Elbasvir / Grazoprevir (2) – Zepatier®

• Clinical trials
  • The pharmaceutical manufacturer presents the results of the non-randomised, open-label, multicentre, single-arm study MK-5172-079 for patients aged 12 to under 18 years.

Young people aged between 12 and < 18 years with chronic hepatitis C (genotypes 1 and 4)

• mortality
  • No deaths occurred.
• morbidity
  • A sustained virological response at 12 (SVR12) or 24 weeks (SVR24) after the end of treatment was achieved with elbasvir/grazoprevir in all 22 patients (100 per cent).
  • The results of the MK-5172-079 study are of a comparable magnitude to those of the appropriate comparator therapy.
  • For ledipasvir/sofosbuvir, SVR12 and SVR24 rates of 95–100% were observed (see the G-BA’s resolution of 21 January 2021).
  • For sofosbuvir/velpatasvir, SVR12 and SVR24 rates of approximately 93% were observed in children aged 6 to < 12 years (see the G-BA resolution of 1 April 2021).
  • For glecaprevir/pibrentasvir, SVR12 rates of 90–98.3% were observed in children aged 6 to < 12 years (see the G-BA resolution of 16 December 2021).
  • It cannot therefore be assumed that there are significant effects compared with the appropriate comparator therapy.
• quality of life
  • No data on health-related quality of life are available.
• Side effects
  • In the MK-5172-079 study, one serious adverse event (SAE) occurred and there were no discontinuations due to AEs.
• Overall assessment
  • The single-arm study MK-5172-079 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 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 elbasvir/grazoprevir in all 21 patients (100 per cent).
  • The results of the MK-5172-079 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.
  • No data on health-related quality of life are available.
  • Overall, no additional benefit can be inferred on the basis of the data presented.

Courtesy translation only, please refer to the German original.