A Prospective, Observational Study of Pregnancy Outcomes Among Women Exposed to Truvada for PrEP Indication

A Prospective, Observational Study of Pregnancy Outcomes Among Women Exposed to Truvada for PrEP Indication Nested in the Antiretroviral Pregnancy Registry

This is a prospective, observational study to describe pregnancy outcomes among HIV-1 uninfected pregnant women who are taking emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) (Truvada®) for a pre-exposure prophylaxis (PrEP) indication nested in the Antiretroviral Pregnancy Registry (APR).

Information on subjects is provided to the APR prospectively (prior to the outcome of the pregnancy being known) through their healthcare provider, with follow-up obtained from the healthcare provider following determination of the pregnancy outcome.

Key Inclusion Criteria:

• Pregnant women
• Part of the prospective arm of the APR Target Group Inclusion Criteria
• HIV-1 Negative
• Choosing to remain on FTC/TDF for PrEP during pregnancy or,
• Choosing to discontinue FTC/TDF for PrEP during pregnancy Comparison Group Inclusion Criteria
• HIV-1 Positive
• On antiretroviral therapy

Key Exclusion Criteria:

• This is an observational nested study and will monitor all reported exposures without intervention/exclusion.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.