RUSSIA’S FIRST EXPERIENCE WITH GLE/PIB FOR THE TREATMENT OF HCV INFECTION GENOTYPE 3A WITH CRYOGLOBULINEMIA AND CONCOMITANT HBV INFECTION IN A HEMODIALYSIS PATIENT WITH CKD С5D AWAITING KIDNEY TRANSPLANTATION

DOI: https://doi.org/10.29296/25877305-2019-02-01
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Issue: 
2
Year: 
2019

D. Sulima(1, 2), MD; Professor D. Lioznov(1, 3), MD; Professor A. Yakovlev(4, 5), MD; Professor A. Smirnov(1), MD; V. Larionov(6); A. Batskikh(1); V. Koryagin(2), Candidate of Medical Sciences; O. Gorchakova(1), Candidate of Medical Sciences; E. Alekseeva(1), Candidate of Medical Sciences; E. Volkov(4); D. Popov(7); A. Vasilyev(1), Candidate of Medical Sciences; E. Kostereva(1); R. Golubev(1) 1-Acad. I.P. Pavlov First Saint Petersburg State Medical University; 2-LLC «Exclusive» Medical Consulting Dental Center (EXCLUSIVE Multidisciplinary Medical Clinic), Saint Petersburg; 3-Research Institute of Influenza, Saint Petersburg; 4-Saint Petersburg State University; 5-S.P. Botkin Clinical Infectious Diseases Hospital, Saint Petersburg; 6-V.A. Almazov Medical Research Center, Saint Petersburg; 7-ZAO «Plasmofiltr», Saint Petersburg

The paper presents Russia’s first case of successful use of a 8-week therapy course using an original interferon-free combination of the third-generation NS3/4A protease inhibitor glecaprevir (GLE) and the second-generation NS5A-replication enzyme inhibitor pibrentasvir (PIB) in clinical practice to treat HCV infection genotype 3A with mixed cryoglobulinemia syndrome and concomitant HBV infection in a patient with chronic kidney disease С5d, who received chronic dialysis after elective bilateral nephrectomy for renal polycystosis and awaited donor kidney transplantation.
Keywords: 
nephrology
HCV infection
HCV genotype 3A
interferon-free therapy
real clinical practice
glecaprevir/pibrentasvir
GLE/PIB
mixed cryoglobulinemia
concomitant HBV infection
chronic kidney disease
kidney transplantation
adverse event
skin itch
sustained virologic response
complete immunological response

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References: 
  1. U.S. Food and Drug Administration. FDA approval of Mavyret for Hepatitis C, 2017. Available at https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ ucm570038.htm [Acc. 05 Jan, 2019].
  2. Kwo P., Poordad F., Asatryan A. et al. Glecaprevir and pibrentasvir yield high response rates in patients with HCV genotype 1-6 without cirrhosis // J. Hepatol. – 2017; 67 (2): 263–71. https://doi.org/10.1016/j.jhep.2017.03.039
  3. Puoti M., Foster G., Wang S. et al. High SVR12 with 8-week and 12-week glecaprevir/pibrentasvir therapy: An integrated analysis of HCV genotype 1-6 patients without cirrhosis // J. Hepatol. – 2018; 69 (2): 293–300. https://doi.org/10.1016/j.jhep.2018.03.007
  4. Forns X., Lee S., Valdes J. et al. Glecaprevir plus pibrentasvir for chronic hepatitis C virus genotype 1, 2, 4, 5, or 6 infection in adults with compensated cirrhosis (EXPEDITION-1): a single-arm, open-label, multicentre phase 3 trial // Lancet Infect. Dis. – 2017; 17 (10): 1062–8. https://doi.org/10.1016/S1473-3099(17)30496-6
  5. Zeuzem S., Foster G., Wang S. et al. Glecaprevir-Pibrentasvir for 8 or 12 Weeks in HCV Genotype 1 or 3 Infection // N. Engl. J. Med. – 2018; 378 (4): 354–69. DOI: 10.1056/NEJMoa1702417.
  6. Poordad F., Pol S., Asatryan A. et al. Glecaprevir/pibrentasvir in patients with HCV genotype 1 or 4 and prior direct-acting antiviral treatment failure // Hepatology. – 2018; 67 (4): 1253–60. DOI: 10.1002/hep.29671.
  7. Wyles D., Poordad F., Wang S. et al. Glecaprevir/pibrentasvir for hepatitis C virus genotype 3 patients with cirrhosis and/or prior treatment experience: A partially randomized phase 3 clinical trial // Hepatology. – 2018; 67 (2): 514–23. DOI: 10.1002/hep.29541.
  8. Toyoda H., Chayama K., Suzuki F. et al. Efficacy and safety of glecaprevir/pibrentasvir in Japanese patients with chronic genotype 2 hepatitis C virus infection // Hepatology. – 2018; 67 (2): 505–13. DOI: 10.1002/hep.29510.
  9. Asselah T., Kowdley K., Zadeikis N. et al. Efficacy of Glecaprevir/Pibrentasvir for 8 or 12 weeks in patients with Hepatitis C Virus genotype 2, 4, 5, or 6 infection without cirrhosis // Clin. Gastroenterol. Hepatol. – 2018; 16 (3): 417–26. DOI: 10.1016/j.cgh.2017.09.027.
  10. Abutaleb A., Kottilil S., Wilson E. et al. Glecaprevir/pibrentasvir expands reach while reducing cost and duration of hepatitis C virus therapy // Hepatol. Int. – 2018; 12 (3): 214–22. DOI: 10.1007/s12072-018-9873-y.
  11. Kumada H., Watanabe T., Suzuki F. et al. Efficacy and safety of glecaprevir/pibrentasvir in HCV-infected Japanese patients with prior DAA experience, severe renal impairment, or genotype 3 infection // J. Gastroenterol. – .2018; 53 (4): 566–75. DOI: 10.1007/s00535-017-1396-0.
  12. Gane E., Lawitz E., Pugatch D. et al. Glecaprevir and pibrentasvir in patients with HCV and severe renal impairment // N. Engl. J. Med. – 2017; 377 (15): 1448–55. DOI: 10.1056/NEJMoa1704053.
  13. Chute D., Chung R., Sise M. et al. Direct-acting antiviral therapy for hepatitis C virus infection in the kidney transplant recipient // Kidney Int. – 2018; 93 (3): 560–7. DOI: 10.1016/j.kint.2017.10.024.
  14. Reau N., Kwo P., Rhee S. et al. MAGELLAN-2: safety and efficacy of glecaprevir/pibrentasvir in liver or renal transplant adults with chronic hepatitis C genotype 1-6 infection // J. Hepatol. – 2017; 66 (1): 90–3. https://doi.org/10.1016/S0168-8278(17)30444-0.
  15. Kosloski M., Zhao W., Marbury T. et al. Effects of Renal Impairment and Hemodialysis on the Pharmacokinetics and Safety of the Glecaprevir and Pibrentasvir Combination in Hepatitis C Virus-Negative Subjects // Antimicrob. Agents Chemother. – 2018; 62 (3): 10e01990-17. DOI: 10.1128/AAC.01990-17.
  16. Al-Rabadi L., Box T., Singhania G. Rationale for treatment of hepatitis C virus infection in end-stage renal disease patients who are not kidney transplant candidates // Hemodial. Int. – 2018; 22 (1): 45–52. DOI: 10.1111/hdi.12656.
  17. RxAbbVie U.S. Prescribing Information. Highlights of Prescribing Information (glecaprevir and pibrentasvir), 2018. Available at http://www.rxabbvie.com/pdf/mavyret_pi.pdf [Acc. 05 Jan, 2019].
  18. US Food and Drug Administration. FDA drug safety communication: FDA warns about the risk of hepatitis B reactivating in some patients treated with direct-acting antivirals for hepatitis C, 2016. Available at https://www.fda.gov/Drugs/DrugSafety/ucm522932.htm [Acc. 05 Jan, 2019].
  19. Resat Ozaras, Bilkul Mere, Fehmi Tabak. Occult Hepatitis B and Risk of Reactivation After Hepatitis C Treatment With Direct-Acting Antivirals // Clinical Gastroenterology and Hepatology. – 2017; 15 (4): 605. DOI: 10.1016/j.cgh.2016.11.030.
  20. Wang C., Ji D., Chen J. et al. Hepatitis due to Reactivation of Hepatitis B Virus in Endemic Areas Among Patients With Hepatitis C Treated With Direct-acting Antiviral Agents // Clin. Gastroenterol. Hepatol. – 2017; 15 (1): 132–6. DOI: 10.1016/j.cgh.2016.06.023.
  21. Mücke M., Backus L., Mücke V. et al. Hepatitis B virus reactivation during direct-acting antiviral therapy for hepatitis C: a systematic review and meta-analysis // Lancet Gastroenterol. Hepatol. – 2018; 3 (3): 172–80. DOI: 10.1016/S2468-1253(18)30002-5.
  22. Pockros P. Black Box Warning for Possible HBV Reactivation During DAA Therapy for Chronic HCV Infection // Gastroenterol. Hepatol. – 2017; 13 (9): 536–40.
  23. Holmes J., Yu M., Chung R. Hepatitis B reactivation during or after direct acting antiviral therapy – implication for susceptible individuals // Expert Opin. Drug Safety. – 2017; 16 (6): 651–72. DOI: 10.1080/14740338.2017.1325869.
  24. RxAbbVie U.S. Prescribing Information. Patient Information MAVYRET, 2017. Available at https://www.rxabbvie.com/pdf/mavyret_PIL.pdf [Acc. 05 Jan, 2019].
  25. Belperio P., Shahoumian T., Mole L. et al. Evaluation of Hepatitis B Reactivation Among 62, 920 Veterans Treated With Oral Hepatitis C Antivirals // Hepatology. – 2017; 66 (1): 27–36. DOI: 10.1002/hep.29135.