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• W3135018183 abstract "Failure on voxilaprevir, velpatasvir, sofosbuvir and efficacy of rescue therapyJournal of HepatologyVol. 74Issue 4PreviewThere are limited data on patients with chronic HCV infection in whom combination voxilaprevir (VOX), velpatasvir (VEL), sofosbuvir (SOF) retreatment fails. Thus, we aimed to assess treatment failure and rescue treatment options in these patients. Full-Text PDF Reply to: “Glecaprevir/pibrentasvir + sofosbuvir + ribavirin offers high cure rate for hepatitis C virus retreatment in real-world settings”Journal of HepatologyVol. 75Issue 1PreviewWe thank Dr. Martin and colleagues for their interest in our study and for presenting additional data on the usage of glecaprevir, pibrentasvir + sofosbuvir + ribavirin (G/P+SOF+RBV) for the rescue treatment of patients with chronic hepatitis C who failed to voxilaprevir, velpatasvir, sofosbuvir (VOX/VEL/SOF) as retreatment. Full-Text PDF We read with interest the recent publication by Dietz et al.[1]Dietz J. Di Maio V.C. de Salazar A. Merino D. Vermehren J. Paolucci S. et al.Failure on voxilaprevir, velpatasvir, sofosbuvir and efficacy of rescue therapy.J Hepatol. 2021; 74: 801-810Abstract Full Text Full Text PDF PubMed Scopus (17) Google Scholar and would like to present additional data regarding salvage HCV treatment in this difficult-to-cure patient population. Patients who fail to achieve sustained virologic response (SVR) with approved direct-acting antiviral (DAA) regimens have limited options for successful retreatment. Usage of a regimen containing an NS3/4A protease inhibitor, NS5A replication complex inhibitor, and NS5B polymerase inhibitor with weight-based ribavirin is appropriate for patients for whom even triple-DAA rescue therapy with sofosbuvir/velpatasvir/voxilaprevir did not achieve cure. In 2018, the European Association for the Study of the Liver (EASL) guidelines first included a recommendation for the use of glecaprevir/pibrentasvir with sofosbuvir and ribavirin for up to 16 to 24 weeks in patients who had twice failed other DAA regimens.[2]European Association for the Study of the LiverEASL Recommendations on treatment of hepatitis C 2018.J Hepatol. 2018; 69: 461-511https://doi.org/10.1016/j.jhep.2018.03.026Abstract Full Text Full Text PDF PubMed Scopus (1222) Google Scholar Updated EASL guidelines published in 2020 recommend its use for 12–24 weeks in twice-failures of DAA regimens, and for 24 weeks in sofosbuvir/velpatasvir/voxilaprevir failures.[3]European Association for the Study of the LiverEASL recommendations on treatment of hepatitis C: final update of the series.J Hepatol. 2020 Nov; 73: 1170-1218https://doi.org/10.1016/j.jhep.2020.08.018Abstract Full Text Full Text PDF PubMed Scopus (372) Google Scholar The joint American Association for the Study of Liver Diseases and Infectious Diseases Society of America (AASLD-IDSA) guidance first included this combination as a recommended retreatment option in November 2019. Since January 2021, American guidance recommends use of this regimen for 16 weeks in glecaprevir/pibrentasvir failures and for 16–24 weeks in sofosbuvir/velpatasvir/voxilaprevir or glecaprevir/pibrentasvir plus sofosbuvir failures.[4]AASLD-IDSA Recommendations for testing, managing, and treating hepatitis C virus. http://www.hcvguidelines.org (Accessed February 12, 2021).Google Scholar Dietz et al. with the European Study Resistance Group, recently reported a 77% SVR rate in 13 sofosbuvir/velpatasvir/voxilaprevir failures who were retreated with glecaprevir/pibrentasvir, sofosbuvir, and ribavirin for 12–24 weeks.[1]Dietz J. Di Maio V.C. de Salazar A. Merino D. Vermehren J. Paolucci S. et al.Failure on voxilaprevir, velpatasvir, sofosbuvir and efficacy of rescue therapy.J Hepatol. 2021; 74: 801-810Abstract Full Text Full Text PDF PubMed Scopus (17) Google Scholar Two case studies report SVR after 24 weeks of this regimen in 2 patients (HIV-coinfected genotype 1b, and genotype 3a), who had thrice-failed other DAA courses (the 3a patient had most recently failed sofosbuvir/velpatasvir/voxilaprevir).[5]Fierer D.S. Wyles D.L. Re-treatment of hepatitis C infection after multiple failures of direct-acting antiviral therapy.Open Forum Infect Dis. 2020 Mar 16; 7 (ofaa095)https://doi.org/10.1093/ofid/ofaa095Crossref PubMed Google Scholar,[6]Bernhard B. Stickel F. Successful fourth line treatment of a relapse patient with chronic hepatitis C virus infection genotype 3a using sofosbuvir, glecaprevir/pibrentasvir, and ribavirin: a case report.Z Gastroenterol. 2020 May; 58: 451-455https://doi.org/10.1055/a-1131-8058Crossref PubMed Scopus (3) Google Scholar One case report describes SVR after the on-treatment addition of sofosbuvir and ribavirin to glecaprevir/pibrentasvir in a treatment-naïve genotype 3a patient.[7]Aragri M. Milana M. Di Maio V.C. Lenci I. Carioti L. Perno C.F. et al.Successful ongoing retreatment with glecaprevir/pibrentasvir + sofosbuvir + ribavirin in a patient with HCV genotype 3 who failed glecaprevir/pibrentasvir with both NS3 and NS5A resistance.Clin Microbiol Infect. 2020 Mar 30; (S1198-743X(20)30167-1)https://doi.org/10.1016/j.cmi.2020.03.022Abstract Full Text Full Text PDF PubMed Scopus (2) Google Scholar Treatment of 23 glecaprevir/pibrentasvir failures resulted in a 96% SVR rate after use of 12–16 weeks of this regimen as part of the MAGELLAN-3 phase IIIb clinical trial.[8]Wyles D. Weiland O. Yao B. Weilert F. Dufour J.F. Gordon S.C. et al.Retreatment of patients who failed glecaprevir/pibrentasvir treatment for hepatitis C virus infection.J Hepatol. 2019; 70: 1019-1023https://doi.org/10.1016/j.jhep.2019.01.031Abstract Full Text Full Text PDF PubMed Scopus (42) Google Scholar An HCV retreatment review article briefly references this trial and refers to this regimen as useful in some populations.[9]Pawlotsky J.M. Retreatment of hepatitis C virus-infected patients with direct-acting antiviral failures.Semin Liver Dis. 2019; 39: 354-368https://doi.org/10.1055/s-0039-1687823Crossref PubMed Scopus (24) Google Scholar We are unaware of published reports on this regimen beyond these 39 patients; only 14 of whom had failed sofosbuvir/velpatasvir/voxilaprevir treatment. This dual-center case series describes the use of glecaprevir/pibrentasvir with sofosbuvir and ribavirin as a salvage regimen in real-world settings in patients who previously failed multiple DAA regimens including sofosbuvir/velpatasvir/voxilaprevir. Authors at 2 urban academic medical centers performed a retrospective review of the electronic medical records of DAA-experienced patients who initiated HCV treatment with glecaprevir/pibrentasvir plus sofosbuvir and ribavirin through April 10, 2020. The data collected included baseline demographics, medical history, HCV treatment-related details, and laboratory values throughout treatment and until SVR was achieved. This study was approved by both sites’ institutional review boards. The primary outcome was SVR following treatment with glecaprevir/pibrentasvir, sofosbuvir, and ribavirin. Six patients began 16–24 weeks of HCV retreatment with glecaprevir/pibrentasvir, sofosbuvir, and ribavirin between July 2018 and March 2020. All patients achieved SVR. Baseline resistance was present in most patients (5/5 assessed for NS5A and 3/4 assessed for NS3), and all had cirrhosis. No patients were on dialysis or had HIV or HBV infection. No patients experienced serious adverse events or died during treatment. See Table 1 for additional patient details.Table 1Patient characteristics.Patient123456Age676061686858GenderMaleMaleFemaleMaleMaleMaleGenotype1b3a31a1b1aStageCirrhosis (CTP A)Cirrhosis (CTP A)Cirrhosis (CTP A)Cirrhosis (CTP A)Cirrhosis (CTP A)Cirrhosis (CTP B)Baseline history of HCCNoIndeterminate liver lesions1Patient 2 was diagnosed with HCC during HCV treatment.NoYes; received Y90 radioembolizationYes; received Y90 radioembolizationNoBaseline NS5A resistanceT17S, T79A, Q288R, R311P, A347T, S396P, D403SY93H, S62TNo resistance panel availableK24K/E, M28T/M, Q30R, Y93NR30Q, L31V, Q54H, Y93HL31VBaseline NS3 resistanceQ80KNo resistance panel availableNo resistance panel availableNo mutations or resistance predictedQ80K/Q, D168VV36MBaseline HCV RNA (IU/ml)2,299,6311,038,041705,684667,1441,960,000886,538Regimen (length in weeks)2Ribavirin dose = 1,200 mg/day (dosed 600 mg twice daily); all patients weighed > 75 kg.G/P + SOF + RBV (16)G/P + SOF + RBV (16)G/P + SOF + RBV (16)G/P + SOF + RBV; then G/P (24)3Patient 4 received G/P + SOF + RBV for 13 weeks 4 days, then had a 14-day interruption due to orthotopic liver transplantation. SOF + RBV were discontinued after day 95 due to acute kidney injury post-transplant, but the patient received G/P through 24 weeks.G/P + SOF + RBV (24)G/P + SOF + RBV (16)Week 4 HCV RNA—Detected, <15 IU/ml—Not detectedNot detectedNot detectedEnd of Treatment HCV RNANot detected—Not detectedNot detectedNot detectedNot detected≥12 weeks after treatment HCV RNANot detectedNot detectedNot detectedNot detectedNot detectedNot detectedFailed previous regimens (length in weeks)Course 1:LDV/SOF (12)PegIFN + RBV (48)SOF/VEL (12)PegIFN + RBV + SOF (12)PegIFN + RBV (48)SOF/VEL (12)Course 2:SOF/VEL/VOX (12)SOF/VEL + RBV (12)SOF/VEL/VOX + RBV (12)LDV/SOF (24)SOF + SMV (12)SOF/VEL/VOX (12)Course 3:—SOF/VEL/VOX (12)—G/P (16)LDV/SOF + RBV (24)—Course 4:———SOF/VEL/VOX + RBV (12)SOF/VEL/VOX (12)—CTP, Child-Turcotte-Pugh; G/P, glecaprevir/pibrentasvir; HCC, hepatocellular carcinoma; HCV, hepatitis C virus; LDV/SOF, ledipasvir/sofosbuvir; PegIFN, pegylated interferon; RBV, ribavirin; SMV, simeprevir; SOF, sofosbuvir; SOF/VEL, sofosbuvir/velpatasvir; SOF/VEL/VOX, sofosbuvir/velpatasvir/voxilaprevir.1 Patient 2 was diagnosed with HCC during HCV treatment.2 Ribavirin dose = 1,200 mg/day (dosed 600 mg twice daily); all patients weighed > 75 kg.3 Patient 4 received G/P + SOF + RBV for 13 weeks 4 days, then had a 14-day interruption due to orthotopic liver transplantation. SOF + RBV were discontinued after day 95 due to acute kidney injury post-transplant, but the patient received G/P through 24 weeks. Open table in a new tab CTP, Child-Turcotte-Pugh; G/P, glecaprevir/pibrentasvir; HCC, hepatocellular carcinoma; HCV, hepatitis C virus; LDV/SOF, ledipasvir/sofosbuvir; PegIFN, pegylated interferon; RBV, ribavirin; SMV, simeprevir; SOF, sofosbuvir; SOF/VEL, sofosbuvir/velpatasvir; SOF/VEL/VOX, sofosbuvir/velpatasvir/voxilaprevir. Weight-based ribavirin (1,200 mg/day; all patients weighed >75 kg) was used for all patients based on authors’ previous experience with the inclusion of ribavirin and extension of treatment length as methods for successful retreatment in DAA failures. Providers ordered complete blood counts and comprehensive metabolic panels every 2–4 weeks during HCV treatment. No patients had hemoglobin levels under 10 g/dL or required ribavirin dose adjustments during treatment. All patients treated with glecaprevir/pibrentasvir, sofosbuvir, and ribavirin achieved a cure. No patients died or had serious adverse events, implicating the safety of this regimen in our small cohort of patients. Providers are advised to monitor hemoglobin/hematocrit levels and renal function during the course of treatment that includes ribavirin and to counsel patients of childbearing potential on the importance of the use of 2 forms of contraception during therapy and for 6 months afterward due to the teratogenicity of ribavirin. Decompensated patients must be managed by a transplant center and closely monitored for elevated liver enzymes and further decompensation with off-label use of a protease inhibitor. This salvage regimen lacks robust published clinical data. Patients were treated prior to the publication of the latest EASL and AASLD-IDSA guidelines, and treatment for 16 weeks was effective in 4 patients. This real-world case series adds to the available literature and demonstrates that salvage therapy with glecaprevir/pibrentasvir, sofosbuvir, and ribavirin is an effective and safe treatment for compensated cirrhotic patients who previously failed sofosbuvir/velpatasvir/voxilaprevir treatment. The authors received no financial support to produce this manuscript. MM led and CC, LK and SP assisted with the study concept and design. MM and SP equally contributed to acquisition of data and analysis and interpretation of data. MM led initial drafting of the manuscript. All authors provided critical revision of the manuscript for important intellectual content, gave final approval of data, and are accountable for the work. CC does not have any conflicts of interest to disclose. LK serves on the advisory board for Bayer, Eisai, Exelixis, Genentech, Gilead and Merck; is on the speakers’ bureau for Bayer, Gilead and Peer View CME; and is a researcher for Target-HCC. MM serves on the speakers’ bureau for AbbVie, has received grant funding from Gilead and Merck, served on the advisory board for AbbVie and Gilead, and is a minor shareholder of AbbVie, Gilead, and Merck stock. SP serves on the speakers’ bureau for AbbVie. Please refer to the accompanying ICMJE disclosure forms for further details. The following is the supplementary data to this article: Download .pdf (.17 MB) Help with pdf files Multimedia component 1" @default.
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