Last week’s blog post discussed the dangerous precedent that exclusivity deals between drug manufacturers and payers set. Deals like the one Express Scripts and AbbVie’s signed for discounted rates on the new Hepatitis C drug, Viekira Pak. I argued that these deals emphasize the payer trend of focusing on immediate savings rather than overall outcomes, total cost of care and most importantly patient safety.

It’s becoming clear that my argument was right.

This past week, our team of analysts released a Drug Safety Monitor note to our clients comparing the safety of AbbVie’s Viekira Pak to Gilead’s Sovaldi / Harvoni. What we found was that while both drugs are indeed equally efficacious, the safety profile of Viekira Pak appears to be inferior to that of Sovaldi.

The report compares Viekira Pak’s pre-approval adverse event information found on its FDA-approved label to the labels of comparator Hepatitis C treatments, Harvoni and Sovaldi. To further reach their conclusions, our analysts included data for Sovaldi that had been reported to the FDA Adverse Event Reporting System (FAERS), obtained both through the FDA’s publicly available data and via Freedom of Information Act (FOIA) requests.


Related Read: How many links does it take to get to the center of the FDA FOIA request?


What we found was that Sovaldi's drug label has a shorter list of AEs compared to Viekira Pak. Contraindications for ribavirin apply if Viekira Pak is administered with this medication. Viekira Pak is not recommended for patients with severe hepatic impairment and is contraindicated with approximately 12 major drug classes. In contrast, Sovaldi's label only lists contraindications associated with ribavirin and Harvoni does not have any contraindications. Additionally, FDA approved Sovaldi and Harvoni for treatment in patients with mild to severe hepatic impairment without dose adjustment, while Viekira Pak is only approved for use in patients with mild hepatic impairment

Furthermore, there are only two side effects on Viekira Pak’s label that have shown up with elevated post-marketing reporting rates for Sovaldi- Jaundice and Haemoglobin Decreased.



To see all side effects that are on Viekira Pak's label but NOT on Sovaldi's click here


Existing data suggests that Harvoni and Sovaldi may be safer options compared to Viekira Pak, and we assume this will be confirmed once further post-marketing ADRs emerge.

It is our belief that exclusivity deals for drugs without significant real-world ADR data are not in the best interest of patient safety, and it is the responsibility of those individuals tasked with deciding formularies and prescribing decisions to use all data available to ensure that they are making the most effective and precise decisions—not limited only to immediate cost savings but for patient safety as well.


Related Reads: Hepatitis C Payer Scorecard: According to Peers, Express Scripts DID Make the Wrong Decision


Given the seriousness of this debate, we have decided to make this Drug Safety Monitor public, free-of-charge. Find the full DSM report here: Safety Comparison of Viekira Pak, the Newly Approved Chronic Genotype 1 Hepatitis Treatment


 Subscribe to Drug Safety Monitor


Jim Davis

Jim Davis

Executive Vice President

Jim Davis LinkedinJim Davis Twitter


Topics: Managed Care, Drug / Indication Information

Jim Davis

Written by Jim Davis

As Executive Vice President, Jim is responsible for the commercialization strategy for Advera Health Analytics.