Background
Methods
Definition of HBV/OBI reactivation
Cost effectiveness analysis
Statistical analysis
Results and discussion
Variable | Overall | HBsAg positive | HBsAg negative |
p
|
---|---|---|---|---|
No. of patients | 498 | 38 | 460 |
-
|
Age - Mean [±SD] | 61,00 [±14,05] | 55,42 [±13,62] | 57,32 [±14,95] |
0,45
|
Sex – M/F | M: 54,40% - | M: 57,89% | M: 47,83% |
0,23
|
F: 45,40% | F: 42,11% | F: 52,17% | ||
No. of patients HBsAb + | 90 [18,07%] | 0 | 90 [19,56%] |
0,003
|
No. of patients HBcAb +/ HBsAg - | 134 [26,90%] | 0 | 96 [20,86%] |
0,002
|
No. of patients HBcAb - / HBsAg - | 274 [55,03%] | 0 | 274 [59,56%] | |
Lymphoma type | Indolent: 47,3% - | Indolent: 33,35% - | Indolent: 44,34% - |
0,22
|
Aggressive: 52,7% | Aggressive: 66,65% | Aggressive: 55,66% |
0,22
| |
Rituximab therapy | Yes: 60,30% - | Yes: 18 [47,37%] | Yes 262 [56,95%] |
0,25
|
No: 39,70% | No: 20 [52,63%] | No: 198 [43,04%] | ||
HBV reactivation | 10 [2,01%] | 0 | 10 [2,17%] |
0,22
|
NUC profilaxys/rescue therapy | 38/10 | 38/0 | 0/10 |
<0,0001
|
“Per year Incidence of reactivation” [mean ± SD] | 1,71% | 0 | 2,04% |
<0,0001
|
±2,43% | ±2,97 | |||
Liver related decompensations/hospitalizations/deaths | 0% | 0% | 0% |
-
|
Therapy type
Rituximab containing protocols | ||||
---|---|---|---|---|
Variable | Overall | Yes | No |
p
|
No. of patients | 96 | 48 | 48 |
ns
|
Age - Mean [±SD] | 64,39 ± 9,63 | 65,17 ± 10,21 | 64,02 ± 8,37 |
ns
|
Sex – M/F | M: 57 | M: 30 | M: 27 |
ns
|
F: 39 | F: 18 | F: 21 | ||
Lymphoma type | Indolent: 50 | Indolent: 17 | Indolent: 33 |
0,001
|
Aggressive: 46 | Aggressive: 31 | Aggressive: 15 | ||
Probable OBI reactivation | 10 [10,42%] | 5 [10,42%] | 5 [10,42%] |
ns
|
NUC profilaxys/rescue therapy | 0/10 | 0/5 | 0/5 |
ns
|
“Per year Incidence of reactivation” [mean ± SD] | 8,23% ± 9,84 | 9,08% ± 10,69 | 11,54% ± 40,74 |
ns
|
Reactivation time [mean weeks after therapy] | 26,67 ± 12,20 | 31,60 ± 14,50 | 20,50 ± 4,72 |
ns
|
Liver related decompensations/hospitalizations/deaths | 0% | 0% | 0% |
-
|
HBV reactivation/OBI reactivation
Patient no. | Age (years) | Sex | Stage of lymphoma | Indolent aggressive (0-1) | Baseline | At diagnosis of HBV reactivation | Time of diagnosis of HBV Reactivation | Time to HBV recovery | Nuc therapy duration | Follow up HBsAg status | Outcome | |||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
HBs-Ag | HBV- DNA (UI/μL) | ALT (U/L) | Rituximab (yes/no) | Therapy | HBV- DNA (UI/μL) | Peak ALT (XN.V.) | Weeks after NHL therapy | Weeks after NUC start | Weeks | Pos/neg | ||||||
1 | 50 | F | IV | 1 | - | 0 | 23 | y | CHOP-R | 350.000 | 4,5x | 40 | 4 | 28 | Neg | Alive (NHL remission) |
2 | 73 | M | IV | 0 | - | 0 | 26 | n | VNCOP-B | 450.000 | 10x | 24 | 8 | Ongoing | Neg | Alive (NHL relapse) |
3 | 64 | F | I | 1 | - | 0 | 34 | y | Fludara-R | 650.000 | 12x | 12 | 4 | 22 | Neg | Alive (NHL remission) |
4 | 62 | M | 1 | - | 0 | 22 | y | CHOP-R | 130.000 | 4x | 44 | 3 | Ongoing | Pos | Alive (NHL relapse) | |
5 | 50 | F | II | 1 | - | 0 | 28 | y | CHOP-R | 910.000 | 20x | 20 | 8 | 44 | Neg | Alive (NHL remission) |
6 | 71 | M | IV | 0 | - | 0 | 19 | n | CHOP | 160.000 | 11x | 24 | 6 | 48 | Neg | NHL related death |
7 | 66 | M | 0 | - | 0 | 36 | n | VNCOP-B | 170.000 | 3,7x | 20 | Ongoing | Pos | Alive | ||
8 | 70 | M | IV | 0 | - | 0 | 31 | y | Fludara Nova -R | 160.000 | 5,4x | 72 | Ongoing | Pos | Alive | |
9 | 52 | F | I | 0 | - | 0 | 29 | n | CHOP | 550.000 | 6,1x | 14 | 7 | 46 | Neg | Alive |
10 | 60 | M | IV | 0 | - | 0 | 34 | n | CEOP, Gem, VNCOP-B | 340.000 | 6x | Until death | Pos | NHL related death |
Reactivation risk
Outcome and follow-up
Cost-effectiveness analysis
Unitary cost | n. patients | Total per patient | Duration [days] | Total | |
---|---|---|---|---|---|
Cost of prophylaxis
| |||||
Lamivudine | € 3,18 | 48 | € 152,64 | 360 | € 54.950,40 |
HBV DNA monitoring | € 130,00 | 48 | € 6.240,00 | 6 | € 37.440,00 |
HBsAg monitoring | € 17,00 | 48 | € 816,00 | 6 | € 4.896,00 |
AST/ALT monitoring | € 5,74 | 48 | € 275,52 | 12 | € 3.306,24 |
Total
| € 155,92 | 48 | € 7.484,16 | € 100.592,64 | |
Cost of HBV Reactivation
| |||||
HBV DNA monitoring | € 130,00 | 48 | € 6.240,00 | 6 | € 37.440,00 |
AST/ALT monitoring | € 5,74 | 48 | € 275,52 | 12 | € 3.306,24 |
Cost of DRG 205 [v24 Grouper] | € 3.769,10 | 5 | - | - | € 18.845,50 |
Total
| € 3.904,84 | - | - | - | € 40.746,24 |