High Efficacy of ABT-493 and ABT-530 Treatment in Patients With HCV Genotype 1 or 3 Infection and Compensated Cirrhosis

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• 作者：Edward Gane¹ ; ^{edgane@adhb.govt.nz" class="auth_mail" title="E-mail the corresponding author} ; Fred Poordad² ; Stanley Wang³ ; Armen Asatryan³ ; Paul Y. Kwo⁴ ; Jacob Lalezari⁵ ; David L. Wyles⁶ ; Tarek Hassanein⁷ ; Humberto Aguilar⁸ ; Benedict Maliakkal⁹ ; Ran Liu³ ; Chih-Wei Lin³ ; Teresa I. Ng³ ; Jens Kort³ ; Federico J. Mensa³
• 关键词：Hepatitis C ; Pibrentasvir ; Glecaprevir ; SURVEYOR
• 刊名：Gastroenterology
• 出版年：2016
• 出版时间：October 2016
• 年：2016
• 卷：151
• 期：4
• 页码：651-659.e1
• 全文大小：1180 K

文摘

The combination of ABT-493 (NS3/4A protease inhibitor) plus ABT-530 (NS5A inhibitor) has shown high rates of sustained virologic response at post-treatment week 12 (SVR12) in noncirrhotic patients infected with hepatitis C virus (HCV) genotypes (GTs) 1–6. We describe 2 open-label phase 2 studies investigating the efficacy and safety of ABT-493 plus ABT-530 with or without ribavirin (RBV) in GT1- or GT3-infected patients with compensated cirrhosis.

Methods

Patients with GT1 infection received 200 mg ABT-493 plus 120 mg ABT-530 for 12 weeks. Patients with GT3 infection were randomized 1:1 to receive 300 mg ABT-493 plus 120 mg ABT-530 with or without once-daily 800 mg RBV for 12 weeks; treatment-experienced patients who were not treated with RBV received 16 weeks of therapy. Efficacy was measured by SVR12, defined as an HCV-RNA level less than 25 IU/mL. Adverse events and laboratory parameters were evaluated throughout the study.

Results

Twenty-seven patients with GT1 infection and 55 patients with GT3 infection were enrolled. The majority were treatment-naive (84%) and male (65%). In patients with GT1 infection, SVR12 was achieved by 96% (26 of 27; 95% confidence interval [CI], 82–99) of patients, with 1 relapse. Among GT3-infected patients, SVR12 was achieved in 96% (27 of 28; 95% CI, 82–99) of patients in the RBV-free arm (1 relapse), and in 100% (27 of 27; 95% CI, 88–100) in the RBV-containing arm. The most common adverse events were headache, fatigue, and nausea. Laboratory abnormalities were rare; no patient discontinued treatment.

Conclusions

In cirrhotic HCV GT1- or GT3-infected patients, ABT-493 plus ABT-530 with or without RBV achieved SVR12 rates of 96%–100% and was well tolerated. ClinicalTrials.gov identifiers NCT02243280 and NCT02243293.