A novel hepatitis C treatment that combines sofosbuvir with another drug not yet approved in the US had a 97% success rate in a group of patients who were coinfected with HIV, according to researchers from the University of California, San Diego School of Medicine.
A novel hepatitis C treatment that combines sofosbuvir with another drug not yet approved in the US had a 97% success rate in a group of patients who were coinfected with HIV, according to a news release from the University of California, San Diego (UCSD) School of Medicine.
UCSD researchers assisted in the study conducted at 37 centers in the US and results were published in the New England Journal of Medicine. The treatment, which combined the FDA-approved drug sofosbuvir (Sovaldi) with daclatasvir, cured the hepatitis C virus (HCV) in 97% of patients who were also infected with HIV.
“These findings are very exciting in the infectious diseases world, as they could help an entire demographic that has historically struggled finally receive successful treatment for HCV,” lead author David Wyles, MD, said in the release.
Daclatasvir is an NS5A inhibitor currently under regulatory review in the US and sofosbuvir is a NS5B inhibitor. The two drugs combined have previously been shown to be effective in clinical trials with hepatitis C virus (HCV) monoinfection, according to the NEJM article.
Chronic infection of HCV can lead to serious liver damage, including cirrhosis, liver cancer and the need for a liver transplant. Liver disease is a leading cause of death among patients with human immunodeficiency virus type 1 (HIV-1).
Up to 30% of patients with hepatitis C are coinfected with HIV, according to the UCSD release. However, treatment options for HCV have been limited for many coinfected patients because of adverse drug interactions with the HIV medicine they take.
“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 Wyles, who serves as an assistant professor in medicine at UCSD School of Medicine. “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.”
The open-label study lasted 12 weeks and was the first to test this particular treatment regimen in patients coinfected with HIV and HCV. It involved 151 patients who had not previously been treated for hepatitis C and 52 patients who had been treated for the virus; all patients also had HIV-1.
Previously untreated patients were randomly assigned in a 2:1 ratio to receive either 12 weeks or 8 weeks of daclatasvir at a standard dose of 60 mg daily (with dose adjustment for concomitant antiretroviral medications) and 400 mg of sofosbuvir daily. Previously treated patients were assigned to undergo 12 weeks of therapy at the same doses.
The primary endpoint was a sustained virologic response 12 weeks after treatment ended among treatment -naive patients with HCV genotype 1 who took the investigational drug regimen for 12 weeks.
Wyles noted that the findings are important because liver damage progresses faster in people 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,” he said.
Daclatasvir is scheduled to be reviewed by the Food and Drug Administration in August, according to the release. Bristol-Myers Squibb sponsored and funded the study.
Clinicians interested in additional information and resources on hepatitis C for their patients should visit the CURE Hepatitis C website and access inspiring stories from patients who have overcome HCV infection.