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dc.contributor.authorDore, GJ
dc.contributor.authorFeld, JJ
dc.contributor.authorThompson, A
dc.contributor.authorMartinello, M
dc.contributor.authorMuir, AJ
dc.contributor.authorAgarwal, K
dc.contributor.authorMullhaupt, B
dc.contributor.authorWedemeyer, H
dc.contributor.authorLacombe, K
dc.contributor.authorMatthews, GV
dc.contributor.authorSchultz, M
dc.contributor.authorKlein, M
dc.contributor.authorHezode, C
dc.contributor.authorMercade, GE
dc.contributor.authorKho, D
dc.contributor.authorPetoumenos, K
dc.contributor.authorMarks, P
dc.contributor.authorTatsch, F
dc.contributor.authorDos Santos, AGP
dc.contributor.authorGane, E
dc.contributor.authorTrinh, R
dc.contributor.authorErratt, A
dc.contributor.authorMercade, GE
dc.contributor.authorQuiene, S
dc.contributor.authorShaw, I
dc.contributor.authorFilep, E
dc.contributor.authorMartinello, M
dc.contributor.authorPetoumenos, K
dc.contributor.authorRoberts, S
dc.contributor.authorFoster, G
dc.contributor.authorCurry, M
dc.contributor.authorWarlow, J
dc.contributor.authorMauss, S
dc.contributor.authorStedman, C
dc.contributor.authorVachon, M-L
dc.contributor.authorChristensen, S
dc.contributor.authorMuir, A
dc.contributor.authorSchultz, M
dc.contributor.authorBaker, D
dc.contributor.authorRamji, A
dc.contributor.authorCornberg, M
dc.contributor.authorBloch, M
dc.contributor.authorHezode, C
dc.contributor.authorBourliere, M
dc.contributor.authorLacombe, K
dc.contributor.authorSemmo, N
dc.contributor.authorAgarwal, K
dc.contributor.authorCannon, M
dc.contributor.authorTam, E
dc.contributor.authorKlein, M
dc.contributor.authorJacobson, I
dc.contributor.authorShaw, D
dc.contributor.authorLevin, J
dc.contributor.authorTsoi, K
dc.contributor.authorCooke, G
dc.contributor.authorThompson, A
dc.contributor.authorMatthews, G
dc.contributor.authorFeld, J
dc.contributor.authorBorgia, SM
dc.contributor.authorBaumgarten, A
dc.identifierpii: S0168-8278(19)30612-9
dc.identifier.citationDore, G. J., Feld, J. J., Thompson, A., Martinello, M., Muir, A. J., Agarwal, K., Mullhaupt, B., Wedemeyer, H., Lacombe, K., Matthews, G. V., Schultz, M., Klein, M., Hezode, C., Mercade, G. E., Kho, D., Petoumenos, K., Marks, P., Tatsch, F., Dos Santos, A. G. P. ,... Baumgarten, A. (2020). Simplified monitoring for hepatitis C virus treatment with glecaprevir plus pibrentasvir, a randomised non-inferiority trial. JOURNAL OF HEPATOLOGY, 72 (3), pp.431-440.
dc.description.abstractBACKGROUND & AIMS: Direct-acting antiviral (DAA) therapy for HCV has high efficacy and limited toxicity. We hypothesised that the efficacy of glecaprevir-pibrentasvir for chronic HCV with a simplified treatment monitoring schedule would be non-inferior to a standard treatment monitoring schedule. METHODS: In this open-label multicentre phase IIIb trial, treatment-naïve adults with chronic HCV without cirrhosis were randomly assigned (2:1) to receive glecaprevir-pibrentasvir 300 mg-120 mg daily for 8 weeks administered with a simplified or standard monitoring strategy. Clinic visits occurred at baseline and post-treatment week 12 in the simplified arm, and at baseline, week 4, week 8, and post-treatment week 12 in the standard arm. Study nurse phone contact occurred at week 4 and week 8 in both arms. Participants requiring adherence support were not eligible, including those reporting recent injecting drug use. The primary endpoint was sustained virological response at post-treatment week 12 (SVR12), with a non-inferiority margin of 6%. RESULTS: Overall, 380 participants (60% male, 47% genotype 1, 32% genotype 3) with chronic HCV were randomised and treated with glecaprevir-pibrentasvir in the simplified (n = 253) and standard (n = 127) arms. In the intention-to-treat population, SVR12 was 92% (95% CI 89%-95%) in the simplified and 95% (95% CI 92%-99%) in the standard arm (difference between arms -3.2%; 95% CI -8.2% to 1.8%) and did not reach non-inferiority. In the per-protocol population, SVR12 was 97% (95% CI 96%-99%) in the simplified and 98% (95% CI 96%-100%) in the standard arm. No treatment-related serious adverse events were reported. CONCLUSIONS: In patients with chronic HCV infection without cirrhosis, treatment with glecaprevir-pibrentasvir was safe and effective. In comparison to standard monitoring, a simplified monitoring schedule did not achieve non-inferiority. TRIAL REGISTRATION: Identifier: NCT03117569. LAY SUMMARY: Direct-acting antiviral (DAA) therapy for hepatitis C is highly effective and well tolerated. The SMART-C randomised trial evaluated an 8-week regimen of glecaprevir-pibrentasvir for hepatitis C treatment, using a simplified monitoring schedule that included no pathology tests or clinic visits during treatment. This simplified strategy produced a high cure rate (92%), but this was not equivalent to the standard monitoring schedule cure rate (95%).
dc.titleSimplified monitoring for hepatitis C virus treatment with glecaprevir plus pibrentasvir, a randomised non-inferiority trial
dc.typeJournal Article
melbourne.affiliation.departmentMedicine (St Vincent's)
melbourne.affiliation.facultyMedicine, Dentistry & Health Sciences
melbourne.source.titleJournal of Hepatology
melbourne.openaccess.statusAccepted version
melbourne.contributor.authorThompson, Alexander
melbourne.accessrightsAccess this item via the Open Access location

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