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Hepsera and lamivudine
Hepsera and lamivudine is a Nucleoside/nucleotide reverse transcriptase inhibitor Small molecule drug developed by University of Washington. It is currently FDA-approved for Chronic hepatitis B infection, Hepatitis B with lamivudine-resistant virus.
Hepsera (adefovir dipivoxil) and lamivudine are nucleoside/nucleotide reverse transcriptase inhibitors that block viral replication in hepatitis B by inhibiting the reverse transcriptase enzyme.
Hepsera (adefovir dipivoxil) and lamivudine are nucleoside/nucleotide reverse transcriptase inhibitors that block viral replication in hepatitis B by inhibiting the reverse transcriptase enzyme. Used for Chronic hepatitis B infection, Hepatitis B with lamivudine-resistant virus.
At a glance
| Generic name | Hepsera and lamivudine |
|---|---|
| Sponsor | University of Washington |
| Drug class | Nucleoside/nucleotide reverse transcriptase inhibitor |
| Target | Hepatitis B virus reverse transcriptase |
| Modality | Small molecule |
| Therapeutic area | Virology/Hepatology |
| Phase | FDA-approved |
Mechanism of action
Both drugs are nucleoside/nucleotide analogs that inhibit hepatitis B virus (HBV) reverse transcriptase, preventing viral DNA synthesis and replication. Adefovir is a nucleotide analog with activity against both wild-type and lamivudine-resistant HBV, while lamivudine is a nucleoside analog. When used in combination, they provide complementary antiviral activity and reduce the risk of resistance development.
Approved indications
- Chronic hepatitis B infection
- Hepatitis B with lamivudine-resistant virus
Common side effects
- Nephrotoxicity (renal dysfunction)
- Headache
- Asthenia/fatigue
- Abdominal pain
- Lactic acidosis
Key clinical trials
- Prevention of Recurrent Hepatitis B After Liver Transplantation
- Carvedilol for Prevention of Esophageal Varices Progression (NA)
- Study Comparing the Safety of Switching From Lamivudine to Adefovir Dipivoxil Versus Overlapping Lamivudine and Adefovir Before Adefovir Dipivoxil Monotherapy in Patients With Chronic Hepatitis B (PHASE4)
- A Comparison of Adefovir and Tenofovir for the Treatment of Lamivudine-Resistant Hepatitis B Virus in People With HIV (PHASE2)
- The Effectiveness of Nelfinavir and Efavirenz, Used Alone or Together, Combined With Other Anti-HIV Drugs in Patients Who Have Taken Anti-HIV Drugs (PHASE2)
- Treatment Success and Failure in HIV-Infected Subjects Receiving Indinavir in Combination With Nucleoside Analogs: A Rollover Study for ACTG 320 (PHASE2)
- Extension Study of Carvedilol RCT Study (NA)
- Safety, Tolerability and Antiviral Activity of Selgantolimod in Virally-Suppressed Participants With Chronic Hepatitis B (PHASE2)
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:
- Hepsera and lamivudine CI brief — competitive landscape report
- Hepsera and lamivudine updates RSS · CI watch RSS
- University of Washington portfolio CI
Frequently asked questions about Hepsera and lamivudine
What is Hepsera and lamivudine?
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Related
- Drug class: All Nucleoside/nucleotide reverse transcriptase inhibitor drugs
- Target: All drugs targeting Hepatitis B virus reverse transcriptase
- Manufacturer: University of Washington — full pipeline
- Therapeutic area: All drugs in Virology/Hepatology
- Indication: Drugs for Chronic hepatitis B infection
- Indication: Drugs for Hepatitis B with lamivudine-resistant virus
- Compare: Hepsera and lamivudine vs similar drugs
- Pricing: Hepsera and lamivudine cost, discount & access