In an early benefit assessment under the Act on the Reform of the Market for Medicinal Products (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) has concluded that Viiv Healthcare’s HIV treatment Tivicay (dolutegravir) provided added benefit over comparator therapy.
The dossier compiled by Viiv, the HIV/AIDS joint venture from the UK’s GlaxoSmithKline (LSE: GSK), US drug giant Pfizer (NYSE: PFE) and Japan’s Shionogi (TYO: 4507),provided proof of a considerable added benefit in adults without pre-treatment and an indication of a minor added benefit in pre-treated adults who require integrase inhibitors (INIs) (ie, whose treatment should include an INI). These patients have fewer side effects with the new drug than with the respective comparator therapy.
No added benefit could be determined for pre-treated adults who do not require INIs (ie, in whom no integrase inhibitor is indicated) and for adolescents above 12 years of age, because there were no study data.
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