Six-week Oral Drug Trial Produces High Hepatitis C Cure Rates

A recent clinical trial, published in The Lancet, involving a 6-week course of a combination of 3 direct-acting oral drugs was found to cure 38 of 40 individuals with hepatitis C virus infection (HCV).

The trial, led by Shyam Kottilil, MD, PhD, previously a member of NIH's National Institute of Allergy and Infectious Diseases, included researchers from the NIH Clinical Center and the National Cancer Institute.

The researchers had found that a 6-week course of therapy is actually half the length of time typically reported to achieve a similar, successful cure rate using only2 direct-acting oral HCV drugs.

For the clinical trial, the first group of 20 volunteers were administered a 6-week course of the newly licensed drug sofosbuvir (Sovaldi) coupled with 2 additional direct-acting oral therapies, ledipasvir and GS-9669 — an experimental drug. The second volunteer group also comprised of 20 individuals had received another 6-week course of sofosbuvir, ledipasvir, and a different experimental drug, GS-9451.

Researchers noted none of the volunteers had previously been treated for their HCV infections, and yet they handled their treatment courses without a hitch. A third group of 20 volunteers were also incorporated in this study; however, they only received 2 oral drugs, sofosbuvir and ledipasvir, for a period of 12 weeks.

Study results indicated that within the first group, only one volunteer relapsed 2 weeks following therapy completion, but the remaining 19 individualsdid not appear to have any trace of the HCV infection when tested 12 weeks after therapy ended, so were reported as cured. In the second group, one individual was “lost to follow-up,” but the remaining 19 had no noticeable HCV symptoms 12 weeks after the end of therapy and were also believed to be cured. Lastly, all 20 participants in the third volunteer group were deemed cured of HCV with that dual drug regimen.

According to the study authors, "This short duration, simple therapy for HCV may prove relevant for the global elimination of hepatitis C, where simple, well-tolerated therapy of short duration is required to ensure adherence.”