Table 10.

Sofosbuvir

Ref.	n	Design	Treatment	Population	Outcome
Kowdley et al[86]	316	Multicenter, open label, phase 2 clinical trial	Sofosbuvir-2a PEGIFN-α-2a/RBV	HCV genotype 1 - non-cirrhotic treatment-naive, patients	SVR occurred in 90% of patients treated with sofosbuvir and PEGIFN/RBV for 12 wk. Depression occurred in 8%-16% of patients across all groups but was not a primary reason for discontinuation
Lawitz et al[87]	147	Two-cohort, phase 2, placebo controlled, clinical trial	Sofosbuvir PEGIFN/RBV	Treatment-naive patients with genotype 1-3 HCV infection	SVR occurred in 90% of patients treated with sofosbuvir and PEGIFN/RBV and the side effects profile was similar to that of PEGIFN/RBV and did not include depression. Depression was not a significant adverse event in this study
Jacobson et al[85]	240	Phase 3 randomized placebo controlled clinical trials	Sofosbuvir RBV	Chronic HCV genotype 2 or 3 previously unable to be treated with IFN, or previously treated with IFN-based therapies	Sofosbuvir and RBV was effective at 12 wk for genotype 2 and 16 wk for genotype 3. Premature discontinuation of the study drug due to adverse events was uncommon in all groups. Depression was not a significant adverse event in this study
Gane et al[84]	75	Open label randomized clinical trial	Sofosbuvir, RBV	HCV genotype 2 or 3 infection. with no response to prior treatment or with no prior treatment	Sofosbuvir plus RBV for 12 wk was effective for patients with genotype 1, 2, or 3 infections. Insomnia occurred in 30%-67% of participants across groups and was the only significant psychiatric symptom to develop during treatment

PEGIFN: Pegylated interferon (peginterferon); RBV: Ribavirin; HCV: Hepatitis C virus; SVR: Sustained virologic response; IFN: Interferon.