Emtricitabine / Tenofovir disoproxil fumarate (HIV pre-exposure prophylaxis)
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| ID | DRUG-EMTRICITABINE-TENOFOVIR-DF-PREP |
|---|---|
| Tipo | Fármaco |
| Alegais | Emtricitabina / Tenofovir DF (HIV PrEP)F/TDFFTC/TDFTruvadaTruvada PrEPЕмтрицитабін / Тенофовіру дизопроксил фумарат (PrEP — преекспозиційна профілактика ВІЛ) |
| Estado | revisto 2026-05-18 |
| Doenças | Nenhuma declaração |
| Fontes | SRC-AASLD-HBV-2024 SRC-NIH-AIDS-2024 |
Fatos sobre as drogas
| Classe | Combinação de dose fixa com duas IRNT — profilaxia pré-exposição do VIH-1 (PrEP) |
|---|---|
| Mecanismo | Fixed-dose combination of two nucleoside / nucleotide reverse- transcriptase inhibitors. Emtricitabine (200 mg) is a cytidine-analog NRTI; after intracellular phosphorylation it competitively inhibits HIV-1 reverse transcriptase and terminates chain elongation. Tenofovir disoproxil fumarate (300 mg) is a phosphonate prodrug of tenofovir delivering tenofovir-DP intracellularly, inhibiting HIV-1 RT and HBV polymerase. As ORAL DAILY PrEP in HIV-negative adults at substantial risk, FTC/TDF reduces HIV acquisition by ≥99% with consistent daily adherence (iPrEx 2010, Partners PrEP, TDF2; >90% relative risk reduction at intention-to-treat). Cancer-prevention pathway: preventing incident HIV infection prevents downstream AIDS-defining malignancies (Kaposi sarcoma, NHL incl. PCNSL, invasive cervical cancer) and several HPV-related and viral hepatitis-related cancers driven by HIV-induced immunos... |
| Dose típica | Adult / adolescent (≥35 kg) PrEP: 1 tablet (200 mg FTC / 300 mg TDF) PO once daily, with or without food. Steady-state intracellular tenofovir-DP requires ~7 days of daily dosing (rectal tissue) and ~20 days (cervicovaginal tissue) — establish high adherence BEFORE potential exposure. Event-driven (2-1-1) PrEP — MSM only (IPERGAY 2015, WHO 2019): 2 tablets 2-24 h before sex, 1 tablet 24 h after first dose, 1 tablet 48 h after first dose. NOT recommended for cisgender women, vaginal sex (insufficient tissue levels in cervicovaginal compartment), or PEP indications. HIV-1 treatment (combination ART): 1 tablet PO daily + 3rd agent. Renal adjustment: CrCl 30-49 → q48h; CrCl <30 → AVOID PrEP (in... |
| Ucrânia registada | Verdade |
| NSZU reembolsado | Falso |
| Ucrânia verificada pela última vez | 2026-05-18 |
Avisos
- Exacerbação aguda grave da hepatite B em doentes infectados pelo VHB após descontinuação — monitorizar TFTs ≥ vários meses após parar
- Risco de resistência ao VIH-1 em indivíduos HIV-positivos que utilizam a dose de PrEP (deve confirmar o estado HIV-negativo no início e a cada 3 meses)
Notas
STUB — v0.2 prevention-workstream authoring (batch 3); pending two- Clinical-Co-Lead signoff per CHARTER §6.1 dev-mode. TRUVADA-FOR-PREP is the original FDA-approved oral PrEP (2012). Two-NRTI fixed-dose combination — daily oral, with or without food. 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) at population level. Distinct entity from DRUG-BICTEGRAVIR-EMTRICITABINE-TENOFOVIR-AF (Biktarvy — HIV treatment only, NOT PrEP) and from DRUG-TENOFOVIR-DF / DRUG-TENOFOVIR-AF (single-agent HBV/HIV-treatment context). Cabotegravir LA (DRUG-CABOTEGRAVIR-LA-PREP, batch 3 sibling) is the long-acting injectable PrEP alternative. Truvada PrEP indications: MSM, transgender women, transgender men, cisgender heterosexual women and men at substantial risk, people who inject drugs. Renal monitoring is the critical safety pillar (baseline CrCl + every 6 months). HIV-status monitoring is the resistance-prevention pillar (every 3 months). HBsAg baseline screen is mandatory — if...
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