Table 3.
Change in Parameters During Treatment and at SVR 12 of Patients With Hepatitis C and Thalassemia Major With Direct Acting Antivirals Compared to Baseline.
| At onset of treatment (mean ± SD) | Peak/nadir values during/end of the treatment (mean ± SD) | P value | At SVR 12 (mean ± SD) | P value | |
|---|---|---|---|---|---|
| Mean AST (IU/l) | 64 ± 49 | 30 ± 15 (ETR) | <0.0001 | 40 ± 21 | 0.2 |
| Mean ALT (IU/l) | 59 ± 33 | 36 ± 19 (ETR) | 0.0005 | 35 ± 17 | <0.0001 |
| Mean ALP (IU) | 107 ± 81 | 126 ± 106 (ETR) | 0.08 | 110 ± 97 | 0.55 |
| Mean Hb (g/dl) | 8.8 ± 1.0 | 7.5 ± 1.5 (nadir) | <0.0001 | 9.1 ± 1.3 | 0.28 |
| Mean ferritin (ng/ml) | 5381 ± 4198 | 4249 ± 3106 (ETR) | 0.08 | 4703 ± 2781 | 0.03 |
| Mean WCC (per cumm) | 10,340 ± 12,987 | 6838 ± 4739 (nadir) | 0.06 | 8975 ± 6991 | 0.4 |
| Mean platelets (per litre ×109) | 298 ± 151 | 266 ± 174 (nadir) | 0.02 | 327 ± 203 | 0.14 |
| Mean albumin (g/dl) | 4 ± 0.4 | 3.9 ± 0.5 (nadir) | 0.3 | 4.0 ± 0.6 | 0.97 |
| Mean bilirubin (mg/dl) | 1.7 ± 0.8 | 2.3 ± 0.8 (peak) | 0.00027 | 1.6 ± 0.5 | 0.8 |
| Deferoxamine—mean weekly vials | 10.1 ± 5.1 | 10.2 ± 4.7 (ETR) | 0.08 | 10.5 ± 5.1 | 0.86 |
| Deferiprone—mean daily dose (mg) | 2807 ± 878 | 2884 ± 984 (ETR) | 0.33 | 3000 ± 1040 | 0.61 |
| Deferasirox—mean defirox dose | 1533 ± 502 | 1542 ± 497 (ETR) | 0.32 | 1516 ± 509 | 0.91 |
| Mean transfusion requirement (ml/month) | 896 ± 199 | 1074 ± 256 (ETR) | 0.0003 | 937 ± 197 | 0.06 |
| Serum creatinine (mg%) | 0.6 ± 0.1 | – | – | 0.6 ± 0.1 | 0.25 |
| Mean HCV RNA (IU/ml) | 1,820,907 ± 3,059,612 | – | – | 0 | 0.001 |
P < 0.05 was considered as significant. Significant p values are shown in bold. The ETR values were taken on completion of treatment. The peak and nadir values were the highest and the least values at any point during the entire course of treatment until the completion of therapy. SD, standard deviation; AST, aspartate amonotransferase; ALT, alanine aminotransferases; ALP, alkaline phosphatase; WCC, white cell count; ETR, end of treatment response.