Rilpivirin (2) – Edurant®
HIV infection, 12 to < 18 years
Characteristics
| Start date | 01.01.2016 – Marketing authorisation: 20.11.2015 |
|---|---|
| Resolution | 16.06.2016 |
| INN | Rilpivirin |
| Brand name | Edurant® |
| Pharm. company | Janssen-Cilag GmbH |
| G-BA Procedure ID | D-209 |
| ATC code | J05AG05 Non-nucleoside reverse transcriptase inhibitors (J05AG) |
| ICD-10 codes (AIS) | B24, Z21Asymptomatic human immunodeficiency virus [HIV] infection status |
| Alpha-ID codes (AIS) | I24822HIV infection, I29605HIV disease |
| DDD | 25 mg O |
| Therapeutic area | Infectious diseases HIV |
| Reason for procedure | New therapeutic indication |
| Therapeutic indication of the resolution |
|---|
|
EDURANT, in combination with other antiretroviral medicinal products, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-naïve patients 12 years of age and older with a viral load ≤ 100,000 HIV-1 RNA copies/ml. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Antiretroviral non-pretreated adolescents in the age range 12 to 17 years inclusive with a viral load of ≤ 100000 HIV-1 RNA copies/ml. | Efavirenz in combination with abacavir + lamivudine |
Studies and Results
|
No. of studies
(best subpopulation) |
1 (TMC278-C213) |
|---|---|
|
Study design
(best subpopulation) |
Single-arm + historical comparison |
|
Meta analysis
(best subpopulation) |
no |
- Clinical trials
- The benefit assessment is based on the single-arm, open-label Phase II registration trial TMC278-C213, which involved 36 patients aged ≥12 to <18 years.
Adolescents aged 12 to 17 years inclusive who have not previously received antiretroviral treatment and have a viral load of ≤ 100,000 HIV-1 RNA copies/ml
- An additional benefit over the appropriate comparator therapy is not proven.
- On the basis of the information in the dossier, the IQWiG’s benefit assessment and the comments on the benefit assessment, the G-BA concludes that the additional benefit of rilpivirine over the appropriate comparator therapy is not proven.
- Morbidity – Virological response
- Rilpivirine was investigated at the authorised dose of 25 mg in combination with two NRTIs as so-called ‘backbone’ therapy. Data were collected at 24 and 48 weeks, and the endpoints ‘virological response’, [...] were examined.
- During the commenting procedure, a non-adjusted indirect comparison of rilpivirine with the appropriate comparator therapy, efavirenz, for the endpoint ‘virological response’ at week 48 was submitted.
- Due to major methodological shortcomings (unequal study populations, differing operationalisation of endpoints, divergent patient characteristics, lack of consistency with the appropriate comparator therapy in the backbone, etc.), the indirect comparison submitted was unsuitable and cannot be taken into account in the context of the benefit assessment.
- Morbidity – Virological failure
- Rilpivirine was investigated at the authorised dose of 25 mg in combination with two NRTIs as so-called ‘backbone’ therapy. Data were collected at 24 and 48 weeks, and the endpoints [...] “virological failure” [...] were assessed.
Courtesy translation only, please refer to the German original.
Associated procedures
| Rilpivirin (2) | Edurant® | Janssen-Cilag GmbH | HIV infection, 12 to < 18 years | 10 | 100% additional benefit not proven | |
| Rilpivirin (1) | Edurant® | Janssen-Cilag GmbH | HIV infection | 1,260 | 100% Proof of minor additional benefit |
<< List of all resolutions