Gilead Sciences, Inc. GILD today announced topline results from
three Phase 3 clinical trials (ION-1, ION-2 and ION-3) evaluating the
investigational once-daily fixed-dose combination of the nucleotide analog
polymerase inhibitor sofosbuvir (SOF) 400 mg and the NS5A inhibitor ledipasvir
(LDV) 90 mg, with and without ribavirin (RBV), for the treatment of genotype 1
chronic hepatitis C virus (HCV) infection.
Across the three studies, 1,952 patients with genotype 1 HCV infection were
randomized to receive SOF/LDV with or without RBV for eight, 12 or 24 weeks of
therapy. Of these, 1,512 patients were treatment-naïve, 440 were treatment
experienced and 224 had compensated cirrhosis.
The intent-to-treat SVR12 rates observed to date in the ION studies are
summarized in the table below. Results of the 24-week arms from ION-1 will be
available in the first quarter of 2014 and will be presented at a future
scientific meeting.
Study Population Treatment Duration SVR12 Rates
SOF/LDV 12 weeks 97.7%
GT 1 treatment-naïve (209/214)
ION-1 SOF/LDV + RBV 12 weeks 97.2%
(including 15.7 percent (211/217)
(136/865) with cirrhosis) SOF/LDV 24 weeks NA (n=217)
SOF/LDV + RBV 24 weeks NA (n=217)
SOF/LDV 12 weeks 93.6%
(102/109)
GT 1 treatment-experienced SOF/LDV+RBV 12 weeks 96.4%
ION-2 (107/111)
(including 20.0 percent SOF/LDV 24 weeks 99.1%
(88/440) with cirrhosis) (108/109)
SOF/LDV+RBV 24 weeks 99.1%
(110/111)
SOF/LDV 8 weeks 94.0%
(202/215)
ION-3 GT 1 treatment-naïve SOF/LDV + RBV 8 weeks 93.1%
(201/216)
SOF/LDV 12 weeks 95.4%
(206/216)
Of the 1,518 patients randomized to the 12-week arms of ION-1 and to all arms
of ION-2 and ION-3, 1,456 patients (95.9 percent) achieved the primary
efficacy endpoint of SVR12. Of the 62 patients (4.1 percent) who failed to
achieve SVR12, 36 patients (2.4 percent) experienced virologic failure: 35 due
to relapse and only one patient due to on-treatment breakthrough (with
documented non-compliance). Twenty-six patients (1.7 percent) were lost to
follow-up or withdrew consent.
Fewer adverse events were observed in the RBV-free, fixed-dose combination
arms compared to the RBV-containing arms in all ION studies. Adverse events
observed in those taking the SOF/LDV tablet were generally mild and included
fatigue and headache. In the RBV-containing arms of the ION studies, the most
common adverse events were fatigue, headache, nausea and insomnia. Anemia,
which is a common side effect associated with RBV, was reported in 0.5 percent
of patients in the SOF/LDV arms versus 9.2 percent of patients in the
RBV-containing arms. Less than 1 percent of patients in the studies
discontinued treatment due to treatment-emergent adverse events.
“The results of the ION studies demonstrate that a simple, safe and short
course of therapy with a single tablet regimen of sofosbuvir/ledipasvir can
provide high cure rates among patients with genotype 1 HCV infection, while
eliminating the need for both interferon and ribavirin,” said Norbert
Bischofberger, PhD, Executive Vice President of Research and Development and
Chief Scientific Officer. “With the availability of these results, Gilead is
finalizing its regulatory filing for sofosbuvir/ledipasvir, with the goal of
submitting a New Drug Application in the first quarter of 2014.”
The FDA has assigned the SOF/LDV fixed-dose combination a Breakthrough Therapy
designation, which is granted to investigational medicines that may offer
major advances in treatment over existing options. Sofosbuvir was approved as
Sovaldi™ in the United States on December 6 and in Canada on December 13.
Applications are pending in the European Union, Australia and New Zealand,
Switzerland and Turkey.
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