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BICTEGRAVIR SODIUM
At a glance
| Generic name | BICTEGRAVIR SODIUM |
|---|---|
| Drug class | Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC] |
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 2018 |
Approved indications
Boxed warnings
- WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued products containing emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF), and may occur with discontinuation of BIKTARVY. Closely monitor hepatic function with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue BIKTARVY. If appropriate, anti-hepatitis B therapy may be warranted [see Warnings and Precautions (5.1) ] . WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B See full prescribing information for complete boxed warning. Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued products containing emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF), and may occur with discontinuation of BIKTARVY. Closely monitor hepatic function in these patients. If appropriate, anti-hepatitis B therapy may be warranted. ( 5.1 )
Common side effects
- Diarrhea
- Nausea
- Headache
- Vomiting
- Flatulence
- Dyspepsia
- Abdominal pain
- Rash
- Depression
Serious adverse events
- Suicidal ideation
- Suicide attempt
- Depression suicidal
Key clinical trials
- A Clinical Trial of Combination HIV-Specific Broadly Neutralizing Monoclonal Antibodies Combined With ART Initiation During Acute HIV Infection to Induce HIV Remission (PHASE2)
- INSTI's For The Management of HIV-associated TB (PHASE2)
- Doravirine and Weight Gain in Antiretroviral Naive (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- BICTEGRAVIR SODIUM CI brief — competitive landscape report
- BICTEGRAVIR SODIUM updates RSS · CI watch RSS