Cabotegravir long-acting (HIV pre-exposure prophylaxis)
Детермінований перегляд YAML-сутності з джерельної бази. Клінічний авторитет лишається за вказаними source ID та статусом клінічного sign-off.
| ID | DRUG-CABOTEGRAVIR-LA-PREP |
|---|---|
| Тип | Препарат |
| Синоніми | ApretudeCAB-LACabotegravir long-acting (HIV PrEP)Long-acting cabotegravir for PrEPКаботегравір тривалої дії (PrEP — преекспозиційна профілактика ВІЛ) |
| Статус | переглянуто 2026-05-18 |
| Хвороби | Не вказано |
| Джерела | SRC-NIH-AIDS-2024 |
Дані про препарат
| Клас | HIV-1 integrase strand transfer inhibitor (INSTI) — long-acting injectable for PrEP |
|---|---|
| Механізм дії | Second-generation HIV-1 integrase strand-transfer inhibitor (INSTI) formulated as a long-acting injectable nanosuspension. Blocks integration of viral DNA into the host chromosome — same INSTI mechanism as dolutegravir and bictegravir, with similar high barrier to resistance. Sustained-release IM depot provides therapeutic plasma cabotegravir for ~2-3 months per dose. As HIV-1 PRE-EXPOSURE PROPHYLAXIS in HIV-negative adults at substantial risk, CAB-LA reduces sexual HIV acquisition by ~69% vs daily oral FTC/TDF in HPTN 083 (cisgender MSM / transgender women) and by ~89% in HPTN 084 (cisgender women at risk in sub-Saharan Africa) — superior efficacy to oral PrEP, driven by improved adherence over daily pills. Cancer-prevention pathway: preventing incident HIV infection prevents downstream AIDS- defining malignancies (Kaposi sarcoma, NHL incl. PCNSL, invasive cervical cancer) and HPV-rela... |
| Типове дозування | Adult / adolescent (≥35 kg) PrEP: Loading: 600 mg IM in gluteal muscle on month 0 and month 1 (~4 weeks apart). Maintenance: 600 mg IM in gluteal muscle every 2 months (8 weeks). Optional oral lead-in (HISTORICAL — REMOVED from FDA label 2023): Cabotegravir 30 mg PO once daily × 4 weeks before first injection to confirm tolerability. Per FDA 2023 label update and HPTN data, this oral lead-in is NO LONGER REQUIRED — direct IM injection is now standard. Missed dose: ≤7 days late: next 2-monthly injection on schedule, no make-up. >7 days late, ≤2 months since last dose: give injection ASAP + resume schedule. >2 months since last dose: consider switching to oral PrEP bridge (FTC/TDF) or restart... |
| Зареєстровано в Україні | False |
| Відшкодовується НСЗУ | False |
| Остання перевірка для України | 2026-05-18 |
Застереження
- Risk of HIV-1 resistance in HIV-positive individuals using PrEP dose — confirm HIV-negative status (with HIV-1 RNA test, not just Ag/Ab) at every injection
Нотатки
STUB — v0.2 prevention-workstream authoring (batch 3); pending two- Clinical-Co-Lead signoff per CHARTER §6.1 dev-mode. APRETUDE (CAB-LA for PrEP) is the first long-acting injectable HIV pre-exposure prophylaxis option (FDA 2021). Bimonthly gluteal IM injection; per FDA 2023 label update, no oral lead-in required. SUPERIOR to oral FTC/TDF PrEP in head-to-head trials (HPTN 083: ~69% lower HIV incidence among MSM/TGW; HPTN 084: ~89% lower among cisgender African women) — driven by adherence advantage. Cancer-prevention rationale: preventing HIV acquisition prevents downstream AIDS-defining cancers (Kaposi sarcoma, NHL incl. PCNSL and Burkitt, invasive cervical cancer) and several non-AIDS-defining cancers (HPV-driven anal, oropharyngeal, hepatocellular, Hodgkin lymphoma). KEY CLINICAL CAVEATS: (1) long pharmacological tail (~12 months below therapeutic level after last injection) — patients who discontinue continued risk must bridge with daily oral FTC/TDF or FTC/TAF PrEP to avoid exposure during waning levels; (2) HIV-1 RNA testing (not just 4th-gen Ag/Ab) every 2 months to detect breakthrough infection before INSTI resistance develops; (3) NOT for HBV — patients with HBV should ha...
Де використовується
Препарат
DRUG-EMTRICITABINE-TENOFOVIR-DF-PREP- Emtricitabine / Tenofovir disoproxil fumarate (HIV pre-exposure prophylaxis)