Tenofoviralafenamid (2) – Vemlidy®

• Clinical trials
  • To demonstrate the additional benefit, the pharmaceutical manufacturer has submitted interim results from the randomised, double-blind and multicentre clinical trials GS108, GS108-C, GS110 and GS110-C.
  • These studies are regulatory trials comparing tenofovir alafenamide with tenofovir disoproxil in treatment-naïve and treatment-experienced adult patients with chronic hepatitis B infection who tested positive (GS110/-C) or negative (GS108/-C) HBe antigen status, respectively.

b) treatment-experienced adult patients with chronic hepatitis B

• For treatment-experienced adult patients with chronic hepatitis B, the additional benefit of tenofovir alafenamide over the appropriate comparator therapy is not proven.
• No relevant data are available for assessing the additional benefit of tenofovir alafenamide compared with the appropriate comparator therapy.
• Although treatment-experienced patients were also included in studies GS108, GS108-C, GS110 and GS110-C, the appropriate comparator therapy tailored to the individual patient was not implemented for these patients.
• It is therefore not possible to infer any additional benefit from the available data.

c) Treatment-naive adolescent patients aged 12 years and over with chronic hepatitis B

• For treatment-naive and treatment-experienced adolescent patients aged 12 years and over with chronic hepatitis B, the additional benefit of tenofovir alafenamide compared with the appropriate comparator therapy is not proven.
• No results from clinical trials were submitted for the benefit assessment for patient populations c) and d).
• The pharmaceutical manufacturer’s search failed to identify any relevant studies, meaning that no comparison with the appropriate comparator therapy is possible.
• No conclusions regarding additional benefit can be drawn.

d) treatment-experienced adolescent patients aged 12 years and over with chronic hepatitis B

• For treatment-naïve and treatment-experienced adolescent patients aged 12 years and over with chronic hepatitis B, the additional benefit of tenofovir alafenamide compared with the appropriate comparator therapy is not proven.
• No results from clinical trials were submitted for the benefit assessment for patient populations c) and d).
• The pharmaceutical manufacturer’s search failed to identify any relevant studies, meaning that no comparison with the appropriate comparator therapy is possible.
• No conclusions regarding additional benefit can be drawn.

Courtesy translation only, please refer to the German original.