Cabotegravir (1) – Vocabria®
HIV-1 infection, pre-treated, combination with rilpivirin
Characteristics
| Start date | 01.05.2021 – Marketing authorisation: 17.12.2020 |
|---|---|
| Resolution | 21.10.2021 |
| INN | Cabotegravir |
| Brand name | Vocabria® |
| Pharm. company | ViiV Healthcare GmbH |
| G-BA Procedure ID | D-645 |
| 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 |
| DDD | 30 mg O |
| Therapeutic area | Infectious diseases HIV |
| Reason for procedure | Initial assessment |
| Therapeutic indication of the resolution |
|---|
|
Vocabria injection is indicated, in combination with rilpivirine injection, for the treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection in adults who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with agents of the NNRTI and INI class |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Adults with HIV-1 infection who are on a stable antiretroviral regimen are virologically suppressed (HIV-1 RNA < 50 copies/mL) with no current or historically documented resistance to the NNRTI or INI class and without virologic failure to NNRTI and INI class agents in the past. | A patient-specific antiretroviral therapy with selection of the approved agents; taking into account previous therapy(ies) and side effects, if any. |
Studies and Results
|
No. of studies
(best subpopulation) |
0 (Data not accepted) |
|---|---|
|
Study design
(best subpopulation) |
Data not accepted (Dossier: Other) |
- Clinical trials
- The ATLAS-2M trial is an open-label, randomised, parallel-group trial investigating the treatment regimen of cabotegravir and rilpivirin Q2M compared with Q1M.
- The FLAIR trial is an open-label, randomised, parallel-group trial investigating cabotegravir + rilpivirine Q1M compared with abacavir/dolutegravir/lamivudine (ABC/DTG/3TC).
Adults 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.
- The additional benefit is not proven.
- Overall, the pharmaceutical manufacturer did not submit any data for the present therapeutic indication that would have been suitable for assessing the additional benefit of cabotegravir in combination with rilpivirine compared with the appropriate comparator therapy.
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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