Format

Send to

Choose Destination
Open Forum Infect Dis. 2017 Jul 22;4(3):ofx154. doi: 10.1093/ofid/ofx154. eCollection 2017 Summer.

Safety and Efficacy of Ombitasvir, Paritaprevir With Ritonavir ± Dasabuvir With or Without Ribavirin in Patients With Human Immunodeficiency Virus-1 and Hepatitis C Virus Genotype 1 or Genotype 4 Coinfection: TURQUOISE-I Part 2.

Author information

1
Universitätsklinikum Bonn, Germany.
2
The Royal London Hospital, United Kingdom.
3
AbbVie Inc., North Chicago, Illinois.
4
Denver Health Medical Center, Colorado.
5
Zuckerberg San Francisco General, University of California.
6
Fondazione Centro San Raffaele del Monte Tabor, Milan, Italy.
7
Innovative Care P.S.C., Bayamon, Puerto Rico.
8
Chelsea and Westminster Hospital, London, United Kingdom.
9
Royal Free London Foundation Trust, United Kingdom.
10
Universitätsklinikum Wuerzburg, Germany.
11
ASST Fatebenefratelli Sacco, Milan, Italy; School of Clinical Medicine, Faculty of Health Science, University of the Witwatersrand, Johannesburg, South Africa.
12
Hopital Saint Antoine, Paris, France.
13
Hospital Germans Trias I Pujol, Barcelona, Spain.
14
Liver Unit, Auckland City Hospital, New Zealand.

Abstract

BACKGROUND:

Ombitasvir, paritaprevir with ritonavir, and dasabuvir (OBV/PTV/r ± DSV) ±ribavirin (RBV) are approved to treat hepatitis C virus (HCV) genotype 1 and 4 infection. Here, we investigate the safety and efficacy of OBV/PTV/r + DSV ±RBV for HCV genotype 1, and OBV/PTV/r + RBV for HCV genotype 4, in human immunodeficiency virus (HIV)-1 coinfected patients with or without compensated cirrhosis.

METHODS:

TURQUOISE-I, Part 2 is a phase 3 multicenter study. Patients with or without cirrhosis were HCV treatment-naive or -experienced, on an HIV-1 antiretroviral regimen containing atazanavir, raltegravir, dolutegravir, or darunavir (for genotype 4 only), and had plasma HIV-1 ribonucleic acid <40 copies/mL at screening. Patients received OBV/PTV/r ± DSV ±RBV for 12 or 24 weeks.

RESULTS:

In total, 228 patients were treated according to guidelines. Sustained virologic response at posttreatment week 12 (SVR12) was achieved by 194 of 200 (97%) and 27 of 28 (96%) patients with HCV genotype 1 and genotype 4 infection, respectively. There were 2 virologic failures: 1 breakthrough and 1 relapse in a cirrhotic and a noncirrhotic patient with genotype 1b and 1a infection, respectively. One reinfection occurred at posttreatment week 12 in a genotype 1a-infected patient. Excluding nonvirologic failures, the SVR12 rates were 98% (genotype 1) and 100% (genotype 4). Adverse events were mostly mild in severity and did not lead to discontinuation. Laboratory abnormalities were rare.

CONCLUSIONS:

The OBV/PTV/r ±DSV was well tolerated and yielded high SVR12 rates in patients with HCV genotype 1 or genotype 4/HIV-1 coinfection. The OBV/PTV/r ± DSV ±RBV is a potent HCV treatment option for patients with HIV-1 coinfection, regardless of treatment experience.

KEYWORDS:

ART; DAA; HCV; HIV; TURQUOISE

Supplemental Content

Full text links

Icon for Silverchair Information Systems Icon for PubMed Central
Loading ...
Support Center