The recently approved Viekira, with or without ribavirin (RBV), is an oral interferon-free treatment for patients with chronic genotype 1 (GT1) hepatitis C virus (HCV) infections; those with compensated cirrhosis are also included. Viekira is the only approved regimen that consists of three different mechanism of action: a non-nucleoside NS5B polymerase inhibitor, a NS3/4A protease inhibitor and a NS5A inhibitor. These mechanisms work together to attack the virus in three stages of its life-cycle so that it is prevented from continuing to reproduce.
AbbVie’s CEO, Richard Gonzalez, said in a press release: “We are proud of the work of our research and development organization to bring this important therapy, offering high cure rates, to patients with hepatitis C. We believe appropriate patients, regardless of their fibrosis stage, should have broad market access to ViekiraA Pak, and we are committed to supporting access to this therapy. This is the first of several potential new therapies that we are advancing to treat a multitude of serious disease states, and we anticipate bringing them to market in the coming years.”
The new approval is based on the success of six Phase 3 studies that enrolled more than 2,300 patients in 25 countries and that showed that the drug cured 95-100 percent of the patients. Less than 2 percent had virological failure, and more than 98 percent completed the entire therapy. Furthermore, the Phase 2 results were also consistent and served to support the FDA decision.
Fred Poordad from UTHealth, San Antonio added: “AbbVie’s clinical trial program includes landmark, placebo-controlled studies evaluating a wide variety of patients with hepatitis C. The studies have shown that treatment with VIEKIRA PAK resulted in high cure rates, even in patients who have historically been challenging to treat, such as patients with cirrhosis, patients who have had liver transplants and patients co-infected with HIV.”
HCV affects more than 3.2 million Americans and about 70 percent of those infected have the GT1 type. Latest public health projections state that the virus in the U.S. over the next twenty years will cost $85 billion to treat and cure.
Michael Severino, from AbbVie, said: “Treating hepatitis C is complex because the virus mutates and replicates rapidly. With so many Americans affected by HCV, it is critical that patients have access to a regimen that, in clinical trials, produced high cure rates with low rates of treatment failures, even in the most difficult-to-treat patients.”
The AbbVie Assistance Program, which provides medication for free for those facing financial difficulties, has launched a patient support program and supports non-profit organizations to assist patients.