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Hepsera
At a glance
| Generic name | Hepsera |
|---|---|
| Sponsor | Gilead Sciences |
| Target | DNA polymerase subunit gamma-1, Capsid protein, Protein P |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | FDA-approved |
Approved indications
- Chronic type B viral hepatitis
Common side effects
- Asthenia
- Increased creatinine
- Headache
- Abdominal pain
- Diarrhea
- Nausea
- Dyspepsia
- Flatulence
- Hypophosphatemia
Serious adverse events
- Renal failure
- Abnormal renal function
- Serum creatinine increase ≥0.3 mg/dL (post-transplant)
- Serum creatinine increase ≥0.3 mg/dL (pre-transplant)
- Hepatitis exacerbation after discontinuation
- Vomiting
- Rash
- Pruritus
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 Study of Several Anti-HIV Drug Combinations in HIV-Infected Patients Who Have Used Indinavir (NA)
- Treatment of Hepatitis in Patients Who Are Triple-Infected With HIV, Hepatitis B Virus (HBV), and Hepatitis C Virus (HCV) (PHASE2)
- 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)
- A Study on Amprenavir in Combination With Other Anti-HIV Drugs in HIV-Positive Patients (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 CI brief — competitive landscape report
- Hepsera updates RSS · CI watch RSS
- Gilead Sciences portfolio CI