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


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.


CONCLUSIONS
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.
Martin-Carbonero
Luz
L
Hospital Carlos III, CIBEREHD, Madrid, Spain.
Nuñez
Marina
M
Mariño
Ana
A
Alcocer
Federico
F
Bonet
Llucía
L
García-Samaniego
Javier
J
López-Serrano
Pilar
P
Cordero
Miguel
M
Portu
Joseba
J
Soriano
Vincent
V
D000284:Administration, Oral; D000998:Antiviral Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D015415:Biomarkers / Q000097:blood; D002986:Clinical Trials as Topic; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D023381:Endpoint Determination; D006678:HIV; D015658:HIV Infections / Q000150:complications*; D016174:Hepacivirus / Q000145:classification / Q000235:genetics / Q000302:isolation & purification*; D019698:Hepatitis C, Chronic / Q000150:complications* / Q000188:drug therapy* / Q000821:virology; D006761:Hospitals; D006801:Humans; D007279:Injections, Subcutaneous; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage / Q000627:therapeutic use*; D015337:Multicenter Studies as Topic; D011092:Polyethylene Glycols / Q000008:administration & dosage / Q000627:therapeutic use*; D016133:Polymerase Chain Reaction; D011237:Predictive Value of Tests; D012367:RNA, Viral / Q000097:blood* / Q000235:genetics; D011994:Recombinant Proteins; D012254:Ribavirin / Q000627:therapeutic use*; D013030:Spain; D016896:Treatment Outcome; D019562:Viral Load
D000998:Antiviral Agents; D015415:Biomarkers; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D012367:RNA, Viral; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C100416:peginterferon alfa-2a