The Efficacy and Safety of 12 Weeks of Sofosbuvir and Ledipasvir versus Sofosbuvir, Ledipasvir, and Ribavirin in Patients with Chronic Hepatitis C, Genotype 1, Who Have Cirrhosis and Have Failed Prior Therapy: A Systematic Review and Meta-Analysis
Table 3
Combined adverse events for SOF/LDV and SOF/LDV/RBV and their associated pooled relative risks, with SOF/LDV/RBV as the reference group.
Adverse effect
SOF/LDV ()
SOF/LDV/RBV ()
Pooled RR (95% CI)
Any side effect
223
523
0.11 (0.04–0.29)
Discontinuation because of adverse effect
0
3
0.66 (0.11–3.84)
Serious
5
7
1.09 (0.64–1.85)
Fatigue/asthenia
33
68
0.57 (0.39–0.83)
Rash
2
18
0.20 (0.06–0.66)
Irritability
2
18
0.19 (0.05–0.70)
Cough/bronchitis
7
23
0.39 (0.17–0.88)
Anemia
3
45
0.11 (0.04–0.24)
HA
44
61
0.97 (0.77–1.24)
Insomnia
10
27
0.67 (0.40–1.10)
Nausea
19
43
0.73 (0.51–1.05)
Diarrhea
7
8
1.16 (0.71–1.90)
URTI
7
23
0.50 (0.21–1.19)
Muscle spasm
1
10
0.29 (0.08–1.06)
Arthralgia
7
20
0.66 (0.36–1.20)
Dry skin
0
10
0.26 (0.04–1.73)
Dizziness
3
13
0.52 (0.21–1.30)
Dyspnea
0
21
0.11 (0.01–1.59)
Hgb < 8.5 g/dL
1
9
0.58 (0.07–4.750)
Lymphocytes < 350 per mm3
0
1
Neutrophils 500–750 per mm3
2
0
Platelets 25–50 per mm3
2
0
1.51 (0.85–2.68)
result not possible as adverse event recorded in one study only.
