REVEAL-HBV
Risk of hepatocellular carcinoma across a biological gradient of serum hepatitis B virus DNA level (REVEAL-HBV cohort)
Phase observationalN = 3,653
- Population
- Participants aged 30-65 years who were HBsAg-seropositive and seronegative for antibodies against hepatitis C virus, recruited to a community-based cancer screening programme in Taiwan.
- Design
- Prospective community-based cohort recruited in Taiwan in 1991-1992 through a cancer screening programme; incident hepatocellular carcinoma was ascertained during follow-up examinations and by linkage to the national cancer registry and death certification systems. Mean follow-up 11.4 years (41,779 person-years). Observational: arms are the lowest and highest baseline HBV DNA categories, not randomised groups.
- Arms
- HBV DNA under 300 copies/mL (control): Baseline serum HBV DNA below 300 copies/mL
- HBV DNA 1 million copies/mL or more (experimental): Baseline serum HBV DNA of 1 million copies/mL or higher
- People
- Chen CJ, REVEAL-HBV Study Group
Δ Incidence of hepatocellular carcinoma+13.6 points
Show the numbers
| Endpoint | Analysis | HBV DNA 1 million copies/mL or more | HBV DNA under 300 copies/mL | Effect |
|---|---|---|---|---|
| Incidence of hepatocellular carcinoma3653 HBsAg-positive participants; the two groups shown are the lowest and highest baseline HBV DNA categoriesCumulative incidence of hepatocellular carcinoma during follow-up by baseline serum HBV DNA level. | primaryChen 2006 | 14.9% | 1.3% | P<.001164 incident HCC cases and 346 deaths over a mean follow-up of 11.4 years (41,779 person-years). Incidence per 100,000 person-years: 108 for HBV DNA below 300 copies/mL and 1152 for 1 million copies/mL or higher. The P value is for the dose-response gradient after adjustment for sex, age, smoking, alcohol, HBeAg status, ALT and cirrhosis at entry. The authors conclude that a level of 10,000 copies/mL or higher is a strong risk predictor independent of HBeAg, ALT and cirrhosis. |
| Endpoint | Analysis | HBV DNA 1 million copies/mL or more | HBV DNA under 300 copies/mL | Effect |
|---|---|---|---|---|
| Incidence of hepatocellular carcinoma3653 HBsAg-positive participants; the two groups shown are the lowest and highest baseline HBV DNA categoriesCumulative incidence of hepatocellular carcinoma during follow-up by baseline serum HBV DNA level. | primaryChen 2006 | 14.9% | 1.3% | P<.001164 incident HCC cases and 346 deaths over a mean follow-up of 11.4 years (41,779 person-years). Incidence per 100,000 person-years: 108 for HBV DNA below 300 copies/mL and 1152 for 1 million copies/mL or higher. The P value is for the dose-response gradient after adjustment for sex, age, smoking, alcohol, HBeAg status, ALT and cirrhosis at entry. The authors conclude that a level of 10,000 copies/mL or higher is a strong risk predictor independent of HBeAg, ALT and cirrhosis. |