TY - JOUR
T1 - Hepatitis B surface antigen quantification as a predictor of seroclearance during treatment in HIV-hepatitis B virus coinfected patients from Sub-Saharan Africa
AU - Boyd, Anders
AU - Maylin, Sarah
AU - Moh, Raoul
AU - Mahjoub, Nadia
AU - Gabillard, Delphine
AU - ANRS 12240 VarBVA study
AU - Eholié, Serge Paul
AU - Danel, Christine
AU - Anglaret, Xavier
AU - Zoulim, Fabien
AU - Girard, Pierre-Marie
AU - Delaugerre, Constance
AU - Lacombe, Karine
N1 - © 2015 Journal of Gastroenterology and Hepatology Foundation and John Wiley & Sons Australia, Ltd.
PY - 2016/3/1
Y1 - 2016/3/1
N2 - Background and Aim: In Sub-Saharan Africa, seroclearance of hepatitis B surface antigen (HBsAg) and hepatitis B "e" antigen (HBeAg), including their quantifiable markers, have rarely been evaluated during long-term antiviral treatment among patients coinfected with HIV and hepatitis B virus (HBV). Methods: In this prospective cohort study from two randomized-control trials in Côte d'Ivoire, 161 antiretroviral-naïve HIV-HBV coinfected patients starting lamivudine (n=76) or tenofovir/emtricitabine (n=85) containing antiretroviral therapy were included. HBV DNA was quantified using an in-house assay (detection limit=12copies/mL) and HBsAg quantification (qHBsAg) using the Elecsys assay. Results: Overall, 33 (20.5%) patients were HBeAg positive, 121 (75.2%) had detectable HBV DNA, and 92/93 (98.9%) harbored HBV genotype E. Median treatment duration was 35.5months (interquartile range: 24.3-36.4). Among HBeAg-positive patients, cumulative proportion with HBeAg seroclearance was 46.3% (n=14). Overall, cumulative proportion of HBsAg seroclearance was 6.6% (n=10). Lower baseline qHBsAg levels and strong 12-month declines in qHBsAg were significantly associated with HBsAg seroclearance for both HBeAg-negative and HBeAg-positive patients. When taken at certain levels, these determinants provided moderate sensitivity (Se) and specificity (Sp) in predicting HBsAg seroclearance at month 36 (≤1000IU/mL at baseline, Se=0.80, Sp=0.80; ≥1.0log10IU/mL drop at month 12, Se=0.57, Sp=1.00). Instead, qHBsAg levels ≤100 or ≤10IU/mL at month 12 were optimal (both Se=0.90 and Sp=1.00). Detectable HBV-DNA provided fairly high Se and Sp when evaluated at baseline (Se=1.00, Sp=0.80), but not at month 12 (Se=0.80, Sp=0.40). Conclusions: HBsAg seroclearance rates are not common in patients from Sub-Saharan Africa treated with anti-HBV containing antiretroviral therapy. qHBsAg levels at 12months of treatment may accurately predict HBsAg seroclearance.
AB - Background and Aim: In Sub-Saharan Africa, seroclearance of hepatitis B surface antigen (HBsAg) and hepatitis B "e" antigen (HBeAg), including their quantifiable markers, have rarely been evaluated during long-term antiviral treatment among patients coinfected with HIV and hepatitis B virus (HBV). Methods: In this prospective cohort study from two randomized-control trials in Côte d'Ivoire, 161 antiretroviral-naïve HIV-HBV coinfected patients starting lamivudine (n=76) or tenofovir/emtricitabine (n=85) containing antiretroviral therapy were included. HBV DNA was quantified using an in-house assay (detection limit=12copies/mL) and HBsAg quantification (qHBsAg) using the Elecsys assay. Results: Overall, 33 (20.5%) patients were HBeAg positive, 121 (75.2%) had detectable HBV DNA, and 92/93 (98.9%) harbored HBV genotype E. Median treatment duration was 35.5months (interquartile range: 24.3-36.4). Among HBeAg-positive patients, cumulative proportion with HBeAg seroclearance was 46.3% (n=14). Overall, cumulative proportion of HBsAg seroclearance was 6.6% (n=10). Lower baseline qHBsAg levels and strong 12-month declines in qHBsAg were significantly associated with HBsAg seroclearance for both HBeAg-negative and HBeAg-positive patients. When taken at certain levels, these determinants provided moderate sensitivity (Se) and specificity (Sp) in predicting HBsAg seroclearance at month 36 (≤1000IU/mL at baseline, Se=0.80, Sp=0.80; ≥1.0log10IU/mL drop at month 12, Se=0.57, Sp=1.00). Instead, qHBsAg levels ≤100 or ≤10IU/mL at month 12 were optimal (both Se=0.90 and Sp=1.00). Detectable HBV-DNA provided fairly high Se and Sp when evaluated at baseline (Se=1.00, Sp=0.80), but not at month 12 (Se=0.80, Sp=0.40). Conclusions: HBsAg seroclearance rates are not common in patients from Sub-Saharan Africa treated with anti-HBV containing antiretroviral therapy. qHBsAg levels at 12months of treatment may accurately predict HBsAg seroclearance.
KW - Africa
KW - Antiviral Agents/administration & dosage
KW - Biomarkers/blood
KW - Cohort Studies
KW - Coinfection/diagnosis
KW - Drug Therapy, Combination
KW - Emtricitabine/administration & dosage
KW - HIV Infections/diagnosis
KW - Hepatitis B Surface Antigens/blood
KW - Hepatitis B e Antigens/blood
KW - Hepatitis B/diagnosis
KW - Humans
KW - Lamivudine/administration & dosage
KW - Predictive Value of Tests
KW - Prospective Studies
KW - Randomized Controlled Trials as Topic
KW - Sensitivity and Specificity
KW - Tenofovir/administration & dosage
KW - Time Factors
UR - https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=84959174916&origin=inward
UR - https://www.ncbi.nlm.nih.gov/pubmed/26313291
U2 - https://doi.org/10.1111/jgh.13156
DO - https://doi.org/10.1111/jgh.13156
M3 - Article
C2 - 26313291
SN - 0815-9319
VL - 31
SP - 634
EP - 644
JO - Journal of gastroenterology and hepatology
JF - Journal of gastroenterology and hepatology
IS - 3
ER -