Successful Phase 3 results for Sovaldi in Japan

Gilead Sciences (GILD) announces positive top-line results from a Phase 3 HCV clinical trial in Japan evaluating the investigational once-daily fixed-dose combination of the NS5A inhibitor ledipasvir (LDV) and Sovaldi (sofosbuvir) (SOF) with and without ribavarin (RBV).

100% (88/88) of treatment-experienced and treatment-naive (83/83) patients receiving LDV/SOF without RBV achieved a sustained virologic response 12 weeks after completing therapy. 96% (80/83) of treatment-naive and 100% (87/87) of treatment-experienced patients receiving LDV/SOF plus ribavarin achieved a sustained virologic response. Across all arms of the study, 99% (75/76) of cirrhosis patients achieved a sustained virologic response.

The study met its primary endpoint of superiority compared to a predefined historical sustained virologic response rate. Patients who achieve this are considered cured of HCV infection.

HCV type 1 is the most common strain of HCV infection in Japan, comprising ~70% of the 1M chronic cases. Gilead plans to submit an NDA for the LDV/SOF fixed-dose combination with the Japanese Pharmaceutical and Medical Devices Agency by the end of 2014.

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Comments (5)
  • bberuch
    , contributor
    Comments (314) | Send Message
    an additional phase iii approval in a large market can't hurt.
    16 Jun 2014, 08:15 AM Reply Like
  • canb888
    , contributor
    Comments (727) | Send Message
    Japan could be a huge market based on their medical coverage system and the existing 1M chronic cases there. Let's see if the drug, once approved, would be priced higher than in the US like drugs in many other treatment are positioned.
    16 Jun 2014, 08:37 AM Reply Like
  • somedata1
    , contributor
    Comments (2064) | Send Message
    Something to celebrate on Monday's morning.
    16 Jun 2014, 08:47 AM Reply Like
  • kirgkyboy
    , contributor
    Comments (77) | Send Message
    I'm a private investor for the most part believe in index stocks, but from time to time I find certain individual stock compelling.
    17 Jun 2014, 04:32 AM Reply Like
  • CSYJ
    , contributor
    Comments (4840) | Send Message
    Need to correct the 1M number. This is the quote from the BMS earnings call transcript:


    With respect to other regulatory developments, the big news this quarter was our recent Japanese approval of our hepatitis C dual regimen, daclatasvir and asunaprevir. Because of significant development for the 1.2 million hepatitis C patients being in Japan, many of whom currently have no treatment options.
    24 Jul 2014, 07:53 PM Reply Like
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