BOSTON – Treating hepatitis C with a combination of ledipasvir and sofosbuvir produced a sustained virologic response in 49 of 50 patients coinfected with genotype 1 hepatitis C and HIV (98%).
Older, interferon-based treatment regimens for hepatitis C historically have not worked well in patients coinfected with hepatitis C and HIV, Dr. Shyamasundaran Kottilil noted at the annual meeting of the American Association for the Study of Liver Diseases.
Dr. Shyamasundaran Kottilil
The fixed-dose combination – containing 90 mg of ledipasvir and 400 mg of sofosbuvir – was effective and well tolerated in the current study, suggesting that HIV infection may not be a major determinant of treatment outcome when using this combination therapy, said Dr. Kottilil, who is codirector of Institute of Human Virology’s Clinical Research Unit and associate director for clinical research in the institute’s Division of Clinical Care and Research of the University of Maryland, Baltimore.
He and his associates studied patients who had not been treated for hepatitis C, giving them the fixed-dose combination once daily for 12 weeks.
Among 13 patients who were not on antiretroviral therapy for HIV, 100% achieved a sustained hepatitis C virologic response at 12 weeks.
Patients were permitted to be on anti-HIV antiretroviral combinations containing tenofovir/emtricitabine (Truvada) with efavirenz, rilpivirine, or raltegrevir for HIV viral suppression. Among the 37 patients on antiretrovirals, all but one achieved a sustained virologic response against hepatitis C by week 12. “We are investigating reasons” for the failure in one patient, Dr. Kottilil said.
No changes in HIV RNA levels or renal parameters were seen. There were no serious adverse events related to study drugs and no discontinuations of therapy because of adverse events.
Men made up 74% of the cohort, and 84% of patients were African American. The mean age was 57 years, 74% had genotype 1a infection, and 78% had an early disease Hepatic Activity Index fibrosis score below 2.
Dr. Kottilil reported having no financial disclosures. Three of his associates reported ties with Gilead Sciences.