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82 PROPHYLACTIC LAMIVUDINE FOR PREVENTION OF CHEMOTHERAPY-INDUCED HEPATITIS B VIRUS REACTIVATION: META-ANALYSIS OF CLINICAL TRIALS F Alsohaibani, K Peltekian
BACKGROUND: Numerous studies and reports have appeared on lamivudine use as a primary prophylaxis to prevent chemotherapy induced hepatitis B virus (HBV) reactivation in hepatitis B surface antigen (HBsAg) seropositive cancer patients. However, the efficacy, safety and cost effectiveness of lamivudine remain unclear.
METHODS: By performing a systematic literature review with a meta-analysis of clinical trails, we evaluated the efficacy, safety and cost effectiveness of lamivudine prophylaxis in HBV carriers undergoing chemotherapy for malignancies. The primary outcomes were evidence for HBV reactivation and its associated morbidity and mortality. The secondary outcomes were disruption of chemotherapy, and lamivudine resistance and tolerability. Electronic searches of the National Library of Medicine were performed to identify all pertinent literature. The key words "hepatitis B", "lamivudine", "chemotherapy" and "prophylaxis" were used. The search was limited to randomized clinical trials and English language.
RESULTS: We identified 10 clinical trials (480 patients), six of these were prospective cohort studies and four were retrospective reviews. Two of the prospective studies had no control groups. In the treatment group 61% were males with mean age ± SD 52±8 years compared with 58% males and 42±7 years in the control group .The mean overall estimate for HBV reactivation was significantly higher in the control group compared with treatment group (46% vs 3%, P<0.001), however there was no significant difference in mortality between the two groups. Requirements for chemotherapy disruption were less in the treatment group (11% vs 31%).The median lamivudine dose was 100 mg/day (50 mg/day to 300 mg/day). On average lamivudine was started 7 days (one to 14 days) before chemotherapy and continued for a mean of 167 days (30 to 365 days) after discontinuation of the chemotherapy. There were no reported cases of lamivudine resistance cases or significant side effects.
CONCLUSION: This meta-analysis showed that primary prophylaxis with lamivudine for chronic HBV carrier cancer patients is well tolerated, probably cost effective and significantly reduce the incidence of chemotherapy-induced HBV reactivation with maintenance of the dosage of chemotherapy.