Drug & Device Development

Combo hepatitis C pill shown effective in small mid-stage trial

Last Updated: 2013-05-02 12:10:22 -0400 (Reuters Health)

By Ransdell Pierson

(Reuters) - Gilead Sciences Inc on Thursday said almost all patients taking a fixed-dose combination of two of its experimental hepatitis C drugs (sofosbuvir and ledipasvir) appeared to have eliminated the virus after either eight weeks or 12 weeks of treatment in a small mid-stage study.

Based on the favorable interim data from the trial of 60 previously untreated patients, named LONESTAR, Gilead said it plans to conduct a third late-stage study of the once-daily fixed-dose combination tablet.

The new Phase III trial, called ION-3, will enroll 600 patients new to treatment who have the most common genotype 1 form of hepatitis C, Gilead said.

It will evaluate the combination tablet for eight weeks of treatment, with and without ribavirin, which is a mainstay of current standard treatments. The trial will also test the combination drug for 12 weeks, without ribavirin.

Gilead said all 19 patients in the LONESTAR trial who took the combo pill for 12 weeks had a sustained virologic response (SVR) as assessed by blood tests given four weeks after completing therapy.

Moreover, the company said 40 of 41 patients who took the tablet for eight weeks were deemed free of the virus eight weeks after they completed treatment. Gilead said one patient relapsed, and that patient was from a group that took the combo tablet but did not take ribavirin.

"We believe this data greatly strengthens Gilead's position in the hepatitis C market, with an all oral once-daily pill across all genotype 1 patients and potentially for only 8 weeks" of treatment, ISI Group analyst Mark Schoenebaum said in a research report.

Hepatitis C affects an estimated 170 million people worldwide, and if left untreated can lead to cirrhosis, liver cancer or the need for a new liver.