KEY FINDINGS In general, findings from the included studies were consistent on the superiority of simeprevir once daily plus PR therapy to placebo plus PR therapy in terms of SVR in patients with chronic hepatitis C genotype 1 who have had an inadequate response to prior PR therapy. [...] Three trials looked at the clinical effectiveness and safety of simeprevir combined with PR in patients with chronic hepatitis C genotype 1 who have had an inadequate response to prior direct acting antiviral PR therapy.28-30 In general, simeprevir plus PR was significantly superior to placebo plus PR in terms of SVR, and was generally well tolerated. [...] Two deaths occurred during the entire treatment phase (1 in each group) 2. What is the clinical effectiveness and safety of simeprevir and/or sofosbuvir and PR combination treatments in patients with chronic hepatitis C genotype 2 who have had an inadequate response to prior DAA plus PR therapy or prior treatment with PR alone? [...] There is no evidence found on the clinical effectiveness and safety of simeprevir and/or sofosbuvir and PR combination treatments in patients with chronic hepatitis C genotype 3 who have had an inadequate response to prior DAA plus PR therapy or prior treatment with PR alone. [...] Limitations Data on the efficacy and safety of simeprevir plus PR compared to PR alone in patients with chronic hepatitis C genotype 1 who have had an inadequate response to prior PR therapy were limited to two phase II and one phase III trial.
- Pages
- 15
- Published in
- Ottawa, Ontario