Drug & Device Development

Some patients in hep C trial show relapse: Gilead

Last Updated: 2012-02-17 13:48:03 -0400 (Reuters Health)

By Esha Dey and Kavyanjali Kaushik

(Reuters) - Gilead Sciences said some patients treated with its experimental hepatitis C drug, which the company acquired with its $11 billion buy of Pharmasset, experienced a relapse of the infection in an ongoing study.

Gilead said six out of the 10 patients treated with a combination of the drug, GS-7977, and widely used antiviral ribavirin in its Electron study experienced viral relapse.

"The issue is the drug combination and duration. 12 weeks of 7977 with ribavirin, just does not seem to be enough. So if they ran a longer duration of treatment, they might see it working," Brean Murray, Carret & Co analyst Brian Skorney said.

Additional antivirals may be needed to effectively cure this hard-to-treat patient population, Gilead said in a statement.

GS-7977 is a nucleotide analog polymerase inhibitor that is currently being studied to treat chronic hepatitis C -- a highly competitive market that is expected to soar to $16 billion by 2015 from $1.7 billion in 2010, according to research firm Decision Resources.

While the mainstay of hepatitis C therapy has been a combination of interferon and ribavirin, side-effects of interferon that causes flu-like symptoms forced many patients to stop or delay treatment.

However, nucleotide polymerase inhibitors, or "nucs", work by targeting polymerase without the interferon, and is the biggest selling point of this new class of drugs.

Bristol-Myers Squibb also gained access to Inhibitex's experimental treatment after it bought the company at a hefty 163 percent premium.

The first data evaluating Gilead's GS-7977 given along with ribavirin for 12 weeks will come from an arm of the Quantum study with 25 patients at the end of the first quarter, the company said.

About 130 million to 170 million people are chronically infected with hepatitis C virus, and more than 350,000 people die from hepatitis C-related liver diseases each year, according to the World Health Organization website.

Untreated, hepatitis C can lead to cirrhosis, liver cancer and the need for a liver transplant. More than 350 000 people die from HCV-related liver diseases each year.