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Adv Ther. 2017 Jun;34(6):1449-1465. doi: 10.1007/s12325-017-0506-y. Epub 2017 May 23.

Randomized Phase 3 Trial of Ombitasvir/Paritaprevir/Ritonavir and Ribavirin for Hepatitis C Virus Genotype 2-Infected Japanese Patients.

Author information

1
Department of Medicine and Molecular Science, Gunma University Graduate School of Medicine, Maebashi, Japan. satoken@gunma-u.ac.jp.
2
Department of Gastroenterology and Metabolism, Institute of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.
3
AbbVie Inc., North Chicago, IL, USA.
4
Department of Gastroenterology, Ogaki Municipal Hospital, Gifu, Japan.
5
Department of Hepatology, Toranomon Hospital, Tokyo, Japan.

Abstract

INTRODUCTION:

In Japan, hepatitis C virus (HCV) genotype (GT) 2 accounts for approximately 32% of HCV infections. Limited treatment options exist in Japan for HCV GT2-infected patients. GIFT-II was a phase 3, randomized, open-label study evaluating the efficacy and safety of 16- and 12-week regimens of co-formulated ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) plus ribavirin (RBV) in Japanese adults with HCV GT2 infection.

METHODS:

Patients were randomized in a 1:1 ratio to once-daily, co-formulated OBV/PTV/r (25/150/100 mg) with weight-based RBV for 16 or 12 weeks. The primary efficacy endpoint was the sustained virologic response at 12 weeks post-treatment (SVR12) rate in the primary efficacy population of non-cirrhotic treatment-naive patients.

RESULTS:

A total of 171 patients were randomized to OBV/PTV/r + RBV. In the primary efficacy population, SVR12 rates were 91.5% (43/47; 95% confidence interval 83.5-99.5%) and 75.0% (36/48; 95% confidence interval 62.8-87.2%) in the 16-week arm and 12-week arm, respectively. No patient in the 16-week arm relapsed by post-treatment week 12. Among non-cirrhotic treatment-experienced patients, the overall SVR rate in the 16-week arm was 75.8% (25/33) and was highest [93.8% (15/16)] among those who had relapsed after previous interferon-based therapy. SVR12 rates were consistently higher in patients with HCV GT2a infection versus HCV GT2b infection [16-week treatment arm: 93.9% (31/33) versus 85.7% (12/14) and 93.8% (15/16) versus 56.3% (9/16) among non-cirrhotic treatment-naive and treatment-experienced patients, respectively]. No patient discontinued treatment because of an adverse event. The most common adverse events were anemia, increased blood bilirubin, and nasopharyngitis.

CONCLUSIONS:

OBV/PTV/r + RBV for 16 weeks resulted in high SVR12 rates in non-cirrhotic Japanese patients infected with HCV GT2 who were treatment-naive or who had relapsed after an interferon-based therapy. Higher SVR12 rates were observed among patients with HCV GT2a infection versus those with GT2b infection. This regimen demonstrated a favorable safety profile.

TRIAL REGISTRATION:

ClinicalTrials.gov identifier, NCT02023112.

FUNDING:

AbbVie.

KEYWORDS:

Co-formulated ombitasvir/paritaprevir/ritonavir; Direct-acting antiviral; HCV genotype 2; IFN-free; Japan

PMID:
28536999
DOI:
10.1007/s12325-017-0506-y
[Indexed for MEDLINE]

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