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-2aplus ribavirin. METHODS: This double-blind randomized trial included HCV genotype 1-infected outpatients from hepatology clinics with body weight≥85kg 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], 0.83-1.39; P = .584) or pooled ribavirin regimens (A + C vs B + D: OR, 1.00; 95% CI, 0.79-1.28; 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.
RCT Entities:
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], 0.83-1.39; P = .584) or pooled ribavirin regimens (A + C vs B + D: OR, 1.00; 95% CI, 0.79-1.28; 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.
Authors: Rajesh Panigrahi; Partha K Chandra; Pauline Ferraris; Ramazan Kurt; Kyoungsub Song; Robert F Garry; Krzysztof Reiss; Imogen R Coe; Tomomi Furihata; Luis A Balart; Tong Wu; Srikanta Dash Journal: J Virol Date: 2014-10-22 Impact factor: 5.103
Authors: John P Rice; David Burnett; Helena Tsotsis; Mary J Lindstrom; Daniel D Cornett; Patricia Voermans; Jill Sawyer; Rob Striker; Michael R Lucey Journal: Hepatology Date: 2012-10 Impact factor: 17.425
Authors: Partha K Chandra; Lili Bao; Kyoungsub Song; Fatma M Aboulnasr; Darren P Baker; Nathan Shores; William C Wimley; Shuanghu Liu; Curt H Hagedorn; Serge Y Fuchs; Tong Wu; Luis A Balart; Srikanta Dash Journal: Am J Pathol Date: 2013-11-09 Impact factor: 4.307
Authors: A Andriulli; A Iacobellis; M R Valvano; F Spirito; A Ippolito; F Bossa; F Terracciano; R Fontana; G Niro Journal: Dig Dis Sci Date: 2012-11-28 Impact factor: 3.199
Authors: K Rajender Reddy; Steven H Belle; Michael W Fried; Nezam Afdhal; Victor J Navarro; Roy L Hawke; Abdus S Wahed; Edward Doo; Catherine M Meyers Journal: Clin Trials Date: 2011-11-04 Impact factor: 2.486