Posted by Michael Wonder on 03 Jul 2017
IQWiG finds no additional benefit for tenofovir alafenamide fumarate in chronic hepatitis B
3 July 2017 - The anti-viral medicine tenofovir alafenamide fumarate has been used in various combinations since 2015 in HIV therapy and has already passed three early benefit evaluations for this indication.
Tenofovir alafenamide fumarate has also been approved for the treatment of adults and adolescents with chronic hepatitis B. In a further early benefit assessment, the IQWiG has investigated whether this medicine offers these patients additional benefits.
The manufacturer did not provide any data for treatment naive or pre-treated adolescents aged twelve years or older in his dossier. The data from two studies for treatment naive or pretreated adults are to a large extent incomplete and therefore not suitable for a benefit assessment. In addition, the distinction between treatment naive and therapy-oriented patients is contradictory and the appropriate comparative therapy was partly not implemented. Therefore, a supplementary use is not shown for any of the four patient groups referred to above.
