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New Drug Combo Treats Hepatitis C in Patients Infected With HIV
Approximately 20% to 30% of patients with hepatitis C virus (HCV) infection are also infected with human immunodeficiency virus type 1 (HIV-1). Both blood-borne viruses share the same modes of transmission, but many HCV medications have significant limitations because of their adverse interactions with HIV treatments. Researchers at the University of California, San Diego, School of Medicine have reported a new drug combination that effectively treats HCV in patients co-infected with HIV.
The study, published online in the New England Journal of Medicine, found that a combination of the oral HCV drugs sofosbuvir (Sovaldi, Gilead Sciences) and daclatasvir (Bristol-Myers Squibb) cured HCV infection in 97% of patients who were also infected with HIV.
“In many HCV/HIV co-infected patients, HCV therapies can have a strong interaction with HIV medications that complicate or potentially exclude them from HCV treatment,” said lead author David Wyles, MD. “This study is novel because it shows the new drug combination was not compromised when used with a wide range of HIV medications, increasing the number of HCV/HIV patients who can be treated without modifying their HIV medications.”
Another reason the study findings are important, said Wyles, is because HCV is a major cause of chronic liver disease in the U.S., and liver damage progresses more rapidly in those also infected with HIV.
“Liver disease is a leading cause of death among HIV patients, so it is a high priority to treat co-infected patients and reduce the potentially fatal effect,” Wyles said.
The open-label study involved 151 patients who had not received HCV treatment and 52 previously treated patients, all of whom were co-infected with HIV-1. The untreated patients were randomly assigned to receive either 12 weeks or 8 weeks of daclatasvir at a standard dosage of 60 mg daily (with dose adjustments for concomitant antiretroviral medications) plus 400 mg of sofosbuvir daily. The previously treated patients received 12 weeks of therapy at the same doses. The study’s primary endpoint was a sustained virologic response at week 12 after the end of therapy among previously untreated patients with HCV genotype 1 who were treated for 12 weeks. All of the patients were closely monitored for up to 24 weeks post-treatment.
Among patients with HCV genotype 1, a sustained virologic response was reported in 96.4% of those treated for 12 weeks and in 75.6% of those treated for 8 weeks among previously untreated patients, and in 97.7% of those treated for 12 weeks among previously treated patients. The rates of sustained virologic response across all genotypes (1 through 4) were 97.0%, 76.0%, and 98.1%, respectively. The most common adverse events were fatigue, nausea, and headache.
Sofosbuvir is already approved for use in the U.S.; daclatasvir is scheduled to be reviewed by the FDA in August.