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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-naïve 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.
The Friends of AIDS Foundation is
dedicated to enhancing the quality of life for HIV positive individuals and
empowering people to make healthy choices to prevent the spread of the HIV
virus. To learn more about The Friends of AIDS Foundation, please visit: http://www.friendsofaids.org.
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