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      MAVIRET ACHIEVED HIGH SVR12 RATES IN GT 1-6 PATIENTS6,7

      Data pooled for GT 1-6 patients treated with Maviret for 8 weeks in SURVEYOR 1 and 2, EXPEDITION 2, 4, and ENDURANCE 1, 2, 3, and 4 studies. Data includes patients with prior experience with peginterferon, ribavirin, and/or sofosbuvir. GT 3 patients were treatment-naive only. Data from open-label and non-randomised or part-randomised registrational studies.6

      SURVEYOR 1 was an open-label, doseranging, multicentre, phase 2, 2-part study conducted to evaluate the efficacy, safety, and pharmacokinetics of Maviret with or without ribavirin in adults (18 to 70 years; N=174) with chronic HCV infection (GT 1, 4, 5, or 6), with or without cirrhosis, and naïve to DAAs. GT 1 patients without cirrhosis were administered Maviret once-daily for 8 or 12 weeks. GT 1 patients with cirrhosis were administered Maviret once-daily for 12 weeks. GT 4-6 patients were administered Maviret once-daily for 12 weeks. The study included treatmentnaïveor pegIFN/RBV-experienced patients without cirrhosis. Primary endpoint: percentage of ITT participants achieving SVR12.8,9

      SURVEYOR 2 was a part-randomised, open-label, dose-ranging, multi-part, multicentre study that evaluated the efficacy, safety, and pharmacokinetics of Maviret dosed once-daily in treatmentnaïveand treatment-experienced (with IFN/ pegIFN ±RBV, or SOF + RBV ±pegIFN therapy) adult GT 2, 3, 4, 5, or 6 patients with or without cirrhosis, with 8, 12, or 16 weeks of therapy (N=694) with or without RBV. Primary endpoint: percentage of ITT participants achieving SVR12.10-12

      For treatment-naïve patients the licensed treatment duration is 8 weeks of therapy.1

      DAA: direct acting antiviral, IFN: interferon, ITT: intention-to-treat, pegIFN: pegylated interferon, RBV: ribavirin, SOF: sofosbuvir.

      EXPEDITION 2 was a multicentre, open-label, phase 3 study to evaluate the efficacy and safety of Maviret in adults (N=153) with chronic HCV infection (GT 1-6) and HIV-1 infection. Patients included were HCV treatment-naïve or treatment-experienced with IFN, pegIFN ±RBV, or SOF + RBV ±pegIFN with or without cirrhosis. Patients were administered Maviret alone once-daily for 8 or 12 weeks. Primary endpoint: percentage of ITT participants achieving SVR12.13

      EXPEDITION 4 was a single-arm, open-label study conducted to evaluate the efficacy and safety of Maviret in adults (N=104) with chronic HCV infection (GT 1-6) and stage 4 or 5 CKD, with or without cirrhosis. Patients were either treatment-naïve or treatmentexperiencedwith IFN/pegIFN ±RBV, or SOF + RBV ±pegIFN therapy. Patients were administered Maviret alone once-daily for 12 weeks. Patients with a history of acute renal failure within 3 months prior to screening were not included. Primary endpoint: percentage of ITT participants achieving SVR12.14

      For treatment-naïve patients the licensed treatment duration is 8 weeks of therapy.1

      CKD: chronic kidney disease, IFN: interferon, ITT: intention-to-treat, pegIFN: pegylated interferon, RBV: ribavirin, SOF: sofosbuvir.

      ENDURANCE 1 was a randomised, open-label, multicentre, phase 3 study conducted to evaluate the efficacy and safety of Maviret in adults (N=703) with chronic HCV infection (GT 1) without cirrhosis and with or without HIV-1. Patients with prior HCV treatment experience with any DAA other than SOF were excluded. Patients were administered Maviret alone once-daily for 8 or 12 weeks. Sequential primary endpoints: 1) Non-inferiority in SVR12 of the 12-week regimen to 91% historical rate, by ITT-PS (exclusion of HIV and prior SOF), with lower margin of the 2-sided 95% CI 2) Non-inferiority in SVR12 of the 8-week to 12-week regimen (5% margin), by ITT-PS-PP (ITT-PS + exclusion of premature discontinuation or virologic failure prior to W8 and missing data in the SVR12 window) 3) Non-inferiority in SVR12 of the 8-week to 12-week regimen (5% margin), by ITT-PS.15

      ENDURANCE 2 was a randomised, double-blind, placebo-controlled, multicentre, phase 3 study conducted to evaluate the efficacy and safety of Maviret in adults (N=302) with chronic HCV infection (GT 2) without cirrhosis. Patients with prior HCV treatment experience with any DAA other than SOF were excluded. Patients were administered Maviret once-daily or placebo for 12 weeks. Primary endpoint: Non-inferiority in SVR12 of the 12-week regimen to 95% historical rate, by ITT.10

      For treatment-naïve patients the licensed treatment duration is 8 weeks of therapy.1

      DAA: direct acting antiviral, DCV: daclatasvir, ITT:intention-to-treat, PP:per protocol, PS: primary subset, SOF: sofosbuvir.

      ENDURANCE 3 was a partially randomised, open-label, active-controlled (SOF and DCV), multicentre study that evaluated the efficacy and safety of Maviret in treatment-naïve adult GT 3 patients without cirrhosis, with 8 weeks (n=157) or 12 weeks (n=233) of Maviret therapy dosed once-daily, or 12 weeks of active comparator therapy. Primary endpoint: non-inferiority in SVR12 of 12 weeks of Maviret compared to 12 weeks of SOF + DCV in ITT population.15

      ENDURANCE 4 is a single-arm, open-label, phase 3 study conducted to evaluate the efficacy and safety of Maviret in adults (N=121) with chronic HCV infection (GT 4, 5, or 6) without cirrhosis. Patients with prior HCV treatment experience with any DAA other than SOF were excluded. Patients were administered Maviret alone once-daily for 12 weeks. Primary endpoint: percentage of ITT participants achieving SVR12.10

      For treatment-naïve patients the licensed treatment duration is 8 weeks of therapy.1

      DAA: direct acting antiviral, DCV: daclatasvir, ITT:intention-to-treat, PP:per protocol, SOF: sofosbuvir.

      Data from GT 1-6 patients treated with Maviret for 8 weeks in the EXPEDITION 8 study.7

      EXPEDITION 8 was a single arm, open-label, phase 3b, multicentre study evaluating the safety and efficacy of 8 weeks of Maviret in GT 1-6 treatment-naïve patients with compensated cirrhosis. Primary efficacy endpoints were SVR12 rates in GT 1, 2, 4-6 patients in the PP and ITT populations. Key secondary efficacy endpoints were SVR12 rates in GT 1-6 patients in the PP and ITT populations. Other secondary efficacy endpoints included SVR12 rates in GT 3 patients in the PP and ITT populations who achieved SVR12, and the percentage of patients with on-treatment virologic failure and post-treatment relapse across genotypes in the ITT population.7

      For treatment-naïve patients the licensed treatment duration is 8 weeks of therapy.1

      ITT:intention-to-treat, PP:per protocol.

      8 WEEKS OF MAVIRET IN REAL-WORLD PWID AND ORT PATIENTS16

      Study sought to examine the effectiveness of Maviret in the presence or absence of drug use, in the 3 months prior to commencing treatment. Comprised retrospective analysis on 354 current and recovering real-world PWIDs living with HCV, who had been prescribed Maviret. 206 patients (58%) were also prescribed ORT. Patients were predominantly GT 3 (53%) followed by GT 1 (35%) and GT 2 (10%). Study included 33 cirrhotic patients (9%) and 12 treatment experienced patients (3%). The mITTpopulation excluded patients with premature discontinuation or non-virological reasons for non-SVR12.16

      Patients commencing Maviret outside clinical trials prior to 1st May 2018 were identified from the Scottish HCV database. Data on baseline demographics, treatment status, ORT-use, intravenous drug use, premature treatment discontinuation and SVR12 were obtained. Frequencies of categorical variables were compared using Chi-square test, while continuous variables were compared using a paired t-test.16

      For treatment-naïve patients the licensed treatment duration is 8 weeks of therapy.1

      ORT:opioid replacement therapy.

       

      *Cure = sustained virologic response (SVR12), defined as HCV RNA less than lower limit of quantification at 12 weeks after the end of treatment and was the primary endpoint in all the studies.1

      ITT: intention-to-treat, mITT: modified intention-to-treat, NS: non-statistically significant, ORT: opioid replacement therapy, PWID: people who inject drugs.


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      References

      1. Maviret Summary of Product Characteristics. AbbVie Ltd. Available at: www.medicines.org.uk
      2. Harvoni Summary of Product Characteristics. Gilead Sciences Ltd. Available at: www.medicines.org.uk (accessed December 2020).
      3. Epclusa Summary of Product Characteristics. Gilead Sciences Ltd. Available at: www.medicines.org.uk (accessed December 2020).
      4. Vosevi Summary of Product Characteristics. Gilead Sciences Ltd. Available at: www.medicines.org.uk (accessed December 2020).
      5. Zepatier Summary of Product Characteristics. Merck Sharp & Dohme Ltd. Available at: www.medicines.org.uk (accessed December 2020).
      6. Puoti M et al. J Hepatol. 2018; 69(20): 293–300.
      7. Brown RS et al. J Hepatol. 2019; doi:10.1016/j.jhep.2019.10.020.
      8. U.S. National Institutes of Health. A study to evaluate the efficacy, safety, and pharmacokinetics of co-administration of ABT-493 and ABT-530 with and without ribavirin in subjects with HCV genotype 1, 4, 5, and 6 infection (SURVEYOR-I). Available at: www.clinicaltrials.gov/ct2/show/NCT02243280 (accessed December 2020).
      9. Kwo PY et al. J Hepatol. 2017; 67(2): 263–71.
      10. Asselah T et al. Clin Gastroenterol Hepatol. 2018; 16: 417–26
      11. U.S. National Institutes of Health. A randomized, open-label, multicenter study to evaluate the efficacy, safety, and pharmacokinetics of co-administration of ABT-493 and ABT-530 with and without RBV in subjects with chronic hepatitis C virus (HCV) genotypes 2, 4, 5, or 6 infection (SURVEYOR-II). Available at: www.clinicaltrials.gov/ct2/show/NCT02243293 (accessed December 2020).
      12. Wyles D et al. Hepatology. 2018; 67(2): 514–23.
      13. Rockstroh J et al. [Poster LB-522]. Presented at the European Association for the Study of the Liver. April 19−23, 2017. Amsterdam, The Netherlands.
      14. Gane E et al. N Engl J Med. 2017; 377(15): 1448–55.
      15. Zeuzem S et al. N Engl J Med. 2018; 378: 354–69.
      16. Boyle A et al. [Poster #0619]. Presented at the American Association for the Study of Liver Diseases. November 9−13, 2018. San Francisco, USA.
       

       

      Adverse events should be reported. Reporting forms and information can be found at yellowcard.mhra.gov.uk .
      Adverse events should also be reported to AbbVie on GBPV@abbvie.com

       

      UK-MAVI-200066. Date of preparation: December 2020