This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The purpose of this protocol is to determine if the virologic response of co-infected HIV-HCV is increased among individuals receiving PEG- interferon plus ribavirin for 18 months compared to individuals receiving the treatment for 12 months. Since its discovery in 1989, hepatitis C virus (HCV) has been recognized as a major cause of chronic hepatitis and hepatic fibrosis that progresses in many patients to cirrhosis and hepatocellular cancer. In the United States, approximately 4 million people have been infected with HCV annually and there are around 10,000 HCV-related deaths each year. Due to shared routes of transmission, HCV and HIV co-infection is common, affecting 60-95% of those with parental exposures, such as injection drug users. As a result, the HCV disease burden among HIV-infected adults is substantial. Similar to HIV, most persons do not experience symptoms early in the course of HCV infection. However, natural history studies indicate that HCV infection can cause progressive inflammation and scarring, which may lead to cirrhosis, cancer, and liver failure in up to 20% of infected individuals in a period of 20-30 years. Among HIV-infected persons, the progression of HCV-related liver disease may be quite rapid (less than 10 years). In the United States, many co-infected patients who were infected with HCV in the 1970s or 1980s are now experiencing progressive HCV-related liver disease. Thus, as deaths from AIDS declines, HCV co-infection is an increasingly important problem. Effective HCV treatment for co-infected individuals is urgently needed. The combination of PEG-interferon and ribavirin has been proven in clinical trials to be effective and improve sustained virologic response in HCV infected individuals. However, to this date HIV-infected individuals have been excluded from clinical trials. In addition, there has been evidence that an increased treatment phase of 18 months with PEG-interferon and ribavirin results in a higher response rate in HCV-infected individuals. This study proposes to study HCV-HIV co-infected individuals for 12 and 18 months to determine the virologic response rate in this special population of HCV infected individuals. This is a treatment protocol that will evaluate the antiviral efficacy, safety and tolerability of PEG-interferon plus ribavirin treatment in individuals who have HIV-HCV co-infection. All eligible and consenting patients will receive a weight-adjusted dose of PEG-interferon and ribavirin for 24 weeks. After the 24-weeks treatment period, subjects will be randomized to receive treatment for another 24 or 48 weeks. Study participants will be carefully monitored for safety and tolerability of the drug during and after the treatment periods. In addition, the two treatment groups will be compared based on treatment duration to determine the overall efficacy of each treatment period.
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