TABLE 4.
Characteristics of the Transplanted Patients
| Characteristics of the Transplanted Patients |
P Values |
||||||
|---|---|---|---|---|---|---|---|
| C Versus As Versus | C Versus | C Versus | |||||
| C | As | AA | All | AA | As | AA | |
| No. of patients | 68 (40.0) | 85 (50.0) | 17 (10.0) | 170 (100) | |||
| Gender, male | 53 (78.0) | 63 (74.1) | 13 (76.5) | 129 (75.9) | NS | NS | NS |
| Age, years (mean ± SD) | 53.1 ± 8.6 | 53.0 ± 10.5 | 43.0 ± 14.9 | 51.9 ± 10.7 | 0.001 | NS | <0.001 |
| OLT indication | 0.008 | 0.014 | NS | ||||
| End-stage cirrhosis | 30 (44.2) | 26 (30.5) | 8 (47.0) | 64 (37.6) | NS | NS | NS |
| HCC | 29 (42.6) | 55 (64.7) | 5 (29.4) | 89 (52.4) | 0.003 | 0.006 | NS |
| Acute liver failure | 9 (13.2) | 4 (4.8) | 4 (23.6) | 17 (10.0) | 0.032 | 0.06 | NS |
| Labs at transplantation | |||||||
| HBeAg (+) | 15/56 (26.8) | 18/69 (21.2) | 4/13 (23.5) | 37/138 (26.8) | NS | NS | NS |
| HBV DNA detectable | 43/64 (67.2) | 46/71 (54.1) | 9/16 (52.9) | 98/151 (64.9) | NS | NS | NS |
| Log10 copies/mL (mean ± SD) | 4.2 ± 2.4 | 4.2 ± 0.2 | 3.7 ± 0.5 | 4.1 ± 2.2 | NS | NS | NS |
| HBV DNA > 5 log10 copies/mL | 25/43 (58.1) | 29/46 (63.0) | 4/9 (44.4) | 58/98 (59.1) | NS | NS | NS |
| ALT, U/L | 58 (13–2796) | 49 (20–3543) | 76 (13–1649) | 53 (13–3543) | NS | NS | NS |
| AST, U/L | 80 (16–6270) | 66 (24–3907 | 71 (30–1946) | 71 (16–6270) | NS | NS | NS |
| Bilirubin, mg/dL | 2.8 (0.5–39) | 2.1 (0.4–59.4) | 5.4 (0.3–24.9) | 2.6 (0.3–59.4) | NS | NS | NS |
| INR | 1.5 (1–7.3) | 1.4 (0.8–4.8) | 1.8 (1.1–4.4) | 1.5 (0.8–7.3) | NS | NS | NS |
| Creatinine, mg/dL | 1.1 (0.1–7.8) | 1.0 (0.5–6) | 1.0 (0.5–9) | 1.5 (0.1–9.0) | NS | NS | NS |
| End-stage cirrhosis: lab MELD | 20 (9–38) | 21 (8–40) | 23 (11–40) | 21 (8–40) | NS | NS | NS |
| HCC: within Milan criteria* | 11/24 (45.3) | 27/52 (52.0) | 3/4 (75.0) | 41/80 (51.2) | NS | NS | NS |
| Antiviral treatment pre-OLT† | 49 (72.0) | 66 (77.6) | 10 (58.8) | 125 (73.5) | NS | NS | NS |
| Breakthrough pre-OLT | 9/49 (18.3) | 10/66 (15.1) | 3/10 (30) | 22/125 (17.6) | NS | NS | NS |
| Confirmed genotypic resistance pre-OLT‡ | 4/5 (80.0) | 5/6 (83.3) | 2/3 (66.6) | 11/14 (78.5) | NS | NS | NS |
| HBV prophylactic regimen post-OLT | |||||||
| HBIG + antiviral | 67 (98.5) | 82 (96.4) | 16 (94.1) | 165 (97.0) | NS | NS | NS |
| HBIG only | 0 (0) | 1 (1.1) | 0 (0) | 1 (0.5) | |||
| Antiviral only | 1 (1.5) | 2 (2.3) | 1 (5.9) | 4 (2.3) | |||
| No. of patients treated for rejection | 7 (10.2) | 14 (16.4) | 2 (11.7) | 23 (13.5) | NS | NS | NS |
| Duration of steroid use, months | 5 (0–27) | 7 (0–17) | 7 (3–13) | 6 (0–27) | NS | NS | NS |
NOTE: The results are expressed as number (%) or median (range) unless specified otherwise.
Abbreviations: ALT, alanine aminotransferase; AA, African Americans; As, Asian Americans; AST, aspartate aminotransferase; C, Caucasians; HBeAg, hepatitis B e antigen; HBIG, hepatitis B immune globulin; HBV, hepatitis B virus; HCC, hepatocellular carcinoma; INR, international normalized ratio; MELD, Model for End-Stage Liver Disease; NS, not significant; OLT, orthotopic liver transplantation; SD, standard deviation.
See Mazzaferro et al.27
Ninety-eight of 123 (76.4%) patients transplanted after September 2002 when adefovir was approved were on antiviral therapy at the time of transplant versus 27 of 47 (57.1%) patients transplanted before September 2002.
Fourteen of 22 patients with virological breakthrough pre-transplant with blood samples collected prior to the initiation of rescue therapy were tested for antiviral resistance