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Sofosbuvir: Indication of added benefit for specific patients
Date:5/2/2014

own who receives which treatment. This poses the risk that patients discontinue the study prematurely depending on which treatment they were randomized to. This compromises the aim of randomization: the comparability of the treatment groups. This is exactly what happened in the FISSION study, which may lead to (highly) biased results.

Mortality and quality of life: added benefit not proven

As no deaths occurred in the FISSION study in the therapeutic indication genotype 2, there could be no differences between the treatment groups, and therefore no proof of added benefit, in the outcome "mortality". This also applies to health-related quality of life, but in this case because the dossier contained no evaluable data for this outcome.

Advantage in sustained virologic response

Instead of the patient-relevant outcome "development of hepatocellular carcinoma (HCC)", the manufacturer used sustained virologic response (SVR). It could show that there was a statistically significant group difference in favour of sofosbuvir. IQWiG conducted its own sensitivity analyses because of the high risk of bias. It tested how the effects changed when missing values were imputed with different strategies. The researchers found out that the result in favour of sofosbuvir was robust.

Valid surrogate for incidence of liver cancer

SVR is not itself a patient-relevant outcome and cannot be equated with "cure", and there are no studies in which SVR is validated as a surrogate outcome in accordance with the usual criteria employed by IQWiG. Nevertheless, the Institute accepts SVR here as a surrogate for the reduced incidence of liver cancer. This is because it is currently accepted that patients with no detectable hepatitis C virus in the blood are at lower risk of liver cancer. However, it is unclear how many cases of liver cancer can in fact be prevented by sofosbuvir.

For the outcome "secondary diseases", I
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Contact: Dr. Anna-Sabine Ernst
presse@iqwig.de
49-022-135-6850
Institute for Quality and Efficiency in Health Care
Source:Eurekalert

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