November 20, 2010

Suicide risk in hepatitis C and during interferon-alpha therapy: a review and clinical update

Journal of Viral Hepatitis
Early View (Articles online in advance of print)
Article first published online: 10 NOV 2010
DOI: 10.1111/j.1365-2893.2010.01393.x
© 2010 Blackwell Publishing Ltd

S. Sockalingam 1,2,3, P. S. Links 3,4, S. E. Abbey 1,2,3

Additional Information (Show All)


Keywords: depression;hepatitis C;interferon-alpha;suicide

Summary.  Chronic hepatitis C (CHC) affects over 170 million individuals worldwide and is a growing public health concern. Despite the availability of CHC treatment, specifically interferon-α and ribavirin, treatment of CHC is limited by concerns about psychiatric side effects including risks of suicide. Although depression has been the focus of neuropsychiatric complications from interferon-alpha (IFNα), emerging evidence has contributed to our understanding of IFNα-induced suicidal ideation and attempts. Using Pubmed, we performed a literature review of all English articles published between 1989 and April 1, 2010 on suicide in untreated and IFNα-treated patients with CHC. References in all identified review articles were scanned and included in our review. A total of 17 articles were identified. Studies have suggested that the first 12 weeks of IFNα therapy are the high-risk period. Moreover, the emergence of suicidal ideation can be linked to neuropsychiatric abnormalities, specifically serotonin depletion. Pretreatment with antidepressant treatment should be reserved for high-risk groups, as this may reduce the risk of depression and thus decrease the suicide risk indirectly. Although there is a paucity of literature on suicide and suicide risk during IFNα therapy for CHC, recent studies on IFNα-induced depression have provided some potential insights into suicide in this patient population. Further research examining the effects of pharmacological and nonpharmacological interventions on suicide risk during IFNα treatment is needed.


The IL-28 Genotype: How It Will Affect the Care of Patients with Hepatitis C Virus Infection

Current Gastroenterology Reports
DOI: 10.1007/s11894-010-0161-9

Brian L. Pearlman


The hypothesis that host genetics play an essential role in the ability not only to clear acute hepatitis C infection but also to achieve sustained virologic response (SVR) to interferon (IFN)-based therapy has been proved with the recent discovery of two single-nucleotide polymorphisms on chromosome 19. Variants in the minor allele rs8099917 and the proximate polymorphism rs12979860, 3 kb upstream of the interleukin (IL)-28B gene, which encodes the endogenous antiviral cytokine IFN-λ, are associated with SVR and with natural viral clearance. The disparate frequencies of these alleles in ethnic groups worldwide may well explain differing rates of SVR among them. The test for one of these polymorphisms is now commercially available and can serve as a powerful predictor of a patient’s chance of achieving SVR. Perhaps more importantly, the test can help the clinician personally tailor the duration and even the type of therapy that is most appropriate for an individual patient, newly or chronically infected with the hepatitis C virus.

Keywords Hepatitis C - Acute hepatitis C - Chronic hepatitis C - Viral hepatitis - IL-28 polymorphisms - Genome-wide association studies - Single-nucleotide polymorphisms


Milk thistle, vitamin E and fish oil fats can prevent and reverse fatty liver disease

Friday, November 19, 2010 by: John Phillip, citizen journalist

(NaturalNews) As many as 1 in 3 Americans are living with a ticking bomb known as nonalcoholic fatty liver disease (NAFLD). The condition is virtually symptomless until the liver becomes inflamed or scarred from decades of dietary abuse. The vast majority of NAFLD is caused by poor dietary choices that increase dangerous blood fat levels. As a consequence, fat is deposited in the liver cells where it triggers inflammation and the release of chemical messengers known as adipokines as the liver attempts to repair itself. Left unchecked, NAFLD can progress to cirrhosis and liver failure. Emerging research provides powerful nutritional options that can dramatically lower the risk of developing fatty liver disease.

Understanding the Cause of Nonalcoholic Fatty Liver Disease

Many chronic conditions are known to initiate and progress due to inflammation within our body, and fatty liver disease is no exception. The liver is responsible for metabolizing cholesterol and influences how fat is either burned for energy or stored for future use. An increasing burden is placed on the organ as we eat excess calories from sugar, refined carbohydrates and hydrogenated fats. Fat metabolism is disrupted as high levels of blood fats become stored in the liver. Eventually this leads to a decline in liver function and finally to total organ failure and death.

Study Supports the Antioxidant Power of Vitamin E

Natural nutrients that are known to exert strong antioxidant and anti-inflammatory properties have proven more effective than any pharmaceutical in the prevention and treatment of NAFLD. Researchers from the Virginia Commonwealth University Medical Center compared the effect of vitamin E and the drug Actos on lowering liver enzymes that are associated with advancement of liver disease. They found that the insulin-sensitizing drug had no effect while vitamin E (800 IU per day) was shown to provide significantly lowered enzyme markers and to improve scarring.

Fish Oil Fatty Acids Improve Blood Lipids, Improve Liver Function

EPA and DHA Omega-3 fats have gained notoriety for their ability to positively regulate cholesterol ratios and lower triglycerides. Research published in the British Medical Journal found that supplementing with 1,000 mg of Omega-3 fats per day markedly decreased serum markers of liver cell damage, triglyceride levels and glucose. Any natural therapy that helps the body eliminate triglycerides and lower blood sugar levels will lower the underlying risk factors for NAFLD.

Milk Thistle Shown to Directly Target the Liver

The active compound in milk thistle, known as silymarin, is a potent antioxidant and anti-inflammatory agent that directly impacts liver function. Researchers have discovered that milk thistle inhibits the release of cytokines from the liver that normally increases with fatty liver inflammation. This action allows the liver to begin the natural healing process while reducing fat accumulation and reducing blood markers associated with liver damage.

Vitamin E, Omega-3 fats and milk thistle each help to restore normal liver function for the millions of men, women and children that suffer the silent effects of fatty liver disease. Including all three of these powerful natural nutrients in your daily disease-fighting arsenal will provide a multi-modal defense against NAFLD.

Article References:

About the author

John Phillip is a Health Researcher and Author who writes regularly on the cutting edge use of diet, lifestyle modifications and targeted supplementation to enhance and improve the quality and length of life. John is the author of 'Your Healthy Weight Loss Plan', a comprehensive EBook explaining how to use Diet, Exercise, Mind and Targeted Supplementation to achieve your weight loss goal. Visit My Optimal Health Resource to continue reading the latest health news updates, and to download your Free 48 page copy of 'Your Healthy Weight Loss Plan'.


The Fatty Liver Dilemna

By Carolyn Salazar
Published November 20, 2010
Fox News Latino

Hispanics children and adolescents are genetically predisposed to developing fatty liver disease, which could trigger cirrhosis, cardiovascular problems and diabetes, two recent studies show.

The study found that Hispanic children who carry a gene variant have increased liver fat and are susceptible to developing liver fat when they have a diet high in sugar, according to the studied published in the journals Diabetes and the American Journal of Clinical Nutrition.

Fatty liver is a disease mostly seen among those who consume excessive alcohol or are obese and can lead to a form of hepatitis. It is a major cause of illness and death in the United States.

Previous reports have shown Hispanics are particularly susceptible to accumulation of fat in the liver, and reports suggest that nearly four of 10 obese Hispanic children have nonalcoholic fatty liver disease.

“Collectively these findings demonstrate that Hispanics are genetically susceptible to the negative health effects of high sugar consumption, and that this effect is manifested early in life,” said Michael I. Goran, director of the University of Southern California’s Childhood Obesity Research Center at the Keck School of Medicine. “This is a major public health concern, especially in the face of massive marketing of sugary beverages to children.”

The researchers studied more than 300 Hispanic youth – ages 8-18 – in the Los Angeles. It found that carriers have almost double the amount of liver fat content as non-carriers.

The effects are strongest among Hispanics because the variant is higher (49 percent) than in whites (23 percent) or African Americans (17 percent), said Jaimie Davis, assistant professor of preventive medicine at the Keck School of Medicine, and a lead author on the studies.

The findings suggest that obese Hispanic children with the variant have an increased capacity for fat storage and a smaller breakdown of stored fats among those whose diets are high in sugar, she said.

Sugar intake is high among youth in Los Angeles, and accounts for nearly half of all daily carbohydrate intake and 25 percent of energy intake, the study shows.

“Specific dietary interventions based on the genetic predisposition may lead to more effective therapeutic outcomes in children with fatty liver disease,” she said. “I think the studies really highlight the need to test such diet and genotyping interventions.”


Kidney transplant 'feasible' for patients with HIV

Michael Carter
Published: 19 November 2010

Kidney transplant is a feasible option for HIV-positive patients with end-stage renal disease, US investigators report in the November 18th edition of the New England Journal of Medicine.

Three years after transplant 88% of patients were still alive, and the transplanted kidney was still functioning in 78% of individuals. Overall, transplant did not complicate HIV disease management.

“Kidney transplantation is highly feasible in HIV-infected recipients,” comment the investigators.

End-stage renal disease is an important cause of illness in HIV-positive patients. Thanks to the success of antiretroviral therapy many HIV-positive patients with severe renal disease are considered good candidates for transplant.

Investigators wanted to see how safe and effective kidney transplant was in patients with HIV. They therefore conducted a multicentre, prospective study involving 150 patients who received a new kidney at 19 transplant centres across the US. The patients were followed for up to three years.

To be eligible for transplant, patients were required to have a CD4 cell count of at least 200 cells/mm3, and an undetectable viral load while taking antiretroviral therapy. Patients who were co-infected with hepatitis B or hepatitis C were only eligible for transplant if they showed no sign of cirrhosis.

The patients had a median age of 46, most (78%) were men, and 69% were black. Median CD4 cell count at the time of transplant was 524 cells/mm3. A total of 19% of patients were co-infected with hepatitis C and 3% were co-infected with hepatitis B.

Enrolment occurred between 2003 and 2009. The median duration of follow-up was 1.7 years, but 53 patients contributed three or more years of follow-up.


Survival rates were good. One year after transplant 95% of patients were alive and the graft had survived in 90%. After three years, 90% of individuals were still alive, and the transplanted kidney was still functioning in 74%.

These survival rates were slightly poorer than those seen in HIV-negative kidney transplant recipients, but were better than the rates observed in older transplant patients.

A total of eleven patients died. Three of the deaths were attributed to cardiac causes, two to sepsis, two to lung infections, two to cancer in the non-transplanted kidney, and two to unknown causes. The new kidney was still functioning in eight patients at the time of their death.

In addition, 13 patients lost their transplanted kidney. For five patients the cause was long-term rejection or chronic graft nephropathy, vascular thrombosis (three patients), acute rejection (three patients), technical reasons (one patient), and non-adherence to treatment (one patient).

Patients who received a kidney from a living donor were significantly less likely to lose their kidney than those whose donor was deceased (p = 0.02).

Antibody induction therapy with antithymocyte globulin was associated with an increased risk of graft rejection (p = 0.03).


A total of 49 patients experienced acute organ rejection. The incidence of rejection after one year was 31%, increasing to 41% after three years. Rejection responded to glucocorticoid therapy in 48% of patients.

Factors associated with an increased risk of rejection were receipt of a kidney from a deceased donor (p = 0.03), and use of the immunosuppressive drug cyclosporine (p = 0.02).


Patients whose donor was dead were more likely than those with a living donor to require dialysis during the first week after transplant (46% vs. 15%).

Episodes of organ rejection were associated with poorer kidney function after one and three years of follow-up (p = 0.05 and p = 0.01 respectively).

HIV disease progression

One year after transplant, patients who received antithymocyte globulin had significantly greater falls in their CD4 cell counts than individuals who did not receive this drug (-238 vs. -135 cells/mm3, p < 0.001). A difference was still apparent after three years (-57 vs. -52 cells/mm3, p = 0.05).

Viral load became detectable in 48 (32%) of patients at least once. Most of these increases in viral load were transient and one patient had a detectable viral load three years after transplant.

There were seven new AIDS-diagnoses.

Of the 150 transplant recipients, 57 had a total of 140 infections that required hospitalisation. Two-thirds of these were due to bacterial infections.

Patients co-infected with hepatitis C had a significantly higher rate of serious infecitons (p = 0.02). Infection rates were also significantly higher among patients treated with antithymocyte globulin (p = 0.002).

“The rates of patient survival and graft survival at 3 years were generally between the reported rates in the national database for older kidney-transplant recipients and for all kidney-transplant recipients,” comment the investigators.

They believe that these “favourable results were influenced by careful patient selection, adherence to clinical management protocols…and close coordination among the multidisciplinary teams.”

However, the investigators highlighted the difficulty of achieving “therapeutic and non-toxic levels of immunosuppressive drugs,” and they believe that this contributed to high rejection rates. The authors therefore caution: “antithymocyte globulin induction therapy should be restricted to patients at very high immunologic risk for rejection.”

Stock PG et al. Outcomes of kidney transplantation in HIV-infected recipients. New Engl J Med 363: 14-25, 2010.


Physicians advise to eat meat in moderate quantity

Updated at: 2030 PST,  Saturday, November 20, 2010

ISLAMABAD: Physicians have advised people to eat meat in moderate quantity as balanced diet promises healthy life while imbalanced diet causes diseases.

According to the physicians overeating of meat can be dangerous for people with liver disorders as well as patients of hepatitis and jaundice.

"Extra intake of meat can increase blood circulation in stomach among cardiac patients, resulting in ischemic heart diseases", said Dr. Usman, who runs a private clinic.

He said that diabetic patients should not consume much meat because its fats contain nine caloric/grams and the sugar level can shoot up.

Health expert Dr. Asim said that one should be careful while defrosting frozen meat. It should be kept lukewarm for at least six hours and later keep it in a microwave oven for 45 minutes to kill germs.

Excessive use of salt and chilies increases acidity in stomach and is dangerous for those having problems of regurgitation, ulcers in stomach and small intestines, he said adding the use of cola drinks with spicy food could be more harmful for individuals, particularly having certain disease.

He said that certain parts of the meat are rich in cholesterol like the brain masala, and Sire Paye, which should be avoided by those having high cholesterol level.

The doctors also cautioned against immediate cooking and improper preservation of the meat of sacrificial animals to avoid infectious and fatal diseases among the people especially patients with diabetic, liver, renal, kidney, cardiac and hepatitis complications.

They advised that the people, particularly suffering from heart and hepatitis diseases, should carefully use the meat (mutton and beef), which could otherwise prove harmful for their health.

The excessive burning of meat during barbecue can also produce some chemicals, which are dangerous for the health and contain potential carcinogens.

Sacrificial meat of animals, including goat, cow, sheep and camel, which is known as red meat, is eaten in greater quantity on the Eid than routine, and it is not good for health.

If taken according to the principles of health and hygiene, red meat is rich in high biological value (HBV) protein.

Patients of chronic liver disease (Hepatitis C) should avoid too much red meat because it precipitates Hepatic Encephalopathy (unconsciousness/coma) among them.

Meat is a complete medium for micro-organisms, hence a precious diet for human consumption. After sacrifice, meat should be kept at a cool place before freezing, because it undergoes mortis phenomenon after slaughtering.

The phenomenon does not complete at freezing temperature and meat becomes rigid, repeated freezing and thawing for cooking should be avoided.

Laparoscopic Liver Resection May Beat Open Surgery

Last Updated: November 18, 2010

Laparoscopic liver resection for malignant tumors appears to result in fewer complications than open surgery and is associated with at least comparable long-term survival, according to research published in the November issue of the Archives of Surgery.

THURSDAY, Nov. 18 (HealthDay News) -- Laparoscopic liver resection for malignant tumors appears to result in fewer complications than open surgery and is associated with at least comparable long-term survival, according to research published in the November issue of the Archives of Surgery.

Kris P. Croome, M.D., and Michael H. Yamashita, M.D., of the Harvard School of Public Health in Boston, conducted a meta-analysis of studies comparing laparoscopic hepatic resection (LHR) with open hepatic resection (OHR) for benign and malignant tumors to evaluate long-term outcomes.

In the 26 relevant studies, the researchers found that patients operated on laparoscopically for malignant tumors had a significantly lower hazard ratio for death, less operative blood loss, and a lower risk for postoperative complications. Laparoscopy patients also had significantly shorter hospital stays, duration of intravenous narcotic use, and less time until oral intake. There was no significant difference in recurrence for malignant tumors between laparoscopy patients and those who received an open resection.

"LHR for malignant tumors is associated with a long-term survival that is at least comparable, if not superior, to OHR with no difference in disease recurrence. The use of LHR for benign and malignant tumors is a safe alternative to OHR with potential operative and postoperative benefits," the authors write.

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Long-term outcome after antiviral therapy of patients with hepatitis C virus infection and decompensated cirrhosis

Clinical Gastroenterology and Hepatology
PII: S1542-3565(10)01109-2
© 2010 AGA Institute. Published by Elsevier Inc. All rights reserved

Article in Press

Angelo Iacobellis, MD, Francesco Perri, MD, PhD, Maria Rosa Valvano, MS, Nazario Caruso, MD, Grazia Anna Niro, MD, Angelo Andriulli, MD

AffiliationsCorrespondence: Angelo Andriulli, Division of Gastroenterology, “Casa Sollievo della Sofferenza” Hospital, IRCSS, viale Cappuccini 1, 71013 San Giovanni Rotondo, Italy, Phone: +39 0882 410263. Fax: +39 0882 835411.

Received 27 May 2010; received in revised form 19 October 2010; accepted 22 October 2010. published online 18 November 2010.

Accepted Manuscript


Background & Aims
We evaluated the long-term outcomes following antiviral therapy of patients with decompensated cirrhosis and hepatitis C virus (HCV) infection.

Seventy-five patients with HCV infection and decompensated cirrhosis received therapy with peginterferon alfa-2b and ribavirin. We compared adverse-event profiles and mortality rates between patients with or without sustained virological responses (SVRs). The mean follow-up time off therapy was 51±18 months (range 3–78 months).

Seven patients with HCV genotypes 1 or 4 (16%) and 17 patients with genotypes 2 or 3 (55%) achieved SVRs. The mean survival times were 53 months among patients that did not achieve SVRs (95% confidence interval [CI], 48–59 months) and 73 months among those that did achieve SVRs (95% CI, 67–80 months) (P=0.004). During the study, 25 patients died (2 with and 23 without SVRs). In the follow up period, 8/24 patients with SVRs (33.3%) and 49 of 51 without SVRs (96.1%) experienced further events of decompensation (P<0.0001). The hospital re-admission rates for patients with and without SVRs were 7.4 and 56 per 1000 person-months, respectively (ratio of 7.5 without/with SVR; 95% CI, 4.0–16.0; P<0.0001). At the end of the follow-up period, the incidence of hepatocellular carcinoma was not associated with clearance of HCV.

Among patients with cirrhosis that is secondary to HCV infection and who have progressed to a stage of liver decompensation, an SVR following anti-viral therapy is a positive prognostic factor.

Keywords: liver disease, clinical trial, chronic hepatitis, peg-IFN

No full text is available. To read the body of this article, please view the PDF online.


Medivir Announces Positive 24-week Interim Data of TMC435 From the ASPIRE Study (C206)

HUDDINGE, Sweden, November 18, 2010 /PRNewswire/ --

- Once Daily Novel Therapy in Treatment-Experienced Hepatitis C Patients

Highlights of the Study

TMC435 Added to Standard of Care:

- Increased the response rates and antiviral efficacy, which progressed through to week 24

- Increased the number of patients with undetectable Hepatitis C Virus (HCV) levels through week 4, 12 and 24

- Safe and well tolerated

Medivir AB (OMX: MVIR), the emerging research-based specialty pharmaceutical company focused on infectious diseases, announces today positive top-line 24-week interim data from the Phase 2b ASPIRE (C206) study of TMC435 in treatment-experienced hepatitis C patients. The results demonstrate the potent and consistent antiviral efficacy of TMC435 in patients who had failed earlier treatment with peg-IFN and ribavirin (standard of care), as well as a safety and adverse event profile for TMC435 that is consistent with what Medivir previously reported in the Phase 2b PILLAR C205 study. TMC435, a hepatitis C protease inhibitor, dosed once daily (q.d.) is being developed jointly by Tibotec Pharmaceuticals and Medivir.

The ASPIRE study evaluates the effect of TMC435 in combination with standard of care in 462 patients infected with the difficult to treat genotype-1 hepatitis C virus who had undergone and failed prior treatment with standard of care. The study includes patients that have relapsed, achieved partial response, or achieved no response (null responders) to treatment with standard of care.

TMC435 was administered once daily at a dose of either 100 mg or 150mg given for either 12, 24, or 48 weeks in combination with standard of care. Standard of care treatment was continued until the study completion at week 48.

Overview of the ASPIRE (C206) Week 24 Interim Study Results

The week 24 interim analysis was performed when all patients completed 24 weeks of treatment or discontinued earlier. An Intention-to-Treat (ITT) analysis was performed including all patients who took at least one dose of TMC435.

In the interim analysis, patients treated with TMC435 and standard of care demonstrated high response rates and antiviral efficacy in all patient groups up to and including week 4, 12 and 24. In the relapser group, 81%, 92% and 94% of patients taking TMC435 and Peg-IFN and ribavirin achieved undetectable HCV RNA levels at week 4, week 12 and week 24, respectively. For the partial responder group 62%, 84% and 86% achieved undetectable HCV RNA levels at week 4, week 12 and week 24, respectively.

The null responder group also demonstrated significant response rates with 38%, 64% and 78% of patients taking TMC435 and Peg-IFN and ribavirin achieving undetectable HCV RNA levels at week 4, week 12 and week 24, respectively. All patients continue on active treatment up until week 48.

In the table below the TMC435 data pooled and all data are taken into account at the specific time point.

An Intention-to-Treat analysis of Virologic Response: HCV
RNA<25IU/mL undetectable

(%) Relapser* responder** Null responder***
TMC435 Placebo TMC435 Placebo TMC435 Placebo
N = 158 N = 27 N = 138 N = 23 N = 100 N = 16
RVR 81 4 62 0 38 0

cEVR 92 31 84 10 64 21

WEEK 24 94 83 86 19 78 44

* Relapser: undetectable at end of trial (EOT) but detectable within 24 weeks of follow-up
** Partial response: >2 log reduction at Week 12 but not achieving undetectable at EOT
*** Null response: <2 log reduction in HCV RNA at Week 12

Safety and Tolerabillty

An Intention-to-Treat analysis was performed including all patients who took at least one dose of TMC435. TMC435 was generally safe and well tolerated and the results were consistent with the previously reported phase 2b PILLAR C205 study. Significant decreases in transaminases (ALT and AST) were observed in all TMC435 treatment groups. The two most frequently reported adverse events (AEs) were fatigue and headache, with comparable results shown from the placebo group.

All TMC435 Placebo
N = 396 N = 66
Fatigue 41 42
Headache 33 33

Commenting on the results, Ron Long, CEO of Medivir, said: "We are extremely encouraged and excited by the pronounced efficacy and advantageous safety of TMC435 in these difficult-to-treat patients that are in a great need of new and improved treatment options. We are now looking forward to the next important development milestone for TMC435, the start of Phase 3 clinical trials in treatment-naive patients in early 2011."

Conference call today

A conference call will take place today at 15:00 (GMT) / 16:00 (CET) / 10:00 (EST) to discuss the Phase 2b TMC435 ASPIRE (C206) data announced today. Please dial: UK: +44(0)20-7906-8535, Sweden Access Number: +46(0)85-063-9549 or US Access Number: +1-703-865-2821, no passcode is required. A seven day replay of the conference call can be accessed via: UK: +44(0)20-3364-5943, Sweden: +46(0)20-089-6353, US: +1-866-286-6997, please quote the passcode 281259#.

About Medivir

Medivir is an emerging research-based specialty pharmaceutical company focused on the development of high-value treatments for infectious diseases. Medivir has world class expertise in polymerase and protease drug targets and drug development. Medivir has a strong R&D portfolio and has recently launched its first product Xerese(TM)/Xerclear(TM). Medivir's key pipeline asset, TMC435, a protease inhibitor, is in phase 2b clinical development for Hepatitis C and is partnered with Tibotec Pharmaceuticals.

Xerese(TM)/Xerclear(TM) is an innovative treatment for cold sores, which has been approved in both the US and Europe. It is partnered with GSK to be sold OTC in Europe and Russia and with Meda in North America. Medivir has retained the Rx rights for Xerclear(TM) in Sweden and Finland.

For more information about Medivir, please visit the Company's website:

About Hepatitis C

Hepatitis C is a blood-borne infectious disease of the liver and is a leading cause of chronic liver disease and liver transplants. The WHO estimates that nearly 180 million people worldwide, or approximately 3% of the world's population, are infected with hepatitis C virus (HCV). The CDC has reported that almost three million people in the United States are chronically infected with HCV.

About TMC435 clinical trial programs

TMC435 is a once daily protease inhibitor jointly developed by Medivir and Tibotec Pharmaceuticals to treat hepatitis C virus infections. TMC435 is currently being studied in three phase 2b clinical trials (TMC435-C205, TMC435-C206 and TMC435-C215) in G1 treatment-naive and in G1 patients that failed previous IFN-based treatment. TMC435 is planned to enter phase 3 studies early 2011.

PILLAR Study (TMC435-C205)

TMC435-C205 is an ongoing randomized double-blind global phase 2b study in 386 genotype-1 treatment-naive patients. It evaluates once daily treatment of TMC435 with different doses and durations given in addition to standard of care treatment, consisting of ribavirin and pegIFNalpha-2A. Week 24 interim results were presented as a late-breaker oral presentation at AASLD 61st Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in Boston, MA., USA.

ASPIRE Study (TMC435-C206)

TMC435-C206 is an ongoing randomized double-blind global phase 2b study in 462 genotype-1 treatment-experienced patients. It evaluates once daily treatment of TMC435 in with different doses of given in addition to standard of care treatment, consisting of ribavirin and pegIFNalpha-2A.

DRAGON Study (TMC435-C215)

TMC435-C215 is an ongoing Japanese phase 2b study in 92 genotype-1 treatment-naive patients. It evaluates once daily treatment of TMC435 with different doses and durations given in addition to standard of care treatment, consisting of ribavirin and pegIFNalpha-2A.

Opera-2 (TMC435-C202)

TMC435-C202 is a completed phase 2a study in treatment-naive genotype 2 to 6 HCV patients. It is a once daily treatment of TMC435 during seven days, at 200 mg. Subsequently, patients could continue with SoC treatment consisting of pegylated interferon and ribavirin upon agreement with the study doctor.

For more information about Medivir, please contact:

Medivir (
Rein Piir, CFO & VP Investor Relations, Mobile: +46-708-537-292
Europe: Mary-Jane Elliott / Amber Bielecka, +44(0)20-7920-2330
USA: Jason Marshall, +1-212-897-5497

SOURCE Medivir


HRSA Awards $1.6 Million to Improve Availability and Expansion of Hepatitis C (HCV) Treatment

ROCKVILLE, Md., Nov. 19, 2010 /PRNewswire-USNewswire/ -- The Health Resources and Services Administration (HRSA) has awarded $1.6 million in grants to support the Hepatitis C Treatment Expansion Initiative. The funds will aid organizations implementing effective, focused interventions designed to increase access to and completion of Hepatitis C (HCV) treatment for HIV-positive patients. Hepatitis C affects about 3.2 million people in the United States, and is responsible for approximately 17,000 deaths each year; about one quarter of HIV-infected persons in the U.S. are also infected with Hepatitis C.

The grants, funded under the Ryan White HIV/AIDS Program, Special Projects of National Significance, were awarded to 15 demonstration sites and one Evaluation and Technical Assistance Center (ETAC). This initiative will evaluate the effectiveness of the interventions to deliver HCV treatment among HIV-positive populations, and share best practice models with Ryan White grantees and other HIV medical providers to improve access and quality of Ryan White services for HIV patients.

"These funds are essential to expanding care and treatment to people living with HIV/AIDS and Hepatitis C," said HRSA Administrator Mary K. Wakefield, R.N., Ph.D. "This is an important opportunity to make measurable progress in treating coexisting conditions and creating a more knowledgeable care community to serve those most in need."

The organizations receiving the awards comprise the first of two demonstration site cohorts, each with two-year project periods. In addition, HRSA awarded a separate four-year cooperative agreement to the University of South Florida to serve as the ETAC, which will evaluate and provide technical assistance to the demonstration sites.

Continue Reading ....

Vaccine testing for hepatitis C promising

Trials in England show boosted immunity

By AARON DERFEL, The Gazette November 20, 2010

Scientists are zeroing in on a promising vaccine to treat hepatitis C, an international symposium was told yesterday in Montreal.

Three preliminary clinical trials in England are showing that a so-called therapeutic vaccine can boost the immune response in those infected with the hepatitis C virus.

Still, a viable vaccine is a decade away, said Paul Klenerman, a University of Oxford physician researcher who is conducting the trials.

"Other vaccine trials have been done already, but ours is the first where we're treating people (with drugs) and giving them the vaccine at the same time."

"What's possible is that you can have a good drug that can get most of the virus, but you might still need a bit more immune response to tidy it all up, because what you don't want to do is have all these drugs suppress it and then it comes back again, which is typically what happens," Klenerman explained.

Hence the need for a therapeutic vaccine, he said. The Oxford trials of about 100 individuals have shown an increased immune response in T cells.

Hepatitis C, first identified as a virus in 1989, is estimated to affect 300,000 Canadians. The infection is at first asymptomatic, but once it takes hold, hepatitis C can progress to scarring of the liver as well as the ultimate failure of the organ. It can also cause liver cancer.

About 20 per cent of people infected are able to clear the virus, HCV, from their bodies. However, the balance must live with chronic hepatitis.

Drugs like interferon-alpha-2b and ribavirin are effective in the long run in slightly more than half of patients with chronic hepatitis.

Many Canadians contracted hepatitis C as a result of tainted blood transfusions from 1980 to 1990. Today, IV drug users are at the greatest risk of HCV infection.

Alain Lamarre, a professor in immunology at the INRS-Institut Armand-Frappier in Laval and chairman of the symposium, said he sees great potential in therapeutic HCV vaccines.

"People with chronic hepatitis C - if they are not treated -accumulate tremendous amounts of virus circulating in their bodies," Lamarre said. "The first goal is to reduce that to a minimal level, and therapeutic vaccines would help."

The symposium was organized by Immunology Montreal, a non-profit organization that promotes education and research.

© Copyright (c) The Montreal Gazette


Organ fat linked to liver surgery problems

By Lynne Peeples
NEW YORK Thu Nov 18, 2010 5:01pm EST

NEW YORK (Reuters Health) - The amount of fat packed between a patient's organs may help predict problems following major liver surgery, suggests a new study.

The fat sitting below the skin, however, appears to be less important.

Any major operation comes with a range of possible complications, and how long patients stay at the hospital varies accordingly, said Dr. Yuman Fong of Memorial Sloan-Kettering Cancer Center in New York City, who led the study.

"Knowing the potential outcome allows patients and families of patients to weigh the risk and benefit of the procedure, and to plan for care after discharge," he told Reuters Health by e-mail.

Liver surgery outcomes depend on a host of factors, including surgeon experience, patient age and blood levels of bilirubin -- the brownish yellow substance found in bile. And the extra pounds weighing down the health of many Americans complicate medical choices even more.

To determine just how much added risk might come with extra weight, and whether or not the location of that fat matters, Fong and his team studied nearly 350 patients undergoing major liver surgery between 1996 and 2001, primarily as part of cancer treatment.

Within 30 days of the surgery, two out of three patients suffered complications and nine died, report the researchers in the Archives of Surgery. The average patient stayed about 11 days in the hospital.

The more fat a patient had around his or her organs -- determined by a CT scan -- the greater the risk of complications, fatal or not, and the longer the hospital stay.

Body mass index, a measure of weight in relation to height, and outer belly fat were not linked to such problems, however.

Based on other data collected by his team, Fong said his findings may be relevant to other kinds of surgery, too, such as removal of tumors in the pancreas or stomach.

According to the researchers, gauging the amount of organ fat doesn't require much extra work, because most patients being considered for abdominal surgery will have a CT scan done anyway.

"Any surgeon in less than a second can glean the information," said Fong.

So the measurement would usually be available without adding extra cost, Dr. Robert Rege of the University of Texas Southwestern Medical Center, in Dallas, told Reuters Health in an e-mail.

"It is not clear if it would be medically or economically reasonable to order a CT scan simply to make the measurement for risk assessment alone," added Rege, who also wrote a commentary in the journal.

To be practical in any surgical setting, Rege suggested that more data are needed to determine how different amounts of organ fat affect outcomes.

"It would be optimal if there were interventions (during surgery) that could decrease the risk in those patients who were determined to have high risk by the measurement," he said.

SOURCE: Archives of Surgery, online November 15, 2010.