FDA approves AbbVie's VIEKIRA PAK for treatment of patients with GT1 HCV infection

AbbVieDec 21 2014

The U.S. Food and Drug Administration (FDA) has approved AbbVie's (NYSE: ABBV) VIEKIRA PAK™, an all-oral, interferon-free treatment, with or without ribavirin (RBV), for the treatment of patients with chronic genotype 1 (GT1) hepatitis C virus (HCV) infection, including those with compensated cirrhosis. VIEKIRA PAK is the only FDA-approved regimen that contains three distinct mechanisms of action - NS5A inhibitor, NS3/4A protease inhibitor and a non-nucleoside NS5B polymerase inhibitor - that work together to attack the virus at three separate stages of the disease lifecycle to inhibit it from reproducing.

"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 VIEKIRA PAK, and we are committed to supporting access to this therapy," said Richard Gonzalez, Chairman of the Board and Chief Executive Officer, AbbVie. "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 approval of VIEKIRA PAK is supported by a robust clinical development program designed to study the safety and efficacy of the regimen in more than 2,300 enrolled patients across 25 countries. The program consisted of six pivotal Phase 3 studies, which demonstrated that VIEKIRA PAK cured 95-100 percent of GT1a and GT1b hepatitis C patients, including patients new and experienced to treatment, and patients with compensated cirrhosis, with less than 2 percent of patients experiencing virological failure. Additionally, more than 98 percent of patients in clinical trials completed a full course of therapy.

VIEKIRA PAK's approval is also based on the results from Phase 2 clinical trials, which showed that VIEKIRA PAK cured 97 percent of liver transplant recipients and 92 percent of patients co-infected with HCV/HIV-1. Patients who achieve a sustained virologic response (SVR₁₂) are considered cured of HCV.

"AbbVie's clinical trial program includes landmark, placebo-controlled studies evaluating a wide variety of patients with hepatitis C," said Fred Poordad, M.D., vice president, academic and clinical affairs, the Texas Liver Institute and Professor of Medicine, University of Texas Health Science Center, San Antonio, and investigator for several VIEKIRA PAK trials. "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 is the most common, blood-borne infection in the United States, affecting more than 3.2 million Americans, which is nearly three times as many people affected by the human immunodeficiency virus (HIV). More than 70 percent of all HCV patients have GT1 infection. It is estimated that more than 1 million people currently living with HCV will develop cirrhosis (scarring of the liver) by the year 2020, and with HCV-related liver transplants on the rise, it has become a critical public health issue. As the population ages and HCV progresses, it is projected that total annual direct medical costs of HCV in the U.S. will reach $85 billion over the next 20 years.

"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," said Michael Severino, M.D., Executive Vice President, Research and Development and Chief Scientific Officer, AbbVie.

For people living with hepatitis C who face financial difficulties, the AbbVie Patient Assistance Program provides medication at no cost. A co-pay assistance program will be available for commercially-insured patients being treated with VIEKIRA PAK. Out-of-pocket costs for eligible patients could be as little as $5.00 per month.

Additionally, AbbVie has launched a patient support program, called proCeed™, which is intended to provide a broad range of patient support options.