Table 1.

Sustained Virologic Response Rates From Clinical Trials Investigating the Efficacy of Direct-Acting Antiviral Therapies in Human Immunodeficiency Virus/Hepatitis C Virus Coinfection

Study Name	Type and No. of Patients	ARV Allowed	SVR Rates	Adverse Events	Reference
PHOTON-1	223 patients enrolled Treatment naive GT 1: 114 4.4% cirrhosis GT 2 and 3: 68 10.4% cirrhosis Treatment experienced GT 2 and 3: 41 24.4% cirrhosis	212 of 223 patients were on ARV therapy. The following agents were allowed: TDF + FTC, EFV, ATV/r, DRV/r, RAL, RPV, other	Treatment naive 76% GT 1 88% GT 2 67% GT 3 Treatment experienced 92% GT 2 94% GT 3	Most common were fatigue, insomnia, headache, and nausea No adverse events on HIV disease or treatment	[19]
PHOTON-2	275 patients enrolled Treatment naive GT 1: 112 15% cirrhosis GT 2: 19 5% cirrhosis GT 3: 58 5% cirrhosis GT 4: 31 26% cirrhosis Treatment experienced GT 2: 6 33% cirrhosis GT 3: 49 47% cirrhosis	265 of 275 patients were on ARV therapy. The following agents were allowed: TDF + FTC, EFV, ATV/r, DRV/r, RAL, RPV, other	Treatment naive 85% GT 1 89% GT 2 91% GT 3 84% GT 4 Treatment experienced 83% GT 2 86% GT 3	Most common were fatigue, insomnia, asthenia, and headache One patient experienced HIV viral breakthrough	[20]
ION-4	335 patients enrolled GT 1: 327 GT 4: 8 20% cirrhosis overall	335 (100%) patients were on ARVs consisting of TDF and FTC with EFV, RPV, or RAL	Both treatment naive and experienced 96% GT 1 100% GT 4	Most common were headache, fatigue, and diarrhea	[33]
ALLY-2	203 patients enrolled 151 treatment naive 101: DCV + SOF for 12 wk ○ 9% cirrhosis 50: DCV + SOF for 8 wk ○ 10% cirrhosis 52 treatment experienced 52: DCV + SOF for 12 wk ○ 29% cirrhosis	199 (98%) patients were on ARVs consisting of DRV/r, ATV/r, LPV/r, EFV, NVP, RPV, RAL, or DTG	GT 1: 96.4% naive for 12 wk 75.6% naive for 8 wk 97.7% experienced for 12 wk GT 1–4 97% naive for 12 wk 76% naive for 8 wk 98.1% experienced for 12 wk	Most common were fatigue, nausea, and headache	[11]
C-EDGE COINFECTION	218 patients enrolled GT 1a: 144 GT 1b: 44 GT 4: 28 GT 6: 2 16% cirrhosis overall	211 (97%) patients were on ARVs consisting of ABC, TDF, RAL, DTG, or RPV	96.5% GT 1a 95.5% GT 1b 96.4% GT 4 100% GT 6	Most common were fatigue, headache, and nausea. No patient discontinued treatment because of an AE. Two patients receiving ART had transient HIV viremia.	[34]
C-WORTHY	218 patients enrolled; 59 (arms 7 and 8) were HCV/HIV coinfected Arm 1: GT 1a + 1b;12 wk Arm 2: GT 1a + 1b;12 wk Arm 3: GT 1b; 12 wk Arm 4: GT 1a; 8 wk Arm 5: GT 1a + 1b; 12 wk Arm 6: GT 1a; 12 wk Arm 7: GT 1a + 1b; 12 wk Arm 8: GT 1a + 1b; 12 wk	59 (100%) of coinfected patients were on ARVs consisting of RAL plus 2 nucleoside or nucleotide reverse transcriptase inhibitors	Arm 1: 93% Arm 2: 93% Arm 3: 98% Arm 4: 80% Arm 5: 93% Arm 6: 98% Arm 7: 97% Arm 8: 87%	Most common were mild to moderate fatigue, headache, nausea, and diarrhea.	[35]
ERADICATE	50 patients enrolled	37 (74%) patients were receiving ARVs consisting of TDF/FTC plus EFV, RAL, RPV, RAL plus RPV, or RAL plus EFV	98%	Most common AEs were nasal congestion, myalgia, headache, and fatigue. No participants discontinued study medications due to adverse effects.	[36]
TURQUOISE-I	63 patients enrolled with HCV GT 1 31 with 12 wk of treatment  19% with cirrhosis 32 with 24 wk of treatment  19% with cirrhosis	63 (100%) patients were receiving ARVs consisting of an atazanavir- or RAL-inclusive ARV regimen	94% with 12 wk of treatment 91% with 24 wk of treatment	Most common AEs were fatigue, insomnia, nausea, and headache. No patient had a confirmed HIV-1 breakthrough of ≥200 copies/mL during treatment.	[37]

Abbreviations: ABC, abacavir; AE, adverse event; ART, antiretroviral therapy; ARV, antiretroviral; ATV/r, ritonavir-boosted atazanavir; DCV, daclatasvir; DRV/r, ritonavir-boosted darunavir; DTG, dolutegravir; EFV, efavirenz; FTC, emtricitabine; GT, genotype; HCV, hepatitis C virus; HIV, human immunodeficiency virus; LPV/r, ritonavir-boosted lopinavir; NVP, nevirapine; RAL, raltegravir; RPV, rilpivirine; SOF, sofosbuvir; SVR, sustained virologic response; TDF, tenofovir disoproxil fumarate.