- After being winning FDA approval on October 10, 2014, Gilead's Harvoni (ledispavir/sofosbuvir) racked up $2.11 billion in sales in less than a full quarter, outpacing Sovaldi's (sofosbuvir) performance for the same post-launch period.
- Three months post-approval, Sovaldi was generating around 6,500 prescriptions per week, compared with Harvoni, which generated more than 7,000 prescriptions per week during the first quarter post-launch.
- Harvoni combines the NS5A inhibitor, ledispavir, with sofosbuvir, with cure rates above 90% in clinical trials.
Harvoni benefited from the "Sovaldi effect" in that it offered all of the game-changing convenience, along with the additional efficacy that comes with the combination. This is especially noticeable when it comes to treating the hard-to-beat hepatitis C genotype 1. In phase III trials, researchers saw cure rates of this variant as high as 99.1%.
Clinically, both Sovaldi and Harvoni offer true clinical value, but with well-publicized initial 12-week regimen costs of $84,000 and $94,500, respectively, push-back against pricing has been aggressive, with payers taking back some of the anticipated profit .
According to Leerink Partners analyst Howard Liang, projected quarterly sales estimates for both drugs are lower than initially expected, according to a report from Fierce PharmaMarketing. Liang projects $403 million in quarterly sales for Sovaldi and $1.7 billion to $1.8 billion for Harvoni.