Background:  Because many adverse effects occur with the hepatitis C virus (HCV) therapy in HIV patients, and at the same time rate of virologic response is moderate and the cost is high, a high priority is to find markers during treatment that allow clinicians to identify patients most likely to benefit from therapy. In this sense it has been described in the HCV mono-infected population that the reductions >2 logs in plasma HCV RNA at week 12 of treatment (early virological response) would be a important value to predict the sustained virological response.

Methods:  Retrospective analysis of data from HIV/HCV-co-infected patients treated with pegylated interferon-alfa-2b (PEG, 100 to 150 mg/week adjusted to body weight) or interferon alfa-2b (INF, 3 MIU 3 times a week) plus ribavirin (RBV, 800 to 1200 mg/day adjusted to body weight) in a randomized, single-center clinical trial. We include patients with detectable HCV RNA, ALAT >1.5-fold upper normal limit, abnormal liver histology, CD4⁺ >250/mm³, and HIV RNA <10,000 copies/mL on stable or without ART. Duration of treatment was 48 weeks but only 24 weeks when HCV genotype was 2 or 3 and baseline HCV RNA <800,000 IU/mL. The primary endpoint was a sustained virological response.

Results:  We randomized 95 patients (43 assigned to INF+RBV and 52 to PEG-INF+RBV):  68% were male, 81% intravenous drug users, 63% had genotype 1 or 4 and 36% genotype 2 or 3, 62% had a fibrosis index ≥grade 2, and 30% a bridging fibrosis or cirrhosis. Of the total, 80 patients had fully all the required data to be included in the analysis of early virological response; 35 of them reached sustained virological response (56% and 30% of patients treated with PEG and with INF, respectively, p = 0.026). early virological response occurred in 55 (69%) patients (80% in PEG arm and 56% in INF arm). Overall, 35 of 55 patients with early virological response at week 12 were sustained responders, yielding a positive predictive value of 64% (70% in PEG arm and 55% in INF arm). None of patients who showed HCV RNA drops <2 logs at week 12 reached sustained virological response (negative predictive value: 100%). 

Conclusions:  Our results confirms the  utility of early virological response to predict the chance of sustained virological response, mainly in the case of using peg-IFN + RBV, in HIV⁺ patients with chronic hepatitis C, as it does in HIV^­ individuals.