Introduction
Indicator/population | IFN-based therapy | IFN-free DAA therapy |
---|---|---|
SVR rate % | ||
Hemodialysis | ||
HIV/HCV co-infection | ||
Liver transplantation | 8–50% [95] | |
Treatment discontinuation rate | ||
Hemodialysis | ||
HIV/HCV co-infection | ||
Liver transplantation | 27.6% [95] |
HCV infection in patients receiving hemodialysis
Treatment regimen (treatment duration) study | Type of study | Patient population | HCV GT | Sample size | SVR rate (%) | SAE (%) | Treatment discontinuation rate (%) | Comments |
---|---|---|---|---|---|---|---|---|
Grazoprevir/elbasvir (12 weeks) | AEs were comparable between intervention and placebo groups | |||||||
C-SURFER Roth et al. [47] | CT | CKD 4/5 including HD | GT1 | 122 (HD: 92) | 94.2% (115/122) | 14.4% (16/111) | 4.1% (5/122)a | |
C-SURFER Bruchfeld et al. [58] | CT | CKD 4/5 including HD | GT1 | 102 | 95.1% (97/102) | 12.7% (13/102) | 2.9% (3/102) | |
PTV/RTV/OBV and DSV ± RBV (12 weeks) | Should be monitored for DDIs | |||||||
RUBY-1 Pockros et al. [31] | CT | CKD 4/5 including HD | GT1 | 20 (CKD5/HD: 14) | 90% (18/20) | 20% (4/20) | 0 | |
PTV/RTV/OBV (12 weeks) | ||||||||
Atsukawa et al. [60] | RW | HD | GT1b | 31 | 96.8% (30/31) | 3.2% (1/31) | 3.2% (1/31) | |
DCV/ASV (24 weeks) | 24-Week treatment regimen SVR rate was not high in patients infected with GT1a | |||||||
Suda et al. [33] | RW | HD | GT1 | 21 | 95.2% (20/21) | 5% (1/21) | 5% (1/21) | |
Toyoda et al. [66] | RW | HD | GT1b | 28 | 100% (28/28) | 3.6% (1/28) | ||
Kawakami et al. [67] | RW | HD | GT1 | 18 | 100% (18/18) | 6% (1/18) | 0% | |
Miyazaki et al. [68] | RW | HD | GT1b | 10 | 100% (10/10) | 20% (2/10) | 0% | |
Suda et al. [32] | RW | HD | GT1 | 123 | 95.9% (118/123) | 3.3% (4/123) | ||
Glecaprevir/pibrentasvir (12 weeks) | Pan-genotypic activity | |||||||
Gane et al. [75] | CT | CKD4/5 including HD | GT1-6 | 104 (HD: 85) | 98% (102/104) | 24% (25/104) | 4% (4/104) | |
SOF-based therapy SOF/PEG-IFN/RBV, SOF/RBV, SOF/SMV, SOF/SMV/RBV | SOF is still not recommended for patients with severe renal dysfunction | |||||||
Saxena et al. [71] | RW | eGFR < 45 mL/min/1.73 m2 | GT1-6 | 73 (HD: 5) | 83% (53/64) | 22% (16/73) | 7% (5/73) | |
eGFR < 30 mL/min/1.73 m2 | GT1-3 | 17 (HD: 5) | 88% (15/17) | 18% (3/17) | 6% (1/17) | |||
SOF/SMV (12 weeks) | ||||||||
Nazario et al. [72] | RW | eGFR < 30 mL/min/1.73 m2 including HD | GT1 | 17 (HD: 15) | 100% (17/17) | 0 | 0 |
IFN-based therapy in hemodialysis patients
IFN-free DAA combination therapy in hemodialysis patients
Grazoprevir and elbasvir
Paritaprevir/ritonavir and ombitasvir with or without dasabuvir
Asunaprevir and daclatasvir
Sofosbuvir-based therapy
Glecaprevir/pibrentasvir
HCV infection in patients with HIV co-infection
Treatment regimen/ study | Type of study | Treatment duration (weeks) | HCV GT | Sample size | SVR rate (%) | SAE rate (%) | Treatment discontinuation rate (%) | Comments |
---|---|---|---|---|---|---|---|---|
Sofosbuvir/ribavirin | ||||||||
PHOTON-1 Sulkowski et al. [84] | CT | 12–24 | GT1–3 | 223 | GT1 24 W: 76% (87/114) GT2 12 W: 88% (23/26) GT2 24 W: 92% (22/24) GT3 12 W: 67% (28/42) GT3 24 W: 94% (16/17) | 6% (14/223) | 3% (7/223) | |
PHOTON-2 Molina et al. [85] | CT | 12–24 | GT1–4 | 274 | GT1 24 W: 85% (95/112) GT2 12 W: 89% (17/19) GT2 24 W: 83% (5/6) GT3 24 W: 89% (94/106) GT4 24 W: 84% (26/31) | 1% (4/274) | 2% (6/274) | |
Sofosbuvir/ledipasvir | Co-administration of ledipasvir and TDF caused an increase in TDF serum concentration | |||||||
ERADICATE study Osinusi et al. [35] | CT | 12 | GT1 | 50 | 98% (49/50) | 2% (1/50) | 0 | |
ION-4 Naggie et al. [36] | CT | 12 | GT1/4 | 335 | 96% (322/335) | 2% (8/335) | 0 | |
PTV/RTV/OBV and DSV | Should be monitored for drug–drug interactions with RTV | |||||||
TURQUOISE-1 Sulkowski et al. [87] | CT | 12–24 | GT1 | 63 | 12 W: 94% (29/31) 24 W: 91% (29/32) | 0 | 0 | |
Elbasvir/grazoprevir | ||||||||
C-EDGE CO-INFECTION Rockstroh et al. [88] | CT | 12 | GT1/4/6 | 218 | 96% (210/218) | 1% (2/218) | 0 | |
Sofosbuvir/velpatasvir | Renal function should be monitored in TDF with velpatasvir co-administration | |||||||
ASTRAL-5 Wyles et al. [107] | CT | 12 | GT1–4 | 106 | 95% (101/106) | 2% (2/106) | 2% (2/106) | |
Sofosbuvir/daclatasvir | ||||||||
ALLY-2 Hinestrosa et al. [90] | CT | 8-12 | GT1–4 | 203 | 12 W: 97.4% (149/153) 8 W: 76% (38/50) | 2% (4/203) | 0 |
IFN-based therapy in patients with HIV/HCV co-infection
Peg-IFN + ribavirin + protease inhibitor in patients with HIV/HCV co-infection
IFN-free DAA therapy in patients with HIV/HCV co-infection
Sofosbuvir and ribavirin
Sofosbuvir/ledipasvir
Paritaprevir/ritonavir/ombitasvir/dasabuvir
Elbasvir/grazoprevir
Sofosbuvir/velpatasvir
Sofosbuvir/daclatasvir
HCV recurrence after liver transplantation
IFN-based therapy in patients with HCV recurrence after liver transplantation
IFN-free DAA therapies in patients with HCV recurrence after liver transplantation
Treatment regimen (treatment duration) study | Type of study | Treatment duration (weeks) | HCV GT | Sample size | SVR rate (ITT) | SAE rate (%) | Treatment discontinuation rate (%) | Comments |
---|---|---|---|---|---|---|---|---|
Sofosbuvir/ribavirin | ||||||||
Charlton et al. [99] | CT | 24 | GT1,3,4 | 40 | 70% (28/40) | 15% (6/40) | 5% (2/40) | |
Daclatasvir/asunaprevir | ||||||||
Ikegami et al. [85] | RW | 24 | GT 1b | 74 | 80.3% | 18% | ||
Sofosbuvir/ledipasvir/RBV | ||||||||
SOLAR-1 Charlton et al. [38] | CT | 12–24 | GT1, (4) | 223 | CH or CP-A: 96–98% CP-B: 85–88% CP-C: 60–75% | 11 to 75% | 0–12% | |
SOLAR-2 Manns et al. [101] | CT | 12–24 | GT1, 4 | 227 | CH/CP-A: 93–100% (GT1) CP-B: 95–100% (GT1) CP-C: 50–80% | 9 to 67% | 3.5% (8/227) | |
Sofosbuvir/ledipasvir | ||||||||
Ueda et al. [102] | RW | 12 | GT1 | 54 | 98 (53/54) | 13% (7/54) | 2% (1/54) | |
Sofosbuvir/daclatasvir/RBV | ||||||||
ALLY-1 Poordad et al. [103] | CT | 12 | GT1,3,6 | 53 | 94 (50/53) | 9% (5/53) | 2% (1/53) | |
PTV/RTV/OBV/DSV + RBV | Concentration of CI should be carefully monitored due to interactions with RTV | |||||||
CORAL-2 Kwo et al. [39] | CT | 24 | GT1 | 34 | 96% (33/34) | 6% (2/34) | 3% (1/34) | |
SMV/sofosbuvir ± RBV | ||||||||
Pungpapong et al. [105] | RW | 12 | GT1 | 123 | 90% (94/105) | 2% (3/123) | 2% (3/123) | |
Brown et al. [106] | RW | 12–24 | GT1 | 151 | 88% (133/151) | 12% (18/151) |