Table 4.
Treatment-Related Adverse Events and Laboratory Abnormalities
| Adverse events and laboratory abnormalities | HCV genotype 1b | HCV genotype 1a | HCV genotype 2a/2b | Total (n=30) | |
|---|---|---|---|---|---|
|
| |||||
| RAV (−) | RAV (+) Y93H | ||||
|
|
|
|
|
||
| DCV and ASV (n=18) | LDV/SOF (n=3) | LDV/SOF (n=5) | SOF and RBV (n=4) | ||
| Patients with SAE | 0 | 0 | 0 | 0 | 0 |
| Discontinued due to AE | 0 | 0 | 0 | 0 | 0 |
| Patients with any AE | |||||
| Headache | 3 (16.7) | 1 (33.3) | 2 (40.0) | 2 (50.0) | 8 (26.7) |
| Fatigue | 6 (33.3) | 1 (33.3) | 1 (20.0) | 2 (50.0) | 10 (33.3) |
| Nausea | 2 (11.1) | 0 | 2 (40.0) | 2 (50.0) | 6 (20.0) |
| Insomnia | 2 (11.1) | 1 (33.3) | 0 | 2 (50.0) | 5 (16.7) |
| Itching | 0 | 1 (33.3) | 0 | 0 | 1 (3.3) |
| Rash | 0 | 0 | 0 | 0 | 0 |
| Diarrhea | 2 (11.1) | 0 | 0 | 0 | 2 (6.7) |
| Anxiety | 0 | 0 | 0 | 1 (25.0) | 1 (3.3) |
| Dizziness | 2 (11.1) | 0 | 1 (20.0) | 2 (50.0) | 5 (16.7) |
| Laboratory abnormalities | |||||
| Hemoglobin (10 to <12 g/dL) | 4 (22.2) | 0 | 2 (40.0) | 2 (50.0) | 8 (26.7) |
| Hemoglobin (8 to <10 g/dL) | 2 (11.1) | 0 | 0 | 2 (50.0) | 4 (13.3) |
| Total bilirubin (>1.0 to 2.5×ULN) | 0 | 0 | 0 | 1 (25.0) | 1 (3.3) |
| Total bilirubin (>2.5 to 5.0×ULN) | 0 | 0 | 0 | 1 (25.0) | 1 (3.3) |
| ALT (>5.0 to 10×ULN) | 2 (11.1) | 0 | 0 | 0 | 2 (6.7) |
| Neutrophil (800 to <1,000×mm3) | 1 (5.6) | 0 | 0 | 0 | 1 (3.3) |
Data are presented as number (%).
HCV, hepatitis C virus; RAV, resistance-associated variant; DCV, daclatasvir; ASV, asunaprevir; LDV/SOF, ledipasvir/sofosbuvir; RBV, ribavirin; SAE, serious adverse event; AE, adverse event; ULN, upper limit of normal; ALT, alanine aminotransferase.