Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
DRV/COBI · 4 trials · 3 indications
Percentage of participants with a HIV-1 RNA \< 50 copies per mL were assessed using FDA snapshot approach which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. The snapshot approach classified participants into 3 outcome categories: 1) virologic success (HIV RNA \< 20/50/200 copies per mL at Week 48), 2) virologic failure (HIV RNA greater than or equal to \[\>=\] 20/50/200 copies per mL at Week 48), 3) no viral load data in the Week 48 visit window (discontinued due to adverse event/death/other reason). The missing HIV-1 RNA is considered as non-response.
The percentage of participants that is able to swallow the medication fully versus partially or not at all, based on the questionnaire for the observer will be reported.
Cmax is defined as the maximum observed plasma concentration of DRV.
AUC (0-last) is the area under the DRV concentration-time curve from time zero to the time of the last measurable (non-below quantification limit \[non-BQL\]) concentration, calculated by linear-linear trapezoidal summation.
AUC (0-infinity) is the area under the DRV concentration-time curve from time zero to infinite time, calculated as the sum of AUC (0-last) and C(last)/lambda(z).
Cmax is the maximum observed analyte concentration.
AUC(0-last) is the Area under the curve (AUC) from time 0 to the time of last measurable (non-below quantification limit) concentration, calculated by linear-linear trapezoidal summation.
AUC(0-infinity) is defined as area under the plasma concentration-time curve from time zero to infinite time.
| Arm | Type | Description |
|---|---|---|
| Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide | EXPERIMENTAL | Subject will receive a single oral tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF fixed dose combination \[FDC\]) once daily along with DRV/COBI FDC-matching and FTC/TDF FDC-matching placebo tablets once daily up to Week 48 analysis unblinding visit (i.e. after last subject has reached Week 48). After Week 48 analysis unblinding visit, subjects will receive a single tablet containing D/C/F/TAF FDC once daily up to Week 96. |
| DRV/COBI fixed dose combination (FDC) and FTC/TDF FDC | ACTIVE_COMPARATOR | Subject will receive DRV 800 mg/COBI 150 mg FDC and FTC 200 mg/TDF 300 mg FDC along with D/C/F/TAF FDC-matching placebo tablet once daily up to Week 48 analysis unblinding (i.e. after last subject has reached Week 48). After Week 48 analysis unblinding, subjects will receive a single tablet containing D/C/F/TAF FDC once daily up to Week 96. |
| Darunavir/Cobicistat (DRV/COBI) Fixed Dose Combination (FDC) | EXPERIMENTAL | Participants will receive the DRV/COBI FDC tablet for oral use, dispersed in water on Day 1. |
| Treatment Sequence AB | EXPERIMENTAL | Participants will receive a single oral dose of darunavir (DRV) and cobicistat (COBI) as one fixed dose combination (FDC) tablet dispersed in water (Treatment A \[test\]) in Treatment Period 1, followed by a single dose DRV suspension and COBI tablet (Treatment B \[Reference\]) in Treatment Period 2 on Day 1 of each Treatment Period under fed conditions. There will be a washout period of at least 7 days from dosing on Day 1 of each Treatment Period. |
| Treatment Sequence BA | EXPERIMENTAL | Participants will receive Treatment B in Treatment Period 1, followed by Treatment A in Treatment Period 2 on Day 1 of each Treatment Period under fed conditions. There will be a washout period of at least 7 days from dosing on Day 1 of each Treatment Period |
| Panel 1: Dabigatran etexilate +DRV/COBI | EXPERIMENTAL | Participants will receive Treatment A (single dose of Dabigatran etexilate orally) on Day 1 followed by Treatment B (single dose of Darunavir/ cobicistat \[DRV/COBI\] as fixed dose combination tablet orally and single dose of dabigatran etexilate) on Day 4 followed by Treatment C (\[DRV/COBI\] as fixed dose combination tablet orally once daily from Day 5 to Day 20 and single dose of dabigatran etexilate on Day 18). |
| Panel 2: Dabigatran etexilate +DRV+rtv | EXPERIMENTAL | Participants will receive Treatment D (single dose of dabigatran etexilate orally) on Day 1 followed by Treatment E (single doses of Darunavir, and ritonavir \[rtv\], and single dose of dabigatran etexilate on Day 4), followed by Treatment F (DRV and rtv orally once daily from Day 5 to Day 20 and single dose of dabigatran etexilate on Day 18). |
| Name | Type | Description |
|---|---|---|
| Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide FDC | DRUG | A tablet containing DRV 800 mg, COBI 150 mg, FTC 200 mg and TAF) 10 mg will be administered once daily. |
| DRV/COBI FDC | DRUG | A tablet containing DRV 800 mg and COBI 150 mg will be administered once daily. |
| FTC/TDF FDC | DRUG | A tablet containing FTC 200 mg and TDF 300 mg will be administered once daily. |
| D/C/F/TAF FDC - Matching Placebo | DRUG | Matching placebo of D/C/F/TAF FDC will be administered once daily. |
| FTC/TDF FDC Matching Placebo | DRUG | Matching placebo of FTC/TDF FDC will be administered once daily. |
| DRV/COBI FDC Matching Placebo | DRUG | Matching placebo of DRV/COBI FDC will be administered once daily. |
| COBI | DRUG | Participants will receive a single oral dose of COBI tablet as per assigned treatment sequence. |
| DRV | DRUG | Participants will receive single oral dose of DRV suspension as per the assigned treatment sequence. |
| Dabigatran Etexilate | DRUG | Participants will receive single dose of dabigatran etexilate orally. |
| DRV/COBI | DRUG | Participants will receive oral tablet of fixed dose combination (FDC) containing darunavir (DRV)/ cobicistat (COBI). |
| Ritonavir | DRUG | Participants will receive ritonavir orally. |
| Darunavir | DRUG | Participants will receive Darunavir orally. |
Inclusion Criteria: * Subject must be antiretroviral (ARV) treatment-naive (never treated with an ARV including post-exposure prophylaxis and pre-exposure prophylaxis); no prior use of any approved or experimental anti- human immunodeficiency virus (anti-HIV) drug for any length of time * Screening...
DRV/COBI is a fixed-dose combination of darunavir and cobicistat being studied for the treatment of Human Immunodeficiency Virus Type 1 (HIV-1) infection. It is also being evaluated in healthy participants for drug interaction studies and in HIV-1 infected children. The drug is currently in clinical development and is not approved.
DRV/COBI is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker symbol JNJ. The company is conducting clinical trials to evaluate the safety and efficacy of this fixed-dose combination in various patient populations.
DRV/COBI is in Phase 1 clinical development. While one completed trial was a Phase 3 study, the most recent trials listed are Phase 1 studies. The drug remains investigational and has not received regulatory approval for any indication.
DRV/COBI has been studied in several completed trials. NCT02431247 was a Phase 3 study in 725 treatment-naive HIV-1 infected adults. NCT04208061 and NCT05378906 were Phase 1 drug interaction studies in healthy participants. NCT05197075 was a Phase 1 acceptability study in HIV-1 infected children.
Yes, DRV/COBI is the same as darunavir/cobicistat. The drug is a fixed-dose combination of these two antiretroviral agents. It is being studied alone or as part of a four-drug regimen with emtricitabine and tenofovir alafenamide for HIV-1 treatment.