Bictegravir / Emtricitabine / Tenofovir alafenamide
Детермінований перегляд YAML-сутності з джерельної бази. Клінічний авторитет лишається за вказаними source ID та статусом клінічного sign-off.
| ID | DRUG-BICTEGRAVIR-EMTRICITABINE-TENOFOVIR-AF |
|---|---|
| Тип | Препарат |
| Синоніми | B/F/TAFBIC/FTC/TAFBictarvyBiktarvyБіктегравір / Емтрицитабін / Тенофовіру алафенамід |
| Статус | переглянуто 2026-05-18 |
| Хвороби | DIS-DLBCL-NOS |
| Джерела | SRC-NIH-AIDS-2024 |
Дані про препарат
| Клас | Fixed-dose combination HIV-1 antiretroviral — integrase strand transfer inhibitor (INSTI) + two NRTIs |
|---|---|
| Механізм дії | Fixed-dose single-tablet regimen (STR) combining three active components. Bictegravir (50 mg) is a second-generation HIV-1 integrase strand- transfer inhibitor (INSTI) that blocks integration of viral DNA into the host chromosome — high barrier to resistance, similar to dolutegravir. Emtricitabine (200 mg) is a cytidine-analog NRTI that, after intracellular phosphorylation, competitively inhibits HIV-1 reverse transcriptase and terminates chain elongation. Tenofovir alafenamide (25 mg) is a phosphonamidate prodrug of tenofovir delivering active tenofovir-DP primarily intracellularly, with reduced systemic exposure and lower renal / bone toxicity than TDF. Cancer-prevention pathway: sustained HIV viral suppression and immune reconstitution reduce risk of AIDS-defining malignancies (Kaposi sarcoma, non-Hodgkin lymphomas including primary CNS lymphoma and Burkitt lymphoma, invasive cervica... |
| Типове дозування | Adult and pediatric (≥25 kg): 1 tablet (50/200/25 mg) PO once daily, with or without food. Pediatric 14-25 kg: low-strength tablet 30/120/15 mg PO once daily. Renal adjustment: NOT recommended in CrCl <30 (use alternative regimen — TAF approved down to CrCl 15, but coformulation studied only to CrCl ≥30). HD patients: 1 tablet daily after dialysis on dialysis days (limited data). Hepatic: no adjustment in mild/moderate (Child-Pugh A/B); avoid in severe hepatic impairment (C). Abrupt discontinuation in HIV/HBV coinfected patients → risk of severe HBV exacerbation (boxed warning — monitor LFTs ≥several months post-stop). PrEP: NOT indicated for HIV pre-exposure prophylaxis (use Truvada or Des... |
| Зареєстровано в Україні | True |
| Відшкодовується НСЗУ | True |
| Остання перевірка для України | 2026-05-18 |
Застереження
- Severe acute exacerbation of hepatitis B upon discontinuation in HIV/HBV coinfected patients — monitor LFTs ≥several months post-stop
Нотатки
STUB — v0.2 prevention-workstream authoring; pending two-Clinical-Co-Lead signoff per CHARTER §6.1 dev-mode. Biktarvy is one of the preferred single-tablet initial ART regimens per NIH-AIDS 2024, IAS-USA, DHHS, ESMO HIV-and-cancer guidance. Single tablet, once-daily, with or without food, no booster (cobicistat / ritonavir), no HLA-B*5701 screening needed. High barrier to resistance. Cancer-prevention rationale: durable viral suppression with CD4 reconstitution reduces incidence of AIDS- defining cancers (Kaposi sarcoma, NHL including PCNSL and Burkitt, invasive cervical cancer) and several non-AIDS-defining cancers (anal, oropharyngeal, hepatocellular, Hodgkin lymphoma) — meta-analyses suggest substantial relative-risk reduction with sustained suppression. Note: Biktarvy is NOT indicated for HIV PrEP (pre-exposure prophylaxis — use Truvada [FTC/TDF] or Descovy [FTC/TAF]) — PrEP is a separate workstream. Polyvalent cation chelation is the major adherence pitfall — patient counseling on supplement timing is critical. Two-Co-Lead signoff queued for v0.2-A clinical review.
Де використовується
Access Pathways
AP-ART-NSZU-HIV- ART regimens (Biktarvy and alternatives) via НСЗУ HIV programme
Contraindications
CI-BIKTARVY-RIFAMYCIN- CI-BIKTARVY-RIFAMYCINCI-TENOFOVIR-SEVERE-RENAL- CI-TENOFOVIR-SEVERE-RENAL
Regimens
REG-HIV-BIKTARVY- Biktarvy — bictegravir/emtricitabine/tenofovir-AF single-tablet ART