Interferon-free Drug Combo Studied in Patients with Hepatitis C and HIV

A combination oral treatment of sofosbuvir and ribavirin resulted in high cure rates of hepatitis C among a patient population that also was infected with human immunodeficiency virus (HIV), according to results from a small multicenter study that were presented at the 2014 International AIDS conference in Melbourne, Australia.

An estimated 7 million people across the globe are coinfected with HIV and the hepatitis C virus (HCV), according to Mark Sulkowksi, MD, of Johns Hopkins University School of Medicine in Baltimore, lead author of the study that was discussed at the conference and published in the Journal of the American Medical Association.

Use of interferon and adverse interactions between HCV drugs and those used to treat HIV have limited treatment options for coinfected patients. An estimated 70 percent are ineligible for treatment that includes interferon, an injection drug traditionally used to treat hepatitis C.

The success of antiretroviral therapies (ARTs) in the treatment of HIV has led to lower death rates caused by the disease itself, but comorbid conditions such as HIV and hepatitis C have begun to emerge, explained Sulkowski in a supplemental audio presentation in the journal. In many parts of the world where highly effective HIV treatment is available, HIV- infected patients are dying due to liver disease from hepatitis C, he said.

“HIV appears to accelerate the pace at which a patient will progress from minimal liver damage to cirrhosis,” Sulkowski said.

The open-label, nonrandomized, uncontrolled phase 3 clinical trial was conducted from August 2012 to November 2013 at 34 clinics in the United States and Puerto Rico. The study included 223 patients coinfected with HIV and with HCV (genotypes 1, 2, or 3).

Study participants were allowed to have evidence of cirrhosis but patients with decompensated liver disease or advanced AIDS were excluded, Sulkowski said. Seven patients stopped taking the drugs before the study ended due to side effects.

Treatment-naïve patients with HCV genotype 2 or 3 were given 400 mg of sofosbuvir once daily and weight-based ribavirin twice daily for 12 weeks. The same treatment was given for 24 weeks to treatment-naïve patients with genotype 1 (the largest group in the study with 114 patients), as well as to patients with genotype 2 or 3 previously treated with peginterferon-ribavirin.

The primary efficacy endpoint was the proportion of patients who achieved sustained virologic response (SVR) 12 weeks after the end of treatment. A patient is generally considered cured when SVR is achieved, an indication that hepatitis C is no longer detectable in the blood.

Study results showed that the highest percentage of patients who achieved SVR were among treatment-experienced patients, 94% with HCV genotype 3 and 92% with HCV genotype 2. Among treatment-naïve patients, the SVR rate was highest among patients with HCV genotype 2 at 88%, followed by HCV genotype 1 patients at 76%, and HCV genotype 3 patients at 67%.

Study limitations included an underrepresentation of women (17%) and patients with cirrhosis (10%). The article also notes that the lack of a control group limited the ability to draw definitive conclusions about the regimen’s safety and efficacy profile.

Study authors concluded that the tested drug combination resulted in high rates of SVR and that further studies among diverse populations of coinfected patients are needed.

Gilead Sciences Inc., which markets sofosbuvir under the name Sovaldi, sponsored the study.