20th International AIDS Conference - Melbourne, Australia


MOAB0104LB - Oral Abstract

TURQUOISE-I: safety and efficacy of ABT-450/r/Ombitasvir, Dasabuvir, and Ribavirin in patients co-infected with hepatitis C and HIV-1

Presented by Mark S. Sulkowski (United States).

M. Sulkowski1, J.J. Eron2, D. Wyles3, R. Trinh4, J. Lalezari5, J. Slim6, J. Gathe7, P.J. Ruane8, C. Wang9, R. Elion10, F. Bredeek11, R. Brennan12, G. Blick13, A. Khatri4, K. Gibbons4, Y.B. Hu4, L. Fredrick4, T. Pilot-Matias4, B. Da Silva-Tillmann4, B. McGovern4, A.L. Campbell4, T. Podsadecki4

1Johns Hopkins University, Baltimore, United States, 2University of North Carolina, Chapel Hill, United States, 3University of California San Diego, San Diego, United States, 4AbbVie Inc., North Chicago, United States, 5Quest Clinical Research, San Francisco, United States, 6St. Michael's Medical Center, Newark, United States, 7Cure C. Consortium, Houston, United States, 8Peter J. Ruane, MD, Inc., Los Angeles, United States, 9Virginia Mason Medical Center, Seattle, United States, 10Whitman-Walker Health, Washington DC, United States, 11Metropolis Medical Group, San Francisco, United States, 12Infecious Diseases Associates of Central Virginia, Lynchburg, United States, 13CIRCLE CARE Center, Norwalk, United States

Background: A limited number of studies evaluating IFN-free HCV treatment regimens in HCV/HIV-1 coinfected adults have been conducted. The 3 direct-acting antiviral (3D) regimen of ABT-450 (identified by AbbVie and Enanta; co-dosed with ritonavir), ombitasvir, and dasabuvir with ribavirin (RBV) has achieved high sustained virologic response (SVR) in HCV genotype (GT)1-monoinfected patients. We assessed the 3D+RBV regimen in adults with HCV GT1 and HIV-1 co-infection with and without cirrhosis.
Methods: TURQUOISE-I is a randomized, open-label study evaluating the 3D+RBV regimen for 12 or 24 weeks. Study eligibility included: HCV treatment-naïve or pegIFN/RBV-experienced, presence or absence of cirrhosis (Child-Pugh A), CD4+ count ≥200 cells/mm3 or CD4+ % ≥14%, and plasma HIV-1 RNA suppressed on a stable atazanavir- or raltegravir-inclusive antiretroviral regimen. The primary endpoint is SVR 12 weeks post-treatment (SVR12). Interim safety and efficacy data are reported; more complete data will be presented.
Results: Sixty-three patients were treated, including: 58 (92.1%) male, 48 (76.2%) white race, 56 (88.9%) HCV GT1a, 51 (81.0%) IL28B non-CC genotype, 12 (19.0%) with cirrhosis, 42 (66.7%) treatment-naïve, and 21 (33.3%) prior treatment-experienced patients. Among patients receiving 12 weeks of 3D+RBV, virologic response at end-of-treatment (EOTR) and 4 weeks post-treatment (SVR4) was achieved by 30/31 (96.8%) and 29/31 (93.5%) patients, respectively. One patient withdrew consent prior to finishing treatment but had an undetectable HCV RNA at last study visit (week 10), and another patient experienced virologic relapse at post-treatment week 2. To date, 29/30 (96.7%) patients receiving 24 weeks of treatment achieved EOTR; 1 patient experienced on-treatment HCV breakthrough at week 16. The most common adverse events (AEs) were fatigue, insomnia, and headache. No patient experienced a serious AE or discontinued study drugs due to an AE. Elevation in total bilirubin was the most common laboratory abnormality, occurring predominantly in patients receiving atazanavir. To date, no patient has had a confirmed HIV-1 RNA ≥200 copies/mL.
Conclusions: The high virologic response rate and low rate of treatment discontinuation observed with 3D+RBV in treatment-naïve and treatment-experienced GT1 HCV/HIV-1 co-infected patients with or without cirrhosis is consistent with those in HCV GT1-monoinfected populations receiving this regimen.

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