Undetectable hepatitis C virus RNA at week 4 as predictor of sustained virological response in HIV patients with chronic hepatitis C.

Abstract

BACKGROUND:

Low baseline serum hepatitis C virus (HCV)-RNA and clearance of viraemia at week 4 with pegylated interferon (pegIFN) plus ribavirin therapy predict sustained virological response (SVR) and enable a shorter duration of therapy in patients with chronic hepatitis C. It is unclear whether this applies to HIV/HCV-co-infected patients.

PATIENTS AND METHODS:

In the Peginterferon Ribavirin ESpaña COinfection (PRESCO) trial, 389 co-infected patients received pegIFN-alpha2a 180 microg/week plus ribavirin 1000-1200 mg/day. Patients with HCV-2/3 were treated for 6 or 12 months, whereas patients with HCV-1/4 were treated for 12 or 18 months. For each genotype, baseline HCV-RNA and rapid virological response (RVR), defined as under 50 IU/ml HCV-RNA at week 4, were evaluated as predictors of SVR in an 'on-treatment' analysis.

RESULTS:

Overall, SVR was achieved by 193 patients (49.6%), 68/191 (35.6%) with genotype 1, 110/152 (72.4%) with genotypes 2/3 and 15/46 (32.6%) with genotype 4. RVR was the best predictor of SVR regardless of HCV genotype. Only for HCV-1 patients, baseline HCV-RNA less than 500 000 IU/ml was also associated with SVR. In HCV-3 patients RVR had a positive predictive value (PPV) for SVR of 90%, with treatment for 24 or 48 weeks. The PPV of SVR for patients with RVR was 69% for HCV-1 and 83% for HCV-4.

CONCLUSION:

Undetectable HCV-RNA at week 4 is the best predictor of curing chronic hepatitis C in HCV/HIV-co-infected patients. In HCV-1 patients, baseline HCV-RNA also predicts response. HIV patients with HCV-3 and RVR may permit shortening therapy duration to only 24 weeks of pegIFN plus 1000-1200 mg ribavirin.

• Authors: Luz Martin-Carbonero, Marina Nuñez, Ana Mariño, Federico Alcocer, Llucía Bonet, Javier García-Samaniego, Pilar López-Serrano, Miguel Cordero, Joseba Portu, Vincent Soriano
• Journal: AIDS (London, England) (AIDS) Vol. 22 Issue 1 Pg. 15-21 (Jan 02 2008) ISSN: 1473-5571 [Electronic] England
• PMID: 18090387 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Antiviral Agents
• Biomarkers
• Interferon alpha-2
• Interferon-alpha
• RNA, Viral
• Recombinant Proteins
• Polyethylene Glycols
• Ribavirin
• peginterferon alfa-2a

Topics

• Administration, Oral
• Antiviral Agents (administration & dosage, therapeutic use)
• Biomarkers (blood)
• Clinical Trials as Topic
• Drug Administration Schedule
• Drug Therapy, Combination
• Endpoint Determination
• HIV
• HIV Infections (complications)
• Hepacivirus (classification, genetics, isolation & purification)
• Hepatitis C, Chronic (complications, drug therapy, virology)
• Hospitals
• Humans
• Injections, Subcutaneous
• Interferon alpha-2
• Interferon-alpha (administration & dosage, therapeutic use)
• Multicenter Studies as Topic
• Polyethylene Glycols (administration & dosage, therapeutic use)
• Polymerase Chain Reaction
• Predictive Value of Tests
• RNA, Viral (blood, genetics)
• Recombinant Proteins
• Ribavirin (therapeutic use)
• Spain
• Treatment Outcome
• Viral Load