1 Institute of Infection & Global Health, University of Liverpool, UK; 2Frimley Park Hospital NHS Foundation Trust, Frimley, UK;. 3Yaoundé Central Hospital ...
Risk of hepatitis B virus (HBV) infection and re-activation after discontinuation of tenofovir and/or lamivudine as part of antiretroviral therapy (ART) in HIV-positive adults in a high HBV endemicity setting A
1 Abdullahi ,
A
1 Beloukas ,
O
3,4 Mafotsing ,
J
4 Torimiro ,
C
3 Kouanfack ,
M
2 Atkins ,
AM
1* Geretti
1 Institute
of Infection & Global Health, University of Liverpool, UK; 2Frimley Park Hospital NHS Foundation Trust, Frimley, UK; 3Yaoundé Central Hospital, Ministry of Public Health, Cameroon ; 4Chantal Biya International Research Centre, Yaoundé, Cameroon
1919 BACKGROUND
AIM: To prospectively determine the risk of HBV infection and HBV reactivation over 48 weeks in HIV-1 positive patients discontinuing HBV-active agents as part of ART In Yaoundé, Cameroon
HBsAg prevalence is 8.8% in SSA6, and 11% in the general population in Cameroon7. The safety of omitting NRTIs with antiHBV activity as part of ART in settings of high HBV endemicity has not been determined
DEFINITIONS HBV infection: Incident detection of HBsAg, HBV DNA, total HBcAb in subjects lacking these markers at baseline HBV reactivation: Incident detection of HBsAg and/or HBV DNA in subjects with total HBcAb at baseline
STUDY POPULATION 81 HIV-1 positive adults established on triple ART who discontinued the NRTIs and continued on a PI within a randomised clinical trial based at Yaoundé Central Hospital At screening, all participants had a negative Determine HBsAg test and a suppressed plasma HIV-1 RNA (100 IU/ml underwent Sanger sequencing of HBV reverse transcriptase (aa 1-344) and surface antigen (aa 1-226)
71 (88) 1 (1) 4 (5) 5 (6) 29 (23, 35) 24 (18, 33)
HBsAg HBcAb
125
HBV genotype Surface mutations Pol mutations E
N59S, E164V
None
Interpretation
Total n (%)
-
+
+/-
+/-
-
Past infection
61 (75)a
-
-
-
-
-
Non immune
15 (19)
-
-
+
-
-
Immune
5 (6)
+
+
+
+
+
False Determine –ve
1 (1)
Characteristics of the population at study entry (Table 1, Table 2) All subjects tested HBV DNA negative Most subjects (61/81, 75%) had serological evidence of a past HBV infection
A smaller but significant subset (15/81, 19%) lacked evidence of HBV immunity 1 subject was HBsAg positive by Architect, indicating that the screening Determine HBsAg test had been falsely negative
a12/61
subjects had isolated Total HBcAb without other markers; HBcAb positivity was confirmed by a second assay. The other 49/61 subjects in this group had HBsAb and/or HBeAb in addition to HBcAb
RESULTS HBV infection 3/81 (4%) subjects showed changes in the HBV profile suggestive of an incident HBV infection (125, 156, 218)
Patient ID: 125 Markers Baseline Wk 4 Wk 12 Wk 24 Wk 26 Wk 36 Wk 105 sAg (-) (-) (+++) (++++) (-) (-) (-) sAb (-) (-) cAb (-) (-) (+) eAb (-) (-) (-) (-) HBV DNA UD UD 28,259 232,569 UD HIV-RNA
