Gilead suffers setback with promising hepatitis C therapy

Majority of hepatitis C genotype 1 patients with prior 'null' response to an interferon-containing regimen enrolled in ELECTRON study experience viral relapse within four weeks of completing treatment with GS-7977 plus ribavirin

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FOSTER CITY, Calif.—Gilead SciencesInc. recently announced that the majority of hepatitis C genotype 1patients with a prior "null" response to an interferon (IFN)-containing regimenenrolled in the ongoing ELECTRON study experienced viral relapse within fourweeks of completing 12 weeks of treatment with GS-7977 plus ribavirin (RBV).Ten patients were randomized to this arm of the ELECTRON study and data areavailable for eight of the 10 patients at this time. Among these eightpatients, six have experienced viral relapse. Two patients have not relapsed;however, they have only reached the two week post-treatment time point.
"These data answer an important question about theuse of GS-7977 and ribavirin for the treatment of genotype 1 null responderpatients, suggesting that additional direct acting antivirals may be necessaryto effectively treat this patient population," said Dr. Norbert Bischofberger, executive vice president of research and development and chief scientificofficer. "We will continue to explore a number of therapeutic approaches toaddress this significant unmet medical need, including combinations with otheroral antivirals."
GS-7977 is a nucleotide analog polymeraseinhibitor that is currently being studied for the treatment of chronichepatitis C. A number of ongoing Phase II and Phase III studies are evaluating thesafety and efficacy of the compound with and without RBV and/or pegylatedinterferon (Peg-IFN) in patients with genotypes 1-6 who are treatment naïve,treatment experienced, or have had a "null" response to Peg-IFN. 

Genotype 2 and 3 data from the ELECTRON study werepresented at the 62nd annual meeting of the American Association for the Studyof Liver Diseases (The Liver Meeting 2011). Data from the genotype 1 nullresponder arm of the study will be presented at an upcoming scientificconference.
Results from ongoing studies in genotype 1treatment-naïve patients will be available in the coming months. The first dataevaluating GS-7977 plus RBV for 12 weeks in genotype 1 naïve patients will comefrom an arm of the QUANTUM study with 25 patients at the end of the firstquarter of 2012. This will be followed in the second quarter by data from theELECTRON study involving 25 patients and, early in the third quarter, data onGS-7977 and RBV treatment for 24 weeks from an arm of the QUANTUM study willbecome available.
This news follows close on the heels of the acquisition earlier this year of Pharmasset Inc. that brought GS-7977 and other compounds into Gilead's pipeline. Early results for some patients had been showing presumed cure rates as high as 100 percent.

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