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) |
| ICD-10 codes (AIS) | B24, Z21Asymptomatic human immunodeficiency virus [HIV] infection status |
| Alpha-ID codes (AIS) | I24822HIV infection, I29605HIV disease |
| DDD | 0.15 g O |
| Therapeutic area | Infectious diseases HIV |
| Reason for procedure | New therapeutic indication |
| Therapeutic indication of the resolution |
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|
Tybost is indicated as a pharmacokinetic enhancer of atazanavir 300 mg once daily or darunavir 800 mg once daily as part of antiretroviral combination therapy in human immunodeficiency virus-1 (HIV-1) infected adolescents aged 12 years and older: • weighing at least 35 kg co-administered with atazanavir or • weighing at least 40 kg co-administered with darunavir. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Adolescent patients with HIV-1 infection aged 12 to < 18 years | Ritonavir in combination with atazanavir or darunavir |
Studies and Results
|
No. of studies
(best subpopulation) |
0 (no data submitted) |
|---|---|
|
Study design
(best subpopulation) |
no data submitted |
- 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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