Portal de Periódicos da CAPES

Glecaprevir–Pibrentasvir for 8 or 12 Weeks in HCV Genotype 1 or 3 Infection

2018; Massachusetts Medical Society; Volume: 378; Issue: 4 Linguagem: Inglês

10.1056/nejmoa1702417

1533-4406

Stefan Zeuzem, Graham R. Foster, Stanley Wang, Armen Asatryan, Edward Gane, Jordan J. Feld, Tarik Asselah, Marc Bourlière, Peter Ruane, Heiner Wedemeyer, Stanislas Pol, Robert Flisiak, Fred Poordad, Wan‐Long Chuang, Catherine Stedman, Steven L. Flamm, Paul Y. Kwo, Gregory J. Dore, Gladys Sepúlveda-Arzola, Stuart K. Roberts, Ruth Soto-Malave, Kelly Kaita, Massimo Puoti, John M. Vierling, Edward Tam, Hugo E. Vargas, Rafi Bruck, Francisco Fuster García, Seung Woon Paik, Franco Felizarta, Jens Kort, Bo Fu, Ran Liu, Teresa I. Ng, Edward Tam, Chih‐Wei Lin, Roger Trinh, Federico Mensa,

Hepatitis B Virus Studies

Glecaprevir and pibrentasvir are direct-acting antiviral agents with pangenotypic activity and a high barrier to resistance. We evaluated the efficacy and safety of 8-week and 12-week courses of treatment with 300 mg of glecaprevir plus 120 mg of pibrentasvir in patients without cirrhosis who had hepatitis C virus (HCV) genotype 1 or 3 infection.We conducted two phase 3, randomized, open-label, multicenter trials. Patients with genotype 1 infection were randomly assigned in a 1:1 ratio to receive once-daily glecaprevir-pibrentasvir for either 8 or 12 weeks. Patients with genotype 3 infection were randomly assigned in a 2:1 ratio to receive 12 weeks of treatment with either glecaprevir-pibrentasvir or sofosbuvir-daclatasvir. Additional patients with genotype 3 infection were subsequently enrolled and nonrandomly assigned to receive 8 weeks of treatment with glecaprevir-pibrentasvir. The primary end point was the rate of sustained virologic response 12 weeks after the end of treatment.In total, 1208 patients were treated. The rate of sustained virologic response at 12 weeks among genotype 1-infected patients was 99.1% (95% confidence interval [CI], 98 to 100) in the 8-week group and 99.7% (95% CI, 99 to 100) in the 12-week group. Genotype 3-infected patients who were treated for 12 weeks had a rate of sustained virologic response at 12 weeks of 95% (95% CI, 93 to 98; 222 of 233 patients) with glecaprevir-pibrentasvir and 97% (95% CI, 93 to 99.9; 111 of 115) with sofosbuvir-daclatasvir; 8 weeks of treatment with glecaprevir-pibrentasvir yielded a rate of 95% (95% CI, 91 to 98; 149 of 157 patients). Adverse events led to discontinuation of treatment in no more than 1% of patients in any treatment group.Once-daily treatment with glecaprevir-pibrentasvir for either 8 weeks or 12 weeks achieved high rates of sustained virologic response among patients with HCV genotype 1 or 3 infection who did not have cirrhosis. (Funded by AbbVie; ENDURANCE-1 and ENDURANCE-3 ClinicalTrials.gov numbers, NCT02604017 and NCT02640157 .).