The combination drug ledipasvir/sofosbuvir may offer a hint of added benefit in sustained virologic response (SVR) for some patients with genotype 1 hepatitis C virus (HCV) infection compared to other therapies, reports the German Institute for Quality and Efficiency in Health Care (IQWiG).
IQWiG examined historical data from seven patient groups (categorized according to genotype of the virus , stage of the disease, and previous treatment) to assess if ledipasvir/sofosbuvir provided an added benefit over other HCV treatments. For three patient groups with genotype 1, over 20 studies indicated a dramatic effect in SVR outcome with ledipasvir/sofosbuvir; following treatment, the virus was no longer detectable in nearly 100% of the patients vs. nearly 35–75% with respective comparative therapies. The success of ledipasvir/sofosbuvir in SVR was observed in treatment-experienced and treatment-naïve patients with and without cirrhosis. No added benefits were seen in any of the other four patients groups due to a lack of or incomplete data.
Because of the significant effect differences, these results may be prone to bias and thus the IQWiG can only conclude that no more than a hint of added benefit can be derived from the data (no indication or proof). It is also unclear how many cases of liver cancer could be prevented in patients with SVR.
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