This year, 2014, has indeed proven to be an exciting one for the advancement of chronic hepatitis C (CHC) genotype 1 treatment.
This month, we saw the FDA approval of Gilead’s new drug Harvoni®, a once-daily single tablet regimen for treatment of chronic HCV genotype 1 in adults. HCV genotype 1 is the main subtype of the virus effecting about 70 percent of cases in the U.S. Harvoni is a Direct Acting Antiviral (DAA) that combines 90mg of the NS5A inhibitor, ledipasvir, and 400mg of the nucleotide analog polymerase inhibitor, sofosbuvir, into a single tablet. Harvoni trial data reports high cure rates and shorter treatment durations of 8, 12 or 24 weeks and fewer, more tolerable side effects for patients. Additionally, the FDA approved this treatment option for administration without interferon or ribavirin.
Following this milestone treatment approval, what else should we expect to see coming down the HCV drug pipeline? Plenty.
We are standing by for exciting news from Abbvie, which submitted promising all oral drug combinations to the FDA for approval in April. These drugs include what is known as the “3D” regimen, and consist of a fixed-dose combination of the protease inhibitor ABT-450 boosted with ritonavir, co-formulated with the NS5A inhibitor ombitasvir (ABT-267), and the NS5B non-nucleoside polymerase inhibitor, dasabuvir (ABT-333), with or without ribavirin.
Results of Abbvie’s wide-ranging phase 3 studies in 2,300 patients across 25 countries demonstrate that “3D” performs exceptionally well in a variety of genotype 1 patients.
In May, we also witnessed Janssen’s Supplemental New Drug Application to the FDA for use of Olysio™ and Sovaldi® together as a Direct Acting Antiviral (DAA) combination therapy for genotype 1 patients. Janssen’s filing was prompted by findings in 12 and 24-week studies of cirrhotic and non-cirrhotic genotype 1 patients that showed notable cure rates. These studies included patients who were treatment-naïve or null responders to certain prior treatments. If approved, this combination treatment would provide an all oral, interferon and ribavirin-free option for genotype 1 treatment.
FDA approval decisions for Abbvie and Janssen’s therapy options are anticipated to occur over the next couple of months.
So what do these advancing HCV treatment options suggest for the race to the cure?
With lower pill burden, fewer and more tolerable side effects, and heightened cure rates, these new therapy options may support improved patient adherence and compliance, and ultimately improve long-term patient outcomes and their associated future costs.
To learn more about the race to the cure, download Ms. Valbh’s whitepaper titled The Future of HCV here.