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

Christensen, Stefan; Buggisch, Peter; Mauss, Stefan; Böker, K. H. W.; Schott, Eckart; Klinker, Hartwig; Zimmermann, Tim; Weber, Bernd; Reimer, Jens; Serfert, Yvonne; Wedemeyer, Heiner

doi:10.1111/add.14128

Cited by 76 publications

(74 citation statements)

References 23 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…Such groups were excluded from clinical trials of DAA treatment efficacy due to strict eligibility criteria; thus, our cohort represents a real‐world PWID population treated with DAAs. We found that there was no difference in SVR by any of these characteristics, which is similar to the findings from others . However, among PWID who did not achieve SVR, there was a substantial loss to follow‐up, some of which was related to death, including drug overdose deaths, while on treatment or before assessment of SVR.…”

Section: Discussionsupporting

confidence: 88%

“…However, among PWID who did not achieve SVR, there was a substantial loss to follow‐up, some of which was related to death, including drug overdose deaths, while on treatment or before assessment of SVR. Loss to follow‐up was higher among male patients, similar to a recent report from Germany on DAA treatment among people on OAT . This highlights two important issues affecting the overall impact of DAAs on health outcomes: loss to follow‐up and high mortality not related to HCV.…”

Section: Discussionsupporting

confidence: 84%

“…Studies of individuals not injecting drugs have shown similar higher SVR rates in clinical trials and real‐world settings, where SVR rates of approximately 90% to 95% have been reported . Available data from small previous studies and the recent reviews assessing treatment outcomes among PWID have shown high SVR rates; these studies include a trial among people on OAT using elbasvir/grazoprevir, which showed an SVR of 95%, and a recent trial on current PWID using SOF/VEL, which showed an SVR of 94% . However, the study population in those trials was selective, as people with HIV were not included and study participants were followed more closely; therefore, loss to follow‐up was lower.…”

Section: Discussionmentioning

confidence: 96%

“…However, PWID participating in RCTs are very different from those in a real‐world situation, and concerns remain about compliance, loss to follow‐up, and treatment effectiveness . Although data on the treatment of PWID from real‐world settings are emerging, many of these studies are small and enroll patients from single practice or community programs, with the exception of a recent German study . As such, broader population‐based data on the treatment of PWID with DAAs are limited.…”

mentioning

confidence: 99%

See 3 more Smart Citations

Effectiveness of Ledipasvir/Sofosbuvir and Sofosbuvir/Velpatasvir in People Who Inject Drugs and/or Those in Opioid Agonist Therapy

et al. 2019

View full text Add to dashboard Cite

We evaluated the effectiveness of ledipasvir/sofosbuvir (LDV/SOF) in treating hepatitis C virus (HCV) genotype 1 and SOF/velpatasvir (SOF/VEL) for all genotypes among people who inject drugs (PWID) and those not injecting drugs and who were on or off opioid agonist therapy (OAT). Study participants comprised a population‐based cohort in British Columbia, Canada. The British Columbia Hepatitis Testers Cohort includes data on individuals tested for HCV from 1990 to 2016 that are integrated with medical visits, hospitalization, and prescription drug data. We classified study participants as off OAT/recent injection drug use (off‐OAT/RIDU), off OAT/past IDU (off‐OAT/PIDU), off OAT/no IDU (off‐OAT/NIDU), on OAT/IDU (on‐OAT/IDU), and on OAT/no IDU (on‐OAT/NIDU). We assessed sustained virologic response (SVR) 10 weeks after HCV treatment among study groups treated with LDV/SOF or SOF/VEL until January 13, 2018. Analysis included 5,283 eligible participants: 390 off‐OAT/RIDU, 598 off‐OAT/PIDU, 3,515 off‐OAT/NIDU, 609 on‐OAT/IDU, and 171 on‐OAT/NIDU. The majority were male patients (64%‐74%) and aged ≥50 years (58%‐85%). The SVRs for off‐OAT/RIDU, off‐OAT/PIDU, off‐OAT/NIDU, on‐OAT/IDU, and on‐OAT/NIDU were 91% (355/390), 95% (570/598), 96% (3,360/3,515), 93% (567/609), and 95% (163/171), respectively. Among those with no SVR, 14 individuals died while on treatment or before SVR assessment, including 4 from illicit drug overdose. In the overall multivariable model, off‐OAT/RIDU, on‐OAT/IDU, male sex, cirrhosis, treatment duration <8 weeks, treatment duration 8 weeks, and treatment with SOF/VEL were associated with not achieving SVR. Conclusion: In this large real‐world cohort, PWID and/or those on OAT achieved high SVRs, although slightly lower than people not injecting drugs. This finding also highlights the need for additional measures to prevent loss to follow‐up and overdose‐related deaths among PWID.

show abstract

Section: Discussionsupporting

confidence: 88%

Section: Discussionsupporting

confidence: 84%

Section: Discussionmentioning

confidence: 96%

mentioning

confidence: 99%

See 2 more Smart Citations

Effectiveness of Ledipasvir/Sofosbuvir and Sofosbuvir/Velpatasvir in People Who Inject Drugs and/or Those in Opioid Agonist Therapy

et al. 2019

View full text Add to dashboard Cite

show abstract

“…Although, it has been shown that IDU and OST could significantly reduce the SVR, in our study these factors were not associated with treatment effectiveness. In a recent study, it has been shown that reinfection rate is higher among recent IDU compared to past IDU .…”

Section: Discussioncontrasting

confidence: 87%

Loss to follow‐up: A significant barrier in the treatment cascade with direct‐acting therapies

Darvishian

Wong

Binka

et al. 2019

Journal of Viral Hepatitis

View full text Add to dashboard Cite

Effectiveness of direct‐acting antiviral (DAA) therapies could be influenced by patient characteristics such as comorbid conditions, which could lead to premature treatment discontinuation and/or irregular medical follow‐ups. Here, we evaluate loss to follow‐up and treatment effectiveness of sofosbuvir/ledipasvir ± ribavirin (SOF/LDV ± RBV), ombitasvir/paritaprevir/ritonavir + dasabuvir ± ribavirin (OBV/PTV/r + DSV ± RBV) for hepatitis C virus (HCV) genotype 1 (GT1) and sofosbuvir + ribavirin (SOF + RBV) for genotype 3 (GT3) in British Columbia Canada: The British Columbia Hepatitis Testers Cohort includes data on individuals tested for HCV since 1992, integrated with medical visit, hospitalization and prescription drug data. HCV‐positive individuals who initiated DAA regimens, irrespective of treatment completion, for GT1 and GT3 until 31 December, 2017 were included. Factors associated with sustained virological response (SVR) and loss to follow‐up were assessed by using multivariable logistic regression models. In total 4477 individuals initiated DAAs. The most common prescribed DAA was SOF/LDV ± RBV with SVR of 95%. The highest SVR of 99.5% was observed among OBV/PTV/r + DSV‐treated patients. Overall, 453 (10.1%) individuals were lost to follow‐up. Higher loss to follow‐up was observed among GT1 patients treated with OBV (17.8%) and GT3 patients (15.7%). The loss to follow‐up rate was significantly higher among individuals aged <60 years, those with a history of injection drug use (IDU), on opioid substitution therapy and with cirrhosis. Our findings indicate that loss to follow‐up exceeds viral failure in HCV DAA therapy and its rate varies significantly by genotype and treatment regimen. Depending on the aetiology of lost to follow‐up, personalized case management for those with medical complications and supporting services among IDU are needed to achieve the full benefits of effective treatments.

show abstract

The Impact of Direct‐Acting Antiviral Therapy on End‐Stage Liver Disease Among Individuals with Chronic Hepatitis C and Substance Use Disorders

et al. 2021

View full text Add to dashboard Cite

BaCKgRoUND aND aIMS: Our aim was to evaluate the impact of direct-acting antivirals (DAAs) on decompensated cirrhosis (DCC) and HCC in patients with chronic HCV and substance use disorder (SUD) compared with those without an SUD. appRoaCH aND ReSUltS: This retrospective cohort study used the MarketScan database (2013)(2014)(2015)(2016)(2017)(2018) to identify 29,228 patients with chronic HCV, where 22% (n = 6,385) had ≥1 SUD diagnosis. The inverse probability of treatment weighted multivariable Cox proportional hazard models were used to compare the risk of developing DCC and HCC. Among the those who were noncirrhotic, treatment reduced the DCC risk among SUD (adjusted hazard ratio [aHR] 0.13; 95% CI, 0.06-0.30) and non-SUD (aHR 0.11; 95% CI, 0.07-0.18), whereas the risk for HCC was not reduced for the SUD group (aHR 0.91; 95% CI, 0.33-2.48). For those with cirrhosis, compared with patients who were untreated, treatment reduced the HCC risk among SUD (aHR, 0.33; 95% CI, 0.13-0.88) and non-SUD (aHR, 0.40; 95% CI, 0.25-0.65), whereas the risk for DCC was not reduced for the SUD group (aHR, 0.64; 95% CI, 0.37-1.13). Among patients with cirrhosis who were untreated, the SUD group had a higher risk of DCC (aHR, 1.52; 95% CI, 1.03-2.24) and HCC (aHR, 1.69; 95% CI, 1.05-2.72) compared with non-SUD group.CoNClUSIoNS: Among the HCV SUD group, DAA treatment reduced the risk of DCC but not HCC for those who were noncirrhotic, whereas DAA treatment reduced the risk of HCC but not DCC for those with cirrhosis. Among the nontreated, patients with an SUD had a significantly higher risk of DCC and HCC compared with those without an SUD. Thus, DAA treatment should be considered for all patients with HCV and an SUD while also addressing the SUD. (Hepatology 2021;74:566-581). HCV infection is the most common chronic bloodborne infection in the United States and is a substantial cause of morbidity and mortality. In the United States, individuals with a substance use disorder (SUD) are disproportionately affected by HCV. In fact, injection drug use, which is the most common risk factor for contracting HCV, accounts for ~75% of newly acquired cases of HCV and ~50% of cases of chronic HCV infection. (1,2) In addition, the majority of patients infected with HCV also have an alcohol use disorder, which is highly associated with concomitant use of illegal substances, leading to an increased risk for HCV.

show abstract

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

Abstract: In Germany, direct-acting antiviral treatment of former or current drug users with or without opioid substitution therapy can achieve equally high sustained virological response rates as in patients with no history of drug use.

Cited by 76 publications

References 23 publications

Effectiveness of Ledipasvir/Sofosbuvir and Sofosbuvir/Velpatasvir in People Who Inject Drugs and/or Those in Opioid Agonist Therapy

Effectiveness of Ledipasvir/Sofosbuvir and Sofosbuvir/Velpatasvir in People Who Inject Drugs and/or Those in Opioid Agonist Therapy

Loss to follow‐up: A significant barrier in the treatment cascade with direct‐acting therapies

The Impact of Direct‐Acting Antiviral Therapy on End‐Stage Liver Disease Among Individuals with Chronic Hepatitis C and Substance Use Disorders

Contact Info

Product

Resources

About