Gilead is stated to continue its dominance in the hep C field owing to an upcoming fixed-dose, once-daily combination tablet to treat those with genotype 1-6, pending approval.
The company’s main drug Harvoni (ledipasvir/sofosbuvir), is approved for all genotypes except 2 and 3. So this combination drug, if approved will be a landmark in the treatment of hep C.
The four Phase III ASTRAL trial tested 12 weeks of treatment of patients with all genotypes for the Sovaldi/velpatasvir application including those who took ribavarin. The cure rates were between 94-100 percent.
Bristol-Myers is seeking approval for the combination of Daklinza in the existing treatment and also Gilead’s Sovaldi to be taken with or without ribaravin to treat individuals coinfected with HIV and advanced cirrhosis.
The Sovaldi and Daklinza combination was approved in July 2015 to treat genotype 3. A decision is expected by late February now that the FDA has granted priority review for BMS’s application.
BMS’s new application is partly based on research from the Phase III ALLY-1 trial of twelve weeks of Sovaldi, Daklinza and ribavarin including patients of all genotypes except 5. Over 90 percent of people with Child-Pugh class A or B of cirrhosis but only 56 percent with class C.
BMS also submitted results from the Phase III ALLY-2 trial in which 97 percent HIV-coinfected people with genotypes 1-4 were cured after 12 weeks of the regimen.
The FDA has granted priority review for AbbVie’s Viekira Pak (ombitasvir/paritaprevir/ritonavir; dasabuvir) which cures genotype 1 b without the need for ribavarin.
Viekira Pak treating genotype 1 was approved in December 2014. Presently, genotype 1 b patients are advised 12 weeks of the regimen with ribavarin. If approved, the new variant can be prescribed without ribavarin.
This new application of AbbVie is based on the Phase IIIb TURQUOISE-III trial, which had a cure rate of 100 percent in patients with compensated liver in 12 weeks.
The company has also applied to the FDA for approval of a latest version of Viekira Pak that can be taken just once instead of twice a day to treat individuals with genotype 1. A decision is expected in the latter half of 2017.