Globally, up to 7 million people have both HIV and HCV infections that may lead to liver fibrosis (the first stage of liver scarring), cirrhosis (further liver scarring), hepatocellular carcinoma (the most common type of liver cancer) and premature death.
For various reasons, therapies of HCV in HIV patients have been limited. Some cannot tolerate the dosing, and many with both infections are not able to take interferon (an antiviral protein used to treat HCV).
Scientists have recently discovered that taking a combination of two new medications (sofosbuvir plus ribavirin) can control HCV in individuals with HIV to a degree where they are considered clinically cured.
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Mark S. Sulkowski, MD, with the Johns Hopkins University School of Medicine in Baltimore, Maryland, and colleagues assessed response to sofosbuvir and ribavirin in 223 people with both HCV and HIV who were not currently taking interferon.
Participants had different types of HCV (genotypes 1, 2 and 3), and took an oral regimen of the medications for either 12 or 24 weeks.
Researchers examined rates of sustained virologic response (SVR), which is clinically considered a “cure.” Response rates to the dual therapy among patients with different types of HCV were high.
After stopping the therapy for 12 weeks, SVR was achieved by 76 percent with genotype 1, 88 percent with genotype 2, and 67 percent with genotype 3 among those who had no previous treatment for HCV. Among patients who had prior HCV treatment, 92 percent with genotype 2 and 94 percent with genotype 3 reached a sustained virologic response.
Investigators noted that three percent of participants (seven individuals) dropped the HCV therapy due to negative reactions—the most common being fatigue, insomnia, headache and nausea. The HCV medications had no observable effect on HIV disease or its treatment.
“In this open-label, nonrandomized, uncontrolled study, HIV-infected patients with HCV genotypes 1, 2, or 3 coinfection who received an oral combination of sofosbuvir plus ribavirin for 12 or 24 weeks had high rates of sustained HCV virologic response 12 weeks after cessation of therapy,” the authors wrote. “Further studies of this regimen in more diverse populations of coinfected patients are needed.”
In an accompanying editorial, Dr. Sulkowski underscored that the use of these new agents can be extremely expensive.
“The average wholesale price of sofosbuvir is more than $1,000 per pill,” he wrote. “When combined with ribavirin, the average wholesale price of a 12-week course of treatment is $94,500 and $189,000 for a 24-week course…. Hopefully, competition among the new products coming to market in the next 18 months will result in substantially lower pricing for the drugs.”
The study was published in the July 23/30 issue of JAMA, a theme issue on HIV/AIDS.
Gilead Sciences funded the trial. Dr. Sulkowski reported receiving research grants and personal and other fees from Gilead, AbbVie, PIPI, Bristol-Myers Squibb, Indenix, Janssen and Merck.