Doravirin / Lamivudin / Tenofovirdisoproxil (2) – Delstrigo®
HIV infection, 12 to < 18 years
Characteristics
| Start date | 01.05.2022 – Marketing authorisation: 28.03.2022 |
|---|---|
| Resolution | 20.10.2022 |
| INN | Doravirin/Lamivudin/Tenofovirdisoproxil |
| Brand name | Delstrigo® |
| Pharm. company | MSD Sharp & Dohme GmbH |
| G-BA Procedure ID | D-818 |
| ATC code | J05AR24 Antivirals for treatment of HIV infections, combinations (J05AR) |
| ICD-10 codes (AIS) | B24, Z21Asymptomatic human immunodeficiency virus [HIV] infection status |
| Alpha-ID codes (AIS) | I24822HIV infection, I29605HIV disease |
| DDD | 1 O |
| Therapeutic area | Infectious diseases HIV |
| Reason for procedure | New therapeutic indication |
| Therapeutic indication of the resolution |
|---|
|
Delstrigo is indicated for the treatment of adolescents aged 12 years and over, weighing at least 35 kg, who are infected with HIV-1, where the HIV viruses must not have mutations known to be associated with resistance to the NNRTI class of compounds, lamivudine or tenofovir, and who have had toxicities that preclude the use of other treatment regimens without tenofovir disoproxil. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Delstrigo is indicated for the treatment of adolescents aged 12 years and over, weighing at least 35 kg, who are infected with HIV-1, where the HIV viruses must not have mutations known to be associated with resistance to the NNRTI class of compounds, lamivudine or tenofovir, and who have had toxicities that preclude the use of other treatment regimens without tenofovir disoproxil. | Individual ART depending on the previous therapy(ies) and taking into account the reason for the change in therapy, in particular therapy failure due to virological failure and any associated development of resistance or due to side effects. |
Studies and Results
|
No. of studies
(best subpopulation) |
1 (IMPAACT 2014) |
|---|---|
|
Study design
(best subpopulation) |
Uncontrolled study |
|
Meta analysis
(best subpopulation) |
no |
- Clinical trials
- The pharmaceutical manufacturer also submits the single-arm IMPAACT 2014 trial, which formed the basis for the marketing authorisation.
- In cohort 1, 9 virologically suppressed adolescents received doravirin in addition to their antiretroviral therapy.
- In cohort 2, 43 pre-treated and 2 treatment-naïve adolescents received doravirin in a fixed-dose combination with lamivudine and tenofovir disoproxil once daily for 96 weeks.
Treatment-experienced adolescents with HIV-1 infection aged 12 to < 18 years, in whom no resistance to the NNRTI class, lamivudine or tenofovir disoproxil has been detected either currently or in the past
- For treatment-experienced adolescents with HIV-1 infection aged 12 to < 18 years, in whom no resistance to the NNRTI class, lamivudine or tenofovir disoproxil; the additional benefit of doravirine/lamivudine/tenofovir disoproxil over the appropriate comparator therapy is not proven.
- The pharmaceutical manufacturer has not provided any direct comparative data for doravirin/lamivudine/tenofovir disoproxil against the appropriate comparator therapy for patients aged 12 to under 18 years with HIV infection.
- As it lacks a comparison with the appropriate comparator therapy, the single-arm study is not suitable for assessing any additional benefit.
Courtesy translation only, please refer to the German original.
Associated procedures
| Doravirin / Lamivudin / Tenofovirdisoproxil (2) | Delstrigo® | MSD Sharp & Dohme GmbH | HIV infection, 12 to < 18 years | 10–20 | 100% additional benefit not proven | |
| Doravirin / Lamivudin / Tenofovirdisoproxil (1) | Delstrigo® | MSD SHARP & DOHME GMBH | HIV infection | 48,800–68,000 | 100% additional benefit not proven |
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