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Label indication STRIBILD ® is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older weighing at least 35 kg who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable antiretroviral regimen for at least 6 months with no history of… FDA label
Also known as Cobicistat TOS, GS-9350, Tybost®
Cobicistat · 1 trial · 2 indications
AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval). AUCtau for ATV (Cohorts 1 Part A, 2, 3, and 4 \[Groups 2 to 4\]); DRV (Cohorts 1 Part A, 2, and 3); TAF (Cohorts 2, 3, 4 \[Groups 1 to 4\] and 5 \[Groups 1 to 3\] taking F/TAF); and TFV (Cohorts 2, 3, 4 \[Groups 1 to 4\] and 5 \[Groups 1 to 3\] taking F/TAF) will be reported.
| Arm | Type | Description |
|---|---|---|
| Cohort 1: Part A and Part B | EXPERIMENTAL | Participants ages 12 to \<18 years old will receive cobicistat 150 mg with either ATV or DRV plus background regimen (BR). The BR may contain additional antiretroviral agents except for the following disallowed agents: saquinavir, indinavir, nelfinavir, double protease inhibitor (PI) regimens, raltegravir, elvitegravir, efavirenz, nevirapine, delavirdine, maraviroc, etravirine, rilpivirine, dolutegravir, and investigational antiretroviral agents. |
| Cohort 2 | EXPERIMENTAL | Participants aged 6 to \<12 years old and ≥25 to \<40kg will receive cobicistat 150 mg and F/TAF 200/25 mg with either ATV or DRV. |
| Cohort 3 | EXPERIMENTAL | Participants age ≥ 2 years old will receive cobicistat 90 mg and F/TAF 120/15 mg with either ATV or DRV. |
| Cohort 4 (Group 1) | EXPERIMENTAL | Participants age ≥ 4 weeks old weighing 14 to \< 25 kg will receive cobicistat tablet for oral suspension (TOS) 90 mg, once daily and F/TAF TOS 120/15 mg, once daily with either ATV or DRV or lopinavir boosted by ritonavir (LPV/r). Minimum age and weight for ATV is ≥ 3 months and ≥ 5 kg, minimum age and weight for DRV is ≥ 3 years and ≥ 15 kg; participants receiving LPV/r will not receive cobicistat TOS. |
| Cohort 4 (Group 2) | EXPERIMENTAL | Participants age ≥ 4 weeks old weighing 10 to \< 14 kg will receive cobicistat TOS 30 mg (twice daily) and F/TAF TOS 60/7.5 mg, once daily with either ATV or LPV/r. Minimum age and weight for ATV is ≥ 3 months and ≥ 5 kg, respectively; participants receiving LPV/r will not receive cobicistat TOS. |
| Cohort 4 (Group 3) | EXPERIMENTAL | Participants age ≥ 4 weeks old weighing 6 to \< 10 kg will receive cobicistat TOS 30 mg (twice daily) and F/TAF TOS 30/3.75 mg, once daily with either ATV or LPV/r. Minimum age and weight for ATV is ≥ 3 months and ≥ 5 kg, respectively; participants receiving LPV/r will not receive cobicistat TOS. |
| Cohort 4 (Group 4) | EXPERIMENTAL | Participants age ≥ 4 weeks old weighing 3 to \< 6 kg will receive cobicistat TOS 30 mg (twice daily) and F/TAF TOS 15/1.88 mg, once daily with either ATV or LPV/r. Minimum age and weight for ATV is ≥ 3 months and ≥ 5 kg, respectively; participants receiving LPV/r will not receive cobicistat TOS. |
| Cohort 5 (Group 1) | EXPERIMENTAL | Participants ages ≥ 4 weeks old weighing ≥ 10 to \< 14 kg will receive F/TAF TOS 60/7.5 mg, once daily with the third unboosted drug. |
| Cohort 5 (Group 2) | EXPERIMENTAL | Participants ages ≥ 4 weeks old weighing ≥ 6 to \< 10 kg will receive F/TAF TOS 30/3.75 mg, once daily with the third unboosted drug. |
| Cohort 5 (Group 3) | EXPERIMENTAL | Participants ages ≥ 4 weeks old weighing ≥ 3 to \< 6 kg will receive F/TAF TOS 15/1.88 mg, once daily with the third unboosted drug. |
| Name | Type | Description |
|---|---|---|
| ATV | DRUG | Capsules administered once daily according to dosing recommendations per product monograph |
| DRV | DRUG | Tablets administered once daily according to dosing recommendations per product monograph |
| Cobicistat | DRUG | Tablets administered orally once daily with food |
| BR | DRUG | Background Regimen (BR) include Food and Drug Administration (FDA)-approved nucleos(t)ide reverse transcriptase inhibitors (NRTIs) including zidovudine (ZDV), stavudine (d4T), didanosine (ddI), abacavir (ABC), tenofovir disoproxil fumarate (TDF), tenofovir alafenamide (TAF), lamivudine (3TC), and emtricitabine (FTC). |
| F/TAF | DRUG | Tablets administered orally once daily |
| LPV/r | DRUG | Solution administered orally |
| Third Unboosted Drug | DRUG | ATV (administered orally), DRV (administered orally), and LPV/r (administered orally) would be general list but unspecified for sites. |
| Cobicistat TOS | DRUG | Tablets for oral suspension |
| F/TAF TOS | DRUG | Tablets for oral suspension |
Key Inclusion Criteria: * HIV-1 infected, virologically suppressed males and females age ≥ 4 weeks to \< 18 years (according to requirements of enrolling Cohort). * Body weight at screening ≥ 25 to \< 40 kg (Cohort 2); ≥ 14 to \< 25 kg (Cohort 3); ≥ 3 to \< 25 kg (Cohort 4); ≥ 3 to \< 14 kg (Cohort...
Cobicistat is used as a pharmacokinetic booster in HIV and AIDS treatment regimens. It has no antiviral activity of its own and is given with other antiretroviral agents to raise their blood levels. In this program it is being studied in children with HIV as part of cobicistat-boosted atazanavir and cobicistat-boosted darunavir combinations.
Cobicistat targets the cytochrome P450 3A enzymes, specifically CYP3A4, CYP3A5, CYP3A43, and CYP3A7. It acts as an inhibitor of these enzymes. By blocking CYP3A-mediated metabolism, cobicistat increases the exposure of co-administered antiretroviral drugs such as atazanavir and darunavir.
Cobicistat is developed by Gilead Sciences, Inc., which trades on the Nasdaq under the ticker GILD. Gilead is the sponsor of the clinical program evaluating cobicistat-boosted regimens in children with HIV.
Cobicistat is in Phase 2 clinical development for pediatric HIV and AIDS. It is investigational and is not approved for the pediatric use being studied in this program. The Phase 2 trial is active and not recruiting, with no completed trials in this development stage.
Cobicistat is being studied in NCT02016924, a Phase 2 trial titled Study of Cobicistat-Boosted Atazanavir (ATV/co), Cobicistat-Boosted Darunavir (DRV/co) and Emtricitabine/Tenofovir Alafenamide (F/TAF) in Children With HIV. The trial is active and not recruiting, has enrolled 133 participants, and is controlled without randomization or double blinding.
Yes, Cobicistat TOS is an alternative name for cobicistat. Both names refer to the same small-molecule CYP3A inhibitor developed by Gilead Sciences for use as a pharmacokinetic booster in HIV and AIDS treatment regimens.