Elbasvir / Grazoprevir (2) – Zepatier®

Chronic hepatitis C (HCV), 12 to < 18 years

Characteristics

Start date 15.11.2021 – Marketing authorisation: 22.10.2021
Resolution 05.05.2022
INN Elbasvir/Grazoprevir
Brand name Zepatier®
Pharm. company Dossier: Merck Sharp & Dohme B.V.
New distributor: HAEMATO PHARM GmbH
G-BA Procedure ID D-745
ATC code J05AP54 Antivirals for treatment of HCV infections (J05AP)
ICD-10 codes (AIS) B18.2Carrier of viral hepatitis C
Alpha-ID codes (AIS) I29602Chronic viral hepatitis C
DDD 50 mg O
Therapeutic area Infectious diseases Hepatitis C (HCV)
Reason for procedure New therapeutic indication
Specialty ACT change

Therapeutic indication of the resolution

Zepatier is indicated for the treatment of chronic hepatitis C (CHC) in patients from 12 to < 18 years of age who weigh at least 30 kg
Subpopulation Indication Comparator
Zepatier is used for the treatment of chronic hepatitis C (CHC) in adolescents from 12 to < 18 years of age and a body weight of at least 30 kg Ledipasvir/Sofosbuvir or Glecaprevir/Pibrentasvir or Sofosbuvir/Velpatasvir

Studies and Results

No. of studies
(best subpopulation) 		1 (MK-5172-079)
Study design
(best subpopulation) 		Single-arm + no comparison
Meta analysis
(best subpopulation) 		no
ACT change 11.10.2021 – Änderung des Therapiestandards

  • 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.

Associated procedures

Elbasvir / Grazoprevir (2) Zepatier® Merck Sharp & Dohme B.V. Infectious diseases Chronic hepatitis C (HCV), 12 to < 18 years 10–17 100% additional benefit not proven
Elbasvir / Grazoprevir (1) Zepatier® MSD Sharp & Dohme GmbH Infectious diseases Chronic hepatitis C 64,800 100% additional benefit not proven


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