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JULUCA
JULUCA is a two-drug combination that inhibits HIV integrase and reverse transcriptase to suppress viral replication.
JULUCA is a two-drug combination that inhibits HIV integrase and reverse transcriptase to suppress viral replication. Used for HIV-1 infection in treatment-experienced adults with no history of integrase inhibitor resistance and no mutations associated with rilpivirine resistance.
At a glance
| Generic name | JULUCA |
|---|---|
| Sponsor | ViiV Healthcare |
| Drug class | Antiretroviral combination (integrase inhibitor + NNRTI) |
| Target | HIV integrase and HIV reverse transcriptase |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease / Virology |
| Phase | FDA-approved |
Mechanism of action
JULUCA combines dolutegravir (an integrase strand transfer inhibitor) and rilpivirine (a non-nucleoside reverse transcriptase inhibitor). Dolutegravir prevents HIV from integrating its genetic material into the host cell genome, while rilpivirine blocks reverse transcriptase, an enzyme HIV uses to replicate. Together, these agents provide dual suppression of HIV replication in treatment-experienced patients.
Approved indications
- HIV-1 infection in treatment-experienced adults as a complete regimen
Common side effects
- Insomnia
- Headache
- Diarrhea
- Nausea
- Fatigue
Key clinical trials
- Study to Evaluate the Efficacy and Safety of a Rilpivarine-based Antiretroviral Tratment Regimen in HIV- Infected Patients With Liver Metabolic Disease Who Maintain Udetectable HIV Viral Load (PHASE4)
- Dolutegravir/Rilpivirine, Antiretroviral Efficacy Study Using Real-world Data in Subjects With Human Immunodeficiency Virus (HIV)-1
- Pharmacokinetics, Safety, Tolerability of Dolutegravir/Rilpivirine in Pediatrics (PHASE1, PHASE2)
- Pharmacokinetics of JULUCA in Hemodialysis (PHASE4)
- Patients' Experiences and Perceptions of 3TC/DTG Dual Therapy (the PEDAL Study)
- Study to Evaluate Pharmacokinetics, Safety and Tolerability of Dolutegravir and Rilpivirine (JULUCA™) 50 Milligram (mg)/25 mg Tablets in Healthy Subjects of Japanese Descent (PHASE1)
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:
- JULUCA CI brief — competitive landscape report
- JULUCA updates RSS · CI watch RSS
- ViiV Healthcare portfolio CI