An international group of researchers has developed a simple, low-cost blood test for hepatitis B virus that accurately identified African patients who were eligible for treatment.
“Once these results are validated by further studies, they could be potentially integrated into the WHO guidelines and local guidelines — and implemented in daily practice,” Yusuke Shimakawa, MD, PhD, epidemiologist at the Pasteur Institute in Paris, said in a news release. “There is great potential to diagnose more people and improve access to treatment.”
According to Shimakawa and colleagues, patients with chronic HBV infections are eligible for treatment based on three factors: viral replication, liver fibrosis and inflammation. The diagnostic tools used to assess these conditions are rarely accessible in low- and middle-income countries (LMICs). Real-time PCR alone — the current standard for measuring viral load — is expensive, costing approximately $60 to $200 per test, and requires specialized equipment and training.
To address this issue, Shimakawa and colleagues developed a simple treatment eligibility score for HBV, known as TREAT-B. The score is based on clinical data from 804 patients with chronic HBV in The Gambia. The test uses HBV e antigen and alanine aminotransferase measurements that can be obtained with a single blood sample. It can be easily implemented in LMICs and used by nonspecialist health care providers, according to the researchers. To further simplify the process, TREAT-B could be made into a finger-stick test, similar to those used for HIV, the release said. The total cost is about $20.
The efficacy of TREAT-B was validated in a cohort of African patients from Senegal, Burkina Faso and Europe with HBV infection (n = 327). The diagnostic accuracy was high, with a sensitivity of 85% and specificity of 77%, the researchers reported. Because HBV DNA is one of the most significant indicators of HBV-related liver diseases, Shimakawa and colleagues compared the performance of TREAT-B with another score incorporating HBV DNA. The area under the curve of each score was similar, indicating the usefulness of TREAT-B when DNA measurements are unavailable, the researchers said. Results further showed that the efficacy of TREAT-B did not vary by age, genotype, the presence of obesity or cirrhosis.
“In conclusion, TREAT-B represents a promising simple and low-cost diagnostic score that can assist physicians to easily identify HBV-infected individuals in need of treatment in Africa,” the researchers wrote. “Its use may contribute toward global HBV elimination by facilitating the scale up and decentralization of HBV treatment programs in LMICS. TREAT-B deserves to be further validated in other African and non-African patients with chronic hepatitis B in LMICS.” – by Stephanie Viguers
Disclosures: One author reports receiving grants from Gilead Sciences. All other authors report no relevant financial disclosures.