Cobicistat (2) – Tybost®
HIV infection, combination with atazanavir or darunavir, 12 to < 18 years
Characteristics
| Start date | 01.04.2020 – Marketing authorisation: 09.03.2020 |
|---|---|
| Resolution | 01.10.2020 |
| INN | Cobicistat |
| Brand name | Tybost® |
| Pharm. company | Gilead Sciences GmbH |
| G-BA Procedure ID | D-537 |
| ATC code | V03AX03 Other therapeutic products (V03AX) |
| DDD | 0.15 g O |
| Therapeutic area | Infectious diseases |
| Reason for procedure | New therapeutic indication |
Studies and Results
- Clinical trials
- For this patient population, the pharmaceutical manufacturer did not submit any study that would have been suitable for assessing the additional benefit of cobicistat in the therapeutic indication compared with the appropriate comparator therapy.
Adolescent patients with HIV-1 infection aged 12 to < 18 years
- An additional benefit is not proven for adolescent patients with HIV-1 infection aged 12 to < 18 years.
- For this patient population, the pharmaceutical manufacturer did not submit any study that would have been suitable for assessing the additional benefit of cobicistat in this therapeutic indication compared with the appropriate comparator therapy.
- Summary of the assessment
- Overall, additional benefit is not proven for cobicistat in combination with atazanavir or darunavir in adolescent patients with HIV-1 infection.
Courtesy translation only, please refer to the German original.
Associated procedures
| Cobicistat (2) | Tybost® | Gilead Sciences GmbH | HIV infection, combination with atazanavir or darunavir, 12 to < 18 years | 130 | 100% additional benefit not proven | |
| Cobicistat (1) | Tybost® | Gilead Sciences GmbH | HIV infection | 57,400 | 100% additional benefit not proven |
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