Table 1.
Trials of direct-acting antivirals for chronic hepatitis C infection in human immunodeficiency virus co-infected patients
| Study | GT | Tx regimen | Tx duration (wk) | Hepatitis C characteristics |
SVR12 |
||
| GT | Fibrosis stage | Treatment status | |||||
| P05411[100] | 1 | PegIFNα-2b + RBV | BOC: 44 | Tx naïve | BOC | ||
| wb (600-1400 mg) + | PegIFN/RBV: 48 | Metavir F0-4 | GT1: 42/64 (66%) | ||||
| BOC vs placebo | Cirrhosis: 3% | GT1a: 32/51 (63%) | |||||
| GT1b: 7/12 (58%) | |||||||
| Placebo GT1: 9/34 (26%) | |||||||
| VX08-950-110[101] | 1 | PegIFNα-2a + RBV | TPV: 12 | Tx naïve | TPV | ||
| 800 mg or wb | PegIFN/RBV: 48 | Metavir F0-4 | GT1: 28/38 (74%) | ||||
| (1000-1200 mg) + | GT1a: 20/27 (74%) | ||||||
| TVR vs placebo | GT1b: 7/11 (64%) | ||||||
| Placebo | |||||||
| GT1: 10/22 (45%) | |||||||
| GT1a: 4/14 (29%) | |||||||
| GT1b: 4/6 (67%) | |||||||
| ANRS HC26 | 1 | PegIFNα-2a + RBV | TPV: 12 | Tx exp | GT1: 55/69 (80%) | F1-2 | Relapse |
| TelapreVIH[95] | wb (1000-1200 mg) | PegIFN/RBV (RGT): 44 or 72 | Metavir F0-4 | GT1a: 36/48 (75%) | 34/42 (81%) | 20/27 (74%) | |
| + TVR | Both cirrhosis and prior | GT1b: 19/21 (90%) | F3-4 | Breakthrough | |||
| null-response excluded | 21/27 (78%) | 5/6 (83%) | |||||
| Partial response | |||||||
| 15/15 (100%) | |||||||
| Null response | |||||||
| 15/21 (71%) | |||||||
| P7977-1910[102] | 1-4 | SOF + PegIFNα-2a | 12 | Tx naïve | All GTs: 21/23 (91%) | ||
| + RBV wb | No cirrhosis | GT1: 17/19 (89%) | |||||
| (1000-1200 mg) | [GT1a: 13/15 (87%) | ||||||
| GT1b: 4/4] | |||||||
| GT2: 1/1 | |||||||
| GT3: 2/2 | |||||||
| GT4: 1/1 | |||||||
| STARTVerso4[103,104] | 1 | FDV 240 mg (EFV) or 120 mg | FDV: 24 or (12 vs 24), | PegIFN/RBV Tx naïve | GT1: 221/308 (72%) | No Cirrhosis | Tx naïve |
| (ATV/r or DRV/r) or 120 vs 240 mg | PegIFN/RBV (RGT): 48 or | or prior relapse | GT1a: 171/242 (71%) | 187/261 (72%) | 164/239 (69%) | ||
| (RAL or MVC or no ART) + | 24 wk vs 48 wk | Compensated cirrhosis: 15% | GT1b: 50/66 (76%) | Cirrhosis | Relapse | ||
| PegIFNα-2a + RBV wb (1000-1200 mg) | 33/45 (73%) | 57/69 (83%) | |||||
| C212[105] | 1 | SMV + PegIFNα-2a + RBV wb | SMV: 12 | PegIFN/RBV Tx naïve | GT1: 78/106 (74%) | F0-2 | Tx naïve |
| (1000-1200 mg) | PegIFN/RBV RGT: (24 vs 48) | or Tx exp | GT1a: 62/88 (70%) | 36/45 (80%) | 42/53 (79%) | ||
| for Tx naïve or prior relapse | Metavir F0-4; Cirrhosis: | GT1b: 16/18 (89%) | F3-4 | Relapse | |||
| or 48 for partial- | 6%-30% by Tx arm | 14/22 (64%) | 13/15 (87%) | ||||
| or null-response or cirrhosis | Partial response | ||||||
| 7/10 (70%) | |||||||
| Null response | |||||||
| 16/28 (57%) | |||||||
| PHOTON-1[106] | 1-3 | SOF + RBV wb (1000-1200 mg) | GT 1: 24 | Tx naïve (GT1-3) or exp (GT2-3) | GT1: 87/114 (76%) | No Cirrhosis | Tx naïve |
| GT 2-3 Tx naïve: 12 | Cirrhosis ≤ 20% | [GT1a: 74/90 (82%) | GT1: 84/109 (77%) | GT1: 87/114 (76%) | |||
| GT 2-3 Tx exp: 24 | GT1b: 13/24 (54%)] | GT2: 22/25 (88%) | GT2: 23/26 (88%) | ||||
| GT2: 44/50 (88%) | GT3: 24/36 (67%) | GT3: 28/42 (67%) | |||||
| GT3: 44/59 (75%) | Cirrhosis | Tx exp | |||||
| GT1: 3/5 (60%) | GT2: 22/24 (92%) | ||||||
| GT2: 1/1 | GT3: 16/17 (94%) | ||||||
| GT3: 4/6 (67%) | |||||||
| PHOTON-2[107] | 1-4 | SOF + RBV wb (1000-1200 mg) | GT 1, 3, 4: 24 | Tx naïve (GT1-4) or exp (GT 2-3) | GT1: 95/112 (85%) | No Cirrhosis | Tx naïve |
| GT 2 Tx naïve: 12 | Compensated cirrhosis: 20% of patients | [GT1a: 84/100 (84%) | GT1: 84/95 (88%) | GT 1: 95/112 (85%) | |||
| GT 2 Tx exp: 24 | GT1b: 10/11 (91%)] | GT2: 19/22 (86%) | GT2: 17/19 (89%) | ||||
| GT2: 22/25 (88%) | GT3: 73/80 (91%) | GT3: 52/57 (91%) | |||||
| GT3: 94/106 (89%) | GT4: 19/23 (83%) | GT4: 26/31 (84%) | |||||
| GT4: 26/31 (84%) | Cirrhosis | Tx exp: | |||||
| GT1: 11/17 (65%) | GT2: 5/6 (83%) | ||||||
| GT2: 3/3 | GT3: 41/49 (84%) | ||||||
| GT3: 21/26 (81%) | |||||||
| GT4: 7/8 (88%) | |||||||
| TURQUOISE-I[108] | 1 | Paritaprevir/r/Ombitasvir + | 12 or 24 | Tx naïve or PegIFN/RBV exp | Tx for 12 wk | ||
| Dasabuvir + RBV wb (1000-1200 mg) | Cirrhosis ≤ 30% | GT1: 29/31 (94%) | |||||
| Tx for 24 wk | |||||||
| 19/20 (95%) | |||||||
| ERADICATE[109] | 1 | SOF/LDV | 12 | Tx naïve | Untreated HIV Infection | ||
| Knodell F0-3 | GT1: 10/10 | ||||||
| C-WORTHY[110] | 1 | Grazoprevir + MK-8742 +/- RBV | 12 | Tx naïve | With RBV | ||
| No cirrhosis | 28/29 (97%) | ||||||
| Metavir F0-3 | Without RBV | ||||||
| 26/29 (90%) | |||||||
/: Indicates co-formulation; +/-: With or without; GT: HCV genotype and subtype; RGT: Response guided therapy; Tx (exp): Treatment (experienced); vs: Indicates randomisation; wb: Weight based; ATV: Atazanavir; BOC: Boceprevir; DRV: Darunavir; EFV: Efavirenz; FDV: Faldaprevir; LDV: Ledipasvir; PegIFN: Pegylated Interferon; r: Ritonavir boosted; RBV: Ribavirin; SMV: Simeprevir; SOF: Sofosbuvir; TVR: Telaprevir.