Hepatitis C Cured in Co-Infected HIV Patients, Study Reports
A team of researchers has reported in a phase III clinical trial that a combination drug therapy cures chronic hepatitis C in the majority of patients co-infected with both HIV and hepatitis C.
"In many settings, hepatitis C is now a leading cause of death among HIV co-infected patients," said Mark Sulkowski, M.D., medical director of the Johns Hopkins Infectious Disease Center for Viral Hepatitis and professor of medicine at the Johns Hopkins University School of Medicine, in the press release.
According to statistics, approximately one-third of HIV patients in the US have hepatitis C and an estimated 7 million patients are co-infected with HIV and hepatitis C worldwide.
This all-oral regimen - Sofosbuvir and ribavirin is considered on-label as Data from the phase III clinical trial were incorporated into the FDA's approval of the new drug, sofosbuvir, last December.
The study participants were enrolled by researchers and doctors from the United States and Peurto Rico through 34 academic, private practice and community health centers.
"We've always termed this to be 'sustained virologic response," added Sulkowski, "but we now know that means hepatitis C has been cured." During the experiment, about 92% patients with genotype 2 and 94% patients with genotype 3 experienced the better cure rates. However 7 patients had to discontinue their treatment as they faced adverse events.
"Doctors and patients alike recognize the idea that it would be difficult, if not impossible, to randomize clinical trial participants to an injectable treatment (interferon) that's linked to many side effects versus an oral treatment (sofosbuvir plus ribavirin). The PHOTON-1 study represents the first clinical trial to demonstrate that we can cure hepatitis C in patients with HIV co-infection without the use of interferon," Sulkowski added in the press release.
"As such, it represents a transformative step in our approach to this therapeutic area."
The trial, paid for by the developers of sofosbuvir, Gilead Sciences, has been published in the July 23 issue of the The Journal of the American Medical Association.