Study/ Country HBV definition/ genotype Study type, N, arms HIV treatment status Followup Outcomes Remarks
Matthews et al., [6] Thailand HBsAg + (61% HBeAg +) B 14%
C 81%
G 3%
RCT
N=36
Arms:
3TC - 13
TDF- 12
TDF+3TC - 11 
Naive 48 weeks median time weighted reduction in HBV viral load
3TC - 4.07 log10 copies/mL
TDF - 4.57 log10 copies/mL
TDF+3TC - 4.73 log log10 copies/mL
no difference among all regimens (p=0.70) undetectable HBV viral load (<170 copies/mL) -
3TC - 6/13 (46%)
TDF - 9/12 (75%)
TDF+3TC - 7/11 (64%)
no difference among all regimens (p=0.65) HBV<1000 copies/mL
3TC - 6/13 (46%)
TDF - 11/12 (92%)
TDF+3TC - 10/11 (91%)
tenofovir and tenofovir plus lamivudine equivalent, both better than lamivudine alone  (p=0.013) HBeAg loss (overall) - 7/22 (33%)
no significant difference between groups HBsAg loss(overall) - 3/36 (8%) Resistance mutations detected:
L180M/M204V - 3TC arm (1)
M204V - 3TC arm (1)
Other treatment failures showed wild type (2), and viral load too low for sequencing (2) Hepatic flares (overall) - 9/36 (25%)
Landmark RCT in treatment naive patients showed tenofovir containing-regimens are superior, but only at an adjusted higher HBV level (<1000 copies/mL vs. undetectable)
Avihingsanon et al., [7] Thailand HBsAg+ (69% HBeAg +) B - 6%
C - 94%
RCT
N=16
Arms:
FTC/ZDV/EFV - 6
FTC/TDF/EFV - 10
Naive 48 weeks median time weighted area under the curve (TWAUC) reduction in HBV viral load
FTC/ZDV/EFV - 3.25. log10 copies/mL
FTC/TDF/EFV - 5.32 log10 copies/mL
Greater reduction in  TWAUC  for FTC/TDF/EFV (p=0.03)   undetectable HBV viral load (<170 copies/mL) -
FTC/ZDV/EFV - 33%
FTC/TDF/EFV - 90%
FTC/TDF/EFV superior to FTC/ZDV/EFV (p=0.036) HBeAg loss (overall) - 4/11 (36%)
no difference among either regimen HBsAg loss (overall) - 1/16 (6%), FTC/ZDV/EFV arm No resistance data avilable Hepatic flares (overall) - 3/16 (19%)
Showed FTC/TDF superior to FTC alone as HBV-active agent Suggested that FTC with synergistic activity to TDF compared to 3TC, hence the difference in findings compared to Matthews et al. 2008 finding
Kamdoung et al., [8] Thailand HBsAg+ (63% HBeAg +) B 17%
C 83%
Prospective cohort
3TC as only active agent
N=30
HBeAg+ - 19
HBeAg- - 11
  12  months up to 5 years undetectable HBV viral load (<2.18 log10 IU/mL, 840 copies/mL)*
12 months
Overall 20/30 (67%)
HBeAg+ - 9/19 (47%)
HBeAg- - 11/11 (100%)
Higher suppression in HBeAg- (p=0.004) 5 years
Overall 9/30 (30%)
HBeAg+ - 2/19 (11%)
HBeAg- - 7/11 (64%) HBeAg loss (overall) - 37%
5 years (7/19 total; 7/8 virally suppressed with samples at 5 years) HBsAg loss (overall) - 14% at 5 years (4/29 total; 4/17 virally suppressed with samples at 5 years) 5-year cumulative resistance: 6/30 (20%), all HBeAg+ Resistance mutations detected:
M204I (1)
L180M/V173L/M204V(1)
L180M/M204V (2)
L180M/M204I (1)
L180M/V173L/M204I (1)
*some samples diluted by 10 due to insufficient quantitiy
Showed good long-term response for 3TC alone especially in HBeAg- patients, with complete suppression in these at 12 months. Long-term suppression (5 years) was 30%
Kim et al [9]

Kenya

HBsAg+

(11% HBeAg +)

A1 - 100%

Prospective cohort
3TC as only active agent
N=27
HBeAg+ - 3
HBeAg- - 24
Naive 18 months undetectable HBV viral load (<100 IU/mL, 560 copies/mL)
Overall 89% (17/19 evaluable patients, with 5 deaths prior to 18 months, cause of deaths not reported)HBeAg loss - not reported
HBsAg loss - not reported
Resistance mutations detected:
M204I (1)
A200V/M204I (1)  
Showed good long-term response for 3TC alone with complete suppression in 89% at 18 months, no long term follow-up
Matthews et al., [10]


Thailand 28.5%
Australia 40.6%
USA 30.9%
HBsAg+

(49% HBeAg +)  

A  47 (50%)
C 33 (35%)
All other types 13 (14%)
Not tested 57
Prospective cohort
N=165
Thailand n=47
Australia n=67
USA n=51

TDF+FTC/3TC - 94 FTC or 3TC - 32
TDF - 21
No HBV drug - 18
HAART- experienced, 89% on HBV-active regimen 2.8 years undetectable HBV viral load (<357 IU/mL, 2000 copies/mL) at study visit
Overall 79.2% of study visits
TDF+FTC/3TC - 86%
FTC or 3TC - 61% TDF - 80%
No HBV drug - 53%
TDF+FTC/3TC associated with higher likelihood of HBV viral suppression at time of visit than any of the other groups, including tenofovir monotherapy (p=0.02) HBeAg loss - not reported
HBsAg loss - not reported
Study looking at treatment-experienced HIV/HBV co-infected patients showing improved outcomes with combination tenofovir therapy
Legend: HBsAg - hepatitis B surface antigen, HBeAg - hepatitis B e antigen, RCT - randomized controlled trial, 3TC - lamivudine, TDF - tenofovir, AZT - zidovudine, FTC- emtricitabine
Table 1: Selected studies involving HBV/HIV co-infected patients in resource-limited settings.
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