A Comparison of the Effectiveness, Safety, and Tolerability of Two Different Hepatitis C Treatments in Patients Infected With Both HIV and Hepatitis C Virus (HCV)
Summary
The purpose of this study is to see if treatment with PEG-interferon-alfa-2a (PEG-IFN) plus ribavirin is a more effective treatment for hepatitis C virus (HCV) than interferon-alfa-2a (IFN) plus ribavirin for patients infected with both HCV and HIV. The study will also compare the 2 regimens to see which has fewer side effects. HCV infection is common in patients infected with HIV. Patients infected with both HIV and HCV viruses seem to have more severe hepatitis C. A combination of IFN and ribavirin has been shown to lessen the severity of HCV. PEG-IFN is a modified form of IFN that stays in the blood longer, which means that patients would not have to take the treatment as often. This study will compare the safety and effectiveness of PEG-IFN to IFN when each is combined with ribavirin.
Timeline
- Start
- 2000-11
- Primary completion
- —
- Completion
- 2006-08
Publications
- Results R Chung, J Andersen, P Volberding, G Robbins, T Liu, K Sherman, M Peters, M Koziel, B Alston, D Colquhoun, T Nevin, G Harb, C van der Horst, and AIDS Clinical Trials Group A5071 Study Team: A Randomized, Controlled Trial of PEG-Interferon-alfa-2a plus Ribavirin vs Interferon-alfa-2a plus Ribavirin for Chronic Hepatitis C Virus Infection in HIV-co-infected Persons: Follow-up Results of ACTG A5071. CROI 2004. Abstract 110.
- Results Chung RT, Andersen J, Volberding P, Robbins GK, Liu T, Sherman KE, Peters MG, Koziel MJ, Bhan AK, Alston B, Colquhoun D, Nevin T, Harb G, van der Horst C; AIDS Clinical Trials Group A5071 Study Team. Peginterferon Alfa-2a plus ribavirin versus interferon alfa-2a plus ribavirin for chronic hepatitis C in HIV-coinfected persons. N Engl J Med. 2004 Jul 29;351(5):451-9. doi: 10.1056/NEJMoa032653.
- Results Plosker GL, Keating GM. Peginterferon-alpha-2a (40kD) plus ribavirin: a review of its use in hepatitis C Virus And HIV co-infection. Drugs. 2004;64(24):2823-43. doi: 10.2165/00003495-200464240-00009.
- Results Sherman KE, Shire NJ, Rouster SD, Peters MG, James Koziel M, Chung RT, Horn PS. Viral kinetics in hepatitis C or hepatitis C/human immunodeficiency virus-infected patients. Gastroenterology. 2005 Feb;128(2):313-27. doi: 10.1053/j.gastro.2004.11.059.
- Results Graham CS, Wells A, Liu T, Sherman KE, Peters M, Chung RT, Bhan AK, Andersen J, Koziel MJ; ACTG 5071 Study Team. Antigen-specific immune responses and liver histology in HIV and hepatitis C coinfection. AIDS. 2005 May 20;19(8):767-73. doi: 10.1097/01.aids.0000168970.80551.3d.
- Results Jones R, Dunning J, Nelson M. HIV and hepatitis C co-infection. Int J Clin Pract. 2005 Sep;59(9):1082-7. doi: 10.1111/j.1742-1241.2005.00596.x.
- Results Graham CS, Wells A, Liu T, Sherman KE, Peters M, Chung RT, Bhan AK, Andersen J, Koziel MJ; ACTG 5071 Study Team. Relationships between cellular immune responses and treatment outcomes with interferon and ribavirin in HIV/hepatitis C virus co-infection. AIDS. 2006 Feb 14;20(3):345-51. doi: 10.1097/01.aids.0000206500.16783.2e.
- Results Bhattacharya D, Umbleja T, Carrat F, Chung RT, Peters MG, Torriani F, Andersen J, Currier JS. Women experience higher rates of adverse events during hepatitis C virus therapy in HIV infection: a meta-analysis. J Acquir Immune Defic Syndr. 2010 Oct;55(2):170-5. doi: 10.1097/QAI.0b013e3181e36420.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Peginterferon alfa-2a | Protein / enzyme biologic | 180 ug | Other |
| Subject | Ribavirin | Small molecule | — | — |
| Subject | interferon alfa | Protein / enzyme biologic | 3 iu | Other |