Induction pegylated interferon Alfa-2a and high dose ribavirin do not increase SVR in heavy patients with HCV genotype 1 and high viral loads
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Background & Aims Patients infected with hepatitis C virus (HCV) genotype 1, body weight <85 kg, and high baseline viral load respond poorly to standard doses of pegylated interferon (peginterferon) and ribavirin. We evaluated intensified therapy with peginterferon alfa-2a plus ribavirin. Methods This double-blind randomized trial included HCV genotype 1-infected outpatients from hepatology clinics with body weight <85 kg and HCV RNA titer <400,000 IU/mL. Patients were randomized to 180 μg/wk peginterferon alfa-2a for 48 weeks plus 1200 mg/day ribavirin (standard of care) (group A, n = 191) or 1400/1600 mg/day ribavirin (group B, n = 189). Additional groups included 360 μg/wk peginterferon alfa-2a for 12 weeks then 180 μg/wk peginterferon alfa-2a for 36 weeks plus 1200 mg/day ribavirin (group C, n = 382) or 1400/1600 mg/day ribavirin (group D, n = 383). Follow-up lasted 24 weeks after treatment. Results Sustained virologic response rates (HCV RNA level <15 IU/mL at end of follow-up) in groups A, B, C, and D were 38%, 43%, 44%, and 41%, respectively. There were no significant differences among the 4 groups or between pooled peginterferon alfa-2a regimens (A + B vs C + D: odds ratio [OR], 1.08; 95% confidence interval [CI], 0.831.39; P = .584) or pooled ribavirin regimens (A + C vs B + D: OR, 1.00; 95% CI, 0.791.28; P = .974). Conclusions In patients infected with HCV genotype 1 who are difficult to treat (high viral load, body weight <85 kg), a 12-week induction regimen of peginterferon alfa-2a and/or higher-dose ribavirin is not more effective than the standard regimen. © 2010 AGA Institute.
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Chronic Hepatitis C , Steatosis and Response to HCV Therapy , Tolerability of High-Dose Pegylated Interferon , Tolerability of High-Dose Ribavirin , colony stimulating factor , peginterferon alpha2a , ribavirin , virus RNA , adult , alopecia , anemia , arthralgia , asthenia , body weight , chill , clinical trial , controlled clinical trial , controlled study , coughing , decreased appetite , depression , diarrhea , dizziness , double blind procedure , drug dose reduction , drug efficacy , drug eruption , drug fever , drug induced headache , drug megadose , drug withdrawal , fatigue , female , follow up , genotype , hemoglobin blood level , hepatitis C , human , insomnia , irritability , major clinical study , male , mediastinum disease , multicenter study , myalgia , nausea , neutrophil count , outpatient , pneumonia , priority journal , pruritus , randomized controlled trial , respiratory tract disease , side effect , thorax disease , thrombocyte count , treatment duration , virus load , Adult , Antiviral Agents , Body Weight , Dose-Response Relationship, Drug , Drug Therapy, Combination , Fatty Liver , Female , Genotype , Hepacivirus , Hepatitis C, Chronic , Humans , Interferon Alfa-2a , Male , Middle Aged , Obesity , Polyethylene Glycols , Ribavirin , Viral Load
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Gastroenterology, v. 139, n. 6, p. 1972-1983, 2010.
