Data arm Gilead for next stage of HCV race

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Gilead shows latest on GT-1 all-oral
Gilead shows latest on GT-1 all-oral

Gilead's Sovaldi is already approved for most patients with hepatitis C, but the biotech may have earned itself some breathing room against rivals in the next stage of the all-oral hepatitis-C arms race. It reported on three Phase III trials for a once-daily HCV pill that combines sofosbuvir, the active ingredient in Sovaldi, with ledipasvir, an NS5A inhibitor still in the experimental stage. The pairing promises to reduce the treatment time for those with the most common subset of the infection.

The fixed-dose cocktail was tested with and without ribavirin—for eight, 12 or 24 weeks of therapy—and the study cohorts consisted of subjects with the genotype 1 (GT-1) form of the virus, both treatment-naïve and -experienced. Data were widely regarded as strong by analysts, and in line with expectations.

Among the treatment-naïve GT-1 patients in the group getting the fixed-dose combo for 12 weeks, without ribavirin, 97.7% achieved sustained virologic response, or SVR. Also among treatment-naïve over an eight-week course of therapy, also without ribavirin, 94% of patients achieved SVR.

Waiting in the wings is AbbVie, whose eight-week, three-drug regimen boasts a 96% SVR rate in treatment-naïve group, however those results were seen when ribavirin was part of the regimen. Another distinction: Gilead's SOF/LDV pill, without ribavirin, is also one-pill-a-day, while AbbVie's requires six pills per day.

“The data are excellent,” said ISI Group analyst Mark Schoenebaum in an investor note this morning. However, he cautioned that this “shouldn't come as a big surprise to the Street…In general, Gilead [continues] to dominate the G1 landscape.”

And while investors may find today's data in line with expectations, the news raised questions on how Gilead's potent SOF/LDV combo, which most likely won't reach market until 2015, could affect 2014 sales of Sovaldi—whose approval from FDA earlier this month included use in GT-1 patients who are ineligible for interferon.

Schoenebaum said he believes the eight-week regimen should be viewed as an entirely new drug and added, “The $84,000 price that Gilead put on single agent sofosbuvir (Sovaldi) has no impact on their decision for the pricing of the combo pill, which was the regimen tested in today's data. “

Gilead also noted that it plans to submit this fixed-dose combo for approval in Q1 2014. However, regardless of the strength of the data, Schoenebaum does not see it dramatically curbing uptake of what's currently available. After all, he noted, these developments have been in line with what he's heard from physicians.

“The data are, indeed, really good,”  he explained, “however they really aren't all that different from expectations expressed by physicians over the past year. Thus, I'm not really convinced that today's data has really changed anything.”

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