Newly Approved Drugs Show High Cure Rates for Hepatitis C
Two new drugs are providing hope to the approximately 3.2 million people in the United States who are infected with the hepatitis C virus. Unlike the previous therapy, the new drugs have minimal side effects and offer most patients an almost 90 percent chance at a cure in just 12 weeks.
Sofosbuvir, a polymerase inhibitor, is approved for use in combination with ribavirin for patients with genotypes 2 and 3. Twelve weeks of therapy for naïve genotype 2 and 24 weeks of therapy for naïve genotype 3 patients result in sustained virologic response (SVR) in more than 90 percent of patients.
“The new drug has essentially no side effects and when combined with ribavirin is extremely well tolerated,” said Jacqueline G. O’Leary, MD, MPH, medical director of hepatology research at Baylor University Medical Center at Dallas. “Patients who have had interferon in the past are amazed. Interferon makes you feel like you have the flu the whole time.”
Treatment-naive patients with genotype 1 have a 12-week option of triple therapy with sofosbuvir, ribavirin, and interferon. This regimen showed an SVR of 89 percent. Sofosbuvir also is approved for re-treatment patients although cure rates are not yet available.
“Patients with genotype 1 who can’t tolerate interferon may be treated with 24 weeks of sofosbuvir and ribavirin,” Dr. O’Leary said. “It’s good to have that as an option for interferon ineligible or intolerant patients.”
Simeprevir, a protease inhibitor, has also been approved for use in combination with interferon and ribavirin for patients with genotype 1. However, when simeprevir was combined with sofosbuvir for just 12 weeks in a small phase II study, more than 90 percent of patients with advanced fibrosis who were prior null responders to pegylated interferon and ribavirin achieved SVR.
“We literally had no new drugs for a decade,” Dr. O’Leary said. “Then in 2011, there was the first release of direct-acting, anti-viral agents. Although this was a major advance, tolerability remained an issue that limited who could be treated and cured. Now just two years later, we have curative therapies for the vast majority of patients. There has been a complete revolution in how we care for patients with hepatitis C.”