title: Hepatitis B surface antigen quantification as a predictor of seroclearance during treatment in HIV-hepatitis B virus coinfected patients from Sub-Saharan Africa.
abstract: OBJECTIVE
  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 = 12 copies/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 35.5 months (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 (≤ 1000 IU/mL at baseline, Se = 0.80, Sp = 0.80; ≥ 1.0 log10  IU/mL drop at month 12, Se = 0.57, Sp = 1.00). Instead, qHBsAg levels ≤ 100 or ≤ 10 IU/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 12 months of treatment may accurately predict HBsAg seroclearance.
authors: INSERM, UMR_S1136, Institut Pierre Louis d'Epidémiologie et de Santé Publique, Paris, France.
authors: Anders
authors: A
authors: Boyd
authors: Laboratoire de Virologie, Hôpital Saint-Louis, AP-HP, Paris, France.|INSERM U941, Paris, France.|Université Paris-Diderot, Paris, France.
authors: Sarah
authors: S
authors: Maylin
authors: Programme PAC-CI, ANRS Research Site, Treichville University Hospital, Abidjan, Ivory Coast.
authors: Raoul
authors: R
authors: Moh
authors: Laboratoire de Virologie, Hôpital Saint-Louis, AP-HP, Paris, France.|INSERM U941, Paris, France.
authors: Nadia
authors: N
authors: Mahjoub
authors: Epidémiologie-Biostatistique, INSERM, U897.|ISPED, University of Bordeaux, Bordeaux, France.
authors: Delphine
authors: D
authors: Gabillard
authors: Medical School, University Felix Houphouet Boigny, Abidjan, Côte d'Ivoire.|Programme PAC-CI, ANRS Research Site, Treichville University Hospital, Abidjan, Ivory Coast.|Department of Infectious and Tropical Diseases, Treichville University Teaching Hospital, Abidjan, Ivory Coast.
authors: Serge Paul
authors: SP
authors: Eholié
authors: Epidémiologie-Biostatistique, INSERM, U897.|ISPED, University of Bordeaux, Bordeaux, France.|Programme PAC-CI, ANRS Research Site, Treichville University Hospital, Abidjan, Ivory Coast.
authors: Christine
authors: C
authors: Danel
authors: Epidémiologie-Biostatistique, INSERM, U897.|ISPED, University of Bordeaux, Bordeaux, France.|Programme PAC-CI, ANRS Research Site, Treichville University Hospital, Abidjan, Ivory Coast.
authors: Xavier
authors: X
authors: Anglaret
authors: Centre de Recherche sur le Cancer de Lyon, Equipes 15 et 16, INSERM, Unité 1052, Lyon, France.
authors: Fabien
authors: F
authors: Zoulim
authors: Department of Infectious and Tropical Diseases, Saint-Antoine Hospital, Paris, France.|Institut Pierre Louis d'Epidémiologie et de Santé Publique, Sorbonne Universités, UPMC Univ Paris 06, UMR S 1136, Paris, France.
authors: Pierre-Marie
authors: PM
authors: Girard
authors: Laboratoire de Virologie, Hôpital Saint-Louis, AP-HP, Paris, France.|INSERM U941, Paris, France.|Université Paris-Diderot, Paris, France.
authors: Constance
authors: C
authors: Delaugerre
authors: Karine
authors: K
authors: Lacombefor
mesh_terms: D000349:Africa; D000998:Antiviral Agents / Q000008:administration & dosage; D015415:Biomarkers / Q000097:blood; D015331:Cohort Studies; D060085:Coinfection / Q000175:diagnosis / Q000188:drug therapy* / Q000821:virology*; D004359:Drug Therapy, Combination; D000068679:Emtricitabine / Q000008:administration & dosage; D015658:HIV Infections / Q000175:diagnosis / Q000188:drug therapy* / Q000821:virology*; D006509:Hepatitis B / Q000175:diagnosis / Q000188:drug therapy* / Q000821:virology*; D006514:Hepatitis B Surface Antigens / Q000097:blood*; D006513:Hepatitis B e Antigens / Q000097:blood; D006801:Humans; D019259:Lamivudine / Q000008:administration & dosage; D011237:Predictive Value of Tests; D011446:Prospective Studies; D016032:Randomized Controlled Trials as Topic; D012680:Sensitivity and Specificity; D000068698:Tenofovir / Q000008:administration & dosage; D013997:Time Factors
chemical_list: D000998:Antiviral Agents; D015415:Biomarkers; D006514:Hepatitis B Surface Antigens; D006513:Hepatitis B e Antigens; D019259:Lamivudine; D000068698:Tenofovir; D000068679:Emtricitabine
keywords: HBeAg quantification; HBsAg quantification; chronic viral hepatitis; immunosuppression; serological endpoints