Voydeya
Voydeya (dapivirine vaginal gel 0.5 % w/w)
Generic Name
Voydeya (dapivirine vaginal gel 0.5 % w/w)
Mechanism
- Non‑nucleoside reverse transcriptase inhibitor (NNRTI)
- Binds to the allosteric pocket of HIV‑1 reverse transcriptase.
- Induces a conformational change that blocks the enzyme’s catalytic activity, preventing viral DNA synthesis and replication.
- Topical delivery concentrates drug locally in vaginal tissue, achieving high mucosal concentrations (>200 ng/mL) with minimal systemic exposure.
Pharmacokinetics
| Parameter | Typical Value | Notes |
| Absorption | Rapid mucosal uptake; 12 h | |
| Drug‑Drug Interactions | None clinically significant for topical use; systemic rap versus moderate CYP3A4 inhibitors/inducers may alter plasma levels slightly but not therapeutic efficacy |
Indications
- HIV‑1 + HIV‑2‐negative women aged 18–55 who are at substantial risk of HIV acquisition.
- Recommended as part of a comprehensive prevention strategy: use with condoms and safe sex counseling.
Contraindications
Contraindications
• Hypersensitivity to dapivirine or any excipient (carbomer, methylparaben, propylene glycol).
• Use is contraindicated in pregnancy if the woman is not using effective contraception (no data on teratogenicity).
Warnings
• Local irritation: burning, itching, discharge may occur; not a reason to discontinue, but advise against using if severe.
• Drug–drug interaction: topical dapivirine has negligible systemic exposure; no known interactions with oral PrEP agents.
• Use among adolescents: ensure adequate menstrual and sexual history; monitor adherence.
Dosing
- Insert 10 mL (1 gram) of the gel at bedtime (mainly 4 pm–9 pm) for 12 h per cycle.
- Cycle: 14 days of daily use followed by 7–14 days of washout before resuming.
- Timing with intercourse: Other than evening use, the gel may be applied within 14 h prior to sexual activity if needed.
- Adherence: Follow up each cycle; consider SMS reminders or text message adherence tools.
Adverse Effects
| Frequency | Adverse Effect | Clinical Note |
| Common | Vaginal burning, itching, irritation | Mild–moderate, resolves spontaneously |
| Common | Headache, upper respiratory tract infection | Non‑systemic, mild |
| Serious | Hypersensitivity rash, anaphylaxis | Rare (<1 %) – discontinue immediately |
| Serious | Systemic QT prolongation | No evidence at therapeutic concentrations |
| Misc | Condom breakage, early condom separation | Counsel about condom use |
Monitoring
- Baseline: HIV test, pregnancy test, baseline viral load if known HIV‑positive partner.
- During use:
- Adherence check at each follow‑up visit.
- HIV screening at 3‑month intervals (as per local guidelines).
- Pregnancy test annually or if contraception changes.
- Side effects: Ask about local irritation; ensure proper gel technique.
Clinical Pearls
- Gel vs. Oral PrEP: Voydeya is a *mucosal‑focused* option with minimal systemic side‑effects, ideal for women preferring a discreet method.
- Condom Compatibility: Gel does not compromise condom integrity, but donors should still use condoms for STI protection.
- Adherence Gear: Ensure patients understand the importance of the 12‑h coverage window; shortfalls shift risk back to unprotected intercourse.
- Age & Pregnancy: While labeled 18–55, the gel is *not* recommended during pregnancy unless effective contraception is used; consider alternative PrEP for women planning pregnancy.
- Partner HIV Status: Educate women that Voydeya protects *only* the user; partner’s viral suppression status remains paramount.
- Storage: Keep at room temperature (20–25 °C); exposure to light may degrade dapivirine; store in a dark container.
- Missed Dose: If >12 h after last application, start new cycle; do not double‑dose.
Bottom line: Voydeya offers a high‑concentration, localized NNRTI for women seeking a discreet, topical PrEP option. Proper adherence, routine HIV screening, and safe sex counseling remain critical for optimal protection.