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Table 2 Side effects and serious adverse events in patients receiving triple therapy

From: Safety and efficacy of protease inhibitor based combination therapy in a single-center “real-life” cohort of 110 patients with chronic hepatitis C genotype 1 infection

  Number BOC TPR P-Value
  (N = 102) (N = 37) (N = 65)  
Grade 3/4 anemia 13 (12.7%)§ 4 (10.8%) 9 (13.8%) 0.77
Grade 3/4 neutropenia 25 (24.5%) 12 (32.4%) 13 (20%) 0.23
Grade 3/4 thrombopenia 14 (13.7%) 3 (8.1%) 11 (16.9%) 0.25
Flu-like symptoms 44 (43.1%) 20 (54.1%) 24 (36.9%) 0.10
GI disorders 43 (42.2%) 16 (43.2%) 27 (41.5%) 1
Grade 1/2 rash 35 (34.3%) 11 (29.7%) 24 (36.9%) 0.52
Psychiatric disorder 29 (28.4%)§§ 11 (29.7%) 18 (27.7%) 1
Fatigue 27 (26.5%) 15 (40.5%) 12 (18.5%) 0.02
Anorectal dyscomfort 25 (24.5%) 1 (2.7%) 24 (36.9%)§§§ <0.01
Insomnia 23 (22.5%) 7 (18.9%) 16 (24.6%) 0.63
Bronchopulmonal symptoms 20 (19.6%) 9 (24.3%) 11 (16.9%) 0.44
Dysgeusia 10 (9.8%) 9 (24.3%) 1 (1.5%) <0.01
Immunothyreoiditis 4 (3.9%) 0 4 (6.2%) 0.29
Serious adverse event Number Comments/Outcome
Grade 4 anemia 2 Both patients received blood transfusions
Grade 4 neutropenia 3 1 patient with neutropenic sepsis; all 3 recovered after dose reduction of peginterferon
Grade 4 thrombopenia 6 1 patient received a platelet concentrate
Grade 3 rash 4 TPR was discontinued early in 1 patient
DRESS/SJS None -
Neurological symptoms 2 Radial nerve paresis (recovery after physiotherapy) and urine incontinency (ongoing)
Localized infections 3 All fully recovered (balanitis, epididymitis, perspiratory gland abscess)
Sepsis 4 2 patients recovered; 2 patients died
Hepatic decompensation 2 Both recovered, but 1 patient died 6 weeks after discontinuation of treatment
Decompensation of autoimmune disorder 1 First manifestation of autoimmune diabetes mellitus.
Ileus 2 Fully recovered after surgical intervention (1x) or conservative treatment (1x)
Cardiac complications 1 Unstable angina pectoris, full recovery after PTCA with stent implantation
  1. 30 SAE occured in 22 individuals. [BOC = boceprevir; TPR = telaprevir; N = number; GI = gastrointestinal; DRESS = drug induced rash and eosinophilia with systemic symptoms; SJS = Stevens Johnson syndrome; PTCA = percutaneous coronary angiography; § = 5 patients received transfusion; §§ = 9 patients with history of psychiatric illness; §§§ = hemorrhagic proctitis in 5 patients].