Treatment of Acute Hepatitis C Virus in HIV Co-Infection
This study is designed to test the hypothesis that treatment of hepatitis C virus (HCV) infection during the first 6 months after acquiring HCV among people who already have pre-existing HIV infection will result in improved responses to HCV therapy with a shorter duration of infection.
Hepatitis C Virus
Human Immunodeficiency Virus
Drug: Pegylated interferon alfa-2a + Ribavirin
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Treatment of Acute Hepatitis C Virus in HIV Co-Infection|
- Proportion of subjects achieving a sustained virologic response (SVR), defined as undetectable HCV RNA 24-weeks after completion of treatment [ Time Frame: 24 weeks after completion of treatment ] [ Designated as safety issue: No ]
- Safety and tolerability of treatment [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
- Predictors of SVR, including early HCV RNA response to treatment [ Time Frame: 24 weeks after the end of treatment ] [ Designated as safety issue: No ]
|Study Start Date:||March 2008|
|Estimated Study Completion Date:||December 2013|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
Experimental: Acute treatment
All subjects will initiate combination therapy with open-label pegylated interferon alfa-2a (PEG-IFN) + ribavirin (RBV). PEG-IFN will be continued for the full 24 weeks of therapy. To determine the duration of RBV, serum HCV RNA will be measured for each subject at week 8 and week 12. Subjects who have undetectable HCV RNA at both weeks 8 and 12 will discontinue RBV at week 12 and complete the 24-week total treatment duration with PEG-IFN only. Subjects who have detectable HCV RNA at either week 8 or week 12 will continue both PEG-IFN + RBV for the full 24 weeks.
All subjects will discontinue all HCV treatment at week 24. Subjects will be followed for an additional 24 weeks to determine SVR status.
Drug: Pegylated interferon alfa-2a + Ribavirin
Pegylated interferon alfa-2a 180 mcg subcutaneous injection once weekly for 24 weeks Ribavirin 1000-1200mg daily, dosed according to body weight and divided twice daily, for 12-24 weeks
Hepatitis C virus (HCV) infection is one of the most important causes of illness and death among people living with HIV/AIDS. Over 200,000 people in the Unites States, including 37,000 in California, are co-infected with HIV and HCV. In the past, people who had both HIV and HCV often died from AIDS before HCV could cause serious problems. However, with improvements in HIV/AIDS care and treatment, more co-infected people are living longer and thus developing complications from their HCV, including liver scarring (called cirrhosis) and death. HCV infection can also make HIV medications more toxic to the liver, limiting HIV treatment options. Treatment for chronic (or long-term) HCV infection has improved in recent years, but people with HIV are still about half as likely to clear their chronic HCV infection with treatment as HIV-negative individuals. Also, HCV treatment can be very toxic and may have serious side effects for patients, particularly those with HIV.
Recent research suggests that treatment started within the first few months after getting HCV infection (called "acute infection") can result in high treatment response rates for people who do not have HIV. It is not known whether similarly high treatment response rates can also be seen in people with HIV. It has also been shown that each individual's response to the early phases of HCV treatment can predict his or her ability to clear HCV infection after the end of treatment. This study will look at whether it is possible to follow each person's own HCV viral load over time as a measure of treatment success and to tailor each individual's treatment to his or her own response. This idea is called "kinetically guided therapy" and is a new way of individualizing treatment regimen to produce high treatment success rates while minimizing the amount of potentially toxic medications that an individual might not need.
In this pilot study, 20 HIV-infected individuals with acute HCV infection will be treated with HCV therapy for 24 weeks. Because HIV co-infection decreases treatment success in chronic HCV infection, treatment will be started with the strong combination of pegylated-interferon plus ribavirin. However, this protocol will monitor each individual's HCV viral load during the first 12 weeks of treatment and will stop the ribavirin at week 12 if the individual has a good early response and might not need to continue both medications. Using this approach, pegylated interferon will be given for the full 24 weeks of treatment, but ribavirin will be continued for either 12 or 24 weeks, depending on each individual's early response to therapy. The primary endpoint for this study is the percentage of people who have a sustained virologic response to the study treatment. The side effects of treatment will also be measured in order to determine the overall risks and benefits of this approach to treatment.
|United States, California|
|San Francisco General Hospital/UCSF|
|San Francisco, California, United States, 94110|
|Principal Investigator:||Brad Hare, MD||University of California, San Francisco|