Beyond the implementation of the Affordable Care Act, one of the biggest healthcare stories of 2013 was the emerging race of pharmaceutical companies to bring new drugs to the market to cure hepatitis C.
The advent of direct-acting antiviral agents in 2011 started a revolution in hepatitis C treatment, but many people with hepatitis C and their providers are awaiting all-oral regimens that avoid the difficult side effects of interferon and ribavirin. By the beginning of 2014, four biotech leaders had emerged in the race to bring the simplest, easiest-to-tolerate HCV treatment regimen to the market.
Gilead Sciences appears to be the front-runner now. In December, Gilead’s Sovaldi (sofosbuvir) became the first all-oral treatment for certain hepatitis C genotypes 2 and 3 when it was approved by the U.S. Food and Drug Administration (FDA) as a component of a combination antiviral treatment regimen. The Sovaldi ribavirin-free regimen only requires patients to take one pill once a day.
Though Sovaldi is highly effective for genotypes 2 and 3, the big prize is an oral regimen for genotype 1, which accounts for two-thirds of all hep C patients. Gilead has some impressive mid-stage results for Solvadi combined with both ribavirin and its own ledipasvir on genotype 1 HCV patients: a ninety-five percent cure rate after eight weeks of treatment.
In even better news for patients who don’t want to take ribavirin, a dual oral regimen of daclatasvir (Bristol-Myers Squibb) plus Sovaldi cured more than ninety percent of chronic hepatitis C patients without interferon or ribavirin, according to a report in the January 16, 2014 issue of The New England Journal of Medicine. A series of new studies of this combination in difficult-to-treat groups including HIV/HCV coinfected people and liver transplant recipients are underway.
Janssen Pharmaceuticals is another in the pack. In November the FDA approved simeprevir (Olysio), an oral, direct-acting antiviral agent used for treating HCV as part of an antiviral treatment regimen in combination with interferon and ribavirin in genotype 1 infected adults with compensated liver disease, including cirrhosis. Janssen (part of Johnson & Johnson) says Olysio may benefit patients with chronic hepatitis C, including those who are treatment naïve or who have failed prior interferon-based therapy.
Bristol-Myers Squibb is preparing to offer an all-oral regimen including daclatasvir, asunaprevir, and BMS-791325. Last April, Bristol-Myers Squibb announced positive Phase II results for the combo. Up to ninety-four percent of patients were cured of hepatitis C after twenty-four weeks of treatment. Bristol-Myers Squibb is now in Phase III testing of the three-drug combo, and the company expects the regimen to reach the market sometime in 2014. This, in addition to the aforementioned positive results from the combination of daclatasvir and Sovaldi (Gilead) puts Bristol-Myers Squibb in contention to grab a big share of the HCV drug market, analysts say.
AbbVie Inc. announced in December that its all-oral HCV therapy cured ninety-six percent of difficult-to-treat genotype 1a patients in a late-stage clinical trial after twelve weeks. However, its ability to compete could be hampered by a larger number of pills that must be taken: three experimental direct acting antiviral drugs that each attack a different target necessary for virus replication, plus the ribavirin. The drugs are the protease inhibitor ABT-450, whose effect is boosted by a widely used antiviral called ritonavir; the polymerase inhibitor ABT-333, and ABT-267 from a highly promising new class known as NS5A inhibitors.
The company has four more Phase III trials underway, and is also testing its drugs without ribavirin. But other companies are shooting for combination regimens that involve just one or two pills a day, giving them a big advantage over AbbVie in the race.
Alliances and combinations also make for a crowded market. Right now, the race to be the first with a simpler, all-oral regimen for HCV looks more cooperative than competitive as companies test their drugs with other companies’ offerings. As an example, now that sofosbuvir has been approved by the FDA, Bristol-Myers Squibb is able use it in combination studies with daclatasvir. Three such Phase III trials are now underway, though not yet recruiting participants.
Then again, which drug maker wins market share for HCV drug regimens matters less to HCV patients than who can provide the easiest and most tolerable—and most affordable—regimen. The global need for hepatitis C therapies is big and growing. More than 170 million are infected worldwide, according to the World Health Organization and up to 30,000 more are likely to be diagnosed with the disease each year in the United States. Those projections have drug wholesaler Express Scripts expecting the spending in the U.S. on hepatitis C to quadruple over the next three years. No matter who “wins” the market share, the amount of attention and money spent on treating HCV should be good news for the millions of infected people around the world.
Larry Buhl is a radio news reporter, screenwriter, and novelist living in Los Angeles. His young adult novel, The Genius of Little Things, debuted last year.