EU approves BMS's Daklinza for hep C combo therapy
- Bristol-Myers Squibb data show that Daklinza combined with Gilead's Sovaldi (sofosbuvir) provides cure rates as high as 100% in clinical trials.
- Daklinza is the first NS5A complex inhibitor to be approved in the EU. It requires a shorter treatment regimen --12 to 24 weeks instead of 48 weeks -- even in patients with difficult-to-treat cases of HPV-C and does not require the use of interferon or ribavirin.
- The effective Daklinza/Sovaldi combo is expensive, starting with Sovaldi’s $84,000 price tag and adding on Daklinza costs. Groups like Doctors Without Borders are complaining that BMS has yet to put a patient access scheme in place.
In clinical trials, the Daklinza plus Sovaldi combo had very high cure rates -- up to 100% -- in harder-to-treat patients, including those with advanced liver disease, genotype 3 HPV-C, and patients who have not responded to previous treatments with protease inhibitors. The combo therapy wasn't just effective -- it was well tolerated by trial participants, with less than 1% of study subjects dropping out because of side effects.
Daklinza brings another treatment option to the table for HCV-infected patients. Even with the best medications, HPV-C can be difficult to treat, but the growing class of DAAs (direct-acting antivirals) is changing the treatment landscape. The biggest challenge at this point is the contentious issue of price and affordability.
- Pharma Times EU green light for B-MS hepatitis C drug