J&J'S rilpivirine also proven for combination HIV product, says IQWiG

Since the start of 2012, a new drug - rilpivirine from US health care giant Johnson & Johnson (NYSE: JNJ) - has been available for adult patients infected with the human immunodeficiency virus type 1 (HIV-1), notes the German Institute for Quality and Efficiency in Health Care (IQWiG).

It is marketed both as a single agent and also as a fixed combination with other HIV drugs - trade name Eviplera (emtricitabine/rilpivirine/tenofovir disoproxil). Because important data were missing in the first dossier assessment of Eviplera that was completed in April under the Act on the Reform of the Market for Medicinal Products (AMNOG; The Pharma Letter April 23), the IQWiG) was initially unable to accord an added benefit to the combination drug.

But on the inclusion of additional study data (eg, on subgroup analyses) that the drug manufacturer subsequently provided in the commenting procedure conducted by the Federal Joint Committee (G-BA), the Institute came to a different conclusion: there is now proof that also in the fixed combination with emtricitabine and tenofovir disoproxil, rilpivirine offers a considerable added benefit for men infected with HIV-1. For women, the available studies provide corresponding indications. This matches the result of the dossier assessment of April 2012 on rilpivirine as a single agent.