Donor livers kept alive outside the body for 24 hours

17:00 15 March 2013 by Andy Coghlan

Donated livers can survive for at least a day outside the body thanks to a new device which keeps the organ ticking over as if it hadn't been removed. The machine is likely to more than double the availability of livers for transplant.

The device was unveiled today in London by its developer Peter Friend, professor of transplantation surgery at the University of Oxford.

In the US and Europe, 2000 livers get discarded each year because they deteriorate in transit, damaged by the ice packs and solutions that, for the past 40 years, have been the usual way to preserve them. At present, a quarter of the 30,000 people on US and European liver transplant waiting lists die each year before receiving an organ.

The new device can keep a donated liver at body temperature, supplying it with blood, sugar, oxygen and nutrients.

Whereas most frozen livers become unusable after about 14 hours of cold storage, the new device keeps them alive and in perfect condition for at least 24 hours. "In animals, we've gone up to 72 hours and see no reason why it shouldn't go even further than that," says Friend.

Buying time

He is hopeful that as well as buying precious time in which to use the organ, the device will enable surgeons to better judge a liver's condition before transplanting it, because in the device, it carries on functioning as normal.

"It gives the opportunity to test-drive the organ before transplanting it," says Constantin Coussios, co-developer of the device and founder of OrganOx, the company set up by the University of Oxford to commercialise it.

Video footage shows Friend plumbing a donated liver into the device. Within seconds of connection, the brown-grey organ turns bright red as blood floods into its capillaries. As in the body, blood and nutrients enter through the hepatic artery and the portal vein, and exit through the inferior vena cava. A fourth connection to the bile duct enables the liver's functioning to be monitored.

The box containing the liver and its plumbing is connected to a master console that monitors and controls the organ's life support.

A pump mimics the heart, an oxygenator mimics the lungs and tubes supply donated blood, explains Stuart Kay of Team Consulting in Cambridge, UK, which miniaturised and optimised the original system developed at Oxford. "The key is that the system 'listens' to the organ to find out how much blood to supply, and at what pressure," says Kay.

Sensors for fluid flow and pressure, plus levels of oxygen, carbon dioxide and sugar in the blood, are part of the disposable circuitry, he adds. Also, the device is fully automated so that non-specialist medical staff can use it and load it easily into planes or ambulances.

Clinical pilot

Two people have received livers kept alive using the device. They were both treated at King's College Hospital, London, in February, and are among 20 people taking part in a pilot clinical trial that, if successful, should allow the device to win approval for use in Europe by next year.

Further randomised trials are planned to compare the performance of the device with existing preservation methods using freezing. Friend says that animal experiments, mainly in pigs, have already demonstrated that the device outperforms freezing. It also enables surgeons to transplant fatty livers that would normally be rejected because they do not respond well to the freezing process, he says.

Friend says that with modifications, the same technology could be applied to preserve the pancreas, kidneys, small bowel and lungs.

Source

A global view of hepatitis C: Physician knowledge, opinions, and perceived barriers to care

Provided By NATAP

Download the PDF here

Hepatology April 2013

"study highlight the significant barriers that may impede the prompt, appropriate treatment of HCV infection......Key findings of our study include marked regional variation in perceived barriers, the importance of patient-level obstacles, concerning deficits in provider knowledge, and the shared pessimism regarding the current state of HCV care......In multivariable regression analysis, only global region, years of experience, and knowledge were significantly associated with perceived barriers to care.........only 35% of physicians believed that patients have adequate access to HCV providers......more than half of HCV-infected persons were unaware of their diagnosis.29 Among injection drug users, this number is as high as 72%-90%.....less than one quarter of respondents believing that the public is aware of HCV and its consequences.....A lack of trained specialists......Recent advances in antiviral therapy have produced dramatic improvements in the treatment of HCV infection. Unfortunately, only a minority of HCV-infected persons will receive treatment as a result of multiple barriers to care. Globally, physicians cite patient-level factors, including fear of side effects and concerns regarding treatment duration and cost, as the greatest barriers to treatment. Inadequate physician knowledge and limited specialist availability may further contribute. Efforts to improve patient and physician education, public awareness, and access to treatment providers are needed......Specific patient-related barriers included fear of side effects and concerns regarding treatment duration, cost, and effectiveness (Supporting Table 1). Payer-related barriers were most prominent in Latin American and Middle East/Africa and included lack of coverage leading to out-of-pocket expense and excessive paperwork requirements. Only one region (Central/Eastern Europe) cited government-related barriers (insufficient funding and lack of treatment promotion) as most significant"

Christopher E. McGowan,1 Ali Monis,2 Bruce R. Bacon,3 Josep Mallolas,4 Fernando L. Goncales,5 Ioannis Goulis,6 Fred Poordad,7 Nezam Afdhal,8 Stefan Zeuzem,9 Teerha Piratvisuth,10 Patrick Marcellin,11 and Michael W. Fried1 From the 1UNC Liver Center, University of North Carolina at Chapel Hill, Chapel Hill, NC; 2Ain Shams Medical School, Cairo, Egypt; 3Division of Gastroenterology and Hepatology, Saint Louis University School of Medicine, St. Louis, MO; 4Infectious Diseases Service, Hospital Clinic, Barcelona, Spain; 5FCMUniversity of Campinas, Sa÷o Paola, Brazil; 6Aristotle University of Thessaloniki, Thessaloniki, Greece; 7Cedars-Sinai Medical Center, Los Angeles, CA; 8Beth Israel

Deaconess Medical Center, Boston, MA; 9Department of Medicine, J.W. Goethe University Hospital, Frankfurt, Germany; 10NKC Institute of Gastroenterology and Hepatology, Prince of Songkla University, Hat Yai, Thailand; and 11Service d'Hepatologie and Centre de Recherches, Hopital Beaujon, Clichy, France.

Abstract

Chronic infection with the hepatitis C virus (HCV) is a leading cause of global morbidity and mortality. Although recent advances in antiviral therapy have led to significant improvements in treatment response rates, only a minority of infected patients are treated. Multiple barriers may impede the delivery of HCV therapy. The aim of this study was to identify perceived barriers to care, knowledge, and opinions among a global sample of HCV treatment providers. An international, multidisciplinary survey of HCV treatment providers was conducted. Each physician responded to a series of 214 questions concerning his or her practice characteristics, opinions regarding the state of HCV care, knowledge regarding HCV treatment, and perception of treatment barriers. A total of 697 physicians from 29 countries completed the survey. Overall, physicians viewed patient-level barriers as most significant, including fear of side effects and concerns regarding treatment duration and cost. There were distinct regional variations, with Central and Eastern European physicians citing government barriers as most important. In Latin America, the Middle East, and Africa, payer-level barriers, including lack of treatment coverage, were prominent. Overall, the perception of barriers was strongly associated with physician knowledge, experience, and region of origin, with the fewest barriers reported by Nordic physicians and the most reported by Middle Eastern and African physicians. Globally, physicians demonstrated deficits in basic treatment principles, including the role of viral kinetics and the management of treatment nonresponders. Two thirds of surveyed physicians believed that patients do not have adequate access to providers in their community.

Conclusion: Barriers to HCV treatment vary globally, though patient-level factors are viewed as most significant by treating physicians. Efforts to improve awareness, education, and specialist availability are needed.

Hepatitis C virus (HCV) infection affects between 130 and 170 million persons worldwide, is a leading indication for liver transplantation, and contributes to 350,000 deaths each year.1 HCV is a potentially curable disease, with the majority of treated patients currently afforded the promise of a sustained virologic response (SVR).2-5 Unfortunately, less than half of HCV-infected persons are aware of their diagnosis, and among those with known infection, only 1%-30% will receive treatment.6-11

Multiple factors serve as impediments to the delivery of antiviral therapy. These barriers may arise at the patient, provider, payer, and/or government level.12 Patients cite fear of treatment-related side effects, lack of symptoms, financial constraints, and social stigmatization as primary reasons for declining therapy.13-16 Physicians may fail to refer patients for subspecialty evaluation or may place undue emphasis on purported contraindications.17 As a result, more than 70% of patients are deemed ineligible for treatment based on psychiatric disease, substance use, or medical comorbidities,6, 7 despite evidence that these factors are not absolute.18, 19 A lack of available and competent specialists may further interfere.20, 21 Finally, limitations in funding, medical coverage, and office staffing may prevent treatment.11, 22 Increasingly, hepatitis C is recognized as a global health crisis, demanding an international, coordinated emphasis on promotion, prevention, and treatment.23 To inform these initiatives, we surveyed an international sample of HCV treatment providers, with an aim of assessing knowledge, opinions toward HCV therapy, and perceived barriers to care.

Materials and Methods

An international, mixed-mode survey study of HCV treatment providers was conducted in December 2010 with an aim to identify physician and practice characteristics, opinions regarding HCV care, knowledge of treatment principles, and perceived barriers to care. A 214-item questionnaire was developed by the International Conquer C Coalition (I-C3; see Appendix), an organization of hepatitis C experts formed with the goal of optimizing global HCV care. The questionnaire was piloted by a 67-member focus group of I-C3 members. Physicians were considered eligible for the study if they treated a minimum of 10 HCV patients each month and if they resided in one of the eight predetermined global regions: United States; Canada; Latin America; Western Europe; Central/Eastern Europe; Nordic; Asia/Pacific; and Middle East/Africa. Target respondents included hepatologists, gastroenterologists, infectious disease (ID) physicians, internists, and general practitioners. The survey was distributed to a sample of 1,400 physicians identified by an international market research database24 and was administered by 25-minute phone interview or internet-based format by a professional survey company (Phoenix Marketing International, Rhinebeck, NY). Participants were asked a series of open-ended, multiple-response, and Likert-scale questions. Translation was provided for non-English-speaking participants. Each participant received a modest honorarium for completing the survey. All responses were anonymous.

Physician/Practice Characteristics and Opinions Regarding HCV Care. Each physician was asked about his or her medical specialty, practice location, patient volume, and patient characteristics. Opinions regarding the current state of HCV care were assessed according to level of agreement with the following statements: (1) national treatment guidelines are available in my country; (2) treatment guidelines and policies are consistent among professional societies, payers, and government; (3) government and/or payers recognize national or international treatment guidelines; (4) healthcare providers have knowledge of screening and treatment guidelines; (5) the general public is aware of HCV; (6) patients understand the consequences of HCV if it is not treated; (7) most patients are aware that HCV is curable; and (8) patients have adequate access to HCV providers in their community; responses were rated on a 10-point Likert scale, with 0 representing "strongly disagree," 5 "neither agree nor disagree," and 10 "strongly agree."

Knowledge.

Physician knowledge was assessed according to level of agreement with the following eight statements: (1) the addition of ribavirin (RBV) to pegylated interferon (Peg-IFN) improves the likelihood of SVR; (2) maintaining an optimal dose of RBV with interferon (IFN) is necessary to achieve an SVR; (3) different viral genotypes require different treatment durations; (4) treatment should be discontinued for patients who fail to achieve a 2-log decrease in HCV RNA by treatment week 12; (5) treatment should be discontinued for patients who have detectable HCV RNA at treatment week 4; (6) patients with stage 1 fibrosis have worse treatment outcomes than patients with stage 4 fibrosis; (7) level of HCV RNA has no correlation with severity of liver disease; and (8) maintenance therapy should be prescribed for treatment nonresponders. Each response was rated on a 10-point Likert scale, with 0 representing "strongly disagree," 5 representing "neither agree nor disagree," and 10 representing "strongly agree." Barriers to Care.

The main focus of this study was to assess perceived barriers to HCV care. Each respondent was presented with 31 potential barriers categorized by patient-, provider-, government-, and payer-related categories (Table 1). Responses were based on a 10-point Likert scale, with 0 representing "not a barrier to treatment," 5 representing "somewhat of a barrier to treatment," and 10 representing "large barrier to treatment."

Statistical Analysis.

Mean, range, standard deviation (SD), and shape of the distribution were examined for each continuous variable, with frequencies tabulated for each categorical variable. Physician and practice characteristics were compared across global regions using Pearson's chi-square test for categorical variables and one-way analysis of variance (ANOVA) for continuous variables. Bivariable analysis was used to examine the relationship between physician and practice characteristics and perceived barriers to care using Pearson's correlation analysis for continuous independent variables and one-way ANOVA for each categorical independent variable. Multiple linear regression was used to identify characteristics independently associated with perceived barriers to care. All analyses were performed using Stata 11 (StataCorp LP, College Station, TX).

Abbreviations

ANOVA, analysis of variance; EVR, early virologic response; GI, gastroenterology; HCV, hepatitis C virus; IDs, infectious diseases; IFN, interferon; Peg-IFN, pegylated interferon; RBV, ribavirin; SD, standard deviation; SVR, sustained virologic response.

Results

A total of 697 physicians were surveyed across eight global regions, representing 29 individual countries (Supporting Fig. 1). Overall response rate was 50%. Physician and practice characteristics are summarized in Table 2. Overall, physicians were in practice for a mean of 16 years and treated an average of 46 HCV patients each month (range, 5-500). Physician specialty varied by region, with HCV care more commonly provided by hepatologists and gastroenterologists in the United States and Western Europe, by infectious disease specialists in Central/Eastern Europe, and by internists or general practitioners in remaining regions. Physicians most frequently worked in a private, urban facility, though a government-affiliated practice was most common in Central/Eastern Europe and Nordic regions. Dedicated treatment nurses and/or assistants were more frequently employed in European countries. Source of medical coverage varied significantly, with patients in Europe, Canada, and Asia/Pacific regions covered primarily by public insurance. A mix of public and private coverage was noted in the United States and Latin America. More than one third of patients in the Middle East and Africa were reportedly uninsured. Overall, approximately one quarter of patients were reported to refuse therapy, with the highest refusal rate in Asia/Pacific countries and the lowest in Nordic countries (37% versus 14%; P < 0.0001).

Opinions Regarding HCV Care.

Physician opinions regarding the current state of HCV care are shown in Table 3.
The majority of physicians indicated that national treatment guidelines existed in their country; however, less than half felt that guidelines were consistent across sources. Only 36%-38% of physicians in North America, Latin America, and Middle East/Africa believed that government and/or payers recognized treatment guidelines, compared to 71%-83% in European countries. Between 20% and 54% of respondents felt that healthcare providers have adequate knowledge of HCV guidelines, with higher levels of agreement across European countries. Globally, less than one quarter of physicians felt that the general public is aware of HCV and know that it is a curable disease. Only 35% of all surveyed physicians believed that patients have adequate access to HCV treatment providers, with the lowest percentage in the United States (17%) and the highest in Nordic countries (62%).

Knowledge.

Knowledge of HCV treatment principles varied significantly by region, with physicians in Western Europe correctly answering the most knowledge questions, and those in Middle East and African countries correctly answering the fewest (6.4 versus 3.2; P < 0.001; Fig. 1A). Overall, physicians understood that RBV is a necessary component of treatment, treatment duration varies by genotype, and treatment should be discontinued for patients who fail to achieve an early virologic response (EVR). However, a majority of physicians incorrectly believed that HCV RNA level correlates with liver disease severity, and that treatment nonresponders should receive maintenance therapy (Table 4). In Middle East/African countries, a majority of respondents also did not appreciate the importance of RBV, the role of HCV viral kinetics, and the significance of liver fibrosis stage. Globally, knowledge was highest among hepatologists and lowest among general practitioners (P < 0.001 for overall comparison; Fig. 1B). Source of treatment information varied by region, with national and government guidelines used most frequently in all regions except in the United States, where guidelines from the American Association for the Study of Liver Diseases were most commonly used (Supporting Fig. 2).

Barriers to Care.

There was significant regional variation in perceived barriers to care, with the greatest barriers reported in Middle East/Africa and the fewest in Nordic countries (P < 0.0001 for overall comparison; Fig. 2A). Globally, patient-related barriers were viewed as most significant, representing the highest rated barrier category in five of eight regions, including the United States (Fig. 2B). Specific patient-related barriers included fear of side effects and concerns regarding treatment duration, cost, and effectiveness (Supporting Table 1). Payer-related barriers were most prominent in Latin American and Middle East/Africa and included lack of coverage leading to out-of-pocket expense and excessive paperwork requirements. Only one region (Central/Eastern Europe) cited government-related barriers (insufficient funding and lack of treatment promotion) as most significant.

Along with geographic region, perceived barriers were significantly associated with physician specialty, physician experience, practice setting, and physician knowledge (Table 5). Subspecialists (hepatology, gastroenterology [GI], and IDs) reported fewer perceived barriers than internists and general practitioners. Likewise, physicians with more experience and higher knowledge scores reported fewer barriers. In multivariable regression analysis, only global region, years of experience, and knowledge were significantly associated with perceived barriers to care (Supporting Table 2).

Discussion

This international, multidisciplinary survey study provides insight into the current state of hepatitis C care, as viewed by treating physicians. Key findings of our study include marked regional variation in perceived barriers, the importance of patient-level obstacles, concerning deficits in provider knowledge, and the shared pessimism regarding the current state of HCV care.

Foremost, barriers to care were not perceived equally across global regions.

Physicians from Nordic and Western European countries had remarkably low perceptions of treatment barriers (mean Likert responses of 1.7 and 2.1, respectively, on a 10-point scale). In contrast, Middle Eastern and African physicians perceived all barrier categories as problematic (mean Likert response: 6.1 of 10). Despite regional differences in the magnitude of perceived barriers, there was agreement regarding the nature of these barriers. Across all global regions, patient-level factors were viewed as the greatest obstacles to treatment. This is consistent with previous surveys of physicians and patients in the United States and United Kingdom.13, 15, 16, 22 Specifically, fear of treatment-related side effects was the most frequently cited barrier in our study. This fear is not unfounded, because nearly all patients will experience at least one treatment-related side effect, and 10%-14% of patients will discontinue treatment as a result.2, 4 Though side effects are common, appropriate pretreatment counseling, along with a structured plan for monitoring and management, may help alleviate such fears.25

Further patient-level barriers included concerns regarding treatment duration and antiviral effectiveness. Fortunately, the recent introduction of direct-acting antivirals offers the potential for improved response rates and reduced treatment lengths. However, these benefits will need to be balanced against a greater incidence of treatment-related side effects.4, 5 Nevertheless, each of these patient-level barriers is addressable and, in many cases, modifiable.

To properly address patient fears, physicians must have a thorough understanding of antiviral therapy. This study identified concerning knowledge deficits, which were most apparent in Middle East/African countries. Physicians in this region often did not acknowledge important treatment principles, including the significance of RBV in HCV therapy, although the frequency of non-specialty physician respondents was also highest in this region. Interestingly, across all regions, more than half of physicians indicated that they would treat nonresponders with maintenance IFN therapy, despite its lack of efficacy.26

Similarly, most physicians incorrectly believed that HCV RNA level reflects liver disease severity. Though previous studies of healthcare providers have demonstrated significant knowledge gaps related to HCV,27 our study documented these deficits in experienced HCV treaters. This is concerning, because inadequate physician knowledge is a known barrier to care.20 Furthermore, independent of geographic region, medical specialty, or experience level, physicians who scored lower on the knowledge assessment tended to perceive greater barriers to care. The implication here is 2-fold: Physicians with less knowledge may treat fewer patients as a result of incorrectly perceived barriers, and these perceived barriers may be overcome through improved education.

Recognizing the current deficits in physician knowledge, the Institute of Medicine recently recommended the development of HCV educational initiatives, emphasizing a need for increased awareness and improved adherence to guidelines.28 In our study, only 40% of respondents believed that providers have adequate knowledge of treatment guidelines, highlighting this need. Physicians held similar views regarding public awareness, with less than one quarter of respondents believing that the public is aware of HCV and its consequences. This view is supported by findings from the National Health and Nutrition Examination Survey, in which more than half of HCV-infected persons were unaware of their diagnosis.29 Among injection drug users, this number is as high as 72%-90%.30, 31 Unfortunately, awareness does not guarantee treatment. In our study, only 35% of physicians believed that patients have adequate access to HCV providers. A lack of trained specialists, combined with their concentration at academic medical centers, may limit the widespread availability of treatment. Indeed, market surveys in the United States indicate that 80% of HCV patients are managed by 20% of gastroenterologists.21 Models of expanded HCV treatment, including the use of tele-health, have shown promise.32 These warrant broader exploration and implementation.

This is the first international study to examine barriers to care among HCV treatment providers. The findings are strengthened by a comprehensive questionnaire, developed and piloted by a panel of internationally recognized HCV experts. The survey achieved a 100% item response rate, eliminating the potential for nonresponse bias. However, as with any survey, the findings in our study may not be representative of the entire population. Likewise, it was not feasible to survey physicians within every country, leading to the potential for coverage error. By grouping our findings into global regions, we may not have adequately addressed the differences that exist between individual countries. Furthermore, the perceptions identified in this study may not be representative of less-experienced physicians. This may have led to an underestimation of treatment barriers. Finally, HCV treatment is frequently delivered by mid-level providers (i.e., nurse practitioners and physician assistants), particularly in the United States. This study did not address the perspective of these providers, which may differ from those of physicians.

Still, the findings of this study highlight the significant barriers that may impede the prompt, appropriate treatment of HCV infection. A focus on patient and provider education, increased awareness, and treatment promotion is necessary if progress is to be made in the global fight against HCV infection. Recent advances in antiviral therapy have produced dramatic improvements in the treatment of HCV infection. Unfortunately, only a minority of HCV-infected persons will receive treatment as a result of multiple barriers to care.

Globally, physicians cite patient-level factors, including fear of side effects and concerns regarding treatment duration and cost, as the greatest barriers to treatment. Inadequate physician knowledge and limited specialist availability may further contribute. Efforts to improve patient and physician education, public awareness, and access to treatment providers are needed.

Source

Infection with hepatitis B and C virus in Europe: a systematic review of prevalence and cost-effectiveness of screening

BMC Infect Dis. 2013 Apr 18;13(1):181. [Epub ahead of print]

Hahné SJ, Veldhuijzen IK, Wiessing L, Lim TA, Salminen M, Laar M.

Abstract

BACKGROUND: Treatment for chronic hepatitis B virus (HBV) and hepatitis C virus (HCV) infection is improving but not benefiting individuals unaware to be infected. To inform screening policies we assessed (1) the hepatitis B surface antigen (HBsAg) and anti-hepatitis C virus antibodies (anti-HCV-Ab) prevalence for 34 European countries; and (2) the cost-effectiveness of screening for chronic HBV and HCV infection.

METHODS: We searched peer-reviewed literature for data on HBsAg and anti-HCV-Ab prevalence and cost-effectiveness of screening of the general population and five subgroups, and used data for people who inject drugs (PWID) and blood donors from two European organizations. Of 1759 and 468 papers found in the prevalence and cost-effectiveness searches respectively, we included 124 and 29 papers after assessing their quality. We used decision rules to calculate weighted prevalence estimates by country.

RESULTS: The HBsAg and anti-HCV-Ab prevalence in the general population ranged from 0.1%-5.6% and 0.4%-5.2% respectively, by country. For PWID, men who have sex with men and migrants, the prevalence of HBsAg and anti-HCV-Ab was higher than the prevalence in the general population in all but 3 countries. There is evidence that HCV screening of PWID and HBsAg screening of pregnant women and migrants is cost-effective.

CONCLUSION: The prevalence of chronic HBV and HCV infection varies widely between European countries. Anti-HCV-Ab screening of PWID and HBsAg screening of pregnant women and migrants are European public health priorities. Cost-effectiveness analyses may need to take effect of antiviral treatment on preventing HBV and HCV transmission into account.

Source

HCV treatment for prevention among people who inject drugs: Modeling treatment scale-up in the age of direct-acting antivirals

Hepatology. 2013 Mar 28. doi: 10.1002/hep.26431. [Epub ahead of print]

Martin NK, Vickerman P, Grebely J, Hellard M, Hutchinson SJ, Lima VD, Foster GR, Dillon JF, Goldberg DJ, Dore GJ, Hickman M.

School of Social and Community Medicine, University of Bristol, Bristol, UK; Social and Mathematical Epidemiology Group, Department of Global Health and Development, London School of Hygiene and Tropical Medicine, London, UK. natasha.martin@bristol.ac.uk.

Abstract

BACKGROUND:

Substantial reductions in HCV prevalence among people who inject drugs (PWID) cannot be achieved by harm reduction interventions such as needle exchange and opiate substitution therapy (OST) alone. Current HCV treatment is arduous and uptake low, but new highly effective and tolerable interferon-free direct-acting antiviral (DAA) treatments could facilitate increased uptake. We projected the potential impact of DAA treatments on PWID HCV prevalence in three settings.

METHODS:

A dynamic HCV transmission model was parameterized to three chronic HCV prevalence settings: Edinburgh, UK (25%); Melbourne, Australia (50%); Vancouver, Canada (65%). Using realistic scenarios of future DAAs (90% sustained viral response, 12 weeks duration, available 2015), we projected the treatment rates required to reduce chronic HCV prevalence by half or three-quarters within 15 years.

RESULTS:

Current HCV treatment rates may minimally impact prevalence in Melbourne and Vancouver (<2% relative reductions), but could reduce prevalence by 26% in 15 years in Edinburgh. Prevalence could halve within 15 years with treatment scale-up to 15, 40, or 76 per 1000 PWID annually in Edinburgh, Melbourne, or Vancouver, respectively (2, 13, 15-fold increases, respectively). Scale-up to 22, 54, or 98 per 1000 PWID annually could reduce prevalence by three-quarters within 15 years. Less impact occurs with delayed scale-up, higher baseline prevalence, or shorter average injecting duration. Results are insensitive to risk heterogeneity or restricting treatment to PWID on OST. At existing HCV drug costs, halving chronic prevalence would require annual treatment budgets of USD$3.2 million in Edinburgh and ˜$50 million in Melbourne and Vancouver.

CONCLUSION:

Interferon-free DAAs could enable increased HCV treatment uptake among PWID, which could have a major preventative impact. However, treatment costs may limit scale-up, and should be addressed. (HEPATOLOGY 2013.).

Copyright © 2013 American Association for the Study of Liver Diseases.

Source

α-fetoprotein levels after interferon therapy and risk of hepatocarcinogenesis in chronic hepatitis C

Asahina Y, Tsuchiya K, Nishimura T, Muraoka M, Suzuki Y, Tamaki N, Yasui Y, Hosokawa T, Ueda K, Nakanishi H, Itakura J, Takahashi Y, Kurosaki M, Enomoto N, Nakagawa M, Kakinuma S, Watanabe M, Izumi N.

Hepatology. 2013 Apr 8. doi: 10.1002/hep.26442. [Epub ahead of print]

Department of Gastroenterology and Hepatology, Musashino Red Cross Hospital, 1-26-1 Kyonan-cho, Musashino-shi, Tokyo 180-8610, Japan; Department of Gastroenterology and Hepatology, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8519, Japan; Department of Liver Disease Control, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8519, Japan. asahina.gast@tmd.ac.jp.

Abstract

The effects of interferon (IFN) treatment and the post-IFN treatment α-fetoprotein (AFP) levels on risk of hepatocellular carcinoma (HCC) in patients with chronic hepatitis C (CHC) are unknown. To determine the relationship between AFP and alanine transaminase (ALT) levels and HCC risk, the cohort consisted of 1818 patients histologically proven to have CHC treated with IFN were studied. Cumulative incidence and HCC risk were analyzed over a mean follow-up period of 6.1 years using the Kaplan-Meier method and Cox proportional hazard analysis. HCC developed in 179 study subjects. According to multivariate analysis, older age, male gender, advanced fibrosis, severe steatosis, lower serum albumin levels, sustained virological response (SVR), and higher post-IFN treatment ALT or AFP levels were identified as independent factors significantly associated with HCC development. Cutoff values for ALT and AFP for prediction of future HCC were determined as 40 IU/L and 6.0 ng/mL, respectively, and negative predictive values of these cutoffs were high at 0.960 in each value. Cumulative incidence of HCC was significantly lower in patients whose post-IFN treatment ALT and AFP levels were suppressed to less than the cutoff values even in non- SVR patients. This suppressive effect was also found in patients whose post-IFN treatment ALT and AFP levels were reduced to less than the cutoff values despite abnormal pre-treatment levels. Conclusion: Post-IFN treatment ALT and AFP levels are significantly associated with the hepatocarcinogenesis. Measurement of these values is useful for predicting future HCC risk after IFN treatment. Suppression of these values after IFN therapy reduces HCC risk even in patients without HCV eradication. (HEPATOLOGY 2013.).

Copyright © 2013 American Association for the Study of Liver Diseases.

PMID

23564522 [PubMed - as supplied by publisher]

Full text: John Wiley & Sons, Inc.

Source

If We Want an AIDS-Free Generation, Why Are We Cutting PEPFAR?

Chris Collins Vice President and Director of Public Policy, amfAR: The Foundation for AIDS Research

Posted: 04/18/2013 9:31 am

The persistent shortchanging of PEPFAR, the President's Emergency Plan for AIDS Relief, is one of the more significant and perplexing trends in America's global health policy. Funding for PEPFAR (America's bilateral global AIDS program) has been falling consistently from its peak in fiscal year 2010. In fiscal year 2012, $250 million was transferred out of the program to the Global Fund to Fight AIDS, Tuberculosis and Malaria. For fiscal year 2013, the White House proposed cutting PEPFAR by $550 million (11 percent) and in March of this year Congress went part way, taking $176 million from the program in the Continuing Resolution.

Funding for PEPFAR has fallen 12 percent since 2010 in the State Department HIV bilateral budget line. Last week, the White House proposed an additional $50 million cut for 2014. When the mandated sequestration cut is taken into account, the program is now at its lowest funding level since 2007.

This downward funding spiral might make sense if there was a consensus that tackling AIDS has become less important, or if PEPFAR was not producing results. But the opposite is true. In November 2011, Secretary of State Hillary Clinton announced that achieving an AIDS-free generation was a "policy priority" for the U.S. government. President Obama went on to set bold new targets for AIDS treatment and other services through PEPFAR. In November 2012, the Administration released a PEPFAR Blueprint lauding the program's accomplishments and affirming the need to "rapidly scale-up core ... interventions." Doing so, the Blueprint argued, would accelerate declines in HIV incidence globally.

In February of this year, President Obama inspired all those engaged in the response to AIDS when, in his State of the Union address, he reaffirmed his commitment to the goal of an AIDS-free generation. The same month, the Institute of Medicine (IOM) weighed in with their assessment of PEPFAR, four years in the making. It concluded that the program has been "globally transformative" and has "had major positive effects on the health and well-being of individual beneficiaries, on institutions and systems in partner countries, and the overall global response to AIDS."

Why the mismatch between results, rhetoric, and financing? Budget deficit pressures do not explain it: total U.S. global health spending is just a quarter of one percent of the federal budget. Politics doesn't explain it either, with PEPFAR maintaining a unique level of bipartisan Congressional support.

The more likely reason for steady reductions in PEPFAR funding is an Administration decision to gradually de-emphasize bilateral AIDS investments in favor of multilateral institutions and multiyear commitments to these institutions. Increased investments in the Global Fund and other multilateral health organizations are a badge of honor for President Obama. These institutions have demonstrated clear results in countries around the world, and U.S. funding leverages investments from others.

The question is not whether increased funding for the Global Fund is good, because clearly it is. The question is whether those increases justify year-on-year reductions in our bilateral AIDS program. It is not a matter of choosing between multilateral and bilateral approaches, but of marshaling sufficient resources to end AIDS.

One concern is that as Global Fund and PEPFAR funding trends head in opposite directions, net U.S. resources dedicated to tackling AIDS are in decline. Since on average approximately 57 percent of Global Fund resources are allocated to combating HIV/AIDS, the $600 million increase in support for the Global Fund since 2010 and the $543 million decrease in funding for PEPFAR during that time adds up to an overall decline in U.S. government funding to tackle the global AIDS epidemic.

Another problem is the lost opportunities to strengthen health systems when PEPFAR is cut. According to the distinguished IOM panel, the program is helping build health systems through improved laboratory capacity, supply chains, and staff training. The IOM observed that PEPFAR is "uniquely situated as a platform for research to spur innovation and to address knowledge gaps" in the global AIDS response.

And then there is the move toward to greater "country ownership" of healthcare financing and decision making. Clearly country ownership is an important goal and should be pursued at a rate that is appropriate for each individual country setting. But a reduced commitment to PEPFAR could lead to an accelerated and premature hand-off of AIDS programs with potentially disastrous consequences. Already there are concerns. A Center for Strategic and International Studies (CSIS) report released in March noted the "legitimate fears" that a rushed transition in South Africa could disrupt the delivery of AIDS treatment to people there.

In many countries where PEPFAR operates, those groups most severely affected by the epidemic, including gay men, people who inject drugs, and sex workers, are socially and legally marginalized. Last year UNAIDS reported that more than 90 percent of funding to address HIV among these populations in low- and middle-income countries came from external sources, not the countries themselves. Though PEPFAR still needs to pay greater attention to these most-at-risk groups, the program has been a leader in tending to their HIV-related needs. If PEPFAR is scaled back, real progress to address the epidemic among the most vulnerable could be in serious jeopardy.
Congress has been broadly supportive of domestic and global AIDS funding for many years. And the President deserves praise for his leadership on AIDS, which includes game changers like the Affordable Care Act, the National HIV/AIDS Strategy, and funding increases for domestic AIDS and the Global Fund. The President is to be commended for being outspoken against HIV-related stigma and for equality for gay people, including young Black gay men, who are perhaps the most vulnerable in America's epidemic.

With the end of AIDS within reach, it is time to think about legacy -- the President's and our own. The most damaging consequence of continual reductions in funding for PEPFAR is slower than necessary progress in pursuing the end of the AIDS pandemic. The PEPFAR Blueprint shows how expanded delivery of proven interventions will yield falling HIV incidence and mortality rates within a few years. The Global Fund has an essential role to play in this effort, and other donors and affected countries need to invest more.

But the honest truth is that the world won't end AIDS without PEPFAR. Some will say, judge PEPFAR on its outcomes, not its funding. But when PEPFAR's own Blueprint calls for rapid scale-up of effective services in order to show tangible gains, it's hard to understand why now is the time to cut back. The urgency of delivering lifesaving services remains acute, with the IOM observing that there is a "substantial remaining unmet need for all services ... that are part of an effective response to HIV."

Congress and the President should not set the AIDS budget based on short-term expediency. Instead they should recognize the longer game: defeating a major infectious disease, and securing this generation's legacy as beginning the end of AIDS. To achieve that goal, both the Global Fund and PEPFAR need appropriate funding.

The IOM panel assessing PEPFAR's work concluded that the program "has the opportunity and the potential to once again transform the way global assistance for health is envisioned and implemented." The question is, will we allow it to seize the opportunity and fulfill its potential?

Chris Collins is vice president and director of public policy at amfAR, The Foundation for AIDS Research. His email is chris.collins@amfar.org

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New Options for Treating HCV/HIV Coinfection on the Horizon

Paul E. Sax, MD

Apr 19, 2013

Hi. This is Dr. Paul Sax from Brigham and Women's Hospital and Harvard Medical School. Infectious disease and HIV specialists, hepatologists, and other clinicians who take care of patients with hepatitis C received some very exciting news recently: New drug applications for simeprevir and sofosbuvir, 2 investigational hepatitis C drugs, were submitted to the FDA.

The submissions were for at least genotype 1 hepatitis C, for use in combination with interferon and ribavirin. Notably, the sofosbuvir treatment course looks like it's going to be shorter, at 12-16 weeks. In addition, sofosbuvir is seeking approval for genotypes 1 and 3 in the submission in combination with ribavirin -- an interferon-free option.

This is very exciting. Both of these drugs are given once daily and look to have a much better toxicity profile than our existing hepatitis C protease inhibitors. But there are additional reasons why this information is very exciting, in particular for HIV care providers.

First, as you know, approximately 15%-20% of the HIV population in the United States is coinfected, and in some regions it's much higher. Second, treatment with our current standard of care, which is interferon-ribavirin plus telaprevir or boceprevir, has been challenging because of toxicity and drug-drug interaction issues. So there was a lot of room for improvement.

Third, we saw some very exciting data at the 20th Conference on Retroviruses and Opportunistic Infections (CROI) combining these 2 drugs, simeprevir and sofosbuvir.^[1] Granted, that was in hepatitis C monoinfected patients, but the combination looked like it had outstanding results even without the use of interferon.

There is an emerging consensus in the field that using regimens that have direct activity against hepatitis C will make the HIV coinfection component of the population much less relevant in the future. A lot of other things, too, may be less relevant, such as IL-28B status, race, and prior treatment failure. All of these are harbingers for good things and progress in the hepatitis C treatment front.

I think we need to stay tuned for new data in this exciting area with the European liver meetings coming up later this month. Also, keep in mind for your patients who have HIV/hepatitis C coinfection that, if they're stable and if they don't have evidence of advanced liver disease, one could very easily make the argument that waiting for newer drugs such as simeprevir and sofosbuvir to be approved makes a lot of sense.

Thanks very much. There is more information on this topic on my blog, HIV and ID Observations. I hope you have a very nice spring, and I hope it's warmer than it is here in Boston, where it is still freezing.

References

1. Lawitz E, Ghalib R, Rodriguez-Torres M, et al. Suppression of viral load through 4 weeks post-treatment results of a once-daily regimen of simeprevir + sofosbuvir with or without ribavirin in hepatitis c virus GT 1 null responders. Program and abstracts of the 20th Conference on Retroviruses and Opportunistic Infections; March 3-6, 2013; Atlanta, Georgia. Abstract 155LB.

Medscape HIV/AIDS © 2013 WebMD, LLC

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Even moderate drinking may be risky with hepatitis C

By Kerry Grens

NEW YORK | Fri Mar 15, 2013 4:19pm EDT

NEW YORK (Reuters Health) - For people with the chronic liver infection hepatitis C, heavy drinking is an obvious no-no, but a new study links even modest alcohol consumption with an increased risk of death - and not just from liver disease.

"What this study shows is... truly, even what might be considered a moderate and safe amount of alcohol use in people without hepatitis C is dangerous to your health if you have hepatitis C," said Rae Jean Proeschold-Bell, a hepatitis C researcher at Duke University in Durham, North Carolina, who was not involved in the study.

The findings support what liver specialists typically recommend - that people with hepatitis C should limit their alcohol use, said Dr. Zobair Younossi, the study's lead author and chair of medicine at Inova Fairfax Hospital in Falls Church, VA.

"Patients with hepatitis C should not really drink," he said.

But the reality is that people with hepatitis C have higher rates of alcohol use than people without the liver disease, said Proeschold-Bell, who studies interventions to reduce drinking among people with the disease.

Doctors have known that excessive drinking can exacerbate liver disease caused by hepatitis C, but there's some debate about whether less frequent drinking would have a similar effect.

Younossi and his colleagues looked to a large national survey on health and lifestyle that tracked people for several years.

They compared 8,767 people without hepatitis C to 218 people with the disease.

Hepatitis C is a virus spread through blood. Some 3.2 million people in the U.S. have a chronic hepatitis C infection, according to the Centers for Disease Control and Prevention.

The disease can cause serious liver damage, and while some people are treated with medications, others will go on to require a liver transplant.

The survey tracked the participants for 13 to 14 years. During that period, 19 percent of those with hepatitis C and 11 percent of those without the infection died.

Younossi's team found that people with hepatitis C who drank excessively - three or more drinks a day - were five times more likely to die than heavy drinkers who were not infected.

That result was not surprising, "We've known heavy drinking is particularly bad if you have hepatitis C," Proeschold-Bell told Reuters Health.

But people infected with hepatitis C who had up to two drinks a day were also twice as likely to die during the study than those with similar drinking habits who were not infected.

For the purposes of the study, a drink was equivalent to 10 grams of alcohol, which is roughly the amount in four ounces of wine, 12 ounces of beer or one ounce of hard liquor.

Younossi said the increased risk of death from liver disease is driving the numbers.

"What is incredibly striking is liver-related death in patients with hepatitis C who even drink moderately," said Younossi.

For instance, the risk of liver-related death among people with hepatitis C who averaged two or fewer drinks a day was 74 times that of similar people without hepatitis C.

Those moderate drinkers with the virus were also nearly three times more likely to die of "all causes," the researchers report in the medical journal Alimentary Pharmacology & Therapeutics.

"A drink a day is not OK," Younossi told Reuters Health. "Even a moderate amount of alcohol use in the setting of hepatitis C can increase the risk of death and liver-related mortality specifically."

Proeschold-Bell said there is a great opportunity for intervening with people's alcohol use given that they are already interacting with the medical system if they have a chronic hepatitis C infection.

"This is potentially very powerful, because if the person with hepatitis C is already going in for medical care, they have some relationship with that clinic. They have some degree of trust, so (perhaps) you can provide alcohol treatment right then and there," she said.

Younossi said there's some evidence that if heavy drinkers without hepatitis C abstain from alcohol, their liver disease can improve.

He said he suspects the same might be true for patients with the infection, but that future studies will have to confirm that hunch.

SOURCE: bit.ly/W2Rtwn Alimentary Pharmacology & Therapeutics, online February 24, 2013.

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New Phone App to Facilitate HIV Screening, Counseling, and Linkage to Care

NEW YORK, April 18, 2013 /PRNewswire-iReach/ -- The Johns Hopkins University School of Medicine, in collaboration with the Institute for Johns Hopkins Nursing, the American Academy of HIV Medicine (AAHIVM), and DKBmed, LLC, has announced the creation of an application (app) that brings essential features of the SCALE HIV™ program to iPhone, iPad, and iPod Touch devices. The app can be found at www.dkbmed.com/scale. The goal of the app is to enhance the ability of healthcare professionals to screen their patients with HIV infection and to link those with positive test results to appropriate counseling and treatment. A key component of the app is direct access to the AAHIVM ReferralLink database.

(Photo: http://photos.prnewswire.com/prnh/20130418/CG97551)

The new SCALE HIV app provides key information, including current CDC recommendations, guidance for counseling HIV-positive patients/partner notification, and how to access expert care. In addition to providing information on screening patients and counseling, the app also includes access to the AAHIVM ReferalLink Database, an essential tool for all clinicians.

Available for the first time on a mobile platform, the AAHIVM ReferalLink Database enables clinicians to find local HIV care providers simply by inputting a zip code and other customizable fields, such as provider expertise, services, and payment types. (This search tool can also be viewed at aahivm.org.)

"ReferralLinkconnects healthcare professionals with credentialed HIV care providers all over the country," said James M. Friedman, MD, Executive Director of the AAHIVM Corporate Scientific Advisory Board. "Making this feature available to more clinicians through an iPhone/Pod/Pad-enabled app will make it even easier for them to connect their patients with high-quality care quickly and efficiently. The app also enables clinicians to print or email referral information for their patients, helping to ensure patients will seek the treatment they need."

SCALE (Screening – Counseling – Linkage – Education) HIV was launched in 2011 to address key practice and knowledge gaps in HIV screening, counseling, linkage to care, and adherence to clinical guidelines among primary care clinicians. The program consists of a series of live symposia, webcasts and podcasts, and a Virtual Clinic where patients can be followed online (www.scalehiv.org).

"It is important to find effective and efficient ways to educate clinicians about HIV screening guidelines and to help them connect their patients to appropriate care," said Dean Beals, President and CEO of DKBmed, LLC. "Tools such as the SCALE HIV app go a long way to achieve those goals. The sooner we can start HIV treatment in the course of the infection, the better a patient's outcome is likely to be."

The U.S. Centers for Disease Control and Prevention recommend routine HIV testing for everyone between the ages of 13 and 64, but many healthcare professionals lack the tools to follow these guidelines. The CDC recently reports that youths ages 13 – 24 account for 25 percent of new HIV cases, but fewer than a third of this age group has been tested for the virus. Clinician inexperience or lack of training also means that many HIV-positive patients are not counseled effectively, if at all. Moreover, linkage to care for HIV-positive individuals is not optimal, especially among minorities and women.

SCALE HIV is supported by an educational grant from Bristol-Myers Squibb.

About DKBmed

DKBmed is an integrated, non-accredited, continuing medical education company operated by a team of experienced medical education. The goal of DKBmed is to provide health care professionals with effective medical education that closes identified knowledge/practice gaps to ensure optimal patient care.

Working with accredited providers, DKBmed develops a range of innovative educational programs and specializes in bringing new adult learning methodologies to the CME landscape. DKBmed was an early adopter of utilizing case scenarios with recorded and live actors, 3D animation, webcasts, podcasts, e-mail, and mobile phone applications for clinicians and patients. These forward-thinking approaches enable users to learn using the latest state-of-the-art techniques and to access educational programs in a manner that is most convenient and appropriate for them.

DKBmed's programs are accessible through the company's web site (www.dkbmed.com). They reach more than 30,000 clinicians specializing in a variety of areas, including neonatology, cystic fibrosis, infectious disease, dermatology, macular degeneration, rheumatoid arthritis, pulmonary disease, nephrology, hematology, transplantation, multiple sclerosis, gout, ulcerative colitis, depression, and pain management.

About the American Academy of HIV Medicine (AAHIVM)

The American Academy of HIV Medicine is a professional organization that supports the HIV practitioner and promotes accessible, quality care for all Americans living with HIV disease. Our membership of HIV practitioners and credentialed providers give direct care to more than three-fourths of HIV patients in the US.

Media Contact: Dean Beals DKBmed, 646-336-6495, dbeals@dkbmed.com

News distributed by PR Newswire iReach: https://ireach.prnewswire.com

SOURCE DKBmed

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IWPR Georgia Prompts Debate on Hepatitis C

The disease is close to epidemic scale, says participant in discussion on how to tackle hepatitis C with limited resources.

By IWPR team in Georgia - Caucasus

CRS Issue 683,

18 Apr 13

An IWPR article on the high incidence of hepatitis C in Georgia prompted health officials, pharmaceutical industry representatives and pressure groups to meet and discuss strategies for combating the disease.

In an article called Hepatitis Unchecked in Georgia, reporter Manana Vardiashvili found that just one in ten people with hepatitis C were receiving treatment as the drugs were so expensive.

This important issue has often been passed over by local media, and is championed only the NGOs that work on it. In the course of interviews for the IWPR, it emerged that the different players – government officials, pharmaceutical companies, and pressure groups – felt left in the dark about what others were doing. IWPR’s Tbilisi office decided it would be a good idea to get them together in the same room to discuss some of the challenges and see whether they could be overcome.

According to the most recent data available, around 200,000 people in Georgia are infected with this particularly virulent form of hepatitis. That is 6.7 per cent of the population. The National Centre for Disease Control and Public Health recorded 1,847 new cases last year.

Georgia is shifting from the free healthcare system of the Soviet era to one based on private insurance. But despite the risk the hepatitis C poses to the nation’s health, neither the government nor the new health insurance companies are prepared to cover the high costs of testing and treatment. Only HIV-positive patients receive free medication for hepatitis C.

A 24-week course of drug treatment costs 6,000 US dollars, a huge sum in a country where the average monthly wage is just over 400 dollars and the unemployment rate is 15 per cent.

In the article, Health Minister David Sergeenko was quoted as saying that even if the government’s entire healthcare budget was given over to treating this one disease, “it still wouldn’t be enough”.

Apart from the funding need, one of the problems with dealing with hepatitis C is the widespread perception that it spreads mainly among drug users sharing infected needles, so it is their own fault. But as Maia Zhamutashvili, a doctor from the Infectious Diseases, AIDS and Clinical Immunology Research Centre , said blood transfusions carried out in past years have been a common source of transmission. Tattoo parlours and acupuncture are also possible routes.

At IWPR’s March 15 discussion event, Konstantin Rukhadze, executive director of the Hepa+ pressure group, said, “According to the only research that’s been done, which was nine years ago, only one in five [40,000 out of 200,000] infected people acquired the virus via the injection of narcotics.”

Paata Sabelashvili of the Georgian Harm Reduction Network warns that the country is one step away from an epidemic, and he placed the blame squarely on the health ministry.

“The Georgian health ministry says that the treatment of hepatitis C patients will cost the government 800 million laris [500 million dollars] and that they can’t afford to cover such high costs, because the ministry’s overall budget is only 650 million laris,” he said. “I think that reflects an irresponsible and uncaring attitude towards the thousands of people infected with hepatitis C.”

During their discussion, participants looked at cases where the governments of developing countries have succeeded in significantly reducing the costs of treatment.

“We have researched several international cases that could be applied to Georgia,” Rukhadze said. “All we need is the government to show the will. “We will continue advocating for increased public awareness and we’ll keep pushing until a national policy is developed.”

As in other former Soviet states, Georgia’s prison system shows a particularly high incidence of hepatitis C, and other infectious diseases.

In 2007, several prisoners filed a case at the European Court of Human Rights demanding that the state fully cover the costs of diagnosis and treatment. They won the case, and the government had to pay up.

The prisons ministry does not have accurate statistics on infection rates, but it insists it has included treatment programmes in its plan for 2013.

“Experts are working on a policy paper which will need to be backed up by comprehensive research in order to determine the right areas for intervention,” deputy minister Archil Talakvadze said at the meeting. “There’s a need to define what treatment systems are needed, and what funds will be required to implement the programme.”

The IWPR event was covered by leading media outlets Radio Liberty (a report in Georgian is available here), and Radio Imedi, which ran a special programme on hepatitis C, with factual input and interviewees provided by IWPR’s Tbilisi office. In a later talk show (audio in Georgian here), Radio Imedi interviewed Sabelashvili from the Harm Reduction Network.

After the meeting, Mariana Chokheli, harm reduction coordinator with the Open Society Georgia Foundation, said it had been valuable.

“The pharmaceutical companies, government representatives, and journalists received some new information from one another, so such meetings must carry on,” she said. “In future, I'd like to see representatives from the Georgian drug agency and health ministry attending such meetings, although I know IWPR did invite them.”

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Dozens of Okla. dentist's patients positive for hepatitis

W. Scott Harrington will appear at a revocation hearing before the Oklahoma Board of Dentistry on August 16.

By CNN Staff

April 18, 2013 -- Updated 1922 GMT (0322 HKT)

(CNN) -- They went to the dentist to get a wisdom tooth pulled or perhaps have their jaw realigned. But they may have also contracted a blood-borne virus.

Health officials in Oklahoma are notifying 57 patients who tested positive for hepatitis C and three patients who tested positive for hepatitis B after visiting oral surgeon W. Scott Harrington's office in Tulsa and a city suburb, according to a joint statement issued Wednesday by the Oklahoma State Department of Health and the Tulsa Health Department.

At least one positive HIV result was also reported, but policy prohibits the Oklahoma State Department of Health from releasing the number if it's less than three.

Health officials stress that it's not yet clear how many of the positive patients were exposed at Harrington's office, if any.

"This is a complex investigation," state epidemiologist Kristy Bradley said in the statement. "The next phase will include more in-depth interviews of persons who test positive to determine the likelihood that their exposure is associated with their dental surgical procedure at the Harrington practice. We will certainly continue to keep the public informed as we learn more."

More than 3,200 of Harrington's patients were screened for HIV, hepatitis B and hepatitis C after health investigators found sterilization violations and other infractions at the oral surgeon's office.

Scores of Tulsa dental patients tested for hepatitis, HIV exposure

"I will tell you that when ... we left, we were just physically kind of sick," Susan Rogers, executive director of the Oklahoma Board of Dentistry, told CNN earlier. "That's how bad it was, and I've seen a lot of bad stuff over the years."

The dentistry board launched its probe after one of Harrington's patients came down with hepatitis C. That patient originally tested positive for HIV, too, but a subsequent test came back negative, the Tulsa Health Department said.

Investigators raised a number of sterilization and "cross-contamination" alarms -- such as "unauthorized, unlicensed" employees using IVs to sedate patients and improper handling of needles.

The outward cleanliness of the office belied the mess elsewhere, Rogers said, noting that "just basic universal precautions for blood-borne pathogens" weren't followed.

Besides being "unlocked and unattended," the drug cabinet was rife with issues -- containing, for example, a drug that expired in 1993, according to the official complaint filed before the state dental board. Other records showed that morphine had been used in patients throughout 2012, even though the dentist had not received a morphine delivery since 2009.

Harrington voluntarily surrendered his dental license on March 20. He will appear at a revocation hearing before the Oklahoma Board of Dentistry on August 16. His attorney could not be immediately reached for comment.

Dentist's office a 'perfect storm' for HIV, hepatitis exposure, health official says

Not all patients who may have contracted a virus have been identified, state health officials said, noting this is the first round of testing results. And the tests used to diagnosis hepatitis and HIV are based on the body's immune system response to infection, so some results could have come back negative prematurely.

"Persons who are tested prior to six months after exposure and are found to be negative should be tested again at six months after exposure to assure they are negative," the statement advised.

Hepatitis C is a contagious liver disease that can lead to liver failure and death, according to the Centers for Disease Control and Prevention. Approximately 70% to 80% of people living with the virus do not have any symptoms. Hepatitis B is a similar liver disease that can range from a mild illness to a serious, chronic condition.

Anyone who was treated at Harrington's dental practice should contact Oklahoma's patient information hotline between 8 a.m. and 5 p.m. at (918) 595-4500 with questions.

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Also See: Dozens of Oklahoma dentist's patients test positive for hepatitis (Reuters)

Dozens of Oklahoma dentist's patients test positive for hepatitis

By Steve Olafson

OKLAHOMA CITY | Fri Apr 19, 2013 1:49am IST

OKLAHOMA CITY (Reuters) - Blood tests conducted on patients treated at an Oklahoma oral surgery practice that has been closed over health concerns show that 57 have hepatitis C, three have hepatitis B and as many as three have HIV, the virus than can lead to AIDS, officials said on Thursday.

Health officials said it will take more investigation - including interviews with each patient and blood tests of the remaining patients - before they can determine whether the viruses were contracted at the dental offices, an extremely rare occurrence.

"Now the real disease detective work goes into effect," state health department spokeswoman Leslea Bennet-Webb said.

Officials cannot be more specific about the number of patients who tested positive for HIV because of the state's confidentiality policy that restricts public disclosure of HIV cases involving fewer than three people, Bennet-Webb said.

Health officials so far have screened 3,122 people who underwent oral surgery procedures at clinics operated by Dr Scott Harrington, a Tulsa oral surgeon who is accused of using improper sterilization techniques that may have exposed his patients to blood-borne viruses.

Harrington agreed to close his Tulsa practice and a nearby satellite clinic last month. Health officials want 7,000 of his patients to have their blood tested.

Harrington's attorney has said his client has an impeccable record with the state dentistry board, which has filed a 17-count complaint against the oral surgeon that accuses him of being a "menace to the public health" because of his unsanitary procedures.

There are only three known cases in the United States of viruses being transmitted during dental procedures, according to Centers for Disease Control.

(Reporting by Steve Olafson; Editing by Mary Wisniewski and Jackie Frank)

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HCV-infected patients bury heads in sand

By Kirsty Oswald, medwireNews Reporter

08 April 2013

J Viral Hepat 2013; Advance online publication

medwireNews: Researchers have found poor levels of knowledge about hepatitis C virus (HCV) among individuals with HCV mono-infection and HCV/HIV co-infection.

Patients who were indifferent to the need for treatment or reported feeling ashamed of their HCV-positive status scored particularly badly in knowledge tests.

Mamta Jain (University of Texas Southwestern Medical Center, Dallas, USA) and colleagues found that both mono- and co-infected patients scored under 50% in a knowledge test, which assessed understanding of HCV disease, transmission, and treatment.

Among 292 respondents recruited through outpatient clinics, many reported fear about their infection, with 56.8% acknowledging that they were scared about their HCV status, and 31.7% feeling stigmatized by it.

Worryingly, 18.0% thought that HCV does not cause health problems, 15.2% thought that they do not require treatment due to lack of symptoms, and 20.7% said feeling ashamed prevented them from seeking treatment.

Knowledge scores were significantly lower among the 26.6% of patients who thought medication was unnecessary for HCV, than for those who did not endorse this belief, at a mean of 15.1 vs 17.5 out of 34, with a similar gap in knowledge between those who did and did not say they felt ashamed about HCV (15.3 vs 17.2).

While knowledge levels were comparable between mono- and co-infected patients, co-infected participants had more knowledge about HCV treatment and about HIV, and perceived less stigma from HCV. The authors suggest this may be due to their ongoing HIV care, and that these patients may perceive their HIV-positive status as more stigmatizing than HCV.

Additionally, 87 patients took an abridged version of the survey before and after a 1-hour education session designed to improve knowledge and attitudes regarding HCV. The authors found that while this did not lead to changes in the respondents' attitudes, it did increase their mean knowledge score from a mean of 17.2 to 23.3 points out of 34.

"However, re-education and ongoing support may be necessary to maintain patients' knowledge level about HCV," say Jain and colleagues, writing in the Journal of Viral Hepatitis.

"There also remains a need to develop interventions that could specifically modify attitudes towards HCV treatment," they add.

Despite effective treatments, which can lead to high rates of sustained virological response, many mono-and co-infected HCV patients fail to get treatment, the authors explain.

"Future studies are needed to effectively change attitudes and determine whether those changes will affect health behaviour among mono-infected and co-infected populations," they conclude.

medwireNews (www.medwirenews.com) is an independent clinical news service provided by Springer Healthcare Limited. © Springer Healthcare Ltd; 2013

Free abstract

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HCV infection alone not linked to diabetes risk

By Ingrid Grasmo, medwireNews Reporter

15 April 2013

Am J Gastroenterol 2013; Advance online publication

medwireNews: Individuals with hepatitis C virus (HCV) infection are at increased risk for developing Type 2 diabetes only if they have elevated alanine aminotransferase (ALT) levels, show study findings published in the American Journal of Gastroenterology.

The authors dismissed the results of previous studies showing a direct association between anti-HCV antibodies at baseline and higher incidence of Type 2 diabetes at follow-up.

In total, 2472 individuals from the electoral register of a town in Southern Italy were randomly selected and followed up over a 20-year period in 1985, 1992, and 2005. At each time point, individuals filled in a questionnaire and gave a blood sample to measure blood glucose and other serum variables including ALT. Anti-HCV antibodies were measured at the first and second timepoints.

Authors Giovanni Misciagna (IRCCS Savierio de Bellis, Bari, Italy) and colleagues found a higher prevalence of diabetes in patients with anti-HCV antibodies in 1985 and 1992. Furthermore, patients with anti-HCV antibodies had a higher incidence of Type 2 diabetes during 1985-1992 compared with 1992-2005.

Regression analysis controlling for gender, age, BMI, and ALT revealed no direct association between Type 2 diabetes and anti-HCV antibodies. However, Type 2 diabetes was associated with increased ALT at baseline. Indeed, HCV was shown to be associated with a 1.47-fold significantly increased risk for Type 2 diabetes only if ALT was elevated compared with negative HCV and ALT status.

The same direct association between anti-HCV antibodies and Type 2 diabetes in the presence of elevated ALT was also observed when the authors used changes in blood glucose levels instead of incident cases of Type 2 diabetes.

"Increased ALT values may be due to either HCV or conditions such as metabolic syndrome or steatohepatitis independently from HCV, conditions that could cause insulin resistance and then [Type 2 diabetes]," say the researchers.

medwireNews (www.medwirenews.com ) is an independent clinical news service provided by Springer Healthcare Limited. © Springer Healthcare Ltd; 2013

Free abstract

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Daclatasvir/asunaprevir effective in difficult-to-treat HCV populations

Suzuki Y. J Hepatol. 2013;58:655-662.

April 5, 2013

Most patients with chronic hepatitis C who had been ineligible for or nonresponsive to interferon-based treatment benefited from dual therapy with daclatasvir and asunaprevir in a recent study.

In an open-label, phase 2a study, researchers administered 24 weeks of dual oral therapy with 60 mg NS5A replication complex inhibitor daclatasvir (DCV) once daily and 200 mg NS3 protease inhibitor asunaprevir (ASV) twice a day to 43 Japanese patients aged 20 to 75 years with chronic HCV genotype 1b. The cohort included 21 null responders and 22 who had been ineligible or intolerant to previous therapy with pegylated interferon-alfa and ribavirin (PegIFN-a/RBV).

Thirty-six participants completed therapy. At 4 weeks, more patients in the intolerant/ineligible group had achieved undetectable HCV RNA levels than null responders, with mean RNA reductions of 5.4 log₁₀ IU/mL among intolerant/ineligible patients and 5.6 log₁₀ IU/mL for null responders. All participants had undetectable HCV RNA levels after 8 weeks. Sustained virologic response (SVR) at 12 and 24 weeks after completion of treatment occurred in 76.7% of the cohort (90.5% of null responders and 63.6% of intolerant/ineligible participants).

Virologic breakthrough occurred in three intolerant/ineligible participants, along with four relapses after treatment. No null responders experienced relapse or virologic breakthrough. Investigators observed no associations between breakthrough or relapse and factors including gender, IL28B genotype, age, HCV RNA level at baseline, fibrosis stage and reasons for previous treatment ineligibility.

Common adverse events, all typically mild, included headache, nasopharyngitis, diarrhea and increases to ALT/AST. Five patients experienced serious events, and three discontinued treatment for hyperbilirubinemia or transaminase elevation.

“Dual oral therapy with daclatasvir and asunaprevir elicited rapid clearance of detectable HCV RNA and achieved high rates of SVR in two difficult-to-treat patient populations,” the researchers concluded. “These results confirm initial findings that HCV genotype 1b infections can be cured with daclatasvir combined with asunaprevir, without PegIFN-a/RBV.

“Further research will assess the benefits of this and other [direct-acting antiviral] combinations in larger and more diverse patient populations.”

Disclosure: See the study for a full list of relevant disclosures.

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Consumers Urged to Avoid Ginkgo in Wake of New Cancer Concerns

CSPI Downgrades Safety Rating of Common Supplement Ingredient

April 18, 2013

Consumers should avoid Ginkgo biloba, a common ingredient in dietary supplements, herbal teas, and some energy drinks, based on a new study from the government's National Toxicology Program that found "clear evidence" that the ingredient caused liver cancer in mice and "some evidence" that ginkgo caused thyroid cancer in rats. That is the advice of the Center for Science in the Public Interest, which today downgraded ginkgo from "safe" to "avoid" in its Chemical Cuisine guide to food additives.

"Ginkgo has been used in recent years to let companies pretend that supplements or energy drinks with it confer some sort of benefit for memory or concentration," said CSPI executive director Michael F. Jacobson. "The evidence for those claims has been dubious, at best. The pretend benefits are now outweighed by the real risk of harm."

Ginkgo is often sold as a supplement on its own by companies such as NatureMade, Nature's Bounty, GNC, and other companies, or as one of several ingredients in supplements marketed as memory aids. It is or has been used in energy drinks such as Rockstar, Crunk, Hansen's Energy Pro, Guru, and Steven Seagal's Lightning Bolt. The Food and Drug Administration has sent warning labels to several drink companies, including Rockstar, stating that ginkgo is not generally recognized as safe, or GRAS, for use in food, though it is legal as an herbal supplement.

Researchers at the NTP gave male and female rats dosages of Ginkgo biloba extract five times a week for two years. The NTP is an interagency program connected to the Department of Health and Human Services and the National Institutes of Health. It is headquartered at the National Institute of Environmental Health Sciences in Research Triangle Park, NC.

"We conclude that Ginkgo biloba extract caused cancers of the thyroid gland in male and female rats and male mice and cancers of the liver in male and female mice," the researchers stated.

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Liver disease: Understanding it will enable the provision of better treatment

Posted By News On April 18, 2013 - 2:30pm

In this prospective study, led by Dr Richard Moreau, INSERM Research Director (Mixed Research Unit 773 "Centre de Recherche biomédicale Bichat-Beaujon"; INSERM/Université Paris Diderot) who is also a practitioner attached to the Hepatology Department of the Beaujon Hospital (AP-HP), researchers studied a cohort of 1343 patients from 12 European countries.

The results, published in the learned journal Gastroenterology, describe, for the first time, the specific profile of sufferers from this syndrome that is associated with cirrhosis. This also makes it possible to more clearly define the actual rules of attribution of the organs in those most severely affected, for whom there is a high risk of early death.

Cirrhosis is an irreversible liver disease. It is characterised by chronic inflammation that destroys the liver cells and produces anarchic regeneration in the form of nodules. The disease causes the liver to lose function and is accompanied by multiple complications. When these complications manifest (bleeding in the digestive tract, bacterial infection, accumulation of liquid in the abdomen, etc.), this is known as decompensated cirrhosis and the patients are hospitalised.

A certain number of these patients quickly develop a syndrome characterised by acute liver failure and/or failure of other vital organs1 (ACLF – acute-on-chronic liver failure). The syndrome is associated with a high risk of death at one month and no diagnostic criteria were clearly established hitherto that might make it possible to describe the condition.

Through a consortium , the researchers in Mixed Research Unit 773 "Centre de Recherche biomédicale Bichat-Beaujon" (INSERM/Université Paris Diderot), analysed data from 1343 patients hospitalised due to acute cirrhosis complications between February and September 2011 in 29 Hepatology Departments in 12

European countries . This enabled them to define robust diagnostic criteria for ACLF, indicating that one-third of the patients enrolled in the study had developed this syndrome.

The researchers noted that, compared to patients not suffering from ACLF, those who developed acute failure of an organ or organs were younger, were most frequently prey to alcoholism, suffered from a larger number of bacterial infections and had higher levels of white blood cells, as well as other markers of organ inflammation.

Quite unexpectedly, failure was most severe in patients without a previous history of cirrhosis complications. A high number of organ malfunctions (liver, kidneys, brain) were observed in these patients, including white blood cells in the blood and a mortality rate within one month of admission to hospital that was15 times greater than in patients who had a previous history.

"The identification of the criteria to define acute failure of an organ or organs enabled us to show that this is a separate syndrome from cirrhosis complications. In addition to organ failure and the high associated mortality, the development of the disease depends on the patient's age and medical history", explains Richard Moreau, INSERM Director of Research, and the Principal Investigator for the study. "We hope to be able to better identify those at risk of early death in order to improve their treatment. Furthermore, these results could lead to improving the current rules for assigning organs for grafting in the severest cases", he concludes.

Source: INSERM (Institut national de la santé et de la recherche médicale)

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Increased incidence of orthopedic fractures in cirrhotic patients: A nationwide population-based study

Journal of Hepatology
Volume 58, Issue 4 , Pages 706-714, April 2013

Chia-Fen Tsai, Chia-Jen Liu, Tzeng-Ji Chen, Chi-Jen Chu, Han-Chieh Lin, Fa-Yauh Lee, Tung-Ping Su, Ching-Liang Lu

Received 18 June 2012; received in revised form 28 November 2012; accepted 1 December 2012. published online 11 December 2012.

Abstract

Background & Aims

Hepatic encephalopathy (HE) is a reversible neuropsychiatric disorder in cirrhotic patients. The cognitive dysfunction and increased accidental falls in HE and osteodystrophy in cirrhotic patients may contribute to orthopedic fractures. This study investigated the fracture incidence and risk factors in cirrhotic patients with HE.

Methods

In total, 3764 cirrhotic patients with HE were identified from the Taiwan National Health Insurance database between 2000 and 2009. The fracture incidence of the HE patients was compared with that of 3764 age-, sex-, and comorbidity-matched cirrhotic patients without HE and non-cirrhotic controls. Cox proportional hazard models were used to estimate the risk of fracture in the HE patients.

Results

Cirrhotic patients with and without HE had comparable increased risks of fracture (p <0.05) and cumulative incidences of fracture than controls (log-rank p <0.001). The estimated fracture rates were 7.09% for the HE group, 7.72% for the cirrhosis without HE group, and 4.05% for the controls, during the 18-month follow-up. The HE group had a higher incidence rate of skull fractures (IRR=2.61, 95% CI 1.04–6.57), but a lower rate of upper limb fractures (IRR=0.45, 95% CI 0.29–0.70) than the cirrhosis without HE group. Alcoholism, heart failure, and cerebrovascular disease were associated with increased risk of fracture in HE patients.

Conclusions

Cirrhotic patients, with or without HE, are at an increased risk of orthopedic fractures. Skull fractures, rather than fractures in weight-bearing bones, are more frequently observed in HE patients, particularly those with comorbidities.

Abbreviations: HE, hepatic encephalopathy, IRR, incidence rate ratio, CI, confidence interval, NHI, National Health Insurance, ICD, International Classification of Diseases, DM, diabetes mellitus, HR, hazard ratio

Keywords: Cirrhosis, Injury, Neuropsychiatric syndrome

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Vitamin B12 supplementation improves rates of sustained viral response in patients chronically infected with hepatitis C virus

Gut2013;62:766-773 doi:10.1136/gutjnl-2012-302344

Hepatology

Original article 

Alba Rocco1, Debora Compare1, Pietro Coccoli1, Ciro Esposito2, Antimo Di Spirito2, Antonio Barbato3, Pasquale Strazzullo3, Gerardo Nardone1

+ Author Affiliations

Correspondence to Professor Gerardo Nardone, Department of Clinical and Experimental Medicine, Gastroenterology Unit, University of Naples “Federico II”, via Pansini 5, 80131 Naples, Italy; nardone@unina.it

Contributors AR, DC, GN: study concept and design and drafting of the manuscript. AR, DC, PC, CE, ADS: acquisition of data. AR, AB: analysis and interpretation of data; statistical analysis. PS, GN: critical revision of the manuscript for important intellectual content.

Revised 5 June 2012

Accepted 6 June 2012

Published Online First 17 July 2012

Abstract

Background In vitro, vitamin B₁₂ acts as a natural inhibitor of hepatitis C virus (HCV) replication.

Objective To assess the effect of vitamin B₁₂ on virological response in patients with chronic HCV hepatitis naïve to antiviral therapy.

Methods Ninety-four patients with chronic HCV hepatitis were randomly assigned to receive pegylated interferon α plus ribavirin (standard-of-care; SOC) or SOC plus vitamin B₁₂ (SOC+B₁₂). Viral response—namely, undetectable serum HCV-RNA, was evaluated 4 weeks after starting treatment (rapid viral response), 12 weeks after starting treatment (complete early viral response) and 24 or 48 weeks after starting treatment (end-of-treatment viral response) and 24 weeks after completing treatment (sustained viral response (SVR)). Genotyping for the interleukin (IL)-28B polymorphism was performed a posteriori in a subset (42/64) of HCV genotype 1 carriers.

Results Overall, rapid viral response did not differ between the two groups, whereas the rates of complete early viral response (p=0.03), end-of-treatment viral response (p=0.03) and SVR (p=0.001) were significantly higher in SOC+B₁₂ patients than in SOC patients. In SOC+B₁₂ patients, the SVR rate was also significantly higher in carriers of a difficult-to-treat genotype (p=0.002) and in patients with a high baseline viral load (p=0.002). Distribution of genotype IL-28B did not differ between the two groups. At multivariate analysis, only easy-to-treat HCV genotypes (OR=9.00; 95% CI 2.5 to 37.5; p=0.001) and vitamin B₁₂ supplementation (OR=6.9; 95% CI 2.0 to 23.6; p=0.002) were independently associated with SVR.

Conclusion Vitamin B₁₂ supplementation significantly improves SVR rates in HCV-infected patients naïve to antiviral therapy.

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