UPDATED: Report: Sovaldi dropout rate 4 times higher than in trials
UPDATE: The full CVS report offers some more perspective on potential reasons for the high discontinuation rate and its implications for pharmacies and Hep C management. It appears that the 8.1% dropout level may be associated with the difficulty of making sure treatment-naive Hep C patients (and those who had previously failed therapy) comply with their full drug regimens -- as evidenced by the fact that 8.7% of previously untreated patients discontinued treatment while 5.3% of previously-treated patients dropped out.
One former Gilead employee questioned several of the report's findings in an email to BioPharma Dive, arguing that they may paint an inaccurate and misleading picture of its uptake and discontinuation rates. The source noted that the sample seemed to rely on a disproportionate share of treatment-naive patients who were being treated with Sovaldi as a monotherapy, rather than in conjunction with other standard of care treatments. The former employee also expressed concerns that the study is unclear about the exact point at which patients discontinued use, raising questions about whether or not the dropout was related to adverse effects or mere forgetfulness.
- A new analysis by CVS Health Corp finds a "plateau and downward trend" in use of Gilead's Hepatitis C pill Sovaldi (sofosbuvir) over the last four months, Reuters reports.
- The study pored through data for 2,000 CVS Caremark patients who filled Sovaldi prescriptions since last December and found a discontinuation rate of 8.1% between May and August -- four times the dropout rate observed during clinical trials.
- Analysts are speculating that Gilead will see a fresh crop of customers once the company wins approval for a new combination therapy that includes sofosbuvir (the active ingredient in Sovaldi) and the experimental compound ledipasvir, which eliminates the need for concurrent treatment with ribavarin and interferon and shortens the overall treatment period.
The analysis suggests that Gen 1 Sovaldi is inching towards a tipping point after a year of blockbuster sales, expected to reach $2.24 billion in Q3. That's not entirely surprising considering that the FDA is expected to give its blessing to Gilead's next-gen Sovaldi combination therapy early next month.
That treatment has been shown to cure some Hep C patients in as little as eight weeks, according to SFGate, and has a staggering 99% cure rate by 24 weeks. The consolidated treatment will be more convenient for patients since it eliminates the need for ribavarin and interferon -- and Gilead has indicated that it won't be all that much pricier than the current combined monotherapies are for Sovaldi users.
“We do plan on launching a better product without having a significant premium," said Gilead executive VP Gregg Alton in an interview with Reuters.