Shorter Treatment Strategy Effective for Hepatitis C

A six-week treatment regimen seems to be as effective as the more standard 12 weeks of therapy for patients with Hepatitis C virus (HCV) infection, according to a new study.

Researchers at the US National Institutes of Health Clinical Center (Bethesda, MD, USA) evaluated a fixed-dose co-formulation of the HCV polymerase inhibitor sofosbuvir and the NS5A inhibitor ledipasvir, both used for brief interferon- and ribavirin-free direct-acting antiviral regimens. The 60 study participants, mostly low-income people with chronic hepatitis C in Washington DC (USA) were randomly assigned to receive therapy with sofosbuvir/ledipasvir alone for 12 weeks, or the co-formulation plus a third direct-acting drug—either the non-nucleoside HCV polymerase inhibitor GS-9669 or the HCV protease inhibitor GS-9451—for six weeks.

The results showed that HCV viral load declined rapidly after starting therapy, and 100% of participants in all arms had undetectable levels at the end of treatment. A single person in the GS-9669 arm relapsed after stopping therapy, resulting in success rates of 100% with 12-week dual therapy, 95% with GS-9669 triple therapy, and 100% with GS-9451 triple therapy. All regimens were generally safe, well tolerated, and with no serious adverse events; the most common side effects were headache, fatigue, and diarrhea. The study was presented at the annual Conference on Retroviruses and Opportunistic Infections, held during March 2014 in Boston (MA, USA).

“What we have learned from this trial is that we can treat patients for shorter durations of therapy and we see that six weeks is effective,” said lead author Anita Kohli, MD. “Secondly, these regimens are very simple: one, two, or three pills a day. Third, our patient population is one that is historically very difficult to treat; more than 80% of the patients were African American, most had genotype 1a, most had high viral loads, and 25%–30% of the patients had advanced-stage liver disease.”

“The reason we wanted to look at the short-duration therapies is because we think it is very important in treatment of hepatitis C globally in limited resource settings. We really need very simple treatments for the 150 million to 180 million people globally,” added Dr. Kohli. “This short duration, simple therapy for HCV may prove relevant for the global elimination of hepatitis C, where uncomplicated, well-tolerated therapy is required to ensure adherence and minimize healthcare expenditures.”

Hepatitis C, also known as non-A and non-B hepatitis, is the most common chronic blood-borne infection in the United States and is the leading indication for liver transplants. While 15%–45% of those infected with HCV are able to clear the virus from their blood within about six months from the time of infection, the rest do not, and suffer from chronic hepatitis C. About 70% of chronically infected persons will develop chronic liver disease, and 1%–5 % of patients may die from chronic liver disease.

Related Links:
US National Institutes of Health Clinical Center