Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Emtricitabine/tenofovir · 2 trials · 1 indication
The Kaplan-Meier estimate of the cumulative probability of virologic failure by week 96. Time to virologic failure was defined as the first time from study entry to the first of two consecutive HIV-1 RNA \>1000 copies/mL at or after week 16 and before week 24, or \>200 copies/mL at or after week 24. Week 16 is defined to occur between 14 (98 days) and 18 weeks (126 days) after study entry, week 24 is defined to occur between 22 (154 days) and 26 (182 days) after study entry, and week 96 is defined to occur between 88 (616 days) and 104 (728 days) after study entry.
The cumulative incidence of discontinuation for toxicity by week 96 was estimated using competing risks with treatment discontinuation for other reasons considered as a competing event; participants completing the study on the RAL or PI component of their randomized regimen were considered censored at the earliest of the date of last patient contact and off study date.
This represents one of the indicators associated with the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM. Participants were assessed for any serum creatinine event of Grade 1 or higher over the course of the study (Week 0 through Week 48).
The percent change in lumbar spine BMD from baseline measurement to Week 48 is calculated as: Percent change= \[(Value at Week 48 - Value at Baseline)/(Value at Baseline)\] x 100 This represents one of the indicators associated with the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM.
The percent change in femoral neck BMD from baseline measurement to Week 48 is calculated as: Percent change= \[(Value at Week 48 - Value at Baseline)/(Value at Baseline)\] x 100 This represents one of the indicators associated with the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM.
The percent change in total body BMD from baseline measurement to Week 48 is calculated as: Percent change= \[(Value at Week 48 - Value at Baseline)/(Value at Baseline)\] x 100 This represents one of the indicators associated with the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM.
The percent change in total hip BMD from baseline measurement to Week 48 is calculated as: Percent change= \[(Value at Week 48 - Value at Baseline)/(Value at Baseline)\] x 100 This represents one of the indicators associated with the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM.
The proportion of subjects with DXA data through Week 48 who experienced varying degrees of decrease in absolute BMD in at least one region (spine, hip, or whole body). This represents one of the indicators associated with the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM.
Behavioral disinhibition/risk compensation was assessed based on a number of questions, including the following related to unprotected sex from the participant ACASI: "Of these males \[male partners\], how many did you have unprotected oral or anal sex with since the last time you took this survey?" An event is defined as an answer of greater than 0. This represents one of the indicators associated with the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM.
Behavioral disinhibition/risk compensation was assessed based on a number of questions, including the following related to related to number of male sexual partners from the participant ACASI: "Since the last time you took this survey, how many male partners have you had sexual contact with (oral or anal)?" This represents one of the indicators associated with the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM.
This represents one of the indicators associated with the objective: Acceptability when YMSM are provided open label FTC/TDF (Truvada®) and information regarding the safety and efficacy of PrEP from prior studies. Acceptability of PrEP as measured by the acceptability assessment that includes questions on usability of PrEP, user-friendliness of the medication regimen, including an assessment of side effects and delivery format, and acceptability of behavioral intervention sessions.
This outcome addresses the objective: Rates of adherence and measured levels of drug exposure when YMSM are provided open label FTC/TDF (Truvada®) and information regarding the safety and efficacy of PrEP from prior studies. Medication adherence is estimated by factors including levels of drug exposure as measured by DBS red blood cell (RBC) samples. The TFV dosing level was translated into number of dosing days per week for week 8 onwards using lab estimates as follows: '\<2 days' is defined as \<350 (fmol/punch), '2 days' as 350 to 700 (fmol/punch), '4 days' as \>700 to 1250 (fmol/punch), and 'Daily' as \>1250 (fmol/punch). The TFV dosing level was translated into number of dosing days for week 4 using lab estimates as follows: '\<2 days' is defined as \<275 (fmol/punch), '2 days' as 275 to 525 (fmol/punch), '4 days' as \>525 to 950 (fmol/punch),and 'Daily' as \>950 (fmol/punch)
| Arm | Type | Description |
|---|---|---|
| Arm A: ATV/RTV + FTC/TDF | EXPERIMENTAL | Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily. |
| Arm B: RAL + FTC/TDF | EXPERIMENTAL | FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily. |
| Arm C: DRV/RTV + FTC/TDF | EXPERIMENTAL | FTC/TDF, darunavir (DRV), and RTV, orally, once daily. |
| PCC Behavioral Intervention Group | EXPERIMENTAL | PCC Behavioral Intervention combined with open label FTC/TDF (Truvada®) as PrEP |
| Name | Type | Description |
|---|---|---|
| Emtricitabine/tenofovir disoproxil fumarate | DRUG | 200 mg emtricitabine/300 mg tenofovir disoproxil fumarate taken orally daily. A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs). |
| Raltegravir | DRUG | 400 mg taken orally twice daily. An integrase inhibitor (INI). |
| Darunavir | DRUG | 800 mg taken orally once daily. A protease inhibitor (PI). |
| Ritonavir | DRUG | 100 mg taken orally once daily. A protease inhibitor (PI). |
| Atazanavir | DRUG | 300 mg taken orally once daily. A protease inhibitor (PI). |
| PCC | BEHAVIORAL | Personalized Cognitive Counseling (PCC) is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. PCC is a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. Counselors ask the client to recall and describe a recent encounter of unprotected anal sex with another man of unknown or sero-discordant HIV status. The client then identifies and expresses thoughts, feelings, or attitudes that might have led to the high-risk behavior. The client and counselor examine and identify thoughts that may have led the client to decide to engage in high transmission risk sex. The client and counselor agree on strategies that can be used to deal with similar situations in the future. |
| Emtricitabine/tenofovir (FTC/TDF (Truvada®)) | DRUG | All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks. |
Inclusion Criteria: * HIV-1 infected * No evidence of any exclusionary mutations defined as any major NRTI or PI resistance-associated mutation on any genotype or evidence of significant NRTI or PI resistance on any phenotype performed at any time prior to study entry. NNRTI-associated resistance m...
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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.