IAS 2013: Many People Need Hepatitis B Treatment in the Gambia

About 8% of people tested through a community-based screening program in the Gambia have hepatitis B, and about 8% of these have advanced liver disease and meet European criteria for antiviral therapy, according to a report presented at the 7th International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention (IAS 2013) this month in Kuala Lumpur.

Maud Lemoine with the Medical Research Council's Gambia Unit reported findings from PROLIFICA -- Prevention of Liver Fibrosis and Liver Cancer in Africa -- the first program aimed at testing, assessing, and treating chronic hepatitis B in West Africa. Funded by the European Commission, the 5-year project aims to enroll 13,000 people in the Gambia, Nigeria, and Senegal. The report at IAS covered preliminary findings from the Gambia.

Hepatitis B virus (HBV) infection is endemic in sub-Saharan Africa and liver cancer -- one of the potential consequences of untreated infection -- is common, Lemoine noted as background. Hepatocellular carcinoma is the leading cancer among men and the second among women in West Africa, with at least half attributable to HBV. But screening and management of liver disease are "sorely lacking."

The PROLIFICA project offered point-of-care HBV testing to individuals age 30 years and older, after providing community education about hepatitis B and liver cancer. Many people under 30 have been vaccinated against HBV through child immunization efforts, Lemoine explained.

People who tested positive for HBV in the screening program were joined by 240 individuals from a historical community-based cohort of people with HBV from the villages of Keneba and Manduar, for a total hepatitis B study population of 558. A majority of participants with HBV were women; Lemoine explained that women were not more likely than men to have hepatitis B, but more frequently sought further evaluation and care. A randomly selected 30% of people who tested HBV negative were asked to act as a control group.

These participants were offered further evaluation with clinical examinations, laboratory analyses including transaminase liver enzyme levels, tests for other infections, liver ultrasound, and transient elastography (FibroScan). Those suspected of having advanced liver disease received liver biopsies, and those with confirmed advanced disease were offered treatment with tenofovir (Viread).

Results

• Between December 2011 and March 2013, a total of 4597 individuals from randomly selected rural and urban areas in the Gambia were tested for HBV.
• 379 tested HBV positive, for a prevalence of 8.3%.
• Almost all were hepatitis B "e" antigen (HBeAg) negative.
• None were previously aware of their HBV status.
• Among screened individuals who tested HBV positive, 318 -- more than 80% -- visited the PROLIFICA liver clinic for further evaluation.
• Among those who tested HBV positive in the screening program plus the historical cohort, 2.2% were co-infected with HIV, compared with 4% among the HBV-uninfected control participants.
• In addition, 1.5% had hepatitis delta and 1% were co-infected with hepatitis C virus (HCV).
• Further evaluation revealed that 13% of people with HBV had elevated transaminase levels, indicating active liver inflammation.
• FibroScan testing showed that 11% had a liver stiffness measurement above 7.2 kiloPascals (kPa), equivalent to Metavir stage F2, or moderate fibrosis.
• Of these, 14 people, or 2.5%, had confirmed advanced liver disease.
• 6 people (1%) had liver lesions detected by ultrasound, including 1 person with hepatocellular carcinoma who died 3 months later.
• Among 74 patients who underwent liver biopsies, 25% were found to have significant fibrosis (stage F2 or higher) and the same proportion had significant histological activity (stage A2 or higher).
• Among the HBV negative control group, in contrast, 5% had elevated transaminase levels, 6% had liver stiffness scores above 7.2 kPa, less than 1% had confirmed advanced liver disease and 5% had ultrasound liver lesions -- all benign.
• Most of the HBV positive participants (72%) were classified as asymptomatic HBeAg negative chronic carriers with normal liver enzyme levels, low HBV viral load, and no significant fibrosis.
• 26% were active chronic carriers with elevated transaminases or high HBV viral load (>2000 IU/mL).
• 2% were HBeAg positive "immunotolerant" carriers with normal liver enzymes and no fibrosis.
• Overall, 8.2% of study participants met European criteria for antiviral treatment according to 2009 EASL guidelines; a majority of this group (64%) were men, with a mean age of 38 years.
• Their mean liver stiffness score was 7.4 kPa, and among those with biopsies, nearly three-quarters had at least stage F2 fibrosis.

"In the Gambia, the preliminary data from the PROLIFICA project suggest that at the community level, 8.3% of the population >30 years is infected with HBV without being aware of their HBV status," the researchers concluded. "Applying the 2009 EASL criteria, 8.2% of HBV-infected subjects are eligible for antiviral therapy."

Based on these findings, the PROLIFICA team urged that tenofovir at generic cost should be made available not only for people with HIV in Africa, but also for HBV mono-infected individuals.

7/15/13

Reference

M Lemoine, Y Shimakawa, H Njai, M Thursz, et al. Rural and urban community-based screening in the Gambia: assessment of chronic hepatitis B reveals a significant proportion of eligible patients for antiviral therapy. 7th International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention. Kuala Lumpur, June 30-July 3, 2013. Abstract TUAB0105.