Safety Summary Among Patients With Chronic HCV Genotype 1 Receiving Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With or Without Ribavirin, Stratified by Receipt of Opioid Substitution Therapy and Receipt of Ribavirin
| No. (%) . | Receiving OST . | Not Receiving OST . | ||||
|---|---|---|---|---|---|---|
| All (n = 149) . | No RBV (n = 11) . | + RBV (n = 138) . | All (n = 4598) . | No RBV (n = 1527) . | + RBV (n = 3071) . | |
| Any AE | 127 (85) | 9 (82) | 118 (85) | 3596 (78) | 991 (65) | 2605 (85) |
| DAA-related AE | 98 (66) | 6 (55) | 92 (67) | 2613 (57) | 666 (44) | 1947 (63) |
| Serious AE | 3 (2) | 0 | 3 (2) | 132 (3) | 27 (2) | 105 (3) |
| DAA-related serious AE | 0 | 0 | 0 | 20 (<1) | 4 (<1) | 16 (1) |
| AE leading to D/C | 3 (2) | 0 | 3 (2) | 37 (1) | 5 (<1) | 32 (1) |
| DAA-related AE leading to D/C | 2 (1) | 0 | 2 (1) | 26 (1) | 2 (<1) | 24 (1) |
| Death | 2 (1) | 1 (10) | 1 (1) | 16 (<1) | 4 (<1) | 12 (<1) |
| No. (%) . | Receiving OST . | Not Receiving OST . | ||||
|---|---|---|---|---|---|---|
| All (n = 149) . | No RBV (n = 11) . | + RBV (n = 138) . | All (n = 4598) . | No RBV (n = 1527) . | + RBV (n = 3071) . | |
| Any AE | 127 (85) | 9 (82) | 118 (85) | 3596 (78) | 991 (65) | 2605 (85) |
| DAA-related AE | 98 (66) | 6 (55) | 92 (67) | 2613 (57) | 666 (44) | 1947 (63) |
| Serious AE | 3 (2) | 0 | 3 (2) | 132 (3) | 27 (2) | 105 (3) |
| DAA-related serious AE | 0 | 0 | 0 | 20 (<1) | 4 (<1) | 16 (1) |
| AE leading to D/C | 3 (2) | 0 | 3 (2) | 37 (1) | 5 (<1) | 32 (1) |
| DAA-related AE leading to D/C | 2 (1) | 0 | 2 (1) | 26 (1) | 2 (<1) | 24 (1) |
| Death | 2 (1) | 1 (10) | 1 (1) | 16 (<1) | 4 (<1) | 12 (<1) |
Abbreviations: AE, adverse event; DAA, direct-acting antiviral (ombitasvir/paritaprevir/ritonavir + dasabuvir); D/C, discontinuation; HCV, hepatitis C virus; OST, opioid substitution therapy; RBV, ribavirin.
Safety Summary Among Patients With Chronic HCV Genotype 1 Receiving Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With or Without Ribavirin, Stratified by Receipt of Opioid Substitution Therapy and Receipt of Ribavirin
| No. (%) . | Receiving OST . | Not Receiving OST . | ||||
|---|---|---|---|---|---|---|
| All (n = 149) . | No RBV (n = 11) . | + RBV (n = 138) . | All (n = 4598) . | No RBV (n = 1527) . | + RBV (n = 3071) . | |
| Any AE | 127 (85) | 9 (82) | 118 (85) | 3596 (78) | 991 (65) | 2605 (85) |
| DAA-related AE | 98 (66) | 6 (55) | 92 (67) | 2613 (57) | 666 (44) | 1947 (63) |
| Serious AE | 3 (2) | 0 | 3 (2) | 132 (3) | 27 (2) | 105 (3) |
| DAA-related serious AE | 0 | 0 | 0 | 20 (<1) | 4 (<1) | 16 (1) |
| AE leading to D/C | 3 (2) | 0 | 3 (2) | 37 (1) | 5 (<1) | 32 (1) |
| DAA-related AE leading to D/C | 2 (1) | 0 | 2 (1) | 26 (1) | 2 (<1) | 24 (1) |
| Death | 2 (1) | 1 (10) | 1 (1) | 16 (<1) | 4 (<1) | 12 (<1) |
| No. (%) . | Receiving OST . | Not Receiving OST . | ||||
|---|---|---|---|---|---|---|
| All (n = 149) . | No RBV (n = 11) . | + RBV (n = 138) . | All (n = 4598) . | No RBV (n = 1527) . | + RBV (n = 3071) . | |
| Any AE | 127 (85) | 9 (82) | 118 (85) | 3596 (78) | 991 (65) | 2605 (85) |
| DAA-related AE | 98 (66) | 6 (55) | 92 (67) | 2613 (57) | 666 (44) | 1947 (63) |
| Serious AE | 3 (2) | 0 | 3 (2) | 132 (3) | 27 (2) | 105 (3) |
| DAA-related serious AE | 0 | 0 | 0 | 20 (<1) | 4 (<1) | 16 (1) |
| AE leading to D/C | 3 (2) | 0 | 3 (2) | 37 (1) | 5 (<1) | 32 (1) |
| DAA-related AE leading to D/C | 2 (1) | 0 | 2 (1) | 26 (1) | 2 (<1) | 24 (1) |
| Death | 2 (1) | 1 (10) | 1 (1) | 16 (<1) | 4 (<1) | 12 (<1) |
Abbreviations: AE, adverse event; DAA, direct-acting antiviral (ombitasvir/paritaprevir/ritonavir + dasabuvir); D/C, discontinuation; HCV, hepatitis C virus; OST, opioid substitution therapy; RBV, ribavirin.
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