Retreatment for hepatitis C virus direct‐acting antiviral therapy virological failure in primary and tertiary settings: The <scp>REACH‐C</scp> cohort

Carson, Joanne; Hajarizadeh, Behzad; Hanson, Josh; Iser, David; Read, Phillip; Balcomb, Anne; Davies, Jane; Doyle, Joseph; Yee, Jasmine; Martinello, Marianne; Marks, Philippa; Matthews, Gail; Dore, Gregory J.; Post, Jeffery; Batey, Robert T.; Smart, John; Dawson, O.; Hill, Sonja; Douglas, Mark W.; Montebello, Mark; Collie, Patricia; Hallinan, Richard; Snelgar, Gail; Baker, David; Galhenage, Sam; Soo, Tuck Meng; Bopage, Rohan; Faros, John; Cooper, Lucy; Nelson, Renjy; Shaw, David R.; Wilson, Mark L.; Pratt, W. P.; Hinton, Stephen; Wade, Amanda; Gessel, Helen Van; Davidson, Leonie; Dibdin, Miranda; Lucas, Micaela; Ahmad, Raghib; Smith, Denise L.; Tan, Khim; Röder, Christine; Harney, Brendan; Holdaway, Susan; Walsh, Jayde; Fox, Penny; Mousavi, Roshanak; Lam, Wendy Wing Tak; Dahal, Rupa Pudasaini; Habel, Philip; Gilliver, Rosie; Silins, Edmund; Ackerman, Jessica E.; Deacon, Rachel; Hall, Edmund; Everson, Arlene; Stewart, Jeffrey; Milner, Margery; Ferguson, C.L.; Tate‐Baker, Jaclyn; Bradshaw, Jane; Duncan, Gai; Baluran, Gilbert; Watson, Belinda; Hey, Camilla; Hickey, Rebecca; Orme, Clare; Miczkova, Silvie

doi:10.1111/jvh.13705

Cited by 9 publications

(13 citation statements)

References 38 publications

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“…Our results revealed that the SVR 12 rates were 97.2% and 100% in the EP and PP populations, which were comparable to the Western studies and meta-analysis reporting the SVR 12 rates of 90-100%. [21][22][23][24][25][26][27][28][29]38 Our results corroborated the SOF/VEL/VOX's excellent effectiveness in managing patients previously treated with NS5A inhibitors, regardless of ethnicity. 30,31 Our study revealed that no speci c patient, viral, or treatment factors predicted treatment responses.…”

Section: Discussionsupporting

confidence: 72%

“…36,39−41 Although some real-world studies indicated that patients with HCV GT3 infection, cirrhosis, previous SOF/VEL treatment, and multiple RASs might adversely affect the SVR 12 rate, the POLARIS-1 trial and the other real-world studies, including ours, did not show such association. [21][22][23][24][25][26][27][28][29]41 those with SOF/VEL/VOX alone. 24,26 While the EASL guidelines recommend SOF/VEL/VOX plus RBV for "di cult-to-cure" patients to intensify the retreatment responses, the AASLD guidelines do not endorse the universal combination except for cirrhotic patients with HCV GT3 infection.…”

Section: Discussionmentioning

confidence: 99%

“…21,22 The real-world studies from Western countries, including the U.S., Canada, Italy, Spain, and Australia, have reported the SVR 12 rates of SOF/VEL/VOX for DAA-experienced patients with HCV ranged from 90-100%, and most patients tolerated treatment well. [23][24][25][26][27][28][29] In contrast, data regarding the performance of SOF/VEL/VOX in the Asian population are limited. Only two smallscaled studies from Taiwan and Singapore recruited two and twenty-ve NA5A inhibitor-experienced patients with HCV, in which the SVR 12 rates were 100% and 96%, respectively.…”

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Sofosbuvir/velpatasvir/voxilaprevir for patients with chronic hepatitis C virus infection previously treated with NS5A direct-acting antivirals: a real-world multicenter cohort in Taiwan

et al. 2023

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BackgroundReal-world data are scarce about the effectiveness and safety of sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) for retreating East Asian patients with hepatitis C virus (HCV) infection who previously received NS5A direct-acting antivirals (DAAs). We conducted a multicenter study to assess the performance of SOF/VEL/VOX in patients who were not responsive to prior NS5A inhibitors in Taiwan. MethodsBetween September 2021 and May 2022, 107 patients who failed NS5A inhibitor-containing DAAs with SOF/VEL/VOX salvage therapy for 12 weeks were included at 16 academic centers. The sustained virologic response at off-treatment week 12 (SVR 12 ) was assessed in the evaluable (EP) and per-protocol (PP) populations. The safety pro les were also reported. ResultsAll patients completed 12 weeks of treatment and achieved an end-of-treatment virologic response. The SVR 12 rates were 97.2% (95% con dence interval (CI): 92.1%-99.0%) and 100% (95% CI: 96.4%-100%) in EP and PP populations. Three (2.8%) patients were lost to off-treatment follow-up and did not meet SVR 12 in the EP population. No baseline factors predicted SVR 12 . Two (1.9%) not-fatal serious adverse events (AE) occurred, but unrelated to SOF/VEL/VOX. Sixteen (15.0%) had grade 2 total bilirubin elevation, and three (2.8%) had grade 2 alanine transaminase (ALT) elevation. Thirteen (81.3%) of the 16 patients with grade 2 total bilirubin elevation had unconjugated hyperbilirubinemia. The estimated glomerular ltration rates (eGFR) were comparable between baseline and SVR 12 , regardless of baseline renal reserve. ConclusionsSOF/VEL/VOX is highly e cacious and well-tolerated for East Asian HCV patients previously treated with NS5A inhibitor-containing DAAs.

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Section: Discussionsupporting

confidence: 72%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Sofosbuvir/velpatasvir/voxilaprevir for patients with chronic hepatitis C virus infection previously treated with NS5A direct-acting antivirals: a real-world multicenter cohort in Taiwan

et al. 2023

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“…In addition, most are small in scale, with some reporting high losses to follow-up. Overlapping risk factors for treatment discontinuation and loss to follow-up are described 6 , 19 – 21 and could lead to underestimations of treatment discontinuation in clinical studies. With all HCV treatment in Australia delivered through the PBS and half of the estimated population with HCV treated between 2016 and 2021, 22 this analysis provides a highly representative picture of treatment discontinuation at a national level.…”

Section: Discussionmentioning

confidence: 99%

“…There may be a broad range of intrapersonal, interpersonal, and structural factors that impact treatment discontinuation. 19 , 32 Patient-centered interventions that promote adherence to treatment and retention in HCV care for at-risk populations 33 , 34 will be critical if elimination is to be achieved. As the majority of prescribers in Australia, general practitioners play a critical role in HCV elimination efforts.…”

Section: Discussionmentioning

confidence: 99%

Increasing national trend of direct-acting antiviral discontinuation among people treated for HCV 2016–2021

Carson

Barbieri

Matthews

et al. 2023

Hepatology Communications

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Background: Direct-acting antiviral (DAA) treatment discontinuation may negatively impact HCV elimination efforts. In Australia, DAA therapy is pharmacy dispensed, generally in 4-week amounts, with the approved duration (8–24 wk) and volume dispensed reported in pharmaceutical administrative data. This analysis assessed national HCV treatment discontinuation. Methods: Individuals commencing DAAs between 2016 and 2021 were assessed for treatment discontinuation. Individuals with a single dispensation of their entire treatment course were excluded. Treatment discontinuation was defined as ≥4 weeks of approved treatment duration not dispensed. Factors associated with treatment discontinuation were assessed using Cox regression. Factors associated with retreatment following treatment discontinuation were assessed using logistic regression. Results: Of 95,275 individuals who were treated, 88,986 were included in the analysis of whom 7532 (9%) discontinued treatment. Treatment discontinuation increased from 6% in the first half of 2016 to 15% in 2021. Longer treatment durations (vs. 8 wk) were associated with increased discontinuation risk (12 wk: adjusted HR = 3.23; 95% CI: 2.90, 3.59; p < 0.001, 16–24 wk: adjusted HR = 6.29; 95% CI: 5.55, 7.14; p < 0.001). Of individuals discontinuing treatment, 24% were retreated. Early discontinuation (4 wk treatment dispensed) increased the likelihood of retreatment (adjusted OR = 3.91; 95% CI: 3.44, 4.44; p < 0.001). Those with early discontinuation of glecaprevir/pibrentasvir 8 weeks (vs. sofosbuvir/velpatasvir 12 wk) had a lower likelihood of retreatment (adjusted OR = 0.62; 95% CI: 0.49, 0.79; p < 0.001). Initial treatment discontinuation was associated with an increased risk of retreatment discontinuation (adjusted HR = 4.41; 3.85, 5.05; p < 0.001). Conclusions: DAA treatment discontinuation increased over time corresponding to increasing treatment uptake through primary care among people who inject drugs. The use of simplified, short-duration therapies may reduce treatment discontinuation. Access to adherence support and retreatment will be essential for HCV elimination.

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Direct-Acting Antivirals Remain Cost-Effective Treatments for Chronic Hepatitis C in Australia Despite Changes to the Treated Population and the Availability of Retreatment: The Glecaprevir/Pibrentasvir (Maviret®) Example

Warren,

Castles,

Sharratt

et al. 2024

Infect Dis Ther

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Introduction The first direct-acting antiviral (DAA) therapies for chronic hepatitis C virus (HCV) infection were reimbursed via Australia’s Pharmaceutical Benefits Scheme (PBS) in March 2016. This was based on the recommendation from the Pharmaceutical Benefits Advisory Committee (PBAC) that the regimens would be acceptably cost-effective at an incremental cost-effectiveness ratio (ICER) no greater than $15,000/quality-adjusted life-year (QALY). Since the initial PBS listings for DAA therapies and subsequent listings of newer DAA treatments such as glecaprevir/pibrentasvir (Maviret ® ), the demographics and some of the disease characteristics of currently treated patients have markedly changed. This analysis aims to reassess the cost-effectiveness of glecaprevir/pibrentasvir, accounting for the changes to the HCV population currently seeking treatment and incorporating retreatment in first-line failures and the treatment of new infections in previously treated individuals. Methods To assess the cost-effectiveness 7 years after initial listing of DAAs, an update was made to the Markov model used to achieve PBS reimbursement for Viekira-Pak ® in May 2016. Amendments to the Viekira-Pak ® model include: changes to baseline age and fibrosis distribution of treated patients, and inclusion of retreatment of first-line failures [those not achieving a sustained virologic response (SVR12)] and reinfected individuals. Treatment-related inputs including SVR12 response rates, adverse events, treatment-related disutility, and discontinuations were sourced from pivotal glecaprevir/pibrentasvir clinical trials. Results Using the published price of glecaprevir/pibrentasvir, the ICER is below $15,000/QALY. Conclusions Despite changes in demographics and disease characteristics of treated patients, and changes to the model structure to reflect retreatment in clinical practice in Australia, DAAs remain cost-effective in 2023.

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Retreatment for hepatitis C virus direct‐acting antiviral therapy virological failure in primary and tertiary settings: The REACH‐C cohort

Cited by 9 publications

References 38 publications

Sofosbuvir/velpatasvir/voxilaprevir for patients with chronic hepatitis C virus infection previously treated with NS5A direct-acting antivirals: a real-world multicenter cohort in Taiwan

Sofosbuvir/velpatasvir/voxilaprevir for patients with chronic hepatitis C virus infection previously treated with NS5A direct-acting antivirals: a real-world multicenter cohort in Taiwan

Increasing national trend of direct-acting antiviral discontinuation among people treated for HCV 2016–2021

Direct-Acting Antivirals Remain Cost-Effective Treatments for Chronic Hepatitis C in Australia Despite Changes to the Treated Population and the Availability of Retreatment: The Glecaprevir/Pibrentasvir (Maviret®) Example

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