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Lamivudine therapy in chronic delta hepatitis: a multicentre randomized-controlled pilot study
G A Niro1, A Ciancio, H L Tillman
1Department of Gastroenterology, Hospital Casa Sollievo della Sofferenza IRCCS, San Giovanni Rotondo, Italy. g.niro@operapadrepio.it
Alimentary Pharmacology & Therapeutics
|August 11, 2005
Summary
Lamivudine treatment did not eliminate Hepatitis D Virus (HDV) RNA in chronic hepatitis patients. While some patients showed partial histological improvement, HDV viraemia remained largely unaffected by the therapy.
Area of Science:
- Hepatology
- Virology
- Gastroenterology
Background:
- Chronic Hepatitis D Virus (HDV) infection presents significant treatment challenges.
- HDV-related liver disease requires effective therapeutic strategies.
Purpose of the Study:
- To assess the efficacy of lamivudine in treating chronic Hepatitis D Virus infection.
- Evaluate lamivudine's impact on HDV RNA levels, liver enzymes, histology, and serological markers.
Main Methods:
- A randomized, placebo-controlled trial involving 31 patients with chronic HDV infection.
- Patients received either lamivudine (100 mg daily) or placebo for 52 weeks, followed by open-label lamivudine treatment.
Main Results:
- No patient achieved HDV RNA negativity at 52 weeks; only 11% were negative at 104 weeks.
- Lamivudine did not significantly impact HDV viraemia, even when suppressing Hepatitis B Virus (HBV) replication.
- Partial histological improvement was observed in 17% of lamivudine-treated patients versus 43% in the placebo group.
Conclusions:
- Lamivudine therapy resulted in a sustained complete response in only 8% of HDV-infected patients.
- Partial histological response was achieved in 26% of patients.
- Hepatitis D Virus viraemia was not significantly affected by lamivudine treatment.