Last reviewed · How we verify
DOVATO
Dovato is a small molecule medication developed by the Saskatchewan Health Authority - Regina Area. However, due to the lack of information on its target, drug class, and approved indications, its exact mechanism of action and clinical use are unknown. As a result, its commercial status, safety considerations, and pharmacokinetic properties, such as half-life and bioavailability, are also unclear. Further research is needed to understand the properties and potential applications of Dovato. Its current ownership by the Saskatchewan Health Authority - Regina Area suggests it may be a novel or experimental compound.
At a glance
| Generic name | DOVATO |
|---|---|
| Also known as | Dolutegravir/Lamivudine, dolutegravir/lamivudine |
| Sponsor | Saskatchewan Health Authority - Regina Area |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | FDA-approved |
Approved indications
Boxed warnings
- WARNING: PATIENTS CO-INFECTED WITH HEPATITIS B VIRUS (HBV) AND HUMAN IMMUNODEFICIENCY VIRUS (HIV-1): EMERGENCE OF LAMIVUDINE-RESISTANT HBV AND EXACERBATIONS OF HBV All patients with HIV-1 should be tested for the presence of HBV prior to or when initiating DOVATO. Emergence of lamivudine-resistant HBV variants associated with lamivudine-containing antiretroviral regimens has been reported. If DOVATO is used in patients co-infected with HIV-1 and HBV, additional treatment should be considered for
Common side effects
- Nausea
- Headache
- Diarrhea
- Insomnia
- Dizziness
- Fatigue
- Anxiety
Serious adverse events
- Suicidal ideation, attempt, behavior, or completion
- Psychiatric disorders
- Hepatitis
- Immune reconstitution syndrome
- Renal impairment
- Anemia
- Neutropenia
- Thrombocytopenia
- Myositis
- Hypersensitivity
Key clinical trials
- A Phase 2b Study Evaluating Oral VH4524184 Regimens in Treatment Naïve Persons With HIV-1 (INNOVATE Study) (PHASE2)
- A Study to Evaluate the Efficacy, Safety, Participant Choice and Preference of an Oral Once-daily Regimen or a Long-acting Injectable Regimen Every Two Months for Treatment of Human Immunodeficiency Virus (HIV-1) in Adults Who Have Not Previously Taken Antiretroviral Therapy (PHASE3)
- Safety and Efficacy of Dolutegravir/Lamivudine (DTG/3TC) in Therapy-naive Human Immunodeficiency Virus-1 (HIV-1) Infected Adolescents (PHASE3)
- A Study to Evaluate Efficacy, Safety and Tolerability in Antiretroviral Therapy (ART)-Experienced Participants of at Least 50 Years of Age Living With Human Immunodeficiency Virus (HIV) With Virologic Suppression Who Switch to DTG/3TC FDC From BIC/FTC/TAF (PHASE3)
- Dolutegravir/Lamivudine Dual Therapy for ART-naïve People With HIV and TB Receiving Rifampin-based TB Treatment (PHASE3)
- Dolutegravir-Lamivudine for naïve HIV-Infected Patients With ≤200 CD4/mm3 (PHASE4)
- DTG/3TC vs. BIC/FTC/TAF Maintenance Therapy in People Living With HIV: (PHASE4)
- Phase IV, a Clinical Trial to Assess Safety and Convenience of the Change From DTG/3TC to BIC/FTC/TAF in People With HIV, Good Virological Control and Neuropsychiatric Vulnerabilities (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:
- DOVATO CI brief — competitive landscape report
- DOVATO updates RSS · CI watch RSS
- Saskatchewan Health Authority - Regina Area portfolio CI