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Effects of Indomethacin on Viral Replication in Asymptomatic Carriers of Hepatitis B; A Randomized Placebo-Controlled Double-Masked Clinical Trial

Hossein Bahrami, MD, MPH1, Nasser E Daryani, MD2, Babak Haghpanah, MD2, Alireza Moayyeri, MD2, Katayoon Fayaz Moghadam, MD3, and Farin Kamangar, MD, MPH1. (1) Department of Epidemiology, Bloomberg School of Public Health, Johns Hopkins University, 1620 McElderry Street, Apt # 518, Baltimore, MD 21205, hbahrami@jhsph.edu, (2) Internal Medicine/ Digestive Disease Research Center-Imam Hospital, Tehran University of Medical Sciences, PO Box: 14515-1511, Tehran, Iran, (3) Park Clinic Laboratory, Vozara Street, Tehran, Iran

OBJECTIVES: There is no effective treatment for asymptomatic carriers of hepatitis B. We evaluated the potential effects of indomethacin on the replication of the virus in asymptomatic carriers of hepatitis B. METHODS: 112 adult subjects with positive serum HBsAg in at least two different occasions with at least 6 months interval, normal liver function tests and no sign of cirrhosis in clinical evaluation and liver ultrasonography, were enrolled in the study. Participants were randomly assigned to two groups, one group (56 participants, mean age 31.7±9.6, 29 male) received indomethacin capsules 25mg three times/day and the other group (56 participants, mean age 33.8±10.2, 33 male) received identical placebo. All participants were under treatment for 6 months and followed up three months thereafter. RESULTS: HBsAg seroconversion rate was not significantly different between two groups (two subjects in each group got seronegative). Seroconversion of HBeAg to anti-HBe occurred only in five participants of the indomethacin group (p = 0.057).Hepatitis B virus DNA became negative in sera of 7 participants in the indomethacin group and no one in the placebo group (p = 0.01). Number of patients needed to be treated for one case of DNA seroconversion was about 9 patients and for HBeAg seroconversion this number was about 11. Adverse events included 2 cases of gastrointestinal discomfort in the indomethacin group and one suspected gastritis case in the placebo group. CONCLUSIONS: We suggest use of indomethacin in the subgroup of asymptomatic HBsAg carriers who have detectable HBV-DNA or HBeAg in their sera.

Learning Objectives: Asymptomatic carriers of hepatitis B are those who are infected with virus, but do not have hepatitis. This condition is very common and regarding the lack of symptoms and active disease, these cases are the main source of HBV infection and burden of disease in the population. At the conclusion of the session, the participant (learner) in this session will be able to

Presenting author's disclosure statement:
I do not have any significant financial interest/arrangement or affiliation with any organization/institution whose products or services are being discussed in this session.

Infectious Disease Epidemiology: Poster Session

The 132nd Annual Meeting (November 6-10, 2004) of APHA