Fixed-dose combination therapy with daclatasvir, asunaprevir, and beclabuvir for noncirrhotic patients with HCV genotype 1 infection

Fred Poordad, William Sievert, Lindsay Mollison, Michael Bennett, Edmund Tse, Norbert Brau, James M Levin, Thomas E Sepe, Samuel S Lee, Peter W Angus, Brian Conway, Stanislas B Pol, Nathalie Boyer, Jean-Pierre Bronowicki, Ira M Jacobson, Andrew J Muir, Kuchikula Rajender Reddy, Edward Tam, Grisell Ortiz-Lasanta, Victor de Ledinghen & 6 others Mark S Sulkowski, Navdeep Boparai, Fiona McPhee, Eric A Hughes, E Scott Swenson, Philip D Yin

Research output: Contribution to journalArticleResearchpeer-review

Abstract

The antiviral activity of all-oral, ribavirin-free, direct-acting antiviral regimens requires evaluation in patients with chronic hepatitis C virus (HCV) infection. OBJECTIVE: To determine the rates of sustained virologic response (SVR) in patients receiving the 3-drug combination of daclatasvir (a pan-genotypic NS5A inhibitor), asunaprevir (an NS3 protease inhibitor), and beclabuvir (a nonnucleoside NS5B inhibitor). DESIGN, SETTING, AND PARTICIPANTS: This was an open-label, single-group, uncontrolled international study (UNITY-1) conducted at 66 sites in the United States, Canada, France, and Australia between December 2013 and August 2014. Patients without cirrhosis who were either treatment-naive (n = 312) or treatment-experienced (n = 103) and had chronic HCV genotype 1 infection were included. INTERVENTIONS: Patients received a twice-daily fixed-dose combination of daclatasvir, 30 mg; asunaprevir, 200 mg; and beclabuvir, 75 mg. MAIN OUTCOMES AND MEASURES: The primary study outcome was SVR12 (HCV-RNA
Original languageEnglish
Pages (from-to)1728 - 1735
Number of pages8
JournalJAMA
Volume313
Issue number17
DOIs
Publication statusPublished - 2015

Cite this

Poordad, Fred ; Sievert, William ; Mollison, Lindsay ; Bennett, Michael ; Tse, Edmund ; Brau, Norbert ; Levin, James M ; Sepe, Thomas E ; Lee, Samuel S ; Angus, Peter W ; Conway, Brian ; Pol, Stanislas B ; Boyer, Nathalie ; Bronowicki, Jean-Pierre ; Jacobson, Ira M ; Muir, Andrew J ; Reddy, Kuchikula Rajender ; Tam, Edward ; Ortiz-Lasanta, Grisell ; de Ledinghen, Victor ; Sulkowski, Mark S ; Boparai, Navdeep ; McPhee, Fiona ; Hughes, Eric A ; Swenson, E Scott ; Yin, Philip D. / Fixed-dose combination therapy with daclatasvir, asunaprevir, and beclabuvir for noncirrhotic patients with HCV genotype 1 infection. In: JAMA. 2015 ; Vol. 313, No. 17. pp. 1728 - 1735.
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abstract = "The antiviral activity of all-oral, ribavirin-free, direct-acting antiviral regimens requires evaluation in patients with chronic hepatitis C virus (HCV) infection. OBJECTIVE: To determine the rates of sustained virologic response (SVR) in patients receiving the 3-drug combination of daclatasvir (a pan-genotypic NS5A inhibitor), asunaprevir (an NS3 protease inhibitor), and beclabuvir (a nonnucleoside NS5B inhibitor). DESIGN, SETTING, AND PARTICIPANTS: This was an open-label, single-group, uncontrolled international study (UNITY-1) conducted at 66 sites in the United States, Canada, France, and Australia between December 2013 and August 2014. Patients without cirrhosis who were either treatment-naive (n = 312) or treatment-experienced (n = 103) and had chronic HCV genotype 1 infection were included. INTERVENTIONS: Patients received a twice-daily fixed-dose combination of daclatasvir, 30 mg; asunaprevir, 200 mg; and beclabuvir, 75 mg. MAIN OUTCOMES AND MEASURES: The primary study outcome was SVR12 (HCV-RNA",
author = "Fred Poordad and William Sievert and Lindsay Mollison and Michael Bennett and Edmund Tse and Norbert Brau and Levin, {James M} and Sepe, {Thomas E} and Lee, {Samuel S} and Angus, {Peter W} and Brian Conway and Pol, {Stanislas B} and Nathalie Boyer and Jean-Pierre Bronowicki and Jacobson, {Ira M} and Muir, {Andrew J} and Reddy, {Kuchikula Rajender} and Edward Tam and Grisell Ortiz-Lasanta and {de Ledinghen}, Victor and Sulkowski, {Mark S} and Navdeep Boparai and Fiona McPhee and Hughes, {Eric A} and Swenson, {E Scott} and Yin, {Philip D}",
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Poordad, F, Sievert, W, Mollison, L, Bennett, M, Tse, E, Brau, N, Levin, JM, Sepe, TE, Lee, SS, Angus, PW, Conway, B, Pol, SB, Boyer, N, Bronowicki, J-P, Jacobson, IM, Muir, AJ, Reddy, KR, Tam, E, Ortiz-Lasanta, G, de Ledinghen, V, Sulkowski, MS, Boparai, N, McPhee, F, Hughes, EA, Swenson, ES & Yin, PD 2015, 'Fixed-dose combination therapy with daclatasvir, asunaprevir, and beclabuvir for noncirrhotic patients with HCV genotype 1 infection' JAMA, vol. 313, no. 17, pp. 1728 - 1735. https://doi.org/10.1001/jama.2015.3860

Fixed-dose combination therapy with daclatasvir, asunaprevir, and beclabuvir for noncirrhotic patients with HCV genotype 1 infection. / Poordad, Fred; Sievert, William; Mollison, Lindsay; Bennett, Michael; Tse, Edmund; Brau, Norbert; Levin, James M; Sepe, Thomas E; Lee, Samuel S; Angus, Peter W; Conway, Brian; Pol, Stanislas B; Boyer, Nathalie; Bronowicki, Jean-Pierre; Jacobson, Ira M; Muir, Andrew J; Reddy, Kuchikula Rajender; Tam, Edward; Ortiz-Lasanta, Grisell; de Ledinghen, Victor; Sulkowski, Mark S; Boparai, Navdeep; McPhee, Fiona; Hughes, Eric A; Swenson, E Scott; Yin, Philip D.

In: JAMA, Vol. 313, No. 17, 2015, p. 1728 - 1735.

Research output: Contribution to journalArticleResearchpeer-review

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