Combo Therapy for HCV, HIV Co-Infection: New Data on Sustained Virologic Response

Bristol-Myers Squibb Company announced results from ALLY-2, a Phase 3 trial evaluating the use of daclatasvir and sofosbuvir for the treatment of patients with chronic hepatitis C virus (HCV) co-infected with HIV.

ALLY-2 is an open-label clinical trial that randomized 151 treatment-naïve and 52 treatment-experienced HCV (genotypes 1-4) patients co-infected with HIV-1 on a broad range of antiretroviral regimens, into three cohorts. Among treatment-naïve patients, one cohort received daclatasvir plus sofosbuvir once daily for 12 weeks, while another received the same dosage and combination for eight weeks. The treatment-experienced cohort also received daclatasvir plus sofosbuvir once daily for 12 weeks. Daclatasvir was dose-adjusted to accommodate concomitant antiretrovirals: 30mg with ritonavir-boosted PIs, 90mg with NNRTIs except rilpivirine. All cohorts had follow-up through post-treatment week 24. The primary endpoint was the sustained virologic response 12 weeks after treatment (SVR12) rate among genotype 1 treatment-naïve patients after 12 weeks of treatment.

RELATED: Complete Response Letter Issued for Daclatasvir in Hepatitis C

Patients treated for 12 weeks (treatment-naïve and -experienced), 97% (n=149/153) achieved SVR12. The study met the primary endpoint, with 96% (n=80/83) of treatment-naïve genotype 1 patients achieving SVR12. Treatment with daclatasvir in combination with sofosbuvir in this study showed high SVR rates.

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