1. A 12 to 24 week regimen of sofosbuvir and ribavirin induced a sustained viral response in hepatitis C (HCV) patients co-infected with HIV.
2. No significant adverse effects from sofosbuvir were observed during this phase 3 trial.
Evidence Rating Level: 2 (Good)
Study Rundown: Until recently, treatment of HCV required prolonged therapy with toxic drugs that were difficult to tolerate and had many drug interactions with anti-retroviral therapy (ART). This study was an open-label, non-randomized, phase 3 trial that administered 12-24 week dual therapy of sofosbuvir (a new anti-HCV drug) along with ribavirin in patients who are co-infected with HIV. Most patients were on ART during the HCV treatment period.
The study showed that patients with HCV genotypes 1 and 2 had higher rates of SVR than those with genotype 3, regardless of prior treatment experience. Study results thus demonstrated that sofosbuvir was effective at achieving a sustained viral response (SVR) in HIV patients on ART, without the major adverse effects of prior treatment regimens.
Strengths of the study include its generalizability to various types of health centers, its efficacy in patients on ART and those who are not on ART, and its subgroup analysis of efficacy based on HCV genotype. However, the study was not blinded and only enrolled 224 patients in total, thus each subgroup had a small sample size. In addition, patients with AIDS (CD4 count <200cells/mcL) were excluded, so the efficacy rates may not be applicable to patients with lower CD4 counts, who may not be able to mount a significant SVR.
In-Depth [open-label, phase 3 study]: This study is a multicenter, open-label, non-randomized, phase 3 clinical trial of sofosbuvir treatment of HCV in the setting of co-infection with HIV. All 224 subjects were greater than 18 years of age, and had to meet criteria for HCV infection as well as HIV infection. Subjects were excluded if they were found to have a positive urine toxicology screen or if they had AIDS (CD4 cell count<200cells/mcL or a viral load >50 copies/mL). Both HCV treatment-naïve and treatment-experienced patients were included in the study.
The primary endpoint was sustained viral response (SVR, viral load <25IU/mL) at 12 weeks after end of treatment. For treatment-experienced patients, 92.7% achieved SVR (95% CI 80.1-98.5%), for treatment-naïve HCV genotype 2 patients, 88% achieved SVR (95%CI, 70-98%), for treatment-naïve HCV genotype 3 patients, 67% achieved SVR (95% CI 51-80%), and for treatment-naïve HCV genotype 1 patients, 76.3% achieved SVR (95% CI 67.4-83.8%). Only 7% of patients discontinued treatment due to adverse effects, with most common being fatigue, insomnia, and headache. Laboratory abnormalities included anemia, lymphopenia. and indirect hyperbilirubinemia. All counts returned to baseline by 12 weeks post end of treatment.
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