TY - JOUR
T1 - Sofosbuvir-based direct-acting antiviral therapies for HCV in people receiving opioid substitution therapy
T2 - An analysis of phase 3 studies
AU - Grebely, Jason
AU - Feld, Jordan J.
AU - Wyles, David
AU - Sulkowski, Mark
AU - Ni, Liyun
AU - Llewellyn, Joe
AU - Mir, Heshaam M.
AU - Sajed, Nika
AU - Stamm, Luisa M.
AU - Hyland, Robert H.
AU - McNally, John
AU - Brainard, Diana M.
AU - Jacobson, Ira
AU - Zeuzem, Stefan
AU - Bourlière, Marc
AU - Foster, Graham
AU - Afdhal, Nezam
AU - Dore, Gregory J.
N1 - Funding Information:
Disclaimers. The Kirby Institute is funded by the Australian Government Department of Health and Ageing. The views expressed in this publication do not necessarily represent the position of the Australian Government. Jason Grebely is supported by a National Health and Medical Research Council Career Development Fellowship. Gregory Dore is supported through National Health and Medical Research Council of Australia Practitioner Fellowship. Financial support. This work was supported by Gilead Sciences.
Publisher Copyright:
© The Author(s) 2018.
PY - 2018/2/1
Y1 - 2018/2/1
N2 - Background. Hepatitis C virus (HCV) direct-acting antiviral therapy is effective among people receiving opioid substitution therapy (OST), but studies are limited by small numbers of nongenotype 1 (GT1) patients. The aim of this study was to evaluate the treatment completion, adherence, SVR12, and safety of sofosbuvir-based therapies in HCV patients receiving and not receiving OST. Methods. Ten phase 3 studies of sofosbuvir-based regimens included ION (ledipasvir/sofosbuvir ± ribavirin for 8, 12, or 24 weeks in GT1), ASTRAL (sofosbuvir/velpatasvir for 12 weeks in GT1-6), and POLARIS (sofosbuvir/velpatasvir and sofosbuvir/ velpatasvir/voxilaprevir in GT1-6). Patients with clinically significant drug use (last 12 months) or noncannabinoids detected at screening were ineligible. Results. Among 4743 patients, 4% (n = 194) were receiving OST (methadone; n = 113; buprenorphine, n = 75; other, n = 6). Compared with those not receiving OST (n = 4549), those receiving OST (n = 194) were younger (mean age, 48 vs 54), more often male (73% vs 61%), GT3 (38% vs 17%), treatment-naïve (78% vs 65%), and cirrhotic (36% vs 23%). Among those receiving and not receiving OST, there was no significant difference in treatment completion (97% vs 99%, P = .06), SVR12 (94% vs 97%, P = .06), relapse (0.5% vs 2.1%, P = .19), adverse events (78% vs 77%, P = .79), or serious adverse events (3.6% vs 2.4%, P = .24). There was no difference in SVR12 in patients with cirrhosis (99% vs 95%, P = .25) or those with G3 (95% vs 95%, P = .77) in those receiving OST. Among patients receiving OST, SVR12 was high among those receiving methadone (95%) and buprenorphine (96%). Conclusion. Sofosbuvir-based therapies are effective and safe in patients receiving OST.
AB - Background. Hepatitis C virus (HCV) direct-acting antiviral therapy is effective among people receiving opioid substitution therapy (OST), but studies are limited by small numbers of nongenotype 1 (GT1) patients. The aim of this study was to evaluate the treatment completion, adherence, SVR12, and safety of sofosbuvir-based therapies in HCV patients receiving and not receiving OST. Methods. Ten phase 3 studies of sofosbuvir-based regimens included ION (ledipasvir/sofosbuvir ± ribavirin for 8, 12, or 24 weeks in GT1), ASTRAL (sofosbuvir/velpatasvir for 12 weeks in GT1-6), and POLARIS (sofosbuvir/velpatasvir and sofosbuvir/ velpatasvir/voxilaprevir in GT1-6). Patients with clinically significant drug use (last 12 months) or noncannabinoids detected at screening were ineligible. Results. Among 4743 patients, 4% (n = 194) were receiving OST (methadone; n = 113; buprenorphine, n = 75; other, n = 6). Compared with those not receiving OST (n = 4549), those receiving OST (n = 194) were younger (mean age, 48 vs 54), more often male (73% vs 61%), GT3 (38% vs 17%), treatment-naïve (78% vs 65%), and cirrhotic (36% vs 23%). Among those receiving and not receiving OST, there was no significant difference in treatment completion (97% vs 99%, P = .06), SVR12 (94% vs 97%, P = .06), relapse (0.5% vs 2.1%, P = .19), adverse events (78% vs 77%, P = .79), or serious adverse events (3.6% vs 2.4%, P = .24). There was no difference in SVR12 in patients with cirrhosis (99% vs 95%, P = .25) or those with G3 (95% vs 95%, P = .77) in those receiving OST. Among patients receiving OST, SVR12 was high among those receiving methadone (95%) and buprenorphine (96%). Conclusion. Sofosbuvir-based therapies are effective and safe in patients receiving OST.
KW - DAA
KW - Drug use
KW - Hepatitis C virus
KW - Interferon-free
KW - Ledipasvir
KW - PWID
KW - Sofosbuvir
KW - Velpatasvir
KW - Voxilaprevir
UR - http://www.scopus.com/inward/record.url?scp=85044428029&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85044428029&partnerID=8YFLogxK
U2 - 10.1093/ofid/ofy001
DO - 10.1093/ofid/ofy001
M3 - Article
C2 - 29450210
AN - SCOPUS:85044428029
SN - 2328-8957
VL - 5
JO - Open Forum Infectious Diseases
JF - Open Forum Infectious Diseases
IS - 2
M1 - ofy001
ER -