- Advera Health Analytics, a healthcare informatics firm, conducted a comprehensive analysis using post-marketing data, as well as data culled from Freedom of Information Act (FOIA) sources. Their analysis found that Gilead's Harvoni is safer than both Sovaldi and AbbVie's Viekira Pak.
- When serious side effects were tallied, VieKira Pak had the most—25 side effects, compared with 20 for Sovaldi and 17 for Harvoni.
- Advera also tracked reporting odds ratio (ROR), which compares the actual number of side effects with the expected number of side effects. An ROR above 1.5 flags a potential safety concern. In the analysis, overall, Harvoni performed best on this metric as well.
In October, Biopharma Dive spoke to Brian Overstreet, President of Advera, about the role of safety in the overall value equation. He explained that a week before the FDA first issued a warning about Viekira Pak and made AbbVie update its label to reflect increased risk of liver injury, hepatic decompensation and liver failure in patients with cirrhosis (which is 15% to 30% of all hepatitis C patients), Advera had picked up the safety signal as part of their ongoing analytics.
The latest analytic data is new. According to this data, the most frequent side effects associated with Harvoni included headache, insomnia and anxiety, whereas the most frequent side effects associated with Sovaldi are anemia, depression, overdose and rash. VieKira Pak was associated with 25 side effects that exceeded the ROR threshold for safety. Frequent side effects include pruritis, insomnia, headache, diarrhea and others.
Although AbbVie has publicly tried to discount the methodology used by Advera, Advera's analysis signaled a safety concern that was separately picked up by the FDA—a validation if ever there was one. One major concern that has come up around VieKira Pak is 'missed doses' suggesting an adherence problem. Whether or not the adherence issue is related to bothersome side effects is not known. Nonetheless, as with all antiviral treatments, adherence is critical.