Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication TYBOST is a CYP3A inhibitor indicated to increase systemic exposure of atazanavir or darunavir (once daily dosing regimen) in combination with other antiretroviral agents in the treatment of HIV-1 infection in adults and in pediatric patients weighing at least 14 kg. FDA label
Also known as Tybost®, GS-9350
COBI · 6 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 predefined time point within an allowed window of time, along with study drug discontinuation status.
Change from baseline in eGFR-CG equation at Week 24 was analyzed in Cohort 1 (treatment-naive).
Change from baseline in eGFR-CG equation at Week 24 was analyzed in Cohort 2 (treatment-experienced).
Change from baseline in eGFR-MDRD equation at Week 24 was analyzed in Cohort 1 (treatment-naive). The calculation was normalized to 1.73 m\^2 body surface area.
Change from baseline in eGFR-MDRD equation at Week 24 was analyzed in Cohort 2 (treatment-experienced). The calculation was normalized to 1.73 m\^2 body surface area.
Change from baseline in eGFR-CKD-EPI based on cystatin C equation (not adjusted for age, sex, and race) at Week 24 was analyzed in Cohort 1 (treatment-naive). The calculation was normalized to 1.73 m\^2 body surface area.
Change from baseline in eGFR-CKD-EPI based on cystatin C equation (not adjusted for age, sex, and race) at Week 24 was analyzed in Cohort 2 (treatment-experienced). The calculation was normalized to 1.73 m\^2 body surface area.
Change from baseline in eGFR-CKD-EPI based on cystatin C equation (adjusted for age, sex, and race) at Week 24 was analyzed in Cohort 1 (treatment-naive). The calculation was normalized to 1.73 m\^2 body surface area.
Change from baseline in eGFR-CKD-EPI based on cystatin C equation (adjusted for age, sex, and race) at Week 24 was analyzed in Cohort 2 (treatment-experienced). The calculation was normalized to 1.73 m\^2 body surface area.
Change from baseline in aGFR at Weeks 2, 4, and 24 was analyzed in Cohort 1 (treatment-naive). aGFR was calculated using iohexol plasma clearance.
Change from baseline in aGFR at Weeks 2, 4, and 24 was analyzed in Cohort 2 (treatment-experienced). aGFR was calculated using iohexol plasma clearance.
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 24 was analyzed in Cohort 1 (treatment-naive) using the FDA snapshot analysis algorithm.
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 24 was analyzed in Cohort 2 (treatment-experienced) using the FDA snapshot analysis algorithm.
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 snapshot algorithm was used which defines a patient'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.
| Arm | Type | Description |
|---|---|---|
| B/F/TAF | EXPERIMENTAL | Randomized Phase: Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) for at least 48 weeks, without regard to food. Extension Phase: After Week 48, participants in countries where B/F/TAF is not available will be given the option to receive B/F/TAF for up to 96 additional weeks or until the product becomes accessible to participants through an access program, or until Gilead Sciences elects to discontinue the study in that country, whichever occurs first. |
| Stay on Baseline Regimen (SBR) | EXPERIMENTAL | Randomized Phase: Participants remained on current antiretroviral (ARV) regimen consisting of ritonavir (RTV)-boosted or cobicistat (COBI)-boosted atazanavir (ATV) or darunavir (DRV), plus either emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) or abacavir/lamivudine (ABC/3TC) for at least 48 weeks with food. Extension Phase: After Week 48, participants in countries where B/F/TAF is not available will be given the option to receive B/F/TAF for up to 96 additional weeks or until the product becomes accessible to participants through an access program, or until Gilead Sciences elects to discontinue the study in that country, whichever occurs first. |
| 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. |
| E/C/F/TDF (Cohort 1) | EXPERIMENTAL | Participants who have not received prior antiretroviral (ARV) treatment and who are virologically unsuppressed at baseline will initiate treatment with elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF) single-tablet regimen (STR) for up to 96 weeks. Following Week 96, participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country. |
| COBI+PI+2 NRTI (Cohort 2) | EXPERIMENTAL | Participants who have received prior ARV treatment and who are virologically suppressed at baseline will continue their treatment regimen, switching the regimen's pharmacoenhancer component from ritonavir to cobicistat (COBI), and continuing their existing protease inhibitor (PI; either atazanavir (ATV) or darunavir (DRV)) plus 2 nucleoside reverse transcriptase inhibitor (NRTI) regimen for up to 96 weeks. Following Week 96, participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country. |
| 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 |
| D/C/F/TAF | EXPERIMENTAL | D/C/F/TAF FDC tablet plus DRV placebo plus COBI placebo plus FTC/TDF placebo |
| DRV+COBI+FTC/TDF | ACTIVE_COMPARATOR | DRV tablet plus COBI tablet plus FTC/TDF 200/300 mg FDC tablet plus D/C/F/TAF placebo |
| Name | Type | Description |
|---|---|---|
| RTV | DRUG | 100 mg capsule coadministered orally with ATV or DRV once daily with food |
| ATV | DRUG | 300 mg capsule administered orally once daily with food |
| DRV | DRUG | 800 mg tablet administered orally once daily with food |
| COBI | DRUG | 150 mg tablet coadministered orally with ATV or DRV once daily with food |
| ATV/co | DRUG | 300/150 mg FDC tablet administered orally once daily with food |
| DRV/co | DRUG | 800/150 mg FDC tablet administered orally once daily with food |
| FTC/TDF | DRUG | 200/300 mg FDC tablet administered orally once daily without regard to food |
| ABC/3TC | DRUG | 600/300 mg tablet administered orally once daily with or without regard to food |
| B/F/TAF | DRUG | 50/200/25 mg FDC tablet administered orally once daily without regard to food |
| 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. |
| E/C/F/TDF | DRUG | E/C/F/TDF (150/150/200/300 mg) STR administered orally once daily |
| NRTI | DRUG | Participants will receive 2 investigator-selected NRTIs, which may include abacavir (ABC), lamivudine (3TC)/zidovudine (ZDV), didanosine (DDI), emtricitabine (FTC), ABC/3TC, 3TC, tenofovir disoproxil fumarate (TDF), or FTC/TDF, administered according to prescribing information. |
| COBI placebo | DRUG | Placebo to match COBI administered orally once daily |
| RTV placebo | DRUG | Placebo to match RTV administered orally once daily |
| D/C/F/TAF | DRUG | DRV 800 mg/COBI 150 mg/FTC 200 mg/TAF 10 mg FDC tablet administered orally once daily |
| D/C/F/TAF Placebo | DRUG | D/C/F/TAF placebo tablet administered orally once daily |
| DRV Placebo | DRUG | DRV placebo tablet administered orally once daily |
| FTC/TDF Placebo | DRUG | FTC/TDF placebo tablet administered orally once daily |
Key Inclusion Criteria: * Currently receiving a once daily antiretroviral regimen consisting of ritonavir or cobicistat boosted ATV or DRV plus either FTC/TDF or ABC/3TC for ≥ 6 months preceding the screening visit * Adequate renal function: * Estimated glomerular filtration rate ≥ 50 mL/min (≥ ...
COBI is used in the treatment of HIV, HIV-1 infection, and acquired immunodeficiency syndrome (AIDS). It is a small molecule antiretroviral developed by Gilead Sciences, Inc. as part of combination regimens for adults living with HIV.
COBI is developed by Gilead Sciences, Inc., which trades on Nasdaq under the ticker GILD. Gilead is the sponsor behind the clinical development program for COBI in HIV and AIDS.
COBI is in Phase 3 clinical development. Its trial program includes Phase 3 studies in HIV-1 infected adults, including virologically suppressed patients and those with mild to moderate renal impairment, along with a Phase 2 study in treatment-naive adults.
COBI has been studied in completed trials including NCT02603107, a Phase 3 study of switching to bictegravir/emtricitabine/tenofovir alafenamide in virologically suppressed HIV-1 infected adults, NCT01440569, a Phase 3 study of cobicistat-boosted darunavir, NCT01363011, a Phase 3 study in patients with mild to moderate renal impairment, and NCT01565850, a Phase 2 study in treatment-naive adults.
Yes, COBI is the short name for cobicistat. It is a small molecule antiretroviral developed by Gilead Sciences, Inc. for use in HIV and AIDS treatment regimens.