1. SWIFT-C study: SOF + RBV or LDV/SOF for acute hepatitis C in HIV-infected patients
Sequencing cohorts
Open-label
Design W8
W12
≥ 18 years
Chronic HIV infection
Acute HCV infection *
Enrollment weeks
from laboratory evidence
of acute HCV infection
On ARV with HIV RNA < 50 c/mL
and CD4 > 200/mm3, or
no ARV and CD4 > 500/mm3
No HBV co-infection
N = 17
SOF 400 mg qd + weight-based RBV
SVR12
LDV/SOF
90/400 mg qd
SVR12
N = 27
* New detectable HCV RNA + ALT ≥ 5 x ULN if normal in prior 12 months, or ALT ≥ 10 x ULN with no baseline ALT, or negative HCV Ab or RNA in prior 6 months
RBV dosed twice daily: 1200 mg if ≥ 75 kg, 1000 mg if < 75 kg
Objective
SVR12 (HCV RNA < 15 UI/ml) with 2-sided 90% CI, 90% power to show that true SVR12 > 60% for SOF + RBV 12 weeks
SWIFT-C
Naggie S. Clin Infect Dis 2017; 64: ; Naggie S. AASLD 2017, Abs. 196

2. Baseline characteristics and outcome
SWIFT-C study: SOF + RBV or LDV/SOF for acute hepatitis C in HIV-infected patients
Baseline characteristics and outcome
SOF + RBV
12 weeks
N = 17
LDV/SOF
8 weeks
N = 27
First HCV infection, %
100 81
Age, years, median 45 46
Male, %
White, % 35 67
IV drug user, % 24 19
Genotype 1a / 1b / 1 other / 2, %
65 / 12 / 12 / 6
GT1 : 96%
HCV RNA, log10 IU/mL, median
6.36
6.17
IL28B CC, % 59
Median days from first evidence of infection
140
116
HIV RNA < 50 c/mL, % 88
CD4/mm3, median
498
561
On ARV regimen, % 94
SVR12 (90% CI)
59% (36 – 78)
7 relapses
100% (90 – 100)
SWIFT-C
Naggie S. Clin Infect Dis 2017; 64: ; Naggie S. AASLD 2017, Abs. 196

3. SWIFT-C study: SOF + RBV or LDV/SOF for acute hepatitis C in HIV-infected patients
Adverse events, N
SOF + RBV
12 weeks
N = 17
LDV/SOF 8 weeks
N = 27
Grade 2 clinical adverse events 7
Grade 3-4 clinical adverse events 1 2
Serious adverse events
1 (unrelated)
Discontinuation for adverse event
Grade 3-4 laboratory abnormalities 3
RBV dose reduction or modification -
Confirmed HIV virologic rebound
Death
LDV/SOF group: 2 patients on TDF-boosted regimens met renal toxicity threshold
SWIFT-C
Naggie S. Clin Infect Dis 2017; 64: ; Naggie S. AASLD 2017, Abs. 196

4. SWIFT-C study: SOF + RBV or LDV/SOF for acute hepatitis C in HIV-infected patients
Summary
SVR12 with 12 weeks of SOF + RBV similar, but not superior to historical PEG-IFN + RBV in acute HCV infection
At the end of 12 weeks of SOF + RBV, HCV RNA < limit of quantification in 100% of patients
High rate of failure (41%), due to relapse or re-infection
No significant predictors of failure
Very good tolerance
SVR12 of 100% with 8 weeks of LDV/SOF (superior to historical control rate of 60%)
Well tolerated
No treatment-related serious adverse events
No discontinuation for adverse event
2 renal toxicity in TDF-boosted regimens
SWIFT-C
Naggie S. Clin Infect Dis 2017; 64: ; Naggie S. AASLD 2017, Abs. 196