AbbVie, a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories, announced that the US Food and Drug Administration (FDA) has approved 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 organisation 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 programme designed to study the safety and efficacy of the regimen in more than 2,300 enrolled patients across 25 countries. The programme consisted of six pivotal phase 3 studies, which demonstrated that Viekira Pak cured 95-100 per cent of GT1a and GT1b hepatitis C patients, including patients new and experienced to treatment, and patients with compensated cirrhosis, with less than 2 per cent of patients experiencing virological failure. Additionally, more than 98 per cent 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 per cent 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 programme includes landmark, placebo-controlled studies evaluating a wide variety of patients with hepatitis C," said Fred Poordad, MD, 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 US 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, MD, 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 programme provides medication at no cost. A co-pay assistance programme 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 programme, called proCeed, which is intended to provide a broad range of patient support options. The proCeed programme can be accessed soon at www.viekira.com or by calling 1-844-2-PROCEED.
AbbVie also supports independent non-profit organizations that assist eligible patients enrolled in federal and private insurance plans with their out-of-pocket medication costs.
AbbVie expects to provide earnings-per-share guidance for 2015 in early January. The company will provide detailed 2015 guidance, including product sales estimates and other financial metrics, on its fourth quarter earnings conference call, scheduled for January 30, 2015.
Viekira Pak (ombitasvir/paritaprevir/ritonavir tablets; dasabuvir tablets) has been studied in a broad range of genotype 1 (GT1) patients with chronic hepatitis C virus (HCV) infection, ranging from treatment-naive to some of the most difficult to treat, such as patients with compensated (mild, Child-Pugh A) cirrhosis of the liver, HCV/HIV-1 co-infection, liver transplant recipients with normal hepatic function and mild fibrosis, and those who have failed previous treatment with pegylated interferon (pegIFN) and ribavirin (RBV). Viekira Pak is not recommended in patients with moderate hepatic impairment (Child-Pugh B), and is contraindicated in patients with severe hepatic impairment (Child-Pugh C). Viekira Pak consists of the fixed-dose combination of ombitasvir 25mg (an NS5A inhibitor), paritaprevir 150mg (an NS3/4A protease inhibitor), and ritonavir 100mg (an approved HIV-1 protease inhibitor), dosed once daily with a meal, and dasabuvir 250mg (a non-nucleoside NS5B palm polymerase inhibitor), dosed twice daily with a meal. Viekira Pak is taken for 12 weeks, except in certain GT1a patients with cirrhosis, who should take it for 24 weeks. Ribavirin should be co-administered in GT1a patients, and in all patients who have cirrhosis or who have received a liver transplant.
Paritaprevir was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for HCV protease inhibitors and regimens that include protease inhibitors. Paritaprevir is being investigated by AbbVie for use in combination with AbbVie's other investigational medicines for the treatment of hepatitis C.
Viekira Pak was granted priority review and designated as a Breakthrough Therapy by the US FDA, a status given to medicines or regimens that may offer substantial improvement over available therapies.