Overview
Bictegravir is a recently approved investigational drug that has been used in trials studying the treatment of HIV-1 and HIV-2 infection. It has been approved for HIV-1 monotherapy combined with 2 other antiretrovirals in a single tablet.
Background
Bictegravir is a recently approved investigational drug that has been used in trials studying the treatment of HIV-1 and HIV-2 infection. It has been approved for HIV-1 monotherapy combined with 2 other antiretrovirals in a single tablet.
Indication
Bictegravir is indicated in the management of HIV-1 infection in patients not previously treated with antiretroviral therapy. Additionally, Bictegravir is indicated in the management of HIV-1 infection in patients who are virologically suppressed (HIV-1 RNA <50 c/mL) on a regular antiretroviral regimen for a minimum of three months without a history of failure in treatment and no known factors associated with the resistance to the individual components of the medication. It is used in combination with tenofovir and emtricitabine.
Associated Conditions
- Human Immunodeficiency Virus Type 1 (HIV-1) Infection
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/22 | Phase 4 | Recruiting | |||
2024/10/07 | Not Applicable | Completed | |||
2024/03/27 | Phase 3 | Active, not recruiting | |||
2023/08/07 | Phase 3 | Active, not recruiting | |||
2022/08/16 | Phase 2 | Active, not recruiting | |||
2021/04/21 | Phase 1 | Withdrawn | |||
2021/03/18 | N/A | Completed | Cliniques universitaires Saint-Luc- Université Catholique de Louvain | ||
2021/01/15 | Not Applicable | UNKNOWN | |||
2020/10/14 | Phase 4 | Completed | Charlotte-Paige Rolle, MD | ||
2020/08/19 | N/A | Active, not recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 6/21/2018 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| BIKTARVY FILM-COATED TABLETS 50MG/200MG/25MG | SIN15604P | TABLET, FILM COATED | 50mg | 1/2/2019 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||