Multidrug Regimen Seen Challenging Recently Approved Drugs from Gilead Sciences
U.S. regulators on Friday approved AbbVie Inc.’s new multidrug regimen for hepatitis C, the latest in a wave of new medicines that is transforming treatment of the liver disease.
The U.S. Food and Drug Administration approved AbbVie’s Viekira Pak, a cocktail of several drugs that cured more than 90% of people with the most common subtype of hepatitis C in the U.S., genotype 1, in clinical trials. The regimen consists of several pills taken daily for about 12 weeks, eliminating the need for an older injected drug, interferon, which many patients find difficult to tolerate.
At least 3.2 million Americans are believed to have chronic infection with hepatitis C, which can cause long-term health problems including liver-scarring cirrhosis if left untreated. The virus is transmitted through contact with an infected person’s blood, including sharing of drug needles.
The AbbVie regimen consists of three new drugs—paritaprevir, ombitasvir and dasabuvir—plus at least one older drug, ritonavir. Some patients will need to take another older drug, ribavirin, with the regimen. Paritaprevir arose from AbbVie’s research collaboration with Enanta Pharmaceuticals, while the other two new drugs were developed internally at AbbVie as part of a hepatitis C research program dating back to 2002.
“They work together by attacking this virus at different points of replication,” said Fred Poordad, a liver-disease specialist at the University of Texas Health Science Center in San Antonio, who helped study the AbbVie regimen. “What this does by offering multiple mechanisms of action is, it decreases the likelihood of [the virus] developing resistance and it increases the likelihood of being effective.”
The introduction of Viekira Pak follows the launch of three other hepatitis C drugs over the past 13 months: Johnson & Johnson’s Olysio and Gilead Sciences Inc.’s Sovaldi and Harvoni. These new antivirals have helped to improve cure rates versus older treatments, shorten the duration of treatment to about three months from as long as one year for many patients, and mitigate side effects.
Gilead’s hepatitis C drugs have dominated the market, with Sovaldi racking up more than $8.5 billion in sales since its introduction a year ago. The FDA in October approved Gilead’s Harvoni, the first combination pill to treat hepatitis C, which can be taken once daily without interferon or ribavirin.
AbbVie’s Viekira Pak also contains combination pills, and poses the first significant competitive challenge to Gilead. Analysts don’t expect it to overtake Gilead, but Credit Suisse analyst Vamil Divan predicts Viekira Pak will get about 15% to 20% of the hepatitis C market, or $2.5 billion to $3 billion in annual sales.
A potential competitive disadvantage for AbbVie’s regimen is that it consists of four or six pills a day, depending on whether a patient needs to take ribavirin. AbbVie says the pill count isn’t a major issue, and it believes doctors will focus on the strong efficacy of the regimen in clinical trials.
What’s more, AbbVie plans to promote studies that found the regimen to be effective in certain difficult-to-treat groups of patients, such as those whose hepatitis C recurs after a liver transplant. “We feel that providing that very clear description of performance in our product will be an advantage for the regimen,” said Michael Severino, AbbVie’s executive vice president of research and development.
In clinical trials, the most common side effects associated with the AbbVie regimen included fatigue and nausea.
For AbbVie, the FDA green light of Viekira Pak represents a much-needed victory for its research-and-development division because it hasn’t had a drug with a new active ingredient approved in more than a decade—dating back years before AbbVie was spun out of Abbott Laboratories at the start of 2013. The last such drug was Humira, the anti-inflammatory drug approved in 2002 and now the best-selling drug in the world. AbbVie, based in North Chicago, Ill., currently relies on Humira for more than 60% of its revenue, and the drug could begin facing copycat competition after a U.S. patent expires in late 2016. The introduction of new products such as Viekira Pak could help AbbVie if Humira sales start to decline.
AbbVie hasn’t yet disclosed a price for the new drug. Gilead’s Sovaldi costs about $84,000 for a standard course of treatment, while Harvoni costs about $94,500.
Some health insurers and administrators of state Medicaid programs and prison systems have complained that the high price tags for the hepatitis C drugs have strained health-care budgets, while restricting access to the drugs for some patients.
Gilead has defended its prices by citing the drugs’ high cure rates, which they say can stave off more costly health-care services down the line if the infection is left untreated.
Reposted from The Wall Street Journal, December 19, 2014: www.wsj.com/articles/fda-approves-abbvies-hepatitis-treatment-1419019392