PHOTON-1 Study: SOF + RBV in HCV-HIV co-infection
Sofosbuvir and Ribavirin for Hepatitis C in Patients With HIV Coinfection
Sulkowski M. JAMA 2014;312:353-61
Anti-HCV
Sofosbuvir
Ribavirin
Sofosbuvir
Ribavirin
Genotype
1
1a
1b
2
3
1
1a
1b
2
3
Treatment history
Naive
IFN-Experienced
Naive
IFN-Experienced
Special population
HIV co-infection
HIV co-infection
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Design
Treatment regimens
- SOF : 400 mg qd
- RBV (bid dosing) : 1000 mg/day if < 75 kg or 1200 mg/day if ≥ 75 kg
Objective
- SVR12 with 2-sided 95% CI, descriptive analysis
- Multivariate analyses of predictors of SVR12
Baseline characteristics and patient disposition
SVR12 (HCV RNA < 25 IU/ml), % (95% CI)
Multivariate analysis of factors associated with SVR12 in genotype 1
Virologic failures
Adverse events, n (%)
Summary
- In this open-label, non-randomised, uncontrolled study, patients with HCV who were co-infected with HIV had high rates of SVR12 with the oral, IFN-free, combination of SOF + RBV
- After 24 weeks of therapy for genotype 1 treatment-naïve and genotype 2 and 3 treatment-experienced
- After 12 weeks of therapy for genotype 2 treatment-naïve
- Low rate of discontinuation for adverse events, however somewhat higher than in HCV monoinfected patients
- Confirmation of the high barrier to resistance of SOF (no resistance mutations at failure)
- Limitations
- Underrepresentation of women and patients with cirrhosis
- Absence of a control group
