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| |  CROI: Patients With HIV and HCV Taking Protease Inhibitors and/or Non-Nucleoside Reverse Transcriptase Inhibitors Appear to Have Greater Prevalence of Advanced Fibrosis By Jerry Ingram BOSTON, MA -- March 1, 2005 -- Patients who are coinfected with HIV and hepatitis C virus (HCV) appear to have a greater prevalence of advanced fibrosis if they are treated with protease inhibitors or non-nucleoside reverse transcriptase inhibitors (NNRTIs). Richard K. Sterling, MD, professor of internal medicine, Virginia Commonwealth University Health System, Richmond, Virginia, presented the findings here on February 25th at the 12th Conference on Retroviruses and Opportunistic Infections. For this investigation, researchers enrolled 868 patients over 18 years of age who were HIV positive and had detectable anti-HCV antibodies in serum, HCV RNA >600 IU/mL, and compensated liver disease. Patients were randomized to 1 of 3 treatment regimens: 1) peginterferon alfa-2a (Pegasys) 180 mcg/week plus ribavirin 400 mg twice daily; 2) Pegasys 180 mcg/week plus placebo twice/day; 3) interferon alfa-2a (Roferon-A) 3 million IU 3 times daily plus ribavirin 400 mg twice/day. Treatment regimens were continued for 48 weeks. Clinicians performed liver biopsies at baseline. Local pathologists scored liver pathology using the Ishak modified Histologic Activity Index system, defining advanced liver histology as a score of 4 to 6. The researchers conducted a retrospective analysis of liver histology according to patients' antiretroviral regimen prior to the liver biopsy, examined and evaluated the presence of advanced fibrosis in each subgroup of patients, and made statistical comparisons between groups using a chi-square test. They also analyzed demographic and disease characteristics based on patients’ fibrosis status, using t-test and the Wilcoxson rank-sum test. Out of 868 patients enrolled in the study, 690 patients had information on prebiopsy antiretroviral therapy available and were included in the analysis. Of these patients, 23% showed signs of advanced fibrosis; 45% took protease inhibitors, 30% received NNRTIs, 8% were prescribed both protease inhibitors and NNRTIs, and 17% were taking neither class of drug. The prevalence of advanced fibrosis was significantly greater in patients receiving a protease inhibitor, an NNRTI, or both when compared with individuals not taking either (P =.026). The prevalence was much lower among patients not taking protease inhibitors and/or NNRTIs, the researchers found. These findings warrant further investigation to determine the risk of advanced fibrosis in patients taking these medications, the researchers concluded.
[Presentation title: Effect of Protease Inhibitors and Non-Nucleoside Reverse Transcriptase Inhibitors on Liver Histology in HIV-HCV Co-Infection: Analysis of Patients Enrolled in the AIDS PEGASYS Ribavirin International Co-Infection Trial (APRICOT). Poster 951]
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