ABSTRACT
This retrospective and longitudinal study evaluated the long-term hepatic tolerance of a nelfinavir (NFV)-antiretroviral combined regimen in 82 patients of the HCV-HIV Cohort of CISIH-Sud of Marseilles. Follow-up data (liver enzyme levels, CD4 cell count, HIV viral load, and metabolic parameters) of patients treated with NFV on inclusion or during the follow-up of the cohort were analyzed under treatment over 24 months. Comparisons were performed with X2 or Kruskal-Wallis tests. At baseline (n = 82), the median exposure to NFV was 4.1 months; 58 patients received NFV combined with NRTI and 24 with NNRTI. The median CD4 cell count was 337/mm3 [interquartile range (IR): 216-480) and 39.7% had an undetectable HIV RNA level. Qualitative HCV PCR was positive in 91% of the patients and 19/51 patients with liver biopsy were F3-F4. Median alanine and aspartate aminotransferase (ALAT, ASAT), gamma-glutamyltransferase (GT), and alkaline phosphatase (ALP) were 46 UI/liter (IR: 36-76), 55 UI/liter (IR: 32-97), 97 UI/liter (IR: 50-194), and 88 UI/liter (IR: 72-104), respectively, with 76% of the patients with ALAT/ASAT grade <2. Median follow-up was 23 months (IR: 13.8-37). No significant difference was observed in the distribution of ALAT, ASAT, GT, and ALP as well as of ALAT/ASAT grades over the 24-month study period. Patients treated with NFV + NNRTI had significantly higher GT and ALP levels at baseline with no significant increase during follow-up. Cholesterol, triglyceride, and glycemia distributions remained stable over time. In conclusion, this study showed a good hepatic and metabolic tolerance of a long-term NFV-combined regimen in HIV-HCV coinfected patients.
Subject(s)
HIV Infections/drug therapy , Hepatitis C/drug therapy , Nelfinavir/therapeutic use , Reverse Transcriptase Inhibitors/therapeutic use , Adult , CD4 Lymphocyte Count , Cohort Studies , Drug Therapy, Combination , Female , HIV Infections/complications , Hepatitis C/complications , Humans , Male , Nelfinavir/administration & dosage , Reverse Transcriptase Inhibitors/administration & dosage , Viral LoadABSTRACT
PURPOSE: To evaluate tolerance and efficacy of an open-label interferon-ribavirin treatment and their determinants in 62 HCV-HIV coinfected patients in routine followup. METHOD: Patients received at least 6 and up to 12 months of combination interferon alpha-2b (peg or not) plus ribavirin. Determinants of therapeutic success were estimated by a multivariate logistic regression. RESULTS: Five patients stopped the study, 4 were lost to follow-up, and 53 participated in the entire therapeutic protocol. Among these 53, the end-of-treatment results showed complete clearance of HCV-RNA in 17 (32%). A sustained virologic response (SVR) after 6 or 9 months was observed in 9 (17%) patients, 3 relapsed, and data were not available for 5. Genotype 3a (odds ratio [OR] = 14.4; confidence interval [CI] = 1.84-110.3) favored SVR and treatment with protease inhibitor (PI) therapeutic resistance (OR = 14.4; CI = 1.01-200); as well, a higher fibrosis score tended to increase resistance (p =.11). Adverse events were reported by 24/53 patients (45.3%). CONCLUSION: HCV therapy associating interferon and ribavirin in HCV-HIV coinfected patients is well accepted even if tolerance is moderate. Treatment permitted SVR in at least 17% of the cases. This is likely when patients initiate treatment at the early fibrosis stage and are infected with genotype 3a. The potential interaction with PI therapy should be explored.
