Objective: Guidelines recommendation to extend treatment duration in genotype 1 hepatitis C virus (HCV)/HIV-coinfected patients who clear the virus later than treatment week 4 is not evidence-based. Our main objective was to study the ability of week 12 viral response [early virologic response (EVR)] to predict long-term outcome in patients treated for 48 weeks.
Design: Multicenter retrospective cohort analysis.
Methods: Genotype 1 HCV treatment-naive, HIV-coinfected adult patients with compensated liver disease who started combination therapy with fixed-dose pegylated-interferon (pegIFN) alfa-2a or weight-based pegIFN alfa-2b plus ribavirin were included. Univariate and forward stepwise logistic regression analysis were used to identify predictors of sustained viral response (SVR) and relapse.
Results: By intention-to-treat analysis, 31.3% (87/278) of patients achieved an SVR. SVR rate was more than three-fold higher in patients who cleared the virus by week 12 of treatment compared with late responders. Among 123 end-of-treatment responders, 36 (29.3%) relapsed. Relapse risk increased in patients with cirrhosis, in those with ribavirin dose reductions and in late responders: more than 65% of patients who cleared the virus between weeks 12 and 24 relapsed following 48 weeks of treatment compared with 10% of those attaining a complete EVR (<15 IU/ml) at treatment week 12 (risk ratio 6.4, 95% confidence interval 2.9–14.4).
Conclusion: Viral response at treatment week 12 is a strong predictor of long-term outcome. Genotype 1 HCV/HIV-coinfected patients who achieve a complete EVR (<15 IU/ml) are at low risk of viral relapse after completing the standard 48 weeks of therapy.
aInfectious Diseases Service, Hospital Vall d'Hebron, Medicine Department, Universitat Autònoma de Barcelona, Spain
bInfectious Disease Service, Hospital Universitari de Bellvitge, Spain
cHIV Clinical Unit, Internal Medicine Department, Fundació de la Lluita contra la SIDA, University Hospital Germans Trias i Pujol, Spain
dLiver Section, Hospital del Mar, Institut Municipal d'Investigació Médica, Universitat Autònoma de Barcelona, Barcelona, Spain
eUnit of Infectious Diseases, Hospital Universitario de Valme, Sevilla, Spain
fCiber de enfermedades hepáticas y digestivas, Instituto de Salud Carlos III, Barcelona, Spain.
Received 8 October, 2009
Revised 29 October, 2009
Accepted 6 November, 2009
Correspondence to Manuel Crespo, Infectious Diseases Department, Hospital Vall d'Hebron, Passeig Vall d'Hebron 119-129, Barcelona 08035, Spain. Tel: +34 630150090; fax: +34 934282762; e-mail: email@example.com