Published: Nov 7, 2013
Coverage of Hepatitis C Virus is supported in part by an independent educational grant from AbbVie Pharmaceuticals.
By Ed Susman , Contributing Writer, MedPage Today
Reviewed by F. Perry Wilson, MD, MSCE; Instructor of Medicine, Perelman School of Medicine at the University of Pennsylvania
- Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.
- Note that this uncontrolled study of patients coinfected with HIV and HCV demonstrated that the combination of sofosbuvir and ribavirin has very good virologic efficacy.
- Be aware that all patients were on antiretroviral therapy and had undetectable HIV levels.
WASHINGTON -- An all-oral regimen to treat the hepatitis C virus (HCV) in patients co-infected with HIV appears to achieve a sustained virologic response against the hepatitis virus without disrupting suppression of the virus that causes AIDS, researchers said here.
Patients with co-infection treated with the investigative nucleotide polymerase inhibitor sofosbuvir plus the workhorse antiviral ribavirin achieved sustained virologic response at week 12 -- considered a cure for HCV infection -- in 76% of 114 patients diagnosed with HCV Genotype 1 infection said Mark Sulkowski, MD, associate professor of medicine at Johns Hopkins Medical Institutions.
Sustained virologic response was also seen in 88% of 36 patients diagnosed with HCV genotype 2 infections and in 67% of 42 patients diagnosed with HCV genotype 3 infection, Sulkowski reported at the annual meeting of the American Association for the Study of Liver Diseases.
"The interferon-free regimen of sofosbuvir plus ribavirin resulted in high sustained virologic response at week 12 rates in hepatitis c virus treatment naïve, HIV-infected patients that were similar to those seen in patients with hepatitis c virus mono-infection," he said in his plenary sessions presentation.
Almost all patients responded to treatment -- 100% of those with genotype 1, 96% of those with genotype 2, and 98% of those with genotype 3.
The regimen was well tolerated by patients who had a variety of antiretroviral therapies. "HIV viral breakthrough was seen exclusively in the setting of poor antiretroviral compliance," Sulkowski said. Furthermore, treatment with the all-oral hepatitis C therapy did not appear to affect levels of CD4-positive cell counts in the patient cohort.
"This is a dramatic new development," Raymond Chung, MD, professor of medicine at Massachusetts General Hospital/Harvard Medical School, told MedPage Today. "It is something that the FDA will take into serious consideration in its labeling." He said that being an all-oral combination gives it advantages over other treatments.
In the study, Sulkowski and colleagues, recruited patients co-infected with the two viral diseases. The mean age of the patients was about 48, about 80% were men and about 33% of the genotype 1 patients were black.
The 114 patients diagnosed with genotype 1 were treated with sofosbuvir and ribavirin for 24 weeks and then they were followed for 12 more weeks to determine if there was a sustained virologic response. The 68 patients diagnosed with genotype 2 and genotype 3 were treated with 12 weeks of therapy, followed again for 12 weeks to determine if sustained virologic responses had been achieved.
"We used broad inclusion criteria," Sulkowski said. Patients with cirrhosis were allowed to enroll; and a wide range of HIV regimens were also permitted as long as the patients had undetectable viral loads and were on a stable antiretroviral regimen. If patients had CD4-positive cell counts greater than 500 cells/mm3 they were also eligible for the trial.
Sulkowski said, in response to questions from the audience, that no control group was used in the study because of medical and ethical concerns.
Sulkowski disclosed commercial relationships with Pfizer, Merck, AbbVie, BIPI, Vertex, Janssen, Gilead, and Bristol-Myers Squibb
Chung disclosed commercial relationships with Idenix, Enanta, Gilead, Merck, and Mass Biologic.
Primary source: American Association for the Study of Liver Diseases.
Source reference: Sulkowski M, et al "All-oral therapy with sofosbuvir plus ribavirin for the treatment of HCV genotype 1, 2, and 3 infection in patients co-infected with HIV (PHOTON-1)"AASLD 2013.