Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Sustiva, BMS-561525
efavirenz containing antiretroviral regimen · 1 trial · 2 indications
Cmax was obtained directly from the concentration-time data.
Cmin was obtained directly from the concentration-time data.
The AUC(TAU), from time 0 to the time of the last measurable concentration (t), was calculated by the linear trapezoidal rule.
Tmax was obtained directly from the concentration-time data.
| Arm | Type | Description |
|---|---|---|
| EFV600mg Participants With Mild Hepatic Impairment | EXPERIMENTAL | - |
| EFV600mg Participants With Moderate Hepatic Impairment | EXPERIMENTAL | - |
| EFV600mg Participants With Severe Hepatic Impairment | EXPERIMENTAL | - |
| EFV600mg Participants With Normal Hepatic Function | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| efavirenz containing antiretroviral regimen | DRUG | Capsule or Tablet, Oral, once daily for 2 days |
Inclusion Criteria: * HIV-1 infection with or without Hepatitis B or C infection * Stable antiretroviral regimen containing efavirenz and nucleoside/nucleotide reverse transcriptase inhibitors (NRTI) for at least 1 month * Mild, moderate or severe hepatic impairment with hepatic cirrhosis Exclusio...
Top 19 of 30 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Pfizer Inc. | PFE | 7 | PHASE3 | VLA15, Prevenar 20, 13vPnC, ATM-AVI, PG4 |
| Sanofi SA Sponsored ADR | SNY | 1 | PHASE3 | PCV21 |
| GSK plc Sponsored ADR | GSK | 4 | PHASE2 | Penmenvy, iNTS-TCV, Strep A vaccine, Pan-Salmonella vaccine |
| Grifols, S.A. Sponsored ADR Class B | GRFS | 1 | PHASE3 | Xembify |
| CorMedix Inc. | CRMD | 1 | PHASE3 | DefenCath |
| Sinovac Biotech Ltd. | SVA | 4 | PHASE3 | Sinovac PCV24, Group ACYW135X Meningococcal Conjugate Vaccine, Group ACYW135 Meningococcal Conjugate Vaccine |
| Novartis AG Sponsored ADR | NVS | 2 | PHASE2 | EDI048 |
| Innoviva, Inc. | INVA | 3 | PHASE2 | Eravacycline, Sulbactam-durlobactam |
| BiomX Inc. | PHGE | 1 | PHASE2 | BX004 |
| Hoffmann-La Roche | RHHBY | 1 | PHASE3 | Baloxavir Marboxil |
| Merck & Co., Inc. | MRK | 2 | PHASE1 | V118C |
| AstraZeneca PLC | AZN | 1 | PHASE1 | AZD7760 |
| BioNTech SE Sponsored ADR | BNTX | 1 | PHASE1 | BNT163 |
| 60 Degrees Pharmaceuticals, Inc. | SXTP | 1 | PHASE2 | Tafenoquine |
| Tarsus Pharmaceuticals, Inc. | TARS | 1 | PHASE2 | TP-05 |
| Moderna, Inc. | MRNA | 1 | PHASE2 | mRNA-1982 |
| AN2 Therapeutics, Inc. | ANTX | 1 | PHASE2 | Epetraborole |
| Emergent BioSolutions Inc. | EBS | 4 | - | AIGIV/kg |
| Phathom Pharmaceuticals, Inc. | PHAT | 1 | - | Vonoprazan |
The efavirenz containing antiretroviral regimen is used to treat HIV Infections. It is an antiretroviral treatment studied in HIV-1 infected subjects, including those with hepatic impairment. Bristol-Myers Squibb Company developed it, and it is a small molecule therapy in the infectious disease area.
Bristol-Myers Squibb Company, which trades under the ticker BMY, is the developer of the efavirenz containing antiretroviral regimen. The company sponsored the clinical study of this regimen in HIV-1 infected subjects with hepatic impairment.
The efavirenz containing antiretroviral regimen is in Phase 1 clinical development. The single recorded trial, NCT00162097, was a Phase 1 study, and it has been completed. The regimen is investigational and is not described as approved.
One clinical trial studied the efavirenz containing antiretroviral regimen: NCT00162097, titled Pharmacokinetics of Efavirenz in HIV-1 Infected Subjects With Hepatic Impairment. It was a completed Phase 1 active-controlled study with 21 enrolled participants, conducted in the United States and Italy, and it enrolled adults aged 18 years and older.
NCT00162097 studied HIV Infections together with hepatic impairment. The trial examined the pharmacokinetics of efavirenz in HIV-1 infected subjects who had hepatic impairment. It enrolled 21 participants across sites in the United States and Italy and has been completed.