The 2016 Hepatitis C Drug Approval Outlook

2016 has been a remarkable year in the expansion of treatment for hepatitis C with many regimens awaiting FDA approval.

The FDA is expected to announce its decision on Merck’s application for its once-daily fixed dosage of combination tablet of the NS3/4A protease inhibitor grazoprevir and the NS5A replication complex elbasvir to treat genotype 1,4 and 6 of HCV by January 28.

The treatment priority review status has been approved by the FDA. It shortens the review period from 10 months to 6 months. Priority is given to investigational treatment for grave conditions that would significantly improve the safety and effectiveness of this treatment over others.

Merck’s treatment and ribavarin cured 94 to 96 percent of people with genotype 1 who had failed a previous treatment in the phase II C-SALVAGE study.
In the Phase II/III C-SURFER trial,grazoprevir/elbasvir cured 99 percent with genotype 1 and advanced kidney disease.


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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.

HOW MUCH IT COSTS TO CURE HEPATITIS C?

Surcation® is already helping patients whose insurance doesn’t cover the cost of Harvoni® with medical tourism. If you chose the similar treatment in the US, it costs between $84,000 and $95,000 just for the medication. If you are approved by your insurance, you still have today’s high deductibles and co-pays. You pay just $5200 when you chose hepatitis medical tourism with Surcation®. You can bring your spouse along for a total price is $6,400. Our clients are offered the best treatment available provided by world renowned doctors at a fraction of the cost. Surcation® offers medical financing if needed.

WE’RE HERE TO HELP

Call 928-328-8909 to get helpful information, a Hep C guide, and facts about managing Hep C.

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