No question, the hepatitis C drug market is about to get even more interesting. With AbbVie's ($ABBV) three-drug regimen up for approval before the end of the year, and Merck ($MRK) and Bristol-Myers Squibb ($BMY) racing up behind, the market share tussle with current players Gilead Sciences ($GILD) and Johnson & Johnson ($JNJ) is coming.
And in hepatitis C, with patient groups broken down by genotype, disease phase, and treatment status, the collection of warring data is rapidly mounting. Companies will be focusing on subgroups of patients to gain an edge on their rivals, and they're working to prove that their next-gen regimens can work more quickly--in as little as four weeks, compared with the current average of 12. Ready to compare cure rates? The American Association for the Study of Liver Diseases meeting has plenty of numbers and news for you. Here's a rundown.
- One much-talked-about presentation was Merck's study of a three-drug combo. In a test of 8 weeks of treatment, the cocktail pairing two Merck meds, grazoprevir and elbasvir, with Gilead's Sovaldi cured almost 95% of cirrhotic, never-before-treated patients. But the combo therapy's four-week cure rate was dismal, at 38.7%. At 6 weeks, almost 87% of non-cirrhotic patients were cured--slightly short of the 90% some analysts think will be key for Merck's competitive edge. Release | Report
- Merck also announced its timeline for its two meds, grazoprevir and elbasvir: It plans to file for FDA approval next year. In a longer-term study, the two meds delivered cure rates of 90% or higher in patients who'd never been treated and those who'd failed previous treatment. That's with or without ribavirin. But the cure rate was even more impressive--100%--in patients treated for 18 weeks along with ribavirin. Report
- AbbVie is crowing about its hep C cocktail and its performance in a Phase II study of liver transplant patients with genotype 1 disease. The company's three-drug cocktail cured 97% of those participants in 12 weeks. Release
- AbbVie's cocktail also proved out in a study of genotype 1 patients co-infected with HIV, an important--and large--subgroup of patients. After 12 weeks of treatment, 93.5% of those patients were cured. Release
- Gilead, already well entrenched with its megablockbuster Sovaldi and gaining ground with its newer combo med Harvoni, put up impressive numbers at AASLD. A Harvoni study yielded cure rates of 96% to 97% in patients with cirrhosis or who'd failed on previous treatments. Those are particularly hard-to-treat groups. The 97% cure rate came at 24 weeks for patients on Harvoni alone, with a 96% result after 12 weeks for those on Harvoni plus ribavirin. Release
- Gilead's longer-term hep C landscape also got some attention. In three small studies of Sovaldi in combination with another Gilead candidate, GS-5816, the combo delivered promising results. After 12 weeks of treatment without ribavirin, cure rates were 100% in genotype 1 patients with or without cirrhosis. In genotype 3 patients with cirrhosis, the rate was 88%. Report
- Johnson & Johnson rolled out new data on its already approved protease inhibitor Olysio. The drug was studied in combination with Gilead's Sovaldi, a combo that just won specific approval from the FDA. And data on Olysio plus Sovaldi and daclatasvir, an experimental Bristol-Myers Squibb drug, also made a debut. Release
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