Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Boosted Protease Inhibitor (bPI)
Boosted Protease Inhibitor · 1 trial · 1 indication
Virologic rebound was defined as: confirmed plasma human immunodeficiency virus - 1 (HIV-1) Ribonucleic Acid (RNA) level greater than or equal to (\>=)50 copies per milliliter (copies/mL) up to, and including the upper bound of the Week 48 window (ie, 54 weeks) and last available on-treatment (single) HIV-1 RNA \>=50 copies/mL at premature discontinuation (irrespective of reason). Percentage of participants with virologic rebound were reported.
| Arm | Type | Description |
|---|---|---|
| Experimental Treatment Regimen | EXPERIMENTAL | Participants will receive a single fixed dose combination (FDC) tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF tablet), orally once daily, up to Week 48. After Week 48, all participants will continue to receive the D/C/F/TAF tablet in a 48 week extension phase (up to Week 96). |
| Current Treatment Regimen | ACTIVE_COMPARATOR | Participants will receive a boosted protease inhibitor (bPI) (limited to darunavir \[DRV\] or atazanavir with low-dose ritonavir \[rtv\] or cobicistat \[COBI\], or lopinavir with rtv) combined with emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) up to Week 52. After Week 52, all participants will receive the D/C/F/TAF tablet in a 44 week extension phase (up to Week 96). |
| Name | Type | Description |
|---|---|---|
| D/C/F/TAF | DRUG | Once-daily single-tablet regimen containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg. |
| Boosted Protease Inhibitor (bPI) | DRUG | Boosted protease inhibitor (limited to darunavir \[DRV\] or atazanavir with low-dose ritonavir \[rtv\] or cobicistat \[COBI\], or lopinavir with rtv) as per current treatment regimen. |
| FTC/TDF | DRUG | Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF). |
Inclusion Criteria: * Currently being treated with a stable antiretroviral (ARV) regimen consisting of a boosted protease inhibitor (limited to darunavir \[DRV\] or atazanavir with low-dose ritonavir \[rtv\] or cobicistat \[COBI\], or lopinavir with rtv) combined with emtricitabine/tenofovir disopr...
Boosted Protease Inhibitor, also known as bPI, is an antiretroviral treatment approach used in Human Immunodeficiency Virus Type 1 (HIV-1) infection. It combines a protease inhibitor with a boosting agent to enhance the drug's effectiveness. It is being developed by Johnson & Johnson (ticker: JNJ) and is currently in Phase 3 clinical development.
Boosted Protease Inhibitor is used for the treatment of Human Immunodeficiency Virus Type 1 (HIV-1) infection. It is specifically studied in virologically suppressed HIV-1 infected participants, as part of combination antiretroviral therapy. The goal is to maintain viral suppression in patients who are already virologically controlled.
Boosted Protease Inhibitor is being developed by Johnson & Johnson, which trades under the ticker symbol JNJ. Johnson & Johnson is a multinational pharmaceutical and healthcare company. The development program is focused on HIV-1 treatment.
Boosted Protease Inhibitor is in Phase 3 clinical development. The only listed trial for this drug is a completed Phase 3 study. It is an investigational treatment and has not been approved by the FDA for any indication.
Boosted Protease Inhibitor has been evaluated in one completed Phase 3 clinical trial, NCT02269917. This trial enrolled 1,149 participants and compared a darunavir/cobicistat/emtricitabine/tenofovir alafenamide regimen versus a boosted protease inhibitor along with emtricitabine/tenofovir disoproxil fumarate in virologically suppressed, HIV-1 infected participants. The study was active-controlled and conducted across multiple countries.
Yes, Boosted Protease Inhibitor is also known as bPI. The abbreviation bPI stands for Boosted Protease Inhibitor. Both terms refer to the same antiretroviral treatment approach being developed by Johnson & Johnson for HIV-1 infection.