Sofosbuvir / Velpatasvir / Voxilaprevir (2) – Vosevi®

• Clinical trials
  • The pharmaceutical manufacturer presents the results of the non-randomised, open-label, multicentre, single-arm Phase II trial G367-1175 for patients aged 12 to under 18 years.

Young people aged between 12 and < 18 years with chronic hepatitis C

• The single-arm study G367-1175 presented here is not suitable for assessing additional benefit due to the lack of a comparison with the appropriate comparator therapy; this would only be possible if there were very large effects compared with the appropriate comparator therapy.
• mortality
  • No deaths occurred.
• morbidity
  • A sustained virological response 12 (SVR12) or 24 weeks (SVR24) after the end of treatment was achieved with sofosbuvir/velpatasvir/voxilaprevir in all 21 patients (100 per cent).
  • The results of the G367-1175 study are of the same order of magnitude as those of the appropriate comparator therapy.
  • It cannot therefore be assumed that there are significant differences compared with the appropriate comparator therapy.
• quality of life
  • Health-related quality of life was assessed in the study using the PedsQL (Pediatric Quality of Life Inventory) at the start of the study and at weeks 12 and 24 after the end of treatment.
  • This resulted in a change in the overall score over the course of the study of –1.0 points at week 12 and –0.2 points at week 24.
  • Due to the lack of comparative data, the results cannot be adequately interpreted.
• Side effects
  • In study G367-1175, one serious adverse event (SAE) occurred and there were no discontinuations due to AEs.
• Overall assessment
  • The single-arm study G367-1175 presented here is not suitable for assessing additional benefit due to the lack of comparison with the appropriate comparator therapy; this would only be possible, at best, if there were very large effects compared with the appropriate comparator therapy.
  • A sustained virological response at 12 (SVR12) or 24 weeks (SVR24) after the end of treatment was achieved with sofosbuvir/velpatasvir/voxilaprevir in all 21 patients (100 per cent). The results of the G367-1175 study are of the same order of magnitude as those of the appropriate comparator therapy.
  • There were no deaths, no serious adverse events and no adverse events leading to therapy discontinuation. The available data on health-related quality of life are insufficient to allow for interpretation.
  • Overall, no additional benefit can be inferred on the basis of the data presented.

Courtesy translation only, please refer to the German original.