth College, Hanover, New Hampshire. Dr. Gallucci is with the Department of Psychiatry, Johns Hopkins University, Baltimore.
OBJECTIVES: People with co-occurring severe mental illness and a substance use disorder are at markedly elevated risk of infection from HIV, hepatitis B virus (HBV), and hepatitis C virus (HCV), but they generally do not receive basic recommended screening or preventive and treatment services. Barriers to services include lack of programs offered by mental health providers and client refusal of available services. Clients from racial-ethnic minority groups are even less likely to accept recommended services. The intervention tested was designed to facilitate integrated infectious disease programming in mental health settings and to increase acceptance of such services among clients. METHODS: A randomized controlled trial (N=236) compared enhanced treatment as usual (control) with a brief intervention to deliver best-practice services for blood-borne diseases in an urban sample of clients with co-occurring disorders who were largely from racial-ethnic minority groups. The "STIRR" intervention included Screening for HIV and HCV risk factors, Testing for HIV and hepatitis, Immunization against hepatitis A and B, Risk reduction counseling, and medical treatment Referral and support at the site of mental health care. RESULTS: Clients randomly assigned to the STIRR intervention had high levels (over 80%) of participation and acceptance of core services. They were more likely to be tested for HBV and HCV, to be immunized against hepatitis A virus and HBV, and to increase their knowledge about hepatitis and reduce their substance abuse. However, they showed no reduction in risk behavior, were no more likely to be referred to care, and showed no increase in HIV knowledge. Intervention costs were $541 per client (including $234 for blood tests). CONCLUSIONS: STIRR appears to be efficacious in providing a basic, best-practice package of interventions for clients with co-occurring disorders.
Related Article:
September 2010: This Month's Highlights
Psychiatr Serv 2010 61: 860. [Full Text] [PDF]
Source
doi: 10.1176/appi.ps.61.9.885
© 2010 American Psychiatric Association
Stanley D. Rosenberg, Ph.D., Richard W. Goldberg, Ph.D., Lisa B. Dixon, M.D., M.P.H., George L. Wolford, Ph.D., Eric P. Slade, Ph.D., Seth Himelhoch, M.D., M.P.H., Gerard Gallucci, M.D., Wendy Potts, M.S., Stephanie Tapscott, M.S. and Christopher J. Welsh, M.D.
Dr. Rosenberg is affiliated with the Departments of Psychiatry and of Community and Family Medicine, Dartmouth Medical School, 1 Medical Center Dr., Lebanon, NH 03756 (e-mail: stanley.rosenberg@dartmouth.edu). Dr. Goldberg, Dr. Dixon, Dr. Slade, Dr. Himelhoch, Ms. Potts, Ms. Tapscott, and Dr. Welsh are with the Department of Psychiatry, University of Maryland University College, Baltimore. Dr. Wolford is with the Department of Psychological and Brain Sciences, Dartmouth College, Hanover, New Hampshire. Dr. Gallucci is with the Department of Psychiatry, Johns Hopkins University, Baltimore.
OBJECTIVES: People with co-occurring severe mental illness and a substance use disorder are at markedly elevated risk of infection from HIV, hepatitis B virus (HBV), and hepatitis C virus (HCV), but they generally do not receive basic recommended screening or preventive and treatment services. Barriers to services include lack of programs offered by mental health providers and client refusal of available services. Clients from racial-ethnic minority groups are even less likely to accept recommended services. The intervention tested was designed to facilitate integrated infectious disease programming in mental health settings and to increase acceptance of such services among clients. METHODS: A randomized controlled trial (N=236) compared enhanced treatment as usual (control) with a brief intervention to deliver best-practice services for blood-borne diseases in an urban sample of clients with co-occurring disorders who were largely from racial-ethnic minority groups. The "STIRR" intervention included Screening for HIV and HCV risk factors, Testing for HIV and hepatitis, Immunization against hepatitis A and B, Risk reduction counseling, and medical treatment Referral and support at the site of mental health care. RESULTS: Clients randomly assigned to the STIRR intervention had high levels (over 80%) of participation and acceptance of core services. They were more likely to be tested for HBV and HCV, to be immunized against hepatitis A virus and HBV, and to increase their knowledge about hepatitis and reduce their substance abuse. However, they showed no reduction in risk behavior, were no more likely to be referred to care, and showed no increase in HIV knowledge. Intervention costs were $541 per client (including $234 for blood tests). CONCLUSIONS: STIRR appears to be efficacious in providing a basic, best-practice package of interventions for clients with co-occurring disorders.
Related Article:
September 2010: This Month's Highlights
Psychiatr Serv 2010 61: 860. [Full Text] [PDF]
Source
Abbott Receives FDA Approval for First Automated Molecular Test for Assessing Hepatitis B Treatment
DES PLAINES, Ill., Sept. 1 /PRNewswire-FirstCall/ -- Abbott (NYSE: ABT) announced today it has received approval from the U.S. Food and Drug Administration (FDA) to market the Abbott RealTime HBV assay for measuring viral load or the amount of hepatitis B virus (HBV) in a patient's blood. It is the first and only approved test capable of automating HBV viral load testing from sample extraction to final results.
The Abbott RealTime HBV assay, based on real-time PCR (polymerase chain reaction) technology, is now available for laboratories that use the Abbott m2000 automated instrument system for molecular diagnostic testing. The test offers sensitive measurement (quantitation) of HBV in human plasma or serum from individuals chronically infected with HBV.
The assay is intended for use as an aid in the management of patients with chronic HBV infection undergoing anti-viral therapy. The assay can be used to measure HBV DNA levels at baseline and during treatment to aid in assessing response to treatment. Assay results must be interpreted within the context of all relevant clinical and lab findings. Use of the assay to determine the clinical stage of HBV infection has not been established. Clinical performance characteristics have been established for individuals treated with adefovir dipivoxil. The assay is not intended as a screening test for HBV or as a diagnostic test for confirming the presence of HBV infection.
"The Abbott RealTime HBV assay, which is the first and only automated HBV viral load test approved by the FDA, is an important tool for helping physicians make and adjust treatment decisions for newly diagnosed patients and those taking anti-viral medications," said Stafford O'Kelly, head of Abbott's molecular diagnostics business. "The test will also help improve laboratory productivity by automating the most labor intensive steps of HBV testing."
Abbott's molecular HBV assay detects and measures all known HBV genotypes (A-H) by targeting an essential, highly conserved segment of the HBV genome. The capability for detecting HBV genotypes is important for both monitoring the disease and guiding treatment decisions. For example, genotype C is prevalent in Asia and is associated with more severe liver disease and development of hepatocellular carcinoma. In contrast, genotype B (also prevalent in Asia) has a better prognosis, is rarely associated with progression to liver cancer, and patients seem to respond better to certain antiviral therapies. Immigration and international travel have increased the incidence of HBV strains predominantly found outside the United States.
In addition, the Abbott RealTime HBV assay offers a broad dynamic range, capable of quantitating both very low levels of the virus (10 IU/mL) and very high levels of the virus (1 billion IU/mL) in a patient's blood. This broad dynamic range is an important factor in helping physicians accurately assess a patient's response to therapy.
The Abbott RealTime HBV assay, initially introduced in Europe and other markets in 2007, was developed for use on the Abbott m2000 system, an automated instrument for DNA and RNA testing. The m2000 is designed to efficiently detect viruses and bacteria in patient samples in less than six hours. The Abbott m2000 instrument is available in most major markets throughout the world. Outside the United States, an extensive menu for infectious disease testing is available that includes HIV-1 viral load, HBV viral load, chlamydia, chlamydia/gonorrhea (CT/NG) combination, hepatitis C (HCV) viral load, HCV genotyping, cytomegalovirus (CMV), Epstein Barr virus (EBV) and human papillomavirus (HPV). In December 2009, Abbott Molecular introduced the first oncology assay on its m2000 system outside the United States — the Abbott RealTime mS9 Colorectal Cancer — that detects the methylated form of Septin 9, a gene linked to colorectal cancer, in blood specimens. In the United States, the following tests are currently available on the m2000 platform: RealTime HIV-1, CT/NG, and now HBV.
About Hepatitis B
According to the World Health Organization, hepatitis B is a serious global public health problem, but preventable with safe and effective vaccines that have been available since 1982. Of the two billion people who have been infected with the hepatitis B virus, more than 350 million have chronic (lifelong) infections. These chronically infected persons are at high risk of death from cirrhosis of the liver and liver cancer, diseases that kill about one million people each year. Although the vaccine will not cure chronic hepatitis, it is 95 percent effective in preventing chronic infections from developing.
The prevalence of HBV infection and the method of transmission vary greatly around the world. In countries with a high prevalence of chronic HBV infection, the most common route of infection is from mother to child at birth or from child to child during early childhood. In areas of low prevalence, the infection is usually acquired during adulthood through intravenous drug use or high-risk sexual activity.
About Abbott Molecular
Abbott Molecular, abbottmolecular.com, is an emerging leader in molecular diagnostics - the analysis of DNA, RNA, and proteins at the molecular level. Some of Abbott Molecular's tests are designed to detect subtle but key changes in human genes and chromosomes. The results of these tests may aid in the earlier detection or diagnosis of disease, may influence the selection of appropriate therapies, or may improve monitoring of disease recurrence.
About Abbott
Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs approximately 83,000 people and markets its products in more than 130 countries.
Abbott's news releases and other information are available on the company's Web site at http://www.abbott.com/.
SOURCE Abbott
RELATED LINKS
http://www.abbott.com/
Source
The Abbott RealTime HBV assay, based on real-time PCR (polymerase chain reaction) technology, is now available for laboratories that use the Abbott m2000 automated instrument system for molecular diagnostic testing. The test offers sensitive measurement (quantitation) of HBV in human plasma or serum from individuals chronically infected with HBV.
The assay is intended for use as an aid in the management of patients with chronic HBV infection undergoing anti-viral therapy. The assay can be used to measure HBV DNA levels at baseline and during treatment to aid in assessing response to treatment. Assay results must be interpreted within the context of all relevant clinical and lab findings. Use of the assay to determine the clinical stage of HBV infection has not been established. Clinical performance characteristics have been established for individuals treated with adefovir dipivoxil. The assay is not intended as a screening test for HBV or as a diagnostic test for confirming the presence of HBV infection.
"The Abbott RealTime HBV assay, which is the first and only automated HBV viral load test approved by the FDA, is an important tool for helping physicians make and adjust treatment decisions for newly diagnosed patients and those taking anti-viral medications," said Stafford O'Kelly, head of Abbott's molecular diagnostics business. "The test will also help improve laboratory productivity by automating the most labor intensive steps of HBV testing."
Abbott's molecular HBV assay detects and measures all known HBV genotypes (A-H) by targeting an essential, highly conserved segment of the HBV genome. The capability for detecting HBV genotypes is important for both monitoring the disease and guiding treatment decisions. For example, genotype C is prevalent in Asia and is associated with more severe liver disease and development of hepatocellular carcinoma. In contrast, genotype B (also prevalent in Asia) has a better prognosis, is rarely associated with progression to liver cancer, and patients seem to respond better to certain antiviral therapies. Immigration and international travel have increased the incidence of HBV strains predominantly found outside the United States.
In addition, the Abbott RealTime HBV assay offers a broad dynamic range, capable of quantitating both very low levels of the virus (10 IU/mL) and very high levels of the virus (1 billion IU/mL) in a patient's blood. This broad dynamic range is an important factor in helping physicians accurately assess a patient's response to therapy.
The Abbott RealTime HBV assay, initially introduced in Europe and other markets in 2007, was developed for use on the Abbott m2000 system, an automated instrument for DNA and RNA testing. The m2000 is designed to efficiently detect viruses and bacteria in patient samples in less than six hours. The Abbott m2000 instrument is available in most major markets throughout the world. Outside the United States, an extensive menu for infectious disease testing is available that includes HIV-1 viral load, HBV viral load, chlamydia, chlamydia/gonorrhea (CT/NG) combination, hepatitis C (HCV) viral load, HCV genotyping, cytomegalovirus (CMV), Epstein Barr virus (EBV) and human papillomavirus (HPV). In December 2009, Abbott Molecular introduced the first oncology assay on its m2000 system outside the United States — the Abbott RealTime mS9 Colorectal Cancer — that detects the methylated form of Septin 9, a gene linked to colorectal cancer, in blood specimens. In the United States, the following tests are currently available on the m2000 platform: RealTime HIV-1, CT/NG, and now HBV.
About Hepatitis B
According to the World Health Organization, hepatitis B is a serious global public health problem, but preventable with safe and effective vaccines that have been available since 1982. Of the two billion people who have been infected with the hepatitis B virus, more than 350 million have chronic (lifelong) infections. These chronically infected persons are at high risk of death from cirrhosis of the liver and liver cancer, diseases that kill about one million people each year. Although the vaccine will not cure chronic hepatitis, it is 95 percent effective in preventing chronic infections from developing.
The prevalence of HBV infection and the method of transmission vary greatly around the world. In countries with a high prevalence of chronic HBV infection, the most common route of infection is from mother to child at birth or from child to child during early childhood. In areas of low prevalence, the infection is usually acquired during adulthood through intravenous drug use or high-risk sexual activity.
About Abbott Molecular
Abbott Molecular, abbottmolecular.com, is an emerging leader in molecular diagnostics - the analysis of DNA, RNA, and proteins at the molecular level. Some of Abbott Molecular's tests are designed to detect subtle but key changes in human genes and chromosomes. The results of these tests may aid in the earlier detection or diagnosis of disease, may influence the selection of appropriate therapies, or may improve monitoring of disease recurrence.
About Abbott
Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs approximately 83,000 people and markets its products in more than 130 countries.
Abbott's news releases and other information are available on the company's Web site at http://www.abbott.com/.
SOURCE Abbott
RELATED LINKS
http://www.abbott.com/
Source
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