Cabotegravir (2) – Vocabria®
HIV-1 infection, treatment-experienced adolescents, combination with rilpivirine, 12 to 17 years of age
Characteristics
| Start date | 15.02.2025 – Marketing authorisation: 13.01.2025 |
|---|---|
| Resolution | 07.08.2025 |
| INN | Cabotegravir |
| Brand name | Vocabria® |
| Pharm. company | ViiV Healthcare GmbH |
| G-BA Procedure ID | D-1162 |
| ATC code | J05AJ04 Integrase inhibitors (J05AJ) |
| ICD-10 codes (AIS) | B24, Z21Asymptomatic human immunodeficiency virus [HIV] infection status |
| Alpha-ID codes (AIS) | I24822HIV infection, I29605HIV disease, I29606Human immunodeficiency virus disease |
| Therapeutic area | Infectious diseases HIV |
| Reason for procedure | New therapeutic indication |
| Therapeutic indication of the resolution |
|---|
|
Vocabria injection is used in combination with rilpivirine injection for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adolescents (aged 12 to 17 years and with a body weight of at least 35 kg), who are virologically suppressed (HIV-1 RNA < 50 copies/ml) on a stable antiretroviral regimen with no current or historically documented resistance to the non-nucleoside reverse transcriptase inhibitor (NNRTI) or integrase inhibitor (INI) class and no history of virological failure to active ingredients of the NNRTI and INI class. Vocabria tablets are used in combination with rilpivirine tablets for short-term treatment to assess the tolerability of Vocabria and rilpivirine prior to the use of long-acting cabotegravir injection plus long-acting rilpivirine injection. Oral therapy is used for adolescents who miss the planned dosage of cabotegravir injection plus rilpivirine injection ("oral bridging"). The present evaluation refers to the entire therapy concept consisting of the oral initiation phase, the intramuscular maintenance phase and the oral bridging therapy. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Adolescents aged 12 to 17 years and weighing at least 35 kg with HIV-1 infection who are virologically suppressed on a stable antiretroviral regimen (HIV-1 RNA < 50 copies/ml) with no current or historically documented resistance to the NNRTI or INI class and no history of virological failure to active ingredients of the NNRTI and INI class | An individualised therapy with a selection of approved antiretroviral active ingredients (INN) |
Studies and Results
|
No. of studies
(best subpopulation) |
1 (IMPAACT 2017) 0 (Data not accepted) |
|---|---|
|
Study design
(best subpopulation) |
Data not accepted (Dossier: Single-arm + no comparison) |
- Clinical trials
- The pharmaceutical manufacturer does not consider the single-arm IMPAACT 2017 trial, which formed the basis for marketing authorisation, to be relevant for the assessment of additional benefit due to the lack of comparison with the appropriate comparator therapy.
Adolescents aged 12 to 17 years and weighing at least 35 kg with HIV-1 infection who are virologically suppressed on a stable antiretroviral regimen (HIV-1 RNA < 50 copies/ml) with no current or historically documented resistance to the NNRTI or INI classes and no history of virological failure with active ingredients from the NNRTI and INI classes
- An additional benefit is not proven.
- Overall, the pharmaceutical manufacturer has not submitted any data for the assessment of the additional benefit of cabotegravir in combination with rilpivirine compared with the appropriate comparator therapy for the indicated therapeutic indication.
- An additional benefit of cabotegravir in combination with rilpivirine compared with the appropriate comparator therapy is not proven.
Courtesy translation only, please refer to the German original.
Associated procedures
| Cabotegravir (2) | Vocabria® | ViiV Healthcare GmbH | HIV-1 infection, treatment-experienced adolescents, combination with rilpivirine, 12 to 17 years of age | 65 | 100% additional benefit not proven | |
| Cabotegravir (1) | Vocabria® | ViiV Healthcare GmbH | HIV-1 infection, pre-treated, combination with rilpivirin | 59,900 | 100% additional benefit not proven |
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