Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
COBI · 3 trials · 4 indications
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the prespecified time point within an allowed window of time, along with study drug discontinuation status.
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 24 was analyzed using the missing = failure method, where participants with missing data were considered to have failed to achieve the endpoint.
| Arm | Type | Description |
|---|---|---|
| COBI-boosted DRV | EXPERIMENTAL | Participants will receive DRV+COBI+2 investigator-selected NRTIs for 48 weeks, and may continue their regimen in the open-label rollover phase. |
| ATV+COBI+FTC/TDF | EXPERIMENTAL | COBI + RTV placebo + ATV + FTC/TDF once daily |
| ATV+RTV+FTC/TDF | ACTIVE_COMPARATOR | RTV + COBI placebo + ATV + FTC/TDF once daily |
| Name | Type | Description |
|---|---|---|
| COBI | DRUG | 150 mg tablet administered orally with food once daily |
| DRV | DRUG | 800 mg (2 x 400 mg tablets) administered orally with food once daily |
| NRTIs | DRUG | Participants will receive 2 nucleoside analogue reverse transcriptase inhibitors (NRTIs) selected by the investigator after resistance testing at screening and administered according to prescribing information. NRTIs may include emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF), zidovudine+FTC/TDF, abacavir (ABC)+TDF, ABC+FTC/TDF, ABC+lamivudine (3TC), or didanosine (DDI)+FTC. |
| RTV | DRUG | Ritonavir (RTV) 100 mg tablet administered orally once daily |
| ATV | DRUG | Atazanavir (ATV) 300 mg capsule administered orally once daily |
| FTC/TDF | DRUG | Emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg fixed-dose combination tablet administered orally once daily |
| COBI placebo | DRUG | Placebo to match COBI administered orally once daily |
| RTV placebo | DRUG | Placebo to match RTV administered orally once daily |
Inclusion Criteria: * Adult ≥ 18 years males or non-pregnant females * Ability to understand and sign a written informed consent form * General medical condition that does not interfere with the assessments and the completion of the trial * Treatment Naive: No prior use of any approved or investiga...
COBI is a small molecule being developed by Gilead Sciences for the treatment of HIV-1 infection, acquired immunodeficiency syndrome, and HIV. It is used as a pharmacokinetic booster in combination with other antiretroviral agents, such as atazanavir or darunavir, to enhance their effectiveness in HIV-1 infected, antiretroviral treatment-naive adults.
COBI is a pharmacoenhancer that targets the cytochrome P450 3A enzyme pathway, specifically inhibiting CYP3A enzymes to boost the systemic exposure of co-administered antiretroviral drugs. This mechanism allows for lower doses of the boosted protease inhibitor while maintaining therapeutic efficacy in treating HIV-1 infection.
COBI is developed by Gilead Sciences, Inc., a biopharmaceutical company publicly traded under the ticker symbol GILD. Gilead is responsible for the clinical development and regulatory strategy for COBI as part of its HIV treatment portfolio.
COBI has completed Phase 3 clinical trials for HIV-1 infection. The drug is investigational and has been studied in completed Phase 3 trials, including NCT01108510 and NCT01440569, which evaluated its safety and efficacy as a booster for atazanavir and darunavir, respectively. It is not yet approved.
COBI has been studied in completed clinical trials, including NCT00892437, a Phase 2 trial with 85 participants, and two Phase 3 trials: NCT01108510 with 698 participants and NCT01440569 with 314 participants. These trials evaluated COBI-boosted atazanavir or darunavir in HIV-1 infected adults.
Yes, COBI is the same as cobicistat. The drug is commonly referred to by its brand name COBI and its generic name cobicistat. In clinical trials, it is often described as cobicistat-boosted therapy, indicating its role as a pharmacokinetic enhancer for HIV protease inhibitors.