Doravirin / Lamivudin / Tenofovirdisoproxil (2) – Delstrigo®

• Clinical trials
  • The pharmaceutical manufacturer also submits the single-arm IMPAACT 2014 trial, which formed the basis for the marketing authorisation.
  • In cohort 1, 9 virologically suppressed adolescents received doravirin in addition to their antiretroviral therapy.
  • In cohort 2, 43 pre-treated and 2 treatment-naïve adolescents received doravirin in a fixed-dose combination with lamivudine and tenofovir disoproxil once daily for 96 weeks.

Treatment-experienced adolescents with HIV-1 infection aged 12 to < 18 years, in whom no resistance to the NNRTI class, lamivudine or tenofovir disoproxil has been detected either currently or in the past

• For treatment-experienced adolescents with HIV-1 infection aged 12 to < 18 years, in whom no resistance to the NNRTI class, lamivudine or tenofovir disoproxil; the additional benefit of doravirine/lamivudine/tenofovir disoproxil over the appropriate comparator therapy is not proven.
• The pharmaceutical manufacturer has not provided any direct comparative data for doravirin/lamivudine/tenofovir disoproxil against the appropriate comparator therapy for patients aged 12 to under 18 years with HIV infection.
• As it lacks a comparison with the appropriate comparator therapy, the single-arm study is not suitable for assessing any additional benefit.

Courtesy translation only, please refer to the German original.