Last reviewed · How we verify
Symtuza
At a glance
| Generic name | Symtuza |
|---|---|
| Also known as | darunavir/cobicistat/emtricitabine/tenofovir alafenamide |
| Sponsor | East Carolina University |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | FDA-approved |
Approved indications
Boxed warnings
- WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B Severe acute exacerbations of hepatitis B (HBV) have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued products containing emtricitabine and/or tenofovir disoproxil fumarate (TDF), and may occur with discontinuation of SYMTUZA. 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 SYMTUZA
Common side effects
- Diarrhea
- Rash
- Nausea
- Fatigue
- Headache
- Abdominal discomfort
- Flatulence
- ALT/AST elevations (Grade 2-4)
Serious adverse events
- Stevens-Johnson syndrome
- Acute hepatitis
- Pancreatitis (acute)
- Osteonecrosis
- Immune reconstitution inflammatory syndrome
- Angioedema
- Drug hypersensitivity
Key clinical trials
- The Late Presenter Treatment Optimisation Study (PHASE3)
- B-free Multistage Trial (PHASE4)
- An Italian Observation of Antiretroviral Treatment in Participants Taking Darunavir/ Cobicistat Plus Emtricitabine and Tenofovir Alafenamide Fumarate
- Integrase Regimen Switch to Symtuza to Increase Tolerability/Adherence (SYMita) (PHASE4)
- Rapid Reinitiation of a Single Tablet Antiretroviral Therapy Using Symtuza® in HIV-1 Infected Treatment-Experienced Patients Off Therapy. (ReSTART) (PHASE4)
- Efficacy of BIC/F/TAF Versus Standard of Care in the Treatment of New HIV Infection Diagnoses in the Context of 'Test and Treat' (PHASE3)
- Effect of Biktarvy & Symtuza on microRNAs in HIV and Correlation With Weight Gain (PHASE4)
- A Clinical Trial to Evaluate the Reversibility of Abacavir/Lamivudine/Dolutegravir CNS-Related Neurotoxicity After Switching to Tenofovir/Alafenamide/Emtricitabine/Darunavir/Cobicistat (TAF/FTC/DRV/c) (PHASE4)
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 |
|---|---|
| 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:
- Symtuza CI brief — competitive landscape report
- Symtuza updates RSS · CI watch RSS
- East Carolina University portfolio CI