Gilead Sciences, Inc. (GILD) announced encouraging results from two phase II studies and a compassionate access study on Sovaldi in patients suffering from chronic hepatitis C virus (:HCV) infection with advanced liver disease.
The first of these studies – an open-label, phase II study (GS-US-334-0125: n=50) – evaluated HCV patients suffering from cirrhosis and portal hypertension, with or without decompensation. These patients were randomized equally to an immediate treatment arm in which Sovaldi and ribavirin was administered for 48 weeks or to a deferred treatment arm in which this regimen was initiated after a 24-week observation period.
Results from the study showed that almost all patients who completed 24 weeks of therapy achieved virologic suppression. Moreover, patients under Sovaldi-based therapy experienced clinical and laboratory parameter improvements in comparison to patients in the observation arm. The Sovaldi-based therapy was also well tolerated during the study.
In the second study – a single-arm open-label phase II study (GS-US-334-0126: n=40) – patients suffering from established recurrent HCV infection after liver transplantation received up to 24 weeks of therapy with Sovaldi and ribavirin. Results revealed that 70% of the patients in the study achieved sustained virologic response rates after 48 weeks.
Results from a compassionate access study, evaluating Sovaldi therapy in post-transplant patients suffering from severe recurrent HCV, also revealed that the majority of the patients in the study experienced clinical improvements on treatment. Around 62% of them achieved sustained virologic response rates after 48 weeks. The Sovaldi therapy in the study was also well tolerated. Results from the studies were presented at the 49th Annual Meeting of the European Association for the Study of the Liver.
We note that Sovaldi was approved in the U.S. in Dec 2013 with a broad label. European approval of the drug came in Jan 2014. The drug is off to a strong start. We believe investor focus will be on the performance of Sovaldi in the first quarter of 2014, results of which are expected later this month. Sovaldi is facing competition primarily from Johnson & Johnson’s (JNJ) Olysio in the U.S.
Gilead carries a Zacks Rank # 3 (Hold). Better-ranked stocks in the healthcare space include Amgen (AMGN) and Alexion Pharmaceuticals, Inc. (ALXN). While Amgen carries a Zacks Rank #1 (Strong Buy), Alexion holds a Zacks Rank #2 (Buy).