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Gilead Announces SVR12 Rates From Three Phase 3 Studies Evaluating A Once-Daily Fixed-Dose Combination Of Sofosbuvir And Ledipasvir For Genotype 1 Hepatitis C Patients

Gilead Sciences, Inc. (Nasdaq: 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.

  Population   Treatment   Duration   SVR12 Rates
ION-1 GT 1 treatment-naïve

(including 15.7 percent(136/865) with cirrhosis)
SOF/LDV   12 weeks   97.7% (209/214)
SOF/LDV + RBV   12 weeks   97.2% (211/217)
SOF/LDV   24 weeks   NA (n=217)
    SOF/LDV + RBV   24 weeks   NA (n=217)
ION-2 GT 1 treatment-experienced

(including 20.0 percent(88/440) with cirrhosis)
SOF/LDV   12 weeks   93.6% (102/109)
SOF/LDV+RBV   12 weeks   96.4% (107/111)
SOF/LDV   24 weeks   99.1% (108/109)
    SOF/LDV+RBV   24 weeks   99.1% (110/111)
ION-3 GT 1 treatment-naïve SOF/LDV   8 weeks   94.0% (202/215)
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.

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