Reddy, K. RajenderShiffman, Mitchell L.Rodrigueztorres, MaribelCheinquer, HugoAbdurakhmanov, DjamalBakulin, IgorMorozov, ViacheslavSilva, Giovanni Faria [UNESP]Geyvandova, NataliaStanciu, CarolRabbia, MichaelMcKenna, MichaelThommes, James A.Harrison, Stephen A.2014-05-272014-05-272010-12-01Gastroenterology, v. 139, n. 6, p. 1972-1983, 2010.0016-5085http://hdl.handle.net/11449/71995Background & 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.1972-1983engChronic Hepatitis CSteatosis and Response to HCV TherapyTolerability of High-Dose Pegylated InterferonTolerability of High-Dose Ribavirincolony stimulating factorpeginterferon alpha2aribavirinvirus RNAadultalopeciaanemiaarthralgiaastheniabody weightchillclinical trialcontrolled clinical trialcontrolled studycoughingdecreased appetitedepressiondiarrheadizzinessdouble blind proceduredrug dose reductiondrug efficacydrug eruptiondrug feverdrug induced headachedrug megadosedrug withdrawalfatiguefemalefollow upgenotypehemoglobin blood levelhepatitis Chumaninsomniairritabilitymajor clinical studymalemediastinum diseasemulticenter studymyalgianauseaneutrophil countoutpatientpneumoniapriority journalpruritusrandomized controlled trialrespiratory tract diseaseside effectthorax diseasethrombocyte counttreatment durationvirus loadAdultAntiviral AgentsBody WeightDose-Response Relationship, DrugDrug Therapy, CombinationFatty LiverFemaleGenotypeHepacivirusHepatitis C, ChronicHumansInterferon Alfa-2aMaleMiddle AgedObesityPolyethylene GlycolsRibavirinViral LoadArtigo10.1053/j.gastro.2010.08.051Acesso restrito2-s2.0-786497158626322604200510676