Direct-acting antiviral treatment of chronic HCV-infected patients on opioid substitution therapy: Still a concern in clinical practice?

Addiction ◽  
2018 ◽  
Vol 113 (5) ◽  
pp. 868-882 ◽  
Author(s):  
Stefan Christensen ◽  
Peter Buggisch ◽  
Stefan Mauss ◽  
Klaus H. W. Böker ◽  
Eckart Schott ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Antiviral Treatment ◽  
Substitution Therapy ◽  
Opioid Substitution Therapy ◽  
Direct Acting Antiviral ◽  
Chronic Hcv ◽  
Direct Acting ◽  
Opioid Substitution

scholarly journals Efficacy and Safety of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With or Without Ribavirin in Patients With Chronic Hepatitis C Virus Genotype 1 Infection Receiving Opioid Substitution Therapy: A Post Hoc Analysis of 12 Clinical Trials

2018 ◽  
Vol 5 (11) ◽  
Author(s):  
Jason Grebely ◽  
Massimo Puoti ◽  
Heiner Wedemeyer ◽  
Curtis Cooper ◽  
Mark S Sulkowski ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Hepatitis C ◽  
Treatment Adherence ◽  
Efficacy And Safety ◽  
Substitution Therapy ◽  
Hcv Treatment ◽  
Opioid Substitution Therapy ◽  
Direct Acting Antiviral ◽  
Direct Acting ◽  
Opioid Substitution

Abstract Background We evaluated the impact of opioid substitution therapy (OST) on the completion, adherence, efficacy, and safety of the 3-direct-acting antiviral regimen of ombitasvir, paritaprevir (identified by AbbVie and Enanta) co-dosed with ritonavir, and dasabuvir ± ribavirin among patients infected with hepatitis C virus (HCV) genotype (GT) 1, with or without compensated cirrhosis. Methods Data were pooled from GT1-infected patients enrolled in 12 phase II/III/IIIb clinical trials and categorized by use of OST. Patients with ongoing drug use were excluded. HCV treatment completion, treatment adherence (≥90%), sustained virologic response at post-treatment week 12 (SVR12), and adverse events were assessed. Results Of 4747 patients, 3% (n = 149) received OST. Among patients receiving OST vs those not receiving OST, 82% (n = 122) vs 52% (n = 2409) had GT1a infection; 76% (n = 113) vs 61% (n = 2792) were treatment naïve; and 17% (n = 25) vs 18% (n = 830) had cirrhosis, respectively. The proportion of patients completing HCV treatment did not differ between those receiving and not receiving OST (97% [n = 144] vs 98% [n = 4510], respectively), whereas adherence to treatment was reduced in patients receiving vs those not receiving OST (88% [n = 105] vs 97% [n = 4057], respectively). SVR12 was similar between patients receiving and not receiving OST (94% [n = 140] vs 96% [n = 4405], respectively; P = .273). Treatment was well tolerated. Conclusions Although treatment adherence was lower in patients receiving OST vs those not receiving OST, treatment completion and SVR12 were similar between groups. These data support the use of direct-acting antiviral therapies in patients receiving OST.

Response to direct-acting antiviral therapy among ongoing drug users and people receiving opioid substitution therapy

2019 ◽  
Vol 71 (1) ◽  
pp. 45-51 ◽  
Author(s):  
Juan Macías ◽  
Luis E. Morano ◽  
Francisco Téllez ◽  
Rafael Granados ◽  
Antonio Rivero-Juárez ◽  
...  
Keyword(s):  
Antiviral Therapy ◽  
Drug Users ◽  
Substitution Therapy ◽  
Opioid Substitution Therapy ◽  
Direct Acting Antiviral ◽  
Direct Acting ◽  
Opioid Substitution

scholarly journals Sofosbuvir-Based Direct-Acting Antiviral Therapies for HCV in People Receiving Opioid Substitution Therapy: An Analysis of Phase 3 Studies

2018 ◽  
Vol 5 (2) ◽  
Author(s):  
Jason Grebely ◽  
Jordan J Feld ◽  
David Wyles ◽  
Mark Sulkowski ◽  
Liyun Ni ◽  
...  
Keyword(s):  
Adverse Events ◽  
Treatment Completion ◽  
Substitution Therapy ◽  
Opioid Substitution Therapy ◽  
Phase 3 ◽  
Serious Adverse Events ◽  
Direct Acting Antiviral ◽  
Significant Difference ◽  
Direct Acting ◽  
Opioid Substitution

Abstract 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.

Characteristics of De novo Hepatocellular carcinoma (HCC) in Chronic HCV Egyptian patients received Direct Acting Antivirals (DAAs) therapy: A pilot study

QJM ◽  
2021 ◽  
Vol 114 (Supplement_1) ◽  
Author(s):  
Amany Ahmed Ibrahim ◽  
Iman M.Fawzy Montasser ◽  
Amira Mahmoud AL Balakosy ◽  
Hoda Mohammed Farid
Keyword(s):  
De Novo ◽  
Antiviral Treatment ◽  
Direct Acting Antiviral ◽  
Class B ◽  
Group A ◽  
Child Class ◽  
The Mean ◽  
Chronic Hcv ◽  
Direct Acting ◽  
De Novo Hepatocellular Carcinoma

Abstract Background Direct-acting antiviral agents for chronic hepatitis C have initiated a revolution in the management and control of this important liver disease with cure rates over 90%. However, it has been suggested that HCC may occur or recur in patients with chronic HCV infection who received DAAs therapy. Aim To compare characteristics and behavior of de novo Hepatocellular carcinoma (HCC) in chronic HCV patients who received direct acting antiviral treatment with those who didn't receive DAAs . Patients and methods The current study was conducted on patients with de novo HCC presented at HCC clinic, Tropical medicine department Ain Shams University Hospitals between December 2017 and December 2018, aged (18-70 years old) . Total number of HCC cases visited the clinic during the study period was 416 patients. 160 patients with de novo HCC were enrolled in the study fullfiling the inclusion criteria and divided to two groups, 80 patients with HCC who received Direct antiviral treatment, the other 80 patients who didn't receive Direct antiviral treatment. Results Unlike some previous concerns about increased biologic aggressiveness of HCC after DAA treatment, resulting in infiltrative pattern and multinodular HCC outside Milan criteria, our results on de novo HCC after DAAs were mostly single, small, and diagnosed in early stages, resulting in BCLC stage 0-B in the majority of patients. There were no statistical differences regarding total size of tumor,or vascular invasion or AFP, but there’s a statistical difference in largest size of HFLs that was more significant in group (A) P = 0.04 The mean Child score was 5.75 in group A, with 61 patients (76.3%) were Child class A,19 patients (23.8%) were Child class B and 0 patients were child C. For the patients in group (B) the mean Child score was 6.15, with 50 patients (62.5%) were Child class A, 26 patients (32.5%) were Child class B and 4 patients (5%) were child C. Conclusion The current study shows no differences between the 2 studied groups as regard tumor aggressiveness, but data on risk of HCC and behaviour after DAAs is still conflicting and further studies are needed

scholarly journals Efficacy of Direct-acting Antivirals for Chronic Hepatitis C Virus Infection in People Who Inject Drugs or Receive Opioid Substitution Therapy: A Systematic Review and Meta-analysis

2019 ◽  
Vol 70 (11) ◽  
pp. 2355-2365 ◽  
Author(s):  
Christiana Graf ◽  
Marcus M Mücke ◽  
Georg Dultz ◽  
Kai-Henrik Peiffer ◽  
Alica Kubesch ◽  
...  
Keyword(s):  
Hepatitis C Virus ◽  
Hepatitis C ◽  
Treatment Outcomes ◽  
People Who Inject Drugs ◽  
Discontinuation Rate ◽  
Direct Acting Antivirals ◽  
Substitution Therapy ◽  
Opioid Substitution Therapy ◽  
Direct Acting ◽  
Opioid Substitution

Abstract Background Treatment uptake for hepatitis C virus (HCV) infection in people who inject drugs (PWID) and patients on opioid substitution therapy (OST) is still low despite treatment guidelines that advocate the use of direct-acting antivirals (DAAs) in all patients. Our aim in this review was to investigate treatment outcomes among PWID and patients on OST in comparison to control cohorts. Methods A search of Embase, Medline, PubMed, and Web of Science (from October 2010 to March 2018) was conducted to assess sustained virologic response (SVR), discontinuation rates, adherence, and HCV reinfection in PWID and patients on OST. Results We identified 11 primary articles and 12 conference abstracts comprising 1702 patients on OST, 538 PWID, and 19 723 patients who served as controls. Among patients on OST, the pooled SVR was 90% (95% confidence interval [CI], 87% to 93%) and pooled treatment discontinuation rate was 7% (95% CI, 4% to 11%). Similarly, the pooled SVR was 88% (95% CI, 80% to 93%) in PWID and the pooled treatment discontinuation rate was 9% (95% CI, 5% to 15%). There was no significant difference regarding pooled rates of SVR, adherence, and discontinuation between patients on OST and controls as well as between PWID and controls. HCV reinfection rates among patients on OST ranged from 0.0 to 12.5 per 100 person-years. Conclusions HCV treatment outcomes in PWID and patients on OST are similar to those in patients without a history of injecting drugs, supporting current guideline recommendations to treat HCV in these patient populations.

Sign in / Sign up

Export Citation Format

Share Document