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| |  PegIntron® and Rebetol® Combination Shows 44% Response in Patients Co-Infected with Hepatitis C and HIV BRUSSELS, BELGIUM -- August 19, 2004 -- Patients co-infected with chronic hepatitis C virus (HCV) and HIV treated with PegIntron® (peginterferon alfa-2b) and Rebetol® (ribavirin) combination therapy achieved significantly higher rates of sustained viral response (SVR) compared to those treated with the combination of Intron® A (interferon alfa-2b) plus Rebetol, 44% vs. 21% (P =.017), respectively, according to results of a new study published in the Sept. 3, 2004, issue of AIDS,1 the official peer-reviewed journal of the International AIDS Society (IAS). SVR, defined as the sustained undetectability of HCV six months following the end of treatment, was the primary endpoint of the study. Importantly, for patients with the most difficult-to-treat HCV genotypes 1 or 4, SVR rates were 38% in the PegIntron plus Rebetol group vs. 7% in the Intron A plus Rebetol group (P =.007), a statistically significant improvement. SVR rates in patients with HCV genotypes 2 or 3 were 53% vs. 47% (P =.730), in these groups, respectively. Genotype 1 virus is the most common worldwide and the most difficult to treat successfully. Genotype 4 virus is the predominate type of HCV in the Middle East and is also considered to be difficult to treat. Infection rates with Genotypes 2 and 3 vary by geography and account for approximately 30% to 50% of HCV infections among European patients. The majority of side effects in the study were mild or moderate, with treatment discontinuation due to adverse effects being similar in both the PegIntron plus Rebetol and Intron A plus Rebetol arms, 17% and 12%, respectively (P =.565). "In our study, peginterferon alfa-2b plus ribavirin achieved significantly higher sustained response rates than standard interferon combination therapy in the treatment of chronic hepatitis C in HIV co-infected patients, with twice as many patients overall achieving a sustained virologic response. Even more promising for patients, our study showed significant improvement over standard interferon combination therapy in the most difficult to treat HCV genotypes 1 and 4," said Josep Mallolas, MD, PhD, Infectious Diseases Unit, Hospital Clínic Universitari de Barcelona, Spain. "For patients already taking numerous medications daily to manage their HIV infection, the activity and tolerability of this combination therapy, and the once-weekly dosing of peginterferon alfa-2b, may be an important step forward in treatment." Study and Results Duration of treatment was 48 weeks except for patients with HCV genotype 2 or 3 and low viral load (baseline HCV-RNA <800,000 IU/mL), who were treated for 24 weeks. The average time of known HCV infection was 17 years and the mean duration of previous treatment for HIV infection was 63 months. Eighty-four patients (88%) were taking HIV medications during the study period. The side effect profiles of patients taking both the PegIntron and Intron A combination therapies were similar, with no unexpected or unique adverse events reported. Flu-like symptoms were the most frequently reported adverse event, occurring in 82% of patients at the beginning of treatment and generally improving after a few weeks. Anemia was the most frequent hematological adverse event, occurring in 27% of patients. Side effects led to treatment discontinuation in 9 patients (17%) in the PegIntron plus Rebetol group and in 5 patients (12%) in the Intron A plus Rebetol group (P =.565). No growth factors (neither granulocyte-colony stimulating factor nor erythropoietin) were used in this study. In the study, 43% of patients developed symptoms of depression (sadness, tiredness, apathy) during the therapy (37% in the PegIntron plus Rebetol group vs. 51% in the Intron A plus Rebetol group). Most of these were not severe and improved with antidepressant therapy, without reduction or cessation of HCV therapy. Mitochondrial toxicity, a side effect well described in the literature in co-infected patients on anti-retroviral therapy (ART) who begin HCV therapy, occurred in 4% of patients. Although most cases were asymptomatic, concomitant use of ribavirin plus ART containing nucleoside analogues like diagnosing or stevedore, should be used with caution or are not recommended. "This study, as well as the previously reported results of the community-based PegIntron RIBAVIC study in co-infected patients, are encouraging, particularly in patients with more difficult to treat HCV genotype 1, and further underscore the value of individualized, weight-based PegIntron and Rebetol combination therapy," said Robert J. Spiegel, M.D., chief medical officer and senior vice president of medical affairs, Schering-Plough Research Institute. The study was supported in part by research grants from Schering-Plough. Peginterferon plus ribavirin combination therapy is the worldwide standard of care in the treatment of chronic hepatitis C virus infection, which affects more than 10 million people in major world countries, including five million in Europe. Co-infection with HCV and HIV is currently seen in about 33% of patients and as high as 75% to 90% in patients with a history of intravenous drug use. Liver disease caused by chronic hepatitis C virus infection is now a leading cause of morbidity and mortality among HIV-infected patients in the developed world, where classic opportunistic complications of severe immunodeficiency have declined dramatically as a result of the widespread use of highly active antiretroviral therapy. Thus, the adequate management of HCV-related chronic liver disease in HIV infected patients arises as a major concern in this population. PegIntron and Rebetol Combination Therapy PegIntron is a longer-acting form of Intron A that uses proprietary PEG technology developed by Enron, Inc. of Bridgewater, N.J., USA. PegIntron, recombinant interferon alfa-2b linked to a 12,000 Dalton polyethylene glycol (PEG) molecule, is a once-weekly therapy dosed according to patient body weight that is designed to achieve an effective balance between antiviral activity and elimination half-life. Schering-Plough holds an exclusive worldwide license to PegIntron. Rebetol is an oral formulation of ribavirin, a synthetic nucleoside analog with broad-spectrum antiviral activity. It is approved worldwide for use in combination with PegIntron or Intron A for the treatment of adult patients with chronic hepatitis C. Schering-Plough has rights to market oral ribavirin for hepatitis C in all major world markets through a licensing agreement with Valiant Pharmaceuticals International (formerly ICN Pharmaceuticals Inc.) of Costa Mesa, Calif., USA. Schering-Plough Europe, based in Brussels, Belgium, is part of Schering-Plough Corporation of Kenilworth, N.J., USA. Schering-Plough is a global science-based health care company with leading prescription, consumer and animal health products. Through internal research and collaborations with partners, Schering-Plough discovers, develops, manufactures and markets advanced drug therapies to meet important medical needs. Schering-Plough's vision is to earn the trust of the physicians, patients and customers served by its more than 30,000 people around the world.
SOURCE: Schering-Plough Europe
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