ALLY-2 Results: Near Total Hepatitis C-HIV Cure Rate

Bristol-Myers Squibb today announced that its Phase III clinical trial of a combination product daclatasvir-sofosbuvir showed dramatic cure rates for patients infected with both HIV and Hepatitis C.

The results of the trial, known as ALLY-2, were presented at the 2015 Conference on Retroviruses and Opportunistic Infections in Seattle, WA.

The drug combination had a 96% cure rate in hepatitis C patients infected with the HVC genotype 1. It had a 100% cure rate among patients with HCV genotype 2,3, and 4 infections. These HCV cure rates were achieved with no need to alter existing HIV medication regimens, the company said in a press release.

The daily dosage was 30, 60, or 90 mgs of daclatasvir plus 400 mgs of sofosbuvir.

The lead investigator in the trial, David Wyles, MD, associate professor of medicine in the Department of Medicie, Division of Infectious Disease at the University of California San Diego said the trial “demonstrated the dosing flexibility afforded by the daclatasvir-sofosbuvir regimen did not require alteration of HIV medications” a frequent problem with other drugs.

In the study patients took the drug combo for 12 weeks. In all there were 151 treatment naïve patients, and 52 who were treatment-experienced. Patients with cirrhosis were included in the study.

More than a third of the subjects (34%) were African American and 98% had a sustained virologic response at the end of the trial.

The trial also included a group of 50 treatment-naïve patients who got the drug for only 8 weeks. The response was not as good in this group, with 38 of 50 patients achieving the desired response.

“Study investigators concluded that further studies are needed to assess the potential of shorter-duration all-oral treatment regimens, the company wrote.