Glecaprevir-Pibrentasvir for 8 or 12 Weeks in HCV Genotype 1 or 3 Infection.
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Zeuzem Stefan, Foster Graham R, Wang Stanley, Asatryan Armen, Gane Edward, Feld Jordan J, Asselah Tarik, Bourlière Marc, Ruane Peter J, Wedemeyer Heiner, Pol Stanislas, Flisiak Robert, Poordad Fred, Chuang Wan-Long, Stedman Catherine A, Flamm Steven, Kwo Paul, Dore Gregory J, Sepulveda-Arzola Gladys, Roberts Stuart K, Soto-Malave Ruth, Kaita Kelly, Puoti Massimo, Vierling John, Tam Edward, Vargas Hugo E, Bruck Rafi, Fuster Francisco, Paik Seung-Woon, Felizarta Franco, Kort Jens, Fu Bo, Liu Ran, Ng Teresa I, Pilot-Matias Tami, Lin Chih-Wei, Trinh Roger, Mensa Federico J
Аннотация
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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 .).