Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Emtricitabine · 4 trials · 3 indications
Participants who achieved/maintained confirmed HIV-1 RNA \< 400 c/mL had to satisfy the following criteria: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug except nevirapine in place of EFV prior to Week 48 visit; 2) achieved confirmed HIV-1 RNA \< 400 c/mL on 2 consecutive visits prior to Week 48 visit (ie, the first of the 2 consecutive HIV-1 RNA \< 400 c/mL occurred prior to the Week 48 visit; 3) not had confirmed HIV-1 RNA \> 400 c/mL after achievement of confirmed HIV RNA levels \< 400 c/mL prior to Week 48 visit.
This endpoint has been included to satisfy the requirements of ClinicalTrials.gov. However, there were no prespecified endpoints in this study.
| Arm | Type | Description |
|---|---|---|
| EFV+CBV | ACTIVE_COMPARATOR | Participants in this group received EFV 600 mg once daily + Combivir (\[CBV\]; the fixed dose combination pill containing lamivudine 150 mg + zidovudine 300 mg) taken twice daily from the start of the study until Week 144. At Week 144 all participants who opted to roll over into the additional 96-week study extension received Atripla (\[ATR\]; the fixed-dose combination tablet containing FTC 200 mg/TDF 300 mg/EFV 600 mg) taken once daily until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study. |
| EFV+FTC+TDF | EXPERIMENTAL | Participants in this arm received 3 component drugs: efaviren (EFV; 600 mg) + emtricitabine (FTC; 200 mg) + tenofovir disoproxil fumarate (tenofovir DF \[TDF\]; 300 mg) as 3 separate pills once daily from the start of the study. At 96 weeks Truvada (\[TVD\] the fixed-dose combination pill containing FTC/TDF \[200/300 mg\] once daily) replaced the 2 component drugs FTC + TDF; participants continued to receive EFV 600 mg once daily. At Week 144 all participants who opted to roll over into the further 96-week study extension received ATR. At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study. |
| 1 | ACTIVE_COMPARATOR | AZT+FTC+EFV |
| 2 | ACTIVE_COMPARATOR | TDF+FTC+EFV |
| Emtricitabine | EXPERIMENTAL | Participants will receive emtricitabine for as long as they continue to meet specific virologic criteria and until either: (1) the participant chooses to discontinue treatment of emtricitabine and withdraw from the rollover protocol; (2) the participant experiences a toxicity that necessitates the permanent discontinuation of emtricitabine, or (3) emtricitabine is approved for market distribution in the participant's country of residence. |
| Name | Type | Description |
|---|---|---|
| Emtricitabine (FTC) | DRUG | Capsule containing 200 mg FTC, taken once daily, for 96 weeks |
| Tenofovir Disoproxil Fumarate (TDF) | DRUG | Tablet containing 300 mg TDF, taken once daily, for 96 weeks |
| Efavirenz (EFV) | DRUG | Tablet containing 600 mg EFV, taken once daily, for 96 weeks |
| FTC/TDF | DRUG | Fixed-dose combination tablet containing FTC 200 mg/TDF 300 mg, once daily, from Week 96 to 144 |
| FTC/TDF/EFV | DRUG | Fixed-dose combination tablet containing FTC 200 mg/TDF 300 mg/EFV 600 mg, taken once daily, from Week 144 to 240 |
| Lamivudine/zidovudine | DRUG | Fixed-dose combination tablet containing lamivudine 150 mg/zidovudine 300 mg, taken twice daily, for 240 weeks |
| Emtricitabine | DRUG | Emtricitabine 200 mg OD + Zidovudine 300 mg BID + EFV OD compared to TDF + FTC + EFV |
Inclusion Criteria: Participants must have met all inclusion criteria within 28 days prior to randomization unless specified otherwise including: * Plasma HIV-1 RNA levels greater than 10,000 c/mL using Roche Amplicor HIV-1 Monitor Test Version 1.5 Standard * Adequate renal function: Calculated cre...
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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.