Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Emtricitabine, Emtricitabine (FTC)
Emtricitabine/tenofovir disoproxil · 10 trials · 8 indications
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.
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.
Acceptability will be assessed by discontinuation of study product
The participants will be considered in therapeutic success at Week 48 if they did not present any of the following events: * Plasma HIV-2 RNA load over or equal to 100 copies/mL, starting from Week 24 and confirmed within the next 4 weeks, * CD4 lymphocytes gain below 100/mm3 at Week 48 compared to the CD4 lymphocytes counts average between Week-4 and Week 0, * Raltegravir permanent discontinuation, * Death from any cause, * New B or C events confirmed by an endpoint review committee
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)
This endpoint has been included to satisfy the requirements of ClinicalTrials.gov. However, there were no prespecified endpoints in this study.
| Arm | Type | Description |
|---|---|---|
| Arm A | ACTIVE_COMPARATOR | emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line) |
| Arm B | ACTIVE_COMPARATOR | abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line) |
| Arm C | ACTIVE_COMPARATOR | emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation) |
| 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. |
| 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. |
| F/TAF | ACTIVE_COMPARATOR | daily oral tablet |
| F/TDF | ACTIVE_COMPARATOR | daily oral tablet |
| raltegravir / emtricitabine / tenofovir disoproxil fumarate | EXPERIMENTAL | - |
| PCC Behavioral Intervention Group | EXPERIMENTAL | PCC Behavioral Intervention combined with open label FTC/TDF (Truvada®) as PrEP |
| 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/tenofovir + lopinavir/ritonavir (WHO recommended second line) | DRUG | Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets in the morning and 2 tablets in the evening |
| abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line) | DRUG | Didanosine 1 entero-coated capsule/day in fasting conditions (dosage 250 mg if weight \< 60 kg, 400 mg if weight \> 60 kg) + abacavir 300 mg 1 tablet in the morning and in the evening + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets morning and evening |
| emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation) | DRUG | Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + darunavir 400 mg 2 tablets + ritonavir 100 mg 1 capsule, in a single dose with food |
| 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). |
| zidovudine and lamivudine (Combivir®) | DRUG | - |
| emtricitabine and tenofovir DF | DRUG | - |
| 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/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 |
| emtricitabine / tenofovir disoproxil fumarate / raltegravir . | DRUG | emtricitabine : 200 mg/day and tenofovir disoproxil fumarate : 300 mg/day, included in one pill of Truvada® QD. raltegravir : 400 mg x 2/day, 400 mg in one pill of Isentress® BID. |
| 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. |
| Emtricitabine | DRUG | Emtricitabine 200 mg OD + Zidovudine 300 mg BID + EFV OD compared to TDF + FTC + EFV |
Inclusion Criteria: * Patient over the age of 18 years at pre-inclusion and monitored under outpatient conditions * Documented HIV-1 infection regardless of clinical stage and CD4 lymphocyte count * Patient with treatment failure after first-line antiretroviral treatment with a combination includin...
Emtricitabine/tenofovir disoproxil is a fixed-dose combination of two small molecule antiretroviral drugs developed by Gilead Sciences, Inc. (GILD). It is studied for HIV, including HIV-1 and HIV-2 infection, and for hepatitis B virus, and has also been evaluated for acceptability of pre-exposure prophylaxis in healthy volunteers.
Emtricitabine/tenofovir disoproxil is used for the treatment and prevention of HIV infection, including HIV-1 and HIV-2, and for hepatitis B virus. Clinical trials have studied it as first-line and second-line antiretroviral therapy and as pre-exposure prophylaxis in adolescents and young men.
Emtricitabine/tenofovir disoproxil is developed by Gilead Sciences, Inc., which trades on Nasdaq under the ticker GILD. Gilead is the sponsor associated with the drug's clinical development program.
Emtricitabine/tenofovir disoproxil is in Phase 2 development. It is an investigational combination that has been tested across Phase 2 and Phase 3 clinical trials, and it is not described as FDA approved in the available development information.
Emtricitabine/tenofovir disoproxil has been studied in trials including NCT05458765, an oral PrEP acceptability study in South Africa and Zimbabwe; NCT01769456, a Phase 2 safety study in young men who have sex with men in the United States; NCT01605890, a first-line combination therapy trial in HIV-2 patients in France; and NCT00928187, a Phase 3 second-line treatment study in Africa.