Sofosbuvir plus Velpatasvir
On January 4, 2016, Gilead issued a press release to announce that the U.S. Food and Drug Administration (FDA) granted priority review to sofosbuvir (polymerase inhibitor) plus velpatasvir (a pan-genotypic NS5A inhibitor). Gilead stated that FDA approval is expected on June 28, 2016.
Below is a brief overview of study results from articles published in the New England Journal of Medicine (vol. 373 no.27 December 31, 2015).
Genotype 1, 2, 4, 5 and 6 (ASTRAL Studies)
In the group of patients with genotype 1, 2, 4, 5, and 6 (624 patients) the cure rates were 99% across all the genotypes. Less than 1% of patients discontinued treatment due to side effects. The most common side effects were headache, fatigue, sore throat, runny nose, and nausea.
Genotype 2 and 3 (ASTRAL 2 & 3 Study)
ASTRAL 2: The results from the Phase 3 clinical trial for the treatment of 134 patients with genotype 2 who were treated with sofosbuvir plus velpatasvir for 12 weeks resulted in a cure rate of 99%.
ASTRAL 3: In the Phase 3 clinical trial of 277 genotype 3 patients the overall cure rate was 95%. Treatment naïve: In the group of patients without cirrhosis the cure rate was 98% (160 of 163 pts); in the group of patients with cirrhosis the cure rate was 93% (40 of 43 pts). Treatment-experienced: in patients without cirrhosis the cure rate was 91% (31 of 34 pts); in patients with cirrhosis the cure rate was 89% (33 of 37 pts).
The ASTRAL 2 and 3 studies had comparator arms that included 132 genotype 2 patients and 275 patients genotype 3 patients who received sofosbuvir plus ribavirin. The patients who received sofosbuvir plus velapatasvir had higher cure rates and less side effects.
The most common side effects in sofosbuvir plus velpatasvir groups were fatigue, headache, nausea and insomnia.
On January 7, 2015, AbbVie issued a press release that the FDA had granted Viekira Pak without ribavirin a priority review status for the treatment of hepatitis C genotype 1b in people with compensated cirrhosis. AbbVie did not provide details on an expected FDA approval date.
AbbVie submitted data to the FDA based on the Phase IIIb TURQUOISE-III study of 60 genotype 1b patients treated with Viekira Pak (ombitasvir, paritaprevir/ritonavir, dasabuvir) for a treatment duration of 12 weeks. The cure rates were 100% (60 of 60 pts). The most common side effects were fatigue, diarrhea, headache and joint pain.
Merck’s Drug Approval
The FDA is expected to approve Merck’s two drug combination of elbasvir plus grazoprevir—brand name Zepatier—one pill, once-a-day by the end of this month. Zepatier’s treatment duration is 12 weeks to treat genotype 1, 4, and 6.
Easing Insurance Restrictions
There have been reports that insurance companies are easing some of the strict fibrosis/cirrhosis restrictions that have prevented many people from accessing HCV treatment. Personally, a friend who that had been denied multiple times by her insurance company for HCV medications was notified that she had been approved for treatment. Since that time I have heard from other patients and other advocates that insurance companies have dropped some of the more severe restrictions. These restrictions included having to have severe liver disease progression—severe fibrosis/cirrhosis (F3/F4). For people who have been denied claims, it just might be a good time to check-in with your medical provider or your insurance company to find out the status of your claim.
2016 will likely be an exciting year for patients and medical providers that will offer more choices and better access to treatment.