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Protease, Polymerase, and Assembly Inhibitors for the Treatment of Hepatitis C Virus Infection
Published in M. Lindsay Grayson, Sara E. Cosgrove, Suzanne M. Crowe, M. Lindsay Grayson, William Hope, James S. McCarthy, John Mills, Johan W. Mouton, David L. Paterson, Kucers’ The Use of Antibiotics, 2017
Marianne Martinello, Jason Grebely, Gregory Dore
Hemodialysis does not significantly affect grazoprevir pharmacokinetics in adults with ESRD. The removal of grazoprevir (< 0.5%) by hemodialysis is negligible (Yeh et al., 2014a). The very high plasma protein binding of grazoprevir is consistent with the small amounts of grazoprevir quantified in dialysate. Grazoprevir concentrations were higher in adults with severe renal impairment not on hemodialysis compared to matched healthy adults (Merck, 2017). Co- formulated grazoprevir–elbasvir for 12 weeks is safe and effective in individuals with HCV genotype 1 infection and advanced stage 4–5 chronic kidney disease, including those with ESRD on hemodialysis (Roth et al., 2015).
Health-related quality of life in people receiving opioid agonist treatment and treatment for hepatitis C virus infection
Published in Journal of Addictive Diseases, 2023
Olav Dalgard, Alain H. Litwin, Oren Shibolet, Jason Grebely, Ronald Nahass, Frederick L. Altice, Brian Conway, Edward J. Gane, Anne F. Luetkemeyer, Cheng-Yuan Peng, David Iser, Isaias Noel Gendrano, Michelle M. Kelly, Barbara A. Haber, Heather Platt, Amy Puenpatom
Elbasvir/grazoprevir is a fixed-dose combination treatment for patients with HCV genotype 1 and 4 infection.6–10 COSTAR was a phase 3 clinical trial that evaluated the efficacy and safety of elbasvir/grazoprevir for 12 weeks in participants with HCV infection who were stable for ≥3 months on opioid agonist therapy. In this placebo-controlled trial, a sustained virologic response (SVR) at 12 weeks (SVR12) after completion of therapy was achieved by 96% of participants (274 of 286 participants in the modified full analysis set [FAS] population) receiving elbasvir/grazoprevir, with an associated safety profile that was generally similar to placebo.11 As this was a placebo-controlled double-blind trial that included people who injected drugs, including those who were using drugs during the study, this provides an unique opportunity to assess the effect of HCV on HRQOL in this population.
Retrieval of patients with hepatitis C who were lost to follow-up in Southern Denmark
Published in Infectious Diseases, 2023
Sandra Dröse, Janne Fuglsang Hansen, Birgit Thorup Røge, Anne Lindebo Holm Øvrehus, Peer Brehm Christensen
Patients who responded had the opportunity to receive a full laboratory assessment including HCV-RNA testing, HCV genotyping and FIB4 before the medical check-up and treatment assessment. When blood tests were available, patients were invited for a clinical appointment, including a FibroScan, and treatment was initiated at the first visit. The only planned follow-up was at 12 weeks after completed treatment, and if sustained virological response (SVR) was obtained, the patients were discharged. Patients with suspected or confirmed cirrhosis were offered post-treatment HCC screening according to standard of care. DAA treatment complied with the national guidelines defined by the Danish Medicines Council and was genotype specific. The Council was responsible for the national procurement and use of DAAs. Treating physicians could deviate from the guidelines at their discretion without any delay or inconvenience to the patient. During the study period, recommended treatments were 12 weeks of elbasvir/grazoprevir for patients with genotype 1/4, 8 weeks of glecaprevir/pibrentasvir for patients with genotype 2/3, and 12 weeks of velpatasvir/sofosbuvir for patients with cirrhosis.
Treatment of hepatitis C virus infection for adults and children: updated Swedish consensus guidelines 2017
Published in Infectious Diseases, 2018
Martin Lagging, Rune Wejstål, Ann-Sofi Duberg, Soo Aleman, Ola Weiland, Johan Westin
Naturally occurring virus variants that entail reduced sensitivity in particular to NS5A inhibitors also may impact the likelihood of achieving SVR [22], especially for HCV genotype 1a or 3 infection. This is most evident for genotype 1a treated with grazoprevir/elbasvir [23]. Analysis of resistance-associated substitutions (RASs), also known as resistance-associated variants (RAVs), however, is relatively complex, can be performed with a variety of different methods yielding varying results, requires experience when evaluating, and is only available at a limited number of virological laboratories. Therefore, routine susceptibility testing is recommended only for patients with genotype 1a infection prior to therapy with grazoprevir/elbasvir, as therapy for 12 weeks without ribavirin may be given if RASs/RAVs are not detected. Alternatively, therapy may be given for 16 weeks with ribavirin if RASs/RAVs are detected or the analysis is not performed. Susceptibility testing is also recommended before retreatment of patients with decompensated cirrhosis, as protease inhibitors should not be given to Child-Pugh B or C cirrhotic patients, as well as after relapse following a second course of DAA, containing three antivirals with differing modes of action.