Glecaprevir / Pibrentasvir (2) – Maviret®

Chronic hepatitis C, 12 to < 18 years

Characteristics

Start date 15.04.2019 – Marketing authorisation: 11.03.2019
Resolution 17.10.2019
INN Glecaprevir/Pibrentasvir
Brand name Maviret®
Pharm. company AbbVie Deutschland GmbH & Co. KG
G-BA Procedure ID D-441
ATC code J05AP57 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 3 U O
Therapeutic area Infectious diseases Hepatitis C (HCV)
Reason for procedure New therapeutic indication

Therapeutic indication of the resolution

Maviret is indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults and adolescents aged 12 to < 18 years.
Subpopulation Indication Comparator
a) Patients with chronic hepatitis C aged 12 to <18 years, genotype 1, 4, 5 or 6. Ledipasvir/Sofosbuvir
b) Patients with chronic hepatitis C aged 12 to < 18 years, genotype 2 or 3. Sofosbuvir + Ribavirin

Studies and Results

No. of studies
(best subpopulation) 		1 (DORA)
Study design
(best subpopulation) 		Single-arm + no comparison
Meta analysis
(best subpopulation) 		no
Reason for dividing into subpopulations (G-BA) Gene/mutation specifics

  • Clinical trials
    • The M16-123 (DORA) study is an open-label, single-arm study investigating glecaprevir/pibrentasvir in previously treated and treatment-naïve children and adolescents aged 3 to 18 years.

a) Patients with chronic hepatitis C aged 12 to < 18 years, genotypes 1, 4, 5 or 6

  • Additional benefit is not proven for glecaprevir/pibrentasvir in adolescent patients with chronic hepatitis C aged 12 to < 18 years, with genotype 1, 4, 5 or 6 infection.
  • Overall, no additional benefit can be established on the basis of the data provided.
  • Morbidity – Sustained virological response (SVR)
    • A sustained virological response at 12 months (SVR12) following the end of treatment was achieved by all patients in the cohort.
    • The results of the DORA study are of the same order of magnitude as those for the appropriate comparator therapy, ledipasvir/sofosbuvir.
    • For ledipasvir/sofosbuvir, SVR12 rates of between 97.5 and 100 per cent were observed (see the G-BA’s resolution of 15 February 2018).
  • Side effects
    • There were no deaths, serious adverse events or adverse events leading to therapy discontinuation.
    • One severe adverse event (depression, CTCAE ≥ 3) was observed in one patient.

b) Patients with chronic hepatitis C aged 12 to < 18 years, genotype 2 or 3

  • Additional benefit from glecaprevir/pibrentasvir is not proven in adolescent patients aged 12 to < 18 years with chronic hepatitis C caused by genotype 2 or 3.
  • Overall, no additional benefit can be established on the basis of the data provided.
  • However, there is no evidence available to assess additional benefit in patient groups that might benefit from ribavirin-free treatment; consequently, there is no hint that there is any additional benefit.
  • Morbidity – Sustained virological response (SVR)
    • A sustained virological response at 12 weeks (SVR12) following the end of treatment was achieved by all patients in the cohort.
    • The results of the DORA study are of the same order of magnitude as those for the appropriate comparator therapy, sofosbuvir (in combination with ribavirin).
    • For sofosbuvir plus ribavirin, SVR12 rates of between 96.4 and 100 per cent were observed (see the G-BA resolution of 15 February 2018).
  • Side effects
    • There were no deaths, no serious or severe adverse events, and no adverse events that led to therapy discontinuation due to adverse events.

Courtesy translation only, please refer to the German original.

Associated procedures



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