The German Institute for Quality and Efficiency in Health Care (IQWiG) recently found that there is no proven added benefit for HIV-1 infected children and adolescents treated with rilpivirine as opposed to the appropriate comparator therapy.
Distributed under the trade name Edurant, the drug was approved as a single agent for adults with HIV-1 in 2011. In November 2015 it received approval for use in children and adolescents, from the age of 12, with the conditions that they must not have undergone any other antiretroviral therapy and have a viral load of no more than 100,000 viral RNA copies per mL.
The manufacturer did not intend a direct comparison with the comparator therapy – for example efavirenz in combination with abacavir and lamivudine – but it did claim a non-quantifiable benefit. The IQWiG evaluated the manufacturers data and found that it was not adequate to establish that conclusion.
The manufacturer’s dossier included data from a one-arm rilpivirine study, which would only be acceptable in establishing added benefits of the drug if the effects on the patient-relevant outcomes were so dramatic that they could not be caused by systemic bias alone. The manufacturer would also have had to present data from other sources on the comparator therapy, which it did not.
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