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) |
| DDD | 0.1 g O |
| Therapeutic area | Infectious diseases |
| Reason for procedure | New therapeutic indication |
Studies and Results
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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