Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
emtricitabine/tenofovir alafenamide · 1 trial · 2 indications
Acceptability will be assessed by discontinuation of study product
| Arm | Type | Description |
|---|---|---|
| F/TAF | ACTIVE_COMPARATOR | daily oral tablet |
| F/TDF | ACTIVE_COMPARATOR | daily oral tablet |
| Name | Type | Description |
|---|---|---|
| emtricitabine/tenofovir alafenamide | DRUG | 200mg/25mg tablet, once daily dosing for 24 weeks |
| Emtricitabine / Tenofovir Disoproxil Oral Tablet | DRUG | 200mg/300mg tablet, once daily dosing for 24 weeks |
Inclusion Criteria: 1. Female, age 15 to 24 years (inclusive) 2. Literate, per local standards, to English and/or local language 3. In general good health, per participant reported medical history and investigator judgement, without any clinically significant systemic disease including but not limi...
Emtricitabine is an investigational small molecule being studied for the treatment and prevention of HIV infections, including HIV-1, and for hepatitis B virus. It is also being evaluated in studies related to the acceptability of health care and medication adherence. Emtricitabine is in Phase 3 clinical development.
Emtricitabine is a nucleoside reverse transcriptase inhibitor (NRTI) that works by inhibiting the reverse transcriptase enzyme, which is essential for viral replication. This mechanism is used in the treatment of HIV and hepatitis B virus infections.
Emtricitabine is developed by Gilead Sciences, Inc., a biopharmaceutical company. Gilead Sciences is publicly traded under the ticker symbol GILD.
Emtricitabine is in Phase 3 clinical development. It is not FDA approved and remains investigational. Clinical trials have been completed, including a Phase 3 study with 1,814 participants.
Emtricitabine has been studied in several completed trials. Notable trials include NCT00743340, a Phase 2 rollover study in pediatric patients with HIV-1 in South Africa, and NCT00811954, a Phase 3 comparative study of NNRTI-sparing HAART regimens in HIV infection. Other trials include NCT01769456 and NCT05458765, which focused on pre-exposure prophylaxis and PrEP acceptability.
Emtricitabine is a component of the combination product Emtricitabine/tenofovir disoproxil fumarate (F/TDF). While Emtricitabine is the single agent, F/TDF combines emtricitabine with tenofovir disoproxil fumarate. The two are related but not identical.