Hepatitis B Clinical Trial
Since a proportion of patients with Acute Viral Hepatitis-B develop severe hepatitis and fulminant hepatic failure, it is logical to believe that a rapid reduction in the HBV DNA levels by using antiviral agents could result in a less intense host response against the hepatitis B virus. However, the experience with lamivudine treatment of immunocompetent patients with AVH-B is limited.The aim of the present study was to evaluate the efficacy, utility and safety of lamivudine in treating immunocompetent patients with AVH-B.
The diagnosis of acute hepatitis B was based on recent onset acute illness including
prodromal symptoms, jaundice and other typical symptoms. The laboratory investigations
supporting the diagnosis of acute hepatitis included the presence of >2.5 times the upper
limit of serum alanine aminotransferase (ALT) and serum bilirubin, and positive IgM anti-HBc
test. Ultrasound, and esophagogastroduodenoscopy was done to look for any evidence of
chronic liver disease. All patients had normal alpha-fetoprotein levels.
Co-infection with hepatitis A, C, D, E and human immunodeficiency virus (HIV) infection was
looked for by appropriate serologic tests conducted within 7 days of presentation.
Patients with co-infection, a history of hepatotoxic drug intake or alcohol use >20g/day, or
any evidence of chronic liver disease in the past, at presentation or during follow-up were
excluded. Patients were also excluded if they had serum bilirubin < 5 mg/dl at presentation.
Patients were classified as severe AVH-B if they fulfilled any two of the following
criteria: (1) hepatic encephalopathy; (2) serum bilirubin ≥10.0 mg/dl; and (3) international
normalized ratio (INR) ≥1.6.
The patients were randomized into 2 groups: Group 1: Treatment with lamivudine 100 mg daily
for 3 months, Group 2: Placebo. Randomization was done using random number table. The
initial study and randomization was planned to enroll 120 patients or continue the study
till three years, whichever was earlier. Individual rather than block randomization was done
The investigators as well as the patients were blinded to the randomisation. The patients in
the placebo group received a placebo pill.
All patients were monitored during treatment for clinical evidence and grade of hepatic
encephalopathy, impaired coagulation (abnormal international normalized ratio, IINR),
AST/ALT, serum albumin bilirubin levels every week for the first month and then monthly. HBV
serology, including serum HBsAg, HBeAg, and anti-HBe were checked at baseline and every 3
months. Anti-HBs titres were checked at 6 and 12 months. Quantitative HBV DNA assay was
performed on day 0, day 4, week 1, week 2, week 3, week 4, then every month for the next 2
months and then every 3 months for 12 months.
All patients were followed for at least 12 months after the onset of AVH-B. Development of
protective anti-HBs(>10 IU/L) was specifically looked for.
Exacerbation of chronic hepatitis B was excluded by investigating thoroughly for any
evidence of chronic liver disease by Ultrasound, Upper GI endoscopy, or low albumin at
presentation. Ultrasound was repeated at 6 and 12 months, and if there was any suspicion
Upper GI endoscopy was also repeated. LFTS were done at every hospital visit.
HBsAg, HBeAg, IgM anti-HBc, anti-HBs, and anti-HBe were tested by commercially available
enzyme-linked immunoassays. Serum quantitative HBV DNA assay was performed by use of an
ultra sensitive Hybrid capture assay [Digene Labs, USA] that has a lower limit of detection
of 4,700 copies/ml. An arbitrary value of 4,700 copies/ml was assigned to values < 4,700
copies/ml for analysis purposes. In such patients HBV DNA was done by an in-house
qualitative PCR test to indicate negativity or positivity of viral DNA. The lower limit of
detection was 600 copies/ml.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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