Doravirin (2) – Pifeltro®
HIV infection, 12 to < 18 years
Characteristics
| Start date | 01.05.2022 – Marketing authorisation: 07.04.2022 |
|---|---|
| Resolution | 20.10.2022 |
| INN | Doravirin |
| Brand name | Pifeltro® |
| Pharm. company | MSD Sharp & Dohme GmbH |
| G-BA Procedure ID | D-819 |
| ATC code | J05AG06 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 | 0.1 g O |
| Therapeutic area | Infectious diseases HIV |
| Reason for procedure | New therapeutic indication |
| Specialty | Combination therapy |
| Therapeutic indication of the resolution |
|---|
|
Pifeltro is indicated in combination with other antiretroviral medicines for the treatment of adolescents aged 12 years and over, weighing at least 35 kg, who are infected with the human immunodeficiency virus (HIV-1). The HI viruses must not have mutations known to be associated with resistance to the NNRTI class of substances. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| a) | Treatment-naïve adolescents with HIV-1 infection between the ages of 12 and < 18 years in whom neither currently nor in the past have resistance to the class of NNRTIs been have been detected | Tenofoviralafenamide plus emtricitabine or abacavir plus lamivudine or abacavir plus emtricitabine, each in combination with – dolutegravir or – atazanavir/ritonavir or – darunavir/ritonavir or – elvitegravir/cobicistat |
| b) | Treatment-experienced adolescents with HIV-1 infection aged 12 to < 18 years who have no current or past evidence of resistance to the NNRTI class | Patient-specific antiretroviral therapy with selection of the approved active substances; taking into account the previous therapy(ies) and 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 |
| Reason for dividing into subpopulations (G-BA) | Previous treatment |
a) treatment-naïve adolescents with HIV-1 infection aged 12 to < 18 years, in whom no resistance to the NNRTI class has been detected either currently or in the past
- For both treatment-naïve and treatment-experienced adolescents with HIV-1 infection aged 12 to < 18 years, in whom no resistance to the NNRTI class has been detected either currently or in the past, the additional benefit of doravirine in combination with other antiretroviral medicinal products is not proven compared with the appropriate comparator therapy.
- Overall, the pharmaceutical manufacturer did not submit any study for this patient population that would have been suitable for assessing the additional benefit of doravirine compared with the appropriate comparator therapy.
b) treatment-experienced adolescents with HIV-1 infection aged 12 to < 18 years, in whom no resistance to the NNRTI class has been detected either currently or in the past
- For both treatment-naïve and treatment-experienced adolescents with HIV-1 infection aged 12 to < 18 years, in whom no resistance to the NNRTI class has been detected either currently or in the past, an additional benefit of doravirine in combination with other antiretroviral medicinal products is not proven compared with the appropriate comparator therapy.
- Overall, the pharmaceutical manufacturer did not submit any study for this patient population that would have been suitable for assessing the additional benefit of doravirine compared with the appropriate comparator therapy.
Courtesy translation only, please refer to the German original.
Associated procedures
| Doravirin (2) | Pifeltro® | MSD Sharp & Dohme GmbH | HIV infection, 12 to < 18 years | 130–140 | 100% additional benefit not proven | |
| Doravirin (1) | Pifeltro® | MSD SHARP & DOHME GMBH | HIV infection | 57,800–73,700 | 100% additional benefit not proven |
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