Report from the GHPP-BloodTrain inspection workshop in Harare the 20th to the 24th of May 2019.

During the training workshop on Inspection of Blood Establishments, which was hosted by the PEI GHPP BloodTrain in Harare from the 20th to the 24th of May 2019, participants from the National Regulatory Authorities from seven Sub-Sahara African countries presented their current experiences related to regulation and inspection of blood establishments in their respective countries. While in all seven countries regulation and inspection of conventional medicinal products manufacturer is performed, the regulatory situation of blood and blood components as well as inspection of blood establishments is still heterogeneous.

Stage of disease in hepatitis B virus infection in Zambian adults is associated with large cell change but not well defined using classic biomarkers.

Background: Hepatocellular malignancy in young adults is a prominent feature of hepatitis B virus (HBV) infection in southern Africa. Here we report a cross-sectional study of liver pathology correlated with biomarkers in adults with HBV infection in Zambia. Methods: We analysed liver biopsies from Zambian patients with persistent HBV infection. Results: We analysed 104 patients with HBV infection and evidence of liver disease. We obtained liver biopsies from 53 adults; of these, 12 (23%) were hepatitis B e antigen seropositive. The genotype was evenly distributed between A and E. One biopsy showed malignancy. Stage was 3 or more in 11 of 52 (21%) biopsies free of malignancy and lobular inflammation was found in 50 (94%). Neither alanine aminotransferase (ALT) nor the γ-glutamyl transferase:platelet ratio (GPR) were correlated with the stage of disease but were correlated with total Ishak score (ρ=0.47, p=0.0004 and ρ=0.33, p=0.02, respectively). Large cell change was observed in 10 of 11 biopsies with fibrosis stage 3 or more and 16 of 41 with early disease (p=0.005). Serum α-fetoprotein was elevated, although still within the normal range, in patients with large cell change (median 3.6 [interquartile range {IQR} 1.6-5.1]) compared with those without (1.7 [IQR 1.0-2.8]; p=0.03). Neither ALT nor GPR predicted large cell change. Conclusions: Large cell change was common in young HBV-infected adults in Zambia. Only serum α-fetoprotein was identified as a biomarker of this phenotype.

HIV, Hepatitis B, and Hepatitis C in Zambia.

OBJECTIVES: Epidemiologic data of HIV and viral hepatitis coinfection are needed in sub-Saharan Africa to guide health policy for hepatitis screening and optimized antiretroviral therapy (ART). MATERIALS AND METHODS: We screened 323 HIV-infected, ART-eligible adults for hepatitis B surface antigen (HBsAg) and hepatitis C antibody (HCV Ab) at a tertiary hospital in Lusaka, Zambia. We collected basic demographic, medical, and laboratory data to determine predictors for coinfection. RESULTS: Of 323 enrolled patients, 32 (9.9%; 95% CI=6.7-13.2%) were HBsAg positive, while 4 (1.2%; 95% CI=0.03-2.4%) were HCV Ab positive. Patients with hepatitis B coinfection were more likely to be <40 years (84.4% vs. 61.4%; P=0.01) when compared to those who were not coinfected. Patients with active hepatitis B were more likely to have mild to moderately elevated AST/ALT (40-199 IU/L, 15.8% vs. 5.4%; P=0.003). Highly elevated liver enzymes (>200 IU/L) was uncommon and did not differ between the two groups (3.4% vs. 2.3%; P=0.5). We were unable to determine predictors of hepatitis C infection due to the low prevalence of disease. CONCLUSIONS: HIV and hepatitis B coinfection was common among patients initiating ART at this tertiary care facility. Routine screening for hepatitis B should be considered for HIV-infected persons in southern Africa.