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FDA Approves Once-Daily Coformulation of AbbVie's Viekira Regimen

The U.S. Food and Drug Administration (FDA) has approved a new once-daily coformulation of AbbVie's paritaprevir-based "3D" regimen for hepatitis C virus (HCV) genotype 1, to be sold as Viekira XR, the company announced this week. AbbVie also said that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion on a shorter 12-week course of treatment with Viekirax for HCV genotype 4 patients with liver cirrhosis.

The AbbVie regimen, dubbed "3D" during its development, consists of the HCV NS3/4A protease inhibitor paritaprevir, a ritonavir booster, and the NS5A inhibitor ombitasvir in a once-daily coformulation, taken with the twice-daily HCV NS5B polymerase inhibitor dasabuvir. In the U.S. the combination, approved in December 2014 for the treatment of HCV genotype 1, has been packaged together and sold as Viekira Pak. Dasabuvir is not effective against HCV genotype 4, so Abbvie has also marketed the paritaprevir/ritonavir/ombitasvir coformulation alone as Technivie. In Europe the 3-drug coformulation is sold as Viekirax and the dasabuvir component as Exviera.

The full regimen is highly effective, curing 95% to 100% of people with chronic HCV genotype 1 infection. The "2D" regimen without dasabuvir is also effective and cures most people with genotype 4. But the regimen's use has been limited by its confusing indications, twice-daily dosing of dasabuvir, and the need for ribavirin in many cases, making it less popular than Gilead Sciences Harvoni (sofosbuvir/ledipasvir).

Now, the FDA has approved a once-daily extended-release coformulation that combines all 4 drugs in Viekira Pak. The new Viekira XR product is taken as 3 tablets with a meal. It can be used by previously untreated people and those who did not respond to prior interferon-based therapy. People with HCV subtype 1b can use Viekira XR alone for 12 weeks, but those with harder-to-treat subtype 1a should combine it with ribavirin, which requires twice-daily administration. Genotype 1a patients with compensated cirrhosis should extend treatment to 24 weeks. Viekira XR should not be used by people with decompensated liver disease.

Paritaprevir-based regimens are not indicated for HCV genotypes 2, 3, 5, or 6. People with genotype 4 should use Technivie instead.

Viekira XR full Prescribing Information, including the Medication Guide, is available online.

In related news, AbbVie announced the same day that the CHMP has given a positive opinion for a 12-week regimen of Viekirax -- the "2D" regimen without dasabuvir -- plus ribavirin for people with HCV genotype 4 with or without compensated cirrhosis. The previous indication for cirrhotics called for 24 weeks of treatment.

The new indication is supported by the AGATE-I trial, in which 97% of genotype 4 patients with cirrhosis were cured using paritaprevir/ritonavir/ombitasvir plus ribavirin for 12 weeks. (In the U.S., the equivalent Technivie is currently only indicated for genotype 4 patients without cirrhosis.)

Genotype 4 -- the predominant type in much of North Africa and the Middle East -- is now becoming increasingly common in several countries in Europe, including Italy, France, Greece, and Spain, according to an AbbVie press release.

7/29/16

Sources

AbbVie. AbbVie Receives U.S. FDA Approval of Once-Daily VIEKIRA XR (dasabuvir, ombitasvir, paritaprevir and ritonavir) for the Treatment of Genotype 1 Chronic Hepatitis C. Press release. July 25, 2016.

CHMP Grants Positive Opinion for Shorter Treatment Duration with AbbVie's VIEKIRAX (ombitasvir/paritaprevir/ritonavir tablets) for Patients with Genotype 4 Chronic Hepatitis C with Compensated Cirrhosis (Child-Pugh A). Press release. July 25, 2016.