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12 Weeks of Daclatasvir in Combination with Sofosbuvir for HIV-HCV Coinfection (ALLY-2 study): Efficacy and Safety by HIV Combination Antiretroviral Regimens
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Clinical Infectious Diseases Advance Access published March 29, 2016
Anne F. Luetkemeyer1, Cheryl McDonald2, Moti Ramgopal3, Stephanie Noviello4, Rafia Bhore5, Peter Ackerman6
Abstract
Background. Highly-effective hepatitis C virus (HCV) direct-acting antiviral therapies are needed that do not require modification of human immunodeficiency virus (HIV) antiretroviral regimens. This analysis evaluates the efficacy and safety of the combination of daclatasvir+sofosbuvir (DCV+SOF) for 12 weeks by antiretroviral regimen in HIV-HCV coinfected patients.
Methods. In the randomized, open-label ALLY-2 study (NCT02032888), HIV-HCV coinfected patients received 8 or 12 weeks of once-daily (QD) DCV 60mg+SOF 400mg. Results were stratified by antiretroviral class for the 151 patients who received 12 weeks of DCV+SOF.
Results. Fifty-one patients were HCV treatment-experienced, 100 were treatment-naïve, 89% were male, 33% were black. HCV genotypes were GT1a (69%), GT1b (15%), GT2 (8%), GT3 (6%), GT4 (2%). Sustained virologic response 12 weeks post-treatment (SVR12) was 97% and was similar across antiretroviral regimens (p=0.774): protease inhibitor-based, 97% (95% CI: 90%-99.7%); non-nucleoside reverse transcriptase inhibitor-based, 100% (95% CI: 91%-100%); and integrase inhibitor-based, 95% [95% CI: 83%-99.4%]). SVR12 by NRTI backbone containing either tenofovir disoproxil fumarate or abacavir was 98% [95% CI: 93%-99.5%] and 100% [95% CI: 85%-100%], respectively. Age, gender, race, cirrhosis, HCV treatment history, HCV genotype, baseline HCV viral load and CD4 cell count did not affect SVR12. HIV virologic control was not compromised. There were no treatment-related serious adverse events (SAEs) or AEs leading to discontinuation.
Conclusion. DCV+SOF QD for 12 weeks led to high SVR rates (97%) across a broad range of antiretroviral regimens and was safe and well tolerated. DCV+SOF is a highly efficacious, all-oral, pangenotypic HCV treatment for HIV-HCV coinfection.
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