Glecaprevir-Pibrentasvir for 8 or 12 Weeks in HCV Genotype 1 or 3 Infection.
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| Abstract | BACKGROUND:
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. 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 .).
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| Authors | Stefan Zeuzem, Graham R Foster, Stanley Wang, Armen Asatryan, Edward Gane, Jordan J Feld, Tarik Asselah, Marc Bourlière, Peter J Ruane, Heiner Wedemeyer, Stanislas Pol, Robert Flisiak, Fred Poordad, Wan-Long Chuang, Catherine A Stedman, Steven Flamm, Paul Kwo, Gregory J Dore, Gladys Sepulveda-Arzola, Stuart K Roberts, Ruth Soto-Malave, Kelly Kaita, Massimo Puoti, John Vierling, Edward Tam, Hugo E Vargas, Rafi Bruck, Francisco Fuster, Seung-Woon Paik, Franco Felizarta, Jens Kort, Bo Fu, Ran Liu, Teresa I Ng, Tami Pilot-Matias, Chih-Wei Lin, Roger Trinh, Federico J Mensa |
| Journal | The New England journal of medicine (N Engl J Med) Vol. 378 Issue 4 Pg. 354-369 (01 25 2018) ISSN: 1533-4406 [Electronic] United States |
| PMID | 29365309 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't) |
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