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PHOTON-1: Sofosbuvir, Ribavirin Combo Yielded High SVR in Coinfected Patients

Issue: September 2014

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Sulkowski MS. JAMA. 2014;312:353-361.

A majority of treatment-experienced and treatment-naive patients with hepatitis C virus and HIV coinfection achieved sustained virologic response after treatment with combination sofosbuvir and ribavirin, according to results from the PHOTON-1 study published in JAMA.

HCV Next Editorial Board member Mark S. Sulkowski, MD, professor of medicine and director of the Viral Hepatitis Center at Johns Hopkins University School of Medicine, and colleagues conducted the open-label, nonrandomized, uncontrolled, phase 3 PHOTON-1 study to determine rates of HCV eradication and adverse events in patients with HCV/HIV coinfection assigned sofosbuvir plus ribavirin. The study included 223 patients from 34 centers in the United States and Puerto Rico treated between August 2012 and November 2013. All patients were receiving antiretroviral therapy with HIV RNA values of ≤50 copies/mL and a CD4 T-cell count >200 cells/mcL, or had untreated HIV with a CD4 T-cell count >500 cells/mcL, according to the study.

Mark S. Sulkowski

In total, 114 patients treatment-naive patients had HCV genotype 1 and 68 had genotype 2 or 3. Forty-one treatment-experienced patients who were treated with pegylated interferon and ribavirin had genotype 2 or 3. The number of patients with cirrhosis was very low.

Treatment-naive patients with genotype 2 or 3 were assigned 400 mg sofosbuvir (Sovaldi, Gilead) once daily and weight-based ribavirin twice daily for 12 weeks. Treatment-naive patients with genotype 1 and treatment-experienced patients with genotype 2 or 3 were assigned the same regimen for 24 weeks.

The primary outcome was sustained virologic response at 12 weeks. Seventy-six percent (95% CI, 67-84) of treatment-naive patients with genotype 1, 88% (95% CI, 70-98) with genotype 2 and 67% (95% CI, 51-80) with genotype 3 achieved SVR at 12 weeks. Ninety-two percent (95% CI, 73-99) of treatment-experienced patients with genotype 2 and 94% with genotype with genotype 3 achieved SVR at 12 weeks.

Fatigue, insomnia, headache and nausea were the most commonly reported adverse events. Three percent of patients discontinued the study treatment due to adverse events.

Disclosure: See the study for a full list of the researchers’ relevant financial disclosures.