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CDC HIV/AIDS/Viral Hepatitis/STD/TB Prevention News Update

SPAIN: Gilead, Bristol Hepatitis C Trial Data Impresses


Reuters (04.19.12) - Friday, April 20, 2012

New results from a clinical study of a hepatitis C treatment combining Gilead Sciences Inc.'s GS-7977 with Bristol-Myers Squibb (BMS) Co.'s daclatasvir showed a 100 percent response rate in treatment-naive patients with the most common, and difficult to treat, form of the virus. Interim data from the mid-stage trial were presented Thursday at the International Liver Congress 2012 in Barcelona.

GS-7977 is a nucleotide polymerase inhibitor. Daclatasvir is an NS5A inhibitor, a new drug class. Both are designed to block enzymes hepatitis C needs to replicate. Neither interferon, an injected drug known to cause significant side effects, nor ribavirin - an older, common antiviral, was used in the combination.

All 44 study patients with hepatitis C genotype 1 had undetectable levels of the virus in their blood four weeks post-treatment, compared to 40 of 44 patients with genotypes 2 or 3. Cured patients are considered those who still have undetectable levels 12 weeks following treatment's end; a sustained viral response at four weeks is considered to be a fairly accurate predictor of cure. Complete trial results are expected later this year.

The combination was found to be well tolerated, with side effects including fatigue, headache, and nausea. Reasons for two patients leaving the study are not believed to be due to the drugs, BMS said.

Despite the impressive data, BMS spokesperson Cristi Barnett said Gilead is "not interested" in a phase III collaboration. Gilead is set to start a trial of GS-7977 with its own experimental NS5A inhibitor, while BMS is testing daclatasvir with a drug similar to GS-7977.


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Information in this article was accurate in April 20, 2012. The state of the art may have changed since the publication date. This material is designed to support, not replace, the relationship that exists between you and your doctor. Always discuss treatment options with a doctor who specializes in treating HIV.