Predictability of sustained virological response to pegylated interferon alpha-2b Plus ribavirin therapy by week-8 viral response in HIV-positive patients with chronic hepatitis C virus infection

Curr HIV Res. 2009 Jul;7(4):447-55. doi: 10.2174/157016209788680507.

Abstract

Chronic hepatitis C is frequent and aggressive in HIV-positive patients. Identification of early predictors of response to anti-HCV therapy is needed for a lower rate of response and higher discontinuations, compared to HCV mono-infected subjects. The aim of our study was to evaluate the predictive value of virological response (VR) at week 4-8-12 of Pegylated interferon alpha-2b (PEG-IFN) plus ribavirin (RBV) on sustained virological response (SVR) in HIV-HCV co-infected patients. 100 patients were treated with PEG-IFN (1.5 mcg/Kg/w) plus RBV (> or =10.6 mg/kg/d) and randomized for 24-48 or 48-72 weeks, respectively for genotype 2-3 and 1-4, in case of response (HCV-RNA PCR negativity) at the end of standard therapy (24 weeks for genotype 2-3, 48 weeks for genotype 1-4). Transcription-Mediated Amplification (TMA) assay for HCV-RNA was also applied. 27 patients reached end-of-treatment response (9 genotype 1-4, 18 genotype 2-3), 21 achieved SVR (8 genotype 1-4, 13 genotype 2-3). 35 patients dropped, 15 due to side-effects. SVR was statistically related to lower baseline HCV-RNA and to VR at week 4-8-12, with PPV 64%, 53% and 58%, and NPV 81%, 96% and 88%, respectively. In 27 patients, TMA was performed and confirmed standard PCR, except in two cases of relapse, who were PCR negative but TMA positive at week-12. In conclusion, VR at week 8 showed the highest NPV on SVR (96%). The study of viral kinetics requires further investigations in HIV-positive patients to guarantee a cost-effective therapy and to guide individually the duration of treatment. In this setting, TMA might be useful.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Antiviral Agents / administration & dosage
  • Antiviral Agents / therapeutic use*
  • Female
  • HIV Infections / complications*
  • Hepacivirus / isolation & purification
  • Hepatitis C, Chronic / complications*
  • Hepatitis C, Chronic / drug therapy*
  • Humans
  • Interferon alpha-2
  • Interferon-alpha / administration & dosage
  • Interferon-alpha / therapeutic use*
  • Male
  • Nucleic Acid Amplification Techniques
  • Predictive Value of Tests
  • RNA, Viral / blood
  • Recombinant Proteins
  • Ribavirin / administration & dosage
  • Ribavirin / therapeutic use*
  • Treatment Outcome
  • Viral Load

Substances

  • Antiviral Agents
  • Interferon alpha-2
  • Interferon-alpha
  • RNA, Viral
  • Recombinant Proteins
  • Ribavirin