Dual Prevention Pill
- User: Female
- Hormonal: Hormonal
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Delivery type:
- Oral
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Intended Duration:
- Short-Acting
- Development Stage: Phase II
- Developer(s)/researcher(s): Viatris, Population Council, AIDS Vaccine Advocacy Coalition (AVAC), HIV Prevention Trials Network
Details
- API: TDF/FTC and LNG/EE (1st Gen), F/TAF and LNG/EE (2nd Gen)
- Target: Progesterone Receptor, Androgen Receptor, Estrogen Receptor
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Mechanism of Action:
- Ovulation Inhibition
- Cervical Mucus Changes
- Endometrial Changes
- Anti-Microbial
- Inactive Materials: Not Yet Determined
- Regimen: 1 Pill/Day
- MPT: Potential MPT
- Promising Attributes: A combined pill may reach users at risk of HIV infection, but who are more motivated by contraceptive goals. A combined pill may also improve compliance.
Product Status
Active/Upcoming Clinical Research Confirmed by Developer
History
The HIV Prevention Trials Network, Viatris, and the Population Council are actively exploring the potential for a multi-purpose prevention technology that co-formulates the APIs of two approved products - an oral PrEP product and an oral contraceptive - into a single pill. To assess acceptability and adherence with this potential technology, the Council has conducted two studies with an over-encapsulated version of the product (rather than a co-formulated tablet). The product is expected to have two "generations", to enable rapid regulatory approval - the first, led by Viatris, will co-formulate FTC/TDF with LNG/EE (both drug combinations currently approved for use in healthy women), and the second, led by Population Council, will co-formulate F/TAF with LNG/EE. F/TAF alone is not currently approved for use by cisgender women, leading to an extended potential approval timeline for the combined product.
In 2025, Viatris submitted information about the product to the WHO prequalification program for regulatory guidance, which was scheduled for issuance in late 2025. A Phase II clinical trial, sponsored by the HIV Prevention Trials Network, will initiate in 2026.