Last reviewed 2026-04-20 · How we verify

Epivir

At a glance

Approved indications

No approved indications tracked.

Boxed warnings

• WARNING: EXACERBATIONS OF HEPATITIS B and DIFFERENT FORMULATIONS OF EPIVIR Exacerbations of Hepatitis B Severe acute exacerbations of hepatitis B have been reported in patients who are co-infected with hepatitis B virus (HBV) and human immunodeficiency virus (HIV-1) and have discontinued EPIVIR. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue EPIVIR and are co-infected with HIV-1 and HBV. If appropri

Common side effects

• Headache
• Nausea
• Malaise & fatigue
• Nasal signs & symptoms
• Cough
• Diarrhea
• Neuropathy
• Musculoskeletal pain
• Nausea & vomiting
• Insomnia & other sleep disorders
• Fever or chills
• Dizziness

Serious adverse events

• Pancreatitis
• Absolute neutrophil count decrease
• Amylase elevation
• ALT elevation
• Hemoglobin decrease
• AST elevation
• Bilirubin elevation
• Platelets decrease

Key clinical trials

• Exploration of the Variability of Exposure to Antiretroviral Treatment in Hair With a View to Validating Its Value as a Diagnostic Tool for Partial and/or Total Non-compliance With Treatment
• Study of Cobicistat-Boosted Atazanavir (ATV/co), Cobicistat-Boosted Darunavir (DRV/co) and Emtricitabine/Tenofovir Alafenamide (F/TAF) in Children With HIV (PHASE2, PHASE3)
• Study to Evaluate the Efficacy, Safety, and Tolerability of Long-acting Intramuscular Cabotegravir and Rilpivirine for Maintenance of Virologic Suppression Following Switch From an Integrase Inhibitor in HIV-1 Infected Therapy Naive Participants (PHASE3)
• A Randomized Clinical Trial to Evaluate Solutions for the Management of Virologic Failure on TLD in Sub-Saharan Africa (NA)
• A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments (PHASE4)
• 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)
• Entecavir Resistance-Associated Mutations in Chronic HBV Patients in Turkey (STREAM Study)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Epivir CI brief — competitive landscape report
• Epivir updates RSS · CI watch RSS
• Bristol-Myers Squibb portfolio CI