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Assessment of HBV Diagnostic Tests for MTCT Risk in Cambodia

This study evaluates the performance of two HBV rapid diagnostic tests in identifying pregnant women at high risk of mother-to-child transmission of HBV in Cambodia. The study compares the tests to gold standards and discusses the potential use of the algorithm in guiding treatment decisions.

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Assessment of HBV Diagnostic Tests for MTCT Risk in Cambodia

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  1. Performance of two HBV rapid diagnostic tests to identify pregnant women at risk of HBV mother-to-child transmission (MTCT)in Cambodia: the pilot ANRS 12328 study Dieynaba N’Diaye Poster MOPDC 0105 Abstract number A-854-0188-03589 O. Ségéral, D.S. N’Diaye, S. Prak, W. Khamduang, J. Nouhin, M. Ek, K. Chim, S. Hout, AM. Roque-Afonso, P. Piola, N. Ngo-Giang-Huong, F. Rouet, for the ANRS 12328 Study Group 

  2. RATIONAL Background • International guidelines suggest/recommend the administration of anti-HBV drugs (as Tenofovir [TDF]) during the third trimester of pregnancy if HBV DNA viral load (VL) levels > 5.3 Log10 IU/mL (associated to immunoprophylaxis) to reduce HBV mother to child transmission (MTCT)1 • How to apply these guidelines in Cambodia? • Prevalence: 5-10% in general population but screening rate very low2,3 • Poor laboratory facilities in health care centers where antenatal care (ANC) takes place • Very poor access to HBV DNA VL quantification, notably in decentralized areas Objective To evaluate the performance of a new diagnosis algorithm using HBsAg and HBeAg rapid diagnostic tests (RDTs) (SD Bioline) to identify pregnant women at high risk of HBV MTCT. Methodology 250 pregnant women during ANC at Calmette Hospital (Phnom Penh), with at least 125 HBsAg+, were tested with the RDT-based algorithm and compared to gold standards: 1) Performance of the SD BiolineHBsAg RDT to detect HBV infection vs. HBsAg ELISA (Murex v3.0 Diasorin) among all pregnant women 2) Performance of the SD BiolineHBeAg RDT as a surrogate marker of high VL vs. HBV DNA quantification (PUMA HBV kit, Omunis, Clapiers) among women found positive for HBsAg ANRS 12328 study, IAS 2017 1 - Sarin et al; Asian-Pacific clinical practice guidelines on the management of hepatitis B.Hepatol Int.2016 ; 2 - Yamada H et al; Hepatol Res. 2015 ; 3 - Reekie J et alJGastroenterolHepatol. 2013

  3. RESULTS: RDTs performance Study population • 250 pregnant women; median age 29 years; 51.2% (128) were HBsAg+ • Among 128 HBsAg+ • 34 (26.5%) with HBV DNA > 5.3 Log10 IU/mL and 28 (21.2%) > 7.3 Log10 IU/mL • 29 (23%) tested positive with HBeAg RDT ANRS 12328 study, IAS 2017

  4. RESULTS: Distribution of HBV DNA VL and HBeAg RDT Figure 1: Distribution of HBV VL for the 128 women with positive HBsAg Figure 2 HBV DNA VL according to HBeAg test results • Among HBV-infected women • 63% have very low HBV VL • 26% have high VL • HBV DNA VL median of positive HBeAg RDT was 8.4 vs 2.2 for negative HBeAg RDT (significant difference, Fisher exact test p-value = 3.1e-9) ANRS 12328 study, IAS 2017

  5. RESULTS: Discordant cases BCP/PC mutations for the 8 women with negative HBeAg RDT and HBV DNA > 5,3 Log10 IU/mL negative HBeAg RDT with HBV DNA VL > 5.3 Log IU/mL ANRS 12328 study, IAS 2017

  6. DISCUSSION HBsAg RDT to detect HBV infection during ANC • Excellent sensitivity and specificity • Point of care, low cost, adapted to routine screening during ANC in decentralized areas HBeAg RDT to predict HBV DNA levelsamong HBsAg+ women • Excellent specificity / lowersensitivity (related to BCP/PC HBV mutants) • Sensitivityincreases for higher HBV DNA level (>7.3 Log10 IU/mL) • Need to beconfirmedwithlarger and more representativesampling (ANRS 12345 TA PROHM study) HBV DNA levels and risk of transmission • Very low risk of transmission for 63% of HBV-infected women, and high risk for 26% • TDF showed effectiveness and safety to reduce MTCT for high risk women in China4 and is largely available in Cambodia • Algorithmcouldbeuseful and cost-effective to detectpregnantwomen at risk of HBV MTCT and predict TDF indication in a country where HBV VL is not routineyavailable • Impact of BCP/PC HBV mutants needs to beconfirmed in a largersample size ANRS 12328 study, IAS 2017 Pan CQ et al;NEngl J Med. 2016

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