Direct-acting antiviral treatment for hepatitis C among people who use or inject drugs: a systematic review and meta-analysis

Hajarizadeh, Behzad; Cunningham, Evan B; Reid, Hannah; Law, Matthew; Dore, Gregory J.; Grebely, Jason

doi:10.1016/s2468-1253(18)30304-2

Cited by 190 publications

(151 citation statements)

References 54 publications

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“…Our results confirm the efficacy of this approach with excellent intention to treat (95.5%) and per‐protocol (100%) results, and 8 weeks is now the recommended duration for treatment‐naive GT3 patients with F0‐3 disease in Scotland . Excellent results in a cohort of patients with significant drug use and high rates of OAT add to the growing body of evidence that current drug use is not a barrier to successful HCV treatment . Two patients achieved SVR after 6 weeks of treatment, one with F2 fibrosis (LSM 8.8 kPa, viral load 6.7 log IU/ml) and one with F3 fibrosis (LSM 10.3 kPa, viral load 6.6 log IU/ml), indicating that for some patients, successful treatment is possible with even shorter durations of therapy.…”

Section: Discussionsupporting

confidence: 83%

Eight weeks of sofosbuvir/velpatasvir for genotype 3 hepatitis C in previously untreated patients with significant (F2/3) fibrosis

Boyle

Marra

Peters

et al. 2019

Journal of Viral Hepatitis

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Summary Twelve weeks sofosbuvir/velpatasvir (SOF/VEL) is a highly effective pan‐genotypic regimen for hepatitis C. Phase 2 data suggest 8 weeks of treatment may be sufficient for previously untreated noncirrhotic patients with genotype 3 (GT3) infection. To maximize the number of patients potentially cured within a fixed treatment budget, we elected to treat such patients locally eligible for treatment (F2/3), with 8 weeks of SOF/VEL. By local protocol, treatment‐naive patients with F2 (LSM > 6.9kPa < 9.5kPa) or F3 fibrosis (≥9.5kPa < 12.5kPa) were eligible for 8‐week SOF/VEL treatment. Patients commencing treatment before 1 Oct 2017 were identified from the Scottish HCV database. Baseline and treatment outcome data obtained. Ninety patients were included for analysis (72 (80%) male, mean age 45 (IQR ± 8.4), 28 (31.1%) F3 fibrosis). Opioid agonist therapy (OAT) was prescribed in 82 (91.1%) patients. Of 49 patients attending Glasgow city Alcohol and Drug Services, 27 (55.1%) had evidence of recent drug use (< 3 months) including 8 (16.3%) with self‐reported intravenous drug use. On an intention‐to‐treat basis, SVR rates were 86/90 (95.6%, 95% CI 89.0‐98.8). Excluding those who prematurely discontinued treatment (n = 4), died prior to SVR testing (n = 1) or whom experienced reinfection (n = 1), per‐protocol SVR rate was 84/84 (100%, 95% CI 95.7‐100.0). In conclusion, eight‐week SOF/VEL is highly effective in treatment‐naive GT3 patients with significant fibrosis. This offers a non‐protease inhibitor‐based 8‐week regimen which may be useful for complex drug interactions or where time‐limited opportunity for treatment. In limited resource settings, reduction in drug acquisition costs may help achieve progress towards the goal of HCV elimination.

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Section: Discussionsupporting

confidence: 83%

Eight weeks of sofosbuvir/velpatasvir for genotype 3 hepatitis C in previously untreated patients with significant (F2/3) fibrosis

Boyle

Marra

Peters

et al. 2019

Journal of Viral Hepatitis

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“…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%

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

et al. 2019

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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.

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“…The enrolment criteria of an episode of injecting drug use within the previous week and the median number of injections within the previous week of 6.5 clearly characterize the study population as high‐risk. Most studies of current PWID have defined recency of injecting as in the previous six, or even 12 months . Second, the study setting is a needle syringe program (NSP) site, a crucial point of engagement for PWID in relation to HCV prevention, and more recently HCV testing and linkage to care.…”

Section: Strategies To Address Hcv Reinfection Among People Who Injecmentioning

confidence: 99%

“…Second, the study setting is a needle syringe program (NSP) site, a crucial point of engagement for PWID in relation to HCV prevention, and more recently HCV testing and linkage to care. Again, previous studies have generally enrolled subjects through hepatitis or liver disease clinical services, community clinics or drug dependence treatment services . Third, the relatively high HCV reinfection rate is similar to the primary infection rate in the setting, and thereby provides a realistic picture of risk level in a highly marginalized PWID population.…”

Section: Strategies To Address Hcv Reinfection Among People Who Injecmentioning

confidence: 99%

“…Again, previous studies have generally enrolled subjects through hepatitis or liver disease clinical services, community clinics or drug dependence treatment services. 4 Third, the relatively high HCV reinfection rate is similar to the primary infection rate in the setting, and thereby provides a realistic picture of risk level in a highly marginalized PWID population. The overall HCV reinfection rate during an 18-month follow-up period after successful HCV treatment of 21.5/100 person years (py) is higher than almost all other studies of HCV reinfection, 5 but not surprising given the factors outlined.…”

mentioning

confidence: 99%

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HCV reinfection as a positive indication of high‐risk population treatment access

Dore

2019

Journal of Viral Hepatitis

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Direct-acting antiviral treatment for hepatitis C among people who use or inject drugs: a systematic review and meta-analysis

Cited by 190 publications

References 54 publications

Eight weeks of sofosbuvir/velpatasvir for genotype 3 hepatitis C in previously untreated patients with significant (F2/3) fibrosis

Eight weeks of sofosbuvir/velpatasvir for genotype 3 hepatitis C in previously untreated patients with significant (F2/3) fibrosis

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

HCV reinfection as a positive indication of high‐risk population treatment access

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