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European Union's CHMP Issues Positive Opinion on PEGINTRON(TM) and REBETOL(R) Combination Therapy for Hepatitis C in Patients Coinfected With HIV
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KENILWORTH, New Jersey, April 30 /PRNewswire/ --
Schering-Plough Corporation (NYSE: SGP) today reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has issued a positive opinion recommending approval of combination therapy with PEGINTRON(TM) (peginterferon alfa-2b, 1.5 mcg/kg once weekly) and REBETOL(R) (ribavirin, 800 - 1,200 mg daily) for the treatment of previously untreated adult patients with chronic hepatitis C who are coinfected with clinically stable HIV. Approximately 40 percent of the estimated 2.5 million people living with HIV in Europe are coinfected with the hepatitis C virus (HCV), according to the World Health Organization (WHO).
The CHMP recommendation serves as the basis for a European Commission approval of this expanded indication for PEGINTRON and REBETOL combination therapy, which is currently approved in the European Union (EU) for treating chronic hepatitis C in previously untreated adult patients. Upon approval, this new coinfection indication will result in Marketing Authorization with unified labeling that will be valid in the current EU 27 member states as well as in Iceland and Norway.
In two clinical studies, HCV/HIV coinfected patients treated with PEGINTRON combination therapy achieved higher statistically significant sustained virological response (SVR) rates overall compared to conventional interferon alfa-2b and ribavirin.(1,2) SVR is defined as undetectable HCV-RNA six months following the end of treatment and is the standard measure of treatment success for hepatitis C.
Importantly, PEGINTRON combination therapy demonstrated a predictable response in HCV/HIV coinfected patients. Early virological response by treatment week 12, defined as a 2 log viral load decrease or undetectable levels of HCV-RNA, has been shown to be predictive for SVR. The negative predictive value for SVR in HCV/HIV coinfected patients treated with PEGINTRON combination therapy was 99 percent.(1) This means patients with hepatitis C who fail to achieve an early virological response are highly unlikely to become sustained virological responders and can stop therapy with confidence. This can be critical to the effective management of coinfected patients, who are at greater risk for treatment-related adverse events.
Liver disease caused by chronic hepatitis C virus is now a leading cause of morbidity and mortality among HIV patients in the developed world, where deaths due to AIDS-related diseases have declined dramatically as a result of the widespread use of highly active antiretroviral therapy (HAART) for HIV.
"HCV/HIV coinfection represents a complex treatment challenge and a major concern for patients, as hepatitis C in coinfected individuals appears to have a more aggressive course," said Robert J. Spiegel, M.D., chief medical officer and senior vice president, Schering-Plough Research Institute. "As a result, effective treatment of HCV is critically important for people living with HIV. The CHMP recommendation for approval of weight-based PEGINTRON combination therapy further underscores the benefits of PEGINTRON HCV treatment."
Clinical Studies
The CHMP recommendation for approval of PEGINTRON and REBETOL combination therapy for HCV/HIV coinfection is based on the results of two published clinical studies in previously untreated adult patients with chronic hepatitis C who were coinfected with HIV. RIBAVIC(1) was a multicentre study that randomized 412 patients to receive either PEGINTRON or conventional interferon alfa-2b (3 MIU three times weekly) in combination with flat-dosed ribavirin (800 mg daily) for 48 weeks. The second study(2) was a randomized, single-centre study in which 95 patients were randomized to receive either PEGINTRON or conventional interferon alfa-2b in combination with weight-based REBETOL (800-1,200 mg daily) for 48 weeks, except for patients infected with HCV genotypes 2 or 3 and HCV viral load less than 800,000 IU/ml (Amplicor) who were treated for 24 weeks.
Based on the results of these studies, the CHMP recommended duration of dosing with PEGINTRON and REBETOL combination therapy for HCV/HIV coinfected patients is 48 weeks, regardless of HCV genotype.
About PEGINTRON and REBETOL Combination Therapy
PEGINTRON and REBETOL combination therapy for chronic hepatitis C was approved in the EU in March 2001. The recommended dose in the EU for combination therapy is PEGINTRON 1.5 mcg/kg once weekly plus REBETOL 800-1,200 mg daily, adjusted to body weight. The recommended duration of treatment is 24 weeks for patients with HCV genotype 1 and low viral load, or HCV genotype 2 or 3. For patients with HCV genotype 1 and high viral load or HCV genotype 4, the recommended duration of treatment is 48 weeks. PEGINTRON had previously received centralized marketing authorization in the EU and is marketed as a monotherapy in cases of intolerance or contraindication to ribavirin for the treatment of adult patients with chronic hepatitis C.
Chronic hepatitis C is estimated to affect more than 10 million people in major world markets, including 5 million in Europe. It is a leading cause of chronic liver disease and one of the most common reasons for liver transplant in Europe.
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 approximately 33,500 people around the world. The company is based in Kenilworth, N.J., and its Web site is www.schering-plough.com.
References:
1. Carrato F, Bani-Sadir F, Pol S et al. JAMA 2004; 292(23): 2839-2848.
2. Laguno M, Murillas J, Blanco J et al. AIDS 2004; 18(13): F27-F36.
Web site: http://www.schering-plough.com
Distributed by PR Newswire on behalf of Schering-Plough Corporation
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