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Viral kinetics and early prediction of non-response to pegylated interferon/ribavirin in HIV infected patients with genotypes 1/4-related chronic hepatitis C

Viral kinetics and early prediction of non-response to pegylated interferon/ribavirin in HIV infected patients with genotypes 1/4-related chronic hepatitis C

Hepatology 38(4 Suppl 1): 749A

Background: Positive serum HCV RNA after 6 months of therapy correlates with failure in monoinfected patients with chronic hepatitis C (CHC). Measuring the initial viral decline during therapy may identify non-responders. In HCV/HIV patients viral kinetics and the feasibility to predict non-response are undetermined. Objectives: To determine in a population of coinfected HIV/HCV patients with genotypes 1/4-related CHC, the rate of response after 6 months of treatment, viral kinetics, the predictive value of the initial viral decline, and early cut-off values predicting failure. Methods: Prospective study of 36 genotype 1 (n=30) or 4 (n=6) naive HIV/HCV patients with CHC after 24 weeks of weight-adjusted peg-IFN alfa-2b and ribavirin: Quantitative HCV RNA was performed at day 0, and weeks 4, 12 and 24; viral decay at week 4 was assessed to determine the most sensitive cut-off value predicting 6th month failure. Results: Most patients were male (78%), and mean age, 39+-3 years. Prior AIDS was present in 7 cases (19%); baseline mean HIV-RNA and CD4 counts were 2.25+-1.11 log10 and 438+-248 cells/mcl, respectively. Biopsy-proven cirrhosis was present in 9 patients (25%), and mean baseline AST, ALT and HCV RNA were 100+-70 IU/L, 110+-96 IU/L, and 5.75+-0.51 log10, respectively. At month 6, 14 patients achieved negative HCV-RNA (39%). The mean viral decays at week 4, 12 and 24 were -1.43+-2.1 log10, -2.17+-2.4 log10 and -2.47+-2.4 log10, respectively. The most sensitive cut-off value of viral decline at week 4 predicting 6th month failure was log10 (no decline or increase from baseline), 8/22 (36%): Se 100%, sp 36%, PPV 50%, NPV 100%), and the ROC curve area, 0.82 (95% CI 0.67-0.97). Conclusions: In HIV/HCV coinfected patients with chronic hepatitis C, serum HCV RNA decay at week 4 is correlated to 6th month treatment failure. A lack of decay, or an increase in baseline HCV-RNA could allow early discontinuation with 100% certainty in a significant proportion of non-responders (36%).

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Accession: 036038228

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DOI: 10.1016/s0270-9139(03)81261-2

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