Gilead's new pangenotype hep C combo scores stellar results in PhIII

Gilead R&D Chief Norbert Bischofberger

Gilead ($GILD) has proved once again that it knows how to cure hepatitis C for a heavy concentration of patients, posting some stellar pangenotype data from a slate of four late-stage studies that combined its blockbuster Sovaldi with the experimental NS5A inhibitor velpatasvir. And the Big Biotech says it's ready to step up with new marketing applications with an eye to continuing its domination.

Gilead won the race to the market with the groundbreaking hep C treatment Sovaldi as well as the Harvoni combo follow-up, which have produced megablockbuster returns for a disease that afflicts millions of people around the world. To follow up on that achievement, Gilead has been testing a new combo that can cover the range of genotypes involved in hepatitis C. And the pangenotype therapy, designated a "breakthrough" drug by the FDA, was another big success.

In three Phase III studies covering genotypes 1 through 6, the combination provided a durable cure for 98% of patients, in what's called the SVR12 rate, after 12 weeks of therapy.

In the fourth study, patients with Child-Pugh class B cirrhosis who received the combo plus ribavirin did better than the combo alone--with a 94% cure rate compared to two groups that achieved SVR12 of 86% (after 24 weeks of treatment) and 83% (after 12 weeks).

"From our discussions with Gilead, the SOF/VEL regimen for 12 weeks will target GT2-6 patients, while Harvoni will remain the key regimen for GT1 given its commercial success and shorter 8 week treatment duration," noted Barclays Geoff Meacham. "In our view, Gilead continues to raise the bar on the competition in hep C, which remains a key value driver."

Gilead surged well into the lead in grabbing the hep C market with Sovaldi's approval and the Harvoni follow-up. But AbbVie ($ABBV) followed up with an FDA approval for a rival combo while Merck ($MRK) is steadily steering toward a first approval of its own.

The developers are far from finished with positioning lead cocktail remedies that can post faster or more comprehensive results. That trend was on display last week as Achillion ($ACHN) posted some new data from small studies that show its NS5A inhibitor odalasvir (or ACH-3102) could feature prominently in one of the fast-acting cocktail therapies now in development at Johnson & Johnson ($JNJ).

Gilead won't be sitting idly by, though, as other companies look to carve out a slice of its franchise.

"The ASTRAL study results demonstrate that a 12-week course of therapy with the first fixed-dose combination of two pan-genotypic compounds can provide high cure rates for patients with all HCV genotypes," said Norbert Bischofberger, the R&D chief at Gilead. "We are pleased to have now brought forward our second single tablet regimen for HCV infection that complements Harvoni, our first single tablet regimen approved specifically for patients with genotype 1 infection and which could eliminate the need for HCV genotype testing. We look forward to advancing the regulatory submissions for the SOF/VEL fixed-dose combination."

- here's the release

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