Emtricitabin / Rilpivirin / Tenofoviralafenamid (1) – Odefsey®
HIV infection
Characteristics
| Start date | 15.07.2016 – Marketing authorisation: 21.06.2016 |
|---|---|
| Resolution | 05.01.2017 |
| INN | Emtricitabin/Rilpivirin/Tenofoviralafenamid |
| Brand name | Odefsey® |
| Pharm. company | Gilead Sciences GmbH |
| G-BA Procedure ID | D-248 |
| ATC code | J05AR19 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 U O |
| Therapeutic area | Infectious diseases HIV |
| Reason for procedure | Initial assessment |
| Therapeutic indication of the resolution |
|---|
|
Odefsey is indicated for the treatment of adults and adolescents (aged 12 years and older with body weight at least 35 kg) infected with human immunodeficiency virus-1 (HIV-1) without known mutations associated with resistance to the non-nucleoside reverse transcriptase inhibitor (NNRTI) class, tenofovir or emtricitabine and with a viral load ≤ 100,000 HIV-1 RNA copies/mL |
| Subpopulation | Indication | Comparator |
|---|---|---|
| a) | Non-antiretroviral pretreated (therapy-naive) adults with HIV-1 infection | Efavirenz or rilpivirine or dolutegravir, each in combination with two nucleoside/nucleotide analogues (Tenofovirdisoproxil + Emtricitabin or Abacavir + Lamivudin) |
| b) | Non-antiretroviral pretreated (therapy-naïve) adolescents from 12 years of age with HIV-1 infection | Efavirenz or rilpivirine or dolutegravir each in combination with abacavir plus lamivudine |
| c) | HIV-1 infection: antiretroviral pretreated (therapy-experienced) adults with HIV-1 infection | Individual antiretroviral therapy |
| d) | Antiretroviral pre-treated (therapy-experienced) adolescents from 12 years of age with HIV-1 infection | Individual antiretroviral therapy |
Studies and Results
|
No. of studies
(best subpopulation) |
0 (no data submitted) |
|---|---|
|
Study design
(best subpopulation) |
no data submitted (Dossier: H2H vs. ACT (off-label)) |
| Reason for dividing into subpopulations (G-BA) | Previous treatment, Age |
- Clinical trials
- No results from clinical trials were submitted for the benefit assessment for patient populations a), b), c) and d), and these could therefore not be taken into account.
a) Adults not previously treated with antiretrovirals (treatment-naive)
- For patient populations a), b), c) and d), an additional benefit over the appropriate comparator therapy is not proven in each case.
- Consequently, no comparison is possible, either directly or indirectly. It is therefore not possible to draw any conclusions regarding additional benefit, particularly in comparison with the appropriate comparator therapy.
b) adolescents aged 12 years and over who have not previously received antiretroviral therapy (treatment-naive)
- For patient populations a), b), c) and d), an additional benefit over the appropriate comparator therapy is not proven.
- Consequently, there is no possibility of comparison, either direct or indirect. It is therefore not possible to draw any conclusions regarding additional benefit, particularly in comparison with the appropriate comparator therapy.
c) Adults who have previously received antiretroviral treatment (treatment-experienced)
- For patient populations a), b), c) and d), an additional benefit over the appropriate comparator therapy is not proven.
- Consequently, there is no possibility of comparison, either directly or indirectly. It is therefore not possible to draw any conclusions regarding additional benefit, particularly in comparison with the appropriate comparator therapy.
d) Adolescents aged 12 years and over who have received prior antiretroviral treatment (treatment-experienced)
- For patient populations a), b), c) and d), an additional benefit over the appropriate comparator therapy is not proven.
- Consequently, there is no possibility of comparison, either directly or indirectly. It is therefore not possible to draw any conclusions regarding additional benefit, particularly in comparison with the appropriate comparator therapy.
Courtesy translation only, please refer to the German original.
Associated procedures
| Emtricitabin / Rilpivirin / Tenofoviralafenamid (1) | Odefsey® | Gilead Sciences GmbH | HIV infection | 56,800–59,300 | 100% additional benefit not proven |
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