Zepatier (grazoprevir/elbasvir) / Merck (MSD) - LARVOL DELTA

Real-world outcomes in patients with Voxilaprevir (VOX)/Velpatasvir (VEL)/Sofosbuvir (SOF) treatment failure: a follow-up study (EASL 2025) - "Most of the patients had been pre-treated with VEL/SOF (55%, 17/31), 13% (4/31) each had received G/P (glecaprevir/pibrentasvir) or GZR/EBR(grazoprevir/elbasvir)±SOF and 10% (3/31) each had been pretreated with LDV(ledipasvir)/SOF or DCV(daclatasvir)/SOF. The combination of G/P+SOF represents an effective third-line treatment option for difficult-to-treat patients, including those with cirrhosis, HCC, or HCV GT3 infection. These findings highlight the importance of tailored salvage therapy to achieve optimal outcomes in this challenging population."

Clinical • Real-world • Real-world evidence • Fibrosis • Hepatitis C • Hepatocellular Cancer • Hepatology • Immunology • Infectious Disease • Oncology • Solid Tumor

Sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) retreatment achieves sustained virological response in direct-acting antiviral experienced patients with hepatitis C virus: a (APASL 2025) - "All participants were DAAs treatment experienced, including Sofosbuvir/Velpatesvir (SOF/VEL, 43.8%), Elbasvir/Grazoprevir (EBR/GZR, 25.0%), Coblopasvir/Sofosbuvir (CLP/SOF, 18.8%) and ledipasvir/Sofosbuvir (LDV/SOF, 12.3%). This real-world study confirms high efficacy and safety of SOF/VEL/VOX for the treatment of DAA-experienced chronic hepatitis C patients, even those with GT3b or cirrhosis in China. Treatment was well tolerated well, even in those received SOF/VEL/VOX plus ribavirin. Table and Figure:Figure 1.Table 1 Patient demographics and baseline characteristics"

Clinical • Fibrosis • Hematological Disorders • Hepatitis C • Hepatocellular Cancer • Hepatology • Human Immunodeficiency Virus • Infectious Disease • Inflammation • Oncology • Solid Tumor

Zepatier in Patients with Substance Use (clinicaltrials.gov) - P=N/A | N=25 | Completed | Sponsor: University of Illinois at Chicago | Active, not recruiting ➔ Completed

Trial completion • Hepatitis C • Hepatology • Human Immunodeficiency Virus • Infectious Disease • Inflammation

LONG-TERM RESULTS OF TREATMENT WITH DIRECT ACTING ANTIVIRALS, CORTICOSTEROIDS, PLASMAPHERESIS AND RITUXIMAB IN A PATIENT WITH CRYOGLOBULINEMIC VASCULITIS AND HCV INFECTION (ISN-WCN 2025) - "She received rituximab (375 mg/m2 X 4 weeks) which was well tolerated and concurrently started direct acting antivirals (DAAs) (elbasvir+grazoprevir) (with some delay from the diagnosis due to logistic reasons). Kidney function is currently normal, and HCV is undetectable. Conclusions A combined treatment consisting of immunosuppressive therapy and DAAs seems to offer a sustained long-term clinical response even in patients with severe MCS."

Clinical • ANCA Vasculitis • Anemia • Cardiovascular • Complement-mediated Rare Disorders • Fibrosis • Gastroenterology • Gastrointestinal Disorder • Glomerulonephritis • Hematological Disorders • Hematological Malignancies • Hepatitis C • Hepatology • Infectious Disease • Inflammatory Arthritis • Inflammatory Bowel Disease • Liver Cirrhosis • Lupus Nephritis • Lymphoma • Nephrology • Non-Hodgkin’s Lymphoma • Oncology • Pain • Pulmonary Disease • Renal Disease • Respiratory Diseases • Ulcerative Colitis • Vasculitis

Direct-Acting Antivirals in Hepatitis C Treatment for Renal Impairment: Liver Safety Concerns and Effectiveness in Peritoneal Dialysis. (PubMed, Biomedicines) - "Background/Objectives: Glecaprevir/pibrentasvir (G/P) and elbasvir/grazoprevir (EBR/GZR) are effective treatments for chronic hepatitis C (CHC), especially in patients with chronic kidney disease (CKD). This real-world study supports the effectiveness of G/P and EBR/GZR in peritoneal dialysis patients. Comorbidities that impair liver function are key predictors of abnormal liver parameters, highlighting the need for careful monitoring during CHC treatment."

Journal • Cardiovascular • Chronic Kidney Disease • Hepatitis C • Hepatology • Hypertension • Infectious Disease • Inflammation • Liver Cancer • Liver Failure • Nephrology • Oncology • Renal Disease • Solid Tumor

HCV cure with direct‐acting antivirals in HIV/HCV coinfected patients belonging to key populations (HIV-Glasgow 2024) - "The availability of DAAs varied during the years: ombitasvir/paritaprevir/ritonavir (4.1%), grazoprevir/elbasvir (14.0%), sofosbuvir/ledipasvir (34.7%), sofosbuvir/velpatasvir (47.1%), sofosbuvir/velpatasvir/voxilaprevir (4.9%). DAA treatment success rate in HIV/HCV coinfected patients from key population was high and comparable to those monoinfected. The SVR rates were similar in PLH infected by sexual mode or in PWIDs, irrespective of the CD4 cell count or HIV-VL. Elimination of HCV requires a targeted scale-up of DAA treatment and behavioural interventions in particular among high-risk populations."

Clinical • Fibrosis • Hepatitis C • Hepatology • Human Immunodeficiency Virus • Immunology • Infectious Disease • CD4

Drugs for hepatitis C virus infection. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Addiction (Opioid and Alcohol) • Hepatitis C • Hepatology • Infectious Disease • Inflammation

TRENDS IN HCV SCREENING, FOLLOW-UP TESTING, AND TREATMENT IN PREGNANT PEOPLE AND INFANTS IN A TERTIARY CARE CENTER (AASLD 2024) - "Of the 32 with viremia, none received antiviral therapy during pregnancy; 9 (28.1%) received postpartum antiviral therapy (3 with ledipasvir-sofosbuvir, 1 with daclatasvir-sofosbuvir, 1 with elbasvir-grazoprevir, 1 with velpatasvir-sofosbuvir, 3 with unknown regimens). From 2014-2023, HCV screening in pregnancy improved to 66%, but remained much lower than universal screening recommendations. HCV viremia was < 1%, with no identified perinatal transmission. However, 58% of babies and 72% of mothers were lost to follow-up, supporting the need for improved screening as well as referral during pregnancy, postpartum, and for pediatric care."

Hepatitis C • Hepatology • Infectious Disease • Inflammation • Pediatrics • Small for Gestational Age

An Increase in the Prevalence of Clinically Relevant Resistance-Associated Substitutions in Four Direct-Acting Antiviral Regimens: A Study Using GenBank HCV Sequences. (PubMed, Pathogens) - "The AASLD-IDSA recommendations were used to identify cr-RASs for three HCV genotypes/subtypes (1a, 1b, and 3) and four DAA regimens: ledipasvir/sofosbuvir; elbasvir/grazoprevir; sofosbuvir/velpatasvir; and glecaprevir/pibrentasvir. This highlights the necessity for ongoing surveillance and adaptation of novel therapeutics to manage HCV resistance effectively. Updating the clinical guidelines and treatment regimens is recommended to counteract the evolving HCV resistance to DAAs."

Journal • Hepatitis C • Hepatology • Infectious Disease • Inflammation

Modeling suggests that undetectable HCV at week 2 of DAA therapy could identify patients for shorter treatment duration (EASL-ILC 2024) - " Previous modeling efforts based on ~300 patients receiving DAA (such as sofosbuvir + velpatasvir, elbasvir+ grazoprevir, sofosbuvir + ledipasvir, or pibrentasvir + glecaprevir) allowed us to characterize viral-host parameters, DAA efficacy in blocking HCV production, and treatment outcomes [Math Biosci. Mathematical modeling of in silico patients that reach undetectable HCV by day 14 predicted that >90% cure rates could be achieved with 4-5 weeks of DAA therapy. This RGT could improve treatment access, facilitate HCV elimination, and reduce cost, particularly in patient groups most affected by HCV such as PWID."

Clinical • Hepatitis C

Validated LC/MS method for simultaneous determination of elbasvir and grazoprevir in human plasma. (PubMed, Ann Pharm Fr) - "A sensitive and accurate LC/MS method for the determination of elbasvir (ELB) and grazoprevir (GZP) in human plasma was established using daclatasvir (DCT) as an internal standard. The intra- and inter-day precision and accuracy of the quality control samples at low, medium, and high concentration levels exhibited relative standard deviations (RSD) < 15%, and the accuracy values ranged from 94.2% to 107.8%. The robustness of the method was established using a two-level full factorial design."

Journal

Hepatitis C Virus Antiviral Drug Resistance and Salvage Therapy Outcomes Across Australia. (PubMed, Open Forum Infect Dis) - "The SVR rate for salvage regimens that included sofosbuvir/velpatasvir/voxilaprevir was 94.3% (n = 140), sofosbuvir/velpatasvir 75.0% (n = 52), elbasvir/grazoprevir 81.6% (n = 38), and glecaprevir/pibrentasvir 84.6% (n = 13). In our cohort, the SVR rate for sofosbuvir/velpatasvir/voxilaprevir was higher than with other salvage regimens. The presence of NS5A, NS5B, or NS3 RASs did not appear to negatively influence retreatment outcomes."

Journal • Fibrosis • Hepatitis C • Hepatology • Immunology • Infectious Disease • Inflammation

Elimination of Hepatitis C Virus in a Hemodialysis Unit in Cipto Mangunkusumo Hospital (APASL 2024) - "While in period 2, there were 9 patients treated with grazoprevir/elbasvir and 2 patients with sofosbuvir/daclatasvir, due to relaps and no respon with previous treatment. The elimination of HCV infection in our HD patients was successful. The most important strategy is to detect patient with a valid method, then treat and re-treat them at the same time."

Clinical • Hepatitis C • Hepatology • Infectious Disease • Inflammation • Renal Disease

Prognosis after SVR of chronic hepatitis C patients treated with Elbasvir/Grazoprevir treatment (APASL 2024) - "The prognosis of patients achieved SVR after EBR/GZR treatment was generally good. However, HCC risk was not completely removed especially in patients with high APRI or FIB-4 score. Therefore, regular follow-up surveillance is still warranted for advanced fibrosis cases"

Clinical • Fibrosis • Gastrointestinal Cancer • Hepatitis C • Hepatocellular Cancer • Hepatology • Infectious Disease • Inflammation • Oncology • Solid Tumor

Eradication of Hepatitis C virus from interferon to DAA in jailed prisoners. (APASL 2024) - "The duration of DAA( Epclusa/Harvoni/Maviret/Zepatier: 117/92/135/11) is 8-16 weeks and AE is minor including skin rash/itching, fatigue, headache and insomnia at 8.8% (31/355). One mortality is decompensated hepatitis and it was not reverse after DAA treatment. The SVR of DAA treatment is extremely excellent as 100% in the coinfection with HBV/HIV."

CNS Disorders • Dermatology • Fatigue • Hepatitis B • Hepatitis C • Hepatology • Human Immunodeficiency Virus • Infectious Disease • Inflammation • Insomnia • Pain • Pruritus • Sleep Disorder

High efficacy of interferon-free therapy for acute hepatitis C in China (APASL 2024) - "According to patients' characteristics, 76 patients started treatment in the first four weeks (76/129, 58.91%), 27 patients started treatment between four and eight weeks (27/129, 20.93%), and 26 patients started treatment between eight and thirty-six weeks (26/129, 20.15%); following 15%, the following DAA regimens were prescribed: daclatasvir/yasunaprevir (6.2%; 8/129), sofosbuvir/radipavir (3.1%; 4/129), ombitasvir/paritaprevir/ritonavir (16.2%; 21/129), grazoprevir/elbasvir (59.6%; 77/129) and sofosbuvir/velpatasvir (14.7%; 19/129). Interferon-free DAA regimens can achieve 100% SVR12 in AHC patients with a favorable safety profile if treatment durations similar to CHC are used."

Clinical • Anorexia • Hepatitis B • Hepatitis C • Hepatology • Human Immunodeficiency Virus • Infectious Disease • Inflammation

Discovery and development of MK-7845 as an investigational treatment for COVID-19 (ACS-Sp 2024) - "This commitment has remained strong, as evidenced by the introduction of Crixivan™ for HIV, Zepatier™ for HCV, and Prevymis™ for CMV. Our company, like many others, initiated a multi-pronged approach to combat SARS-CoV-2; one major effort was focused on the discovery of an effective inhibitor of the viral 3-chymotrypsin-like protease (3CLPro). This presentation will focus on the invention and rapid development of MK-7845 as an oral protease inhibitor for the treatment of COVID-19."

Human Immunodeficiency Virus • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

ESPGHAN recommendations on treatment of chronic hepatitis C virus infection in adolescents and children including those living in resource-limited settings. (PubMed, J Pediatr Gastroenterol Nutr) - "Three regimens with pangenotypic activity (glecaprevir/pibrentasvir, sofosbuvir/velpatasvir and sofosbuvir/velpatasvir/voxilaprevir) and three regimens with genotype-specific activity (sofosbuvir/ribavirin, sofosbuvir/ledipasvir and elbasvir/grazoprevir) have been approved with age-specific limitation for treatment of children with chronic hepatitis C by the European Medicines Agency and the United States Food and Drug Administration. The World Health Organization has set the ambitious target to eliminate hepatitis C as a major public health threat by 2030 and based its actions against HCV on the large use of direct acting antivirals. These updated European Society for Pediatric Gastroenterology, Hepatology and Nutrition recommendations on treatment of hepatitis C describe the optimal therapeutic management of adolescents and children with HCV infection including specific indications for those living in resource-limited settings."

Journal • Gastroenterology • Hepatitis C • Hepatology • Infectious Disease • Inflammation • Pediatrics

TOTAL HCV PATIENTS TREATED WITH DIRECT ACTING ANTIVIRALS SINCE 2014 (AASLD 2023) - "National registration dates of sofosbuvir (SOF), ombitasvir + paritaprevir + ritonavir, glecaprevir + pibrentasvir, and elbasvir + grazoprevir based treatments were used to allocate treated patients to specific regimens. The access to DAAs in low- and middle-income countries (LMIC) has had a profound impact on the total number of HCV patients treated globally with generic sofosbuvir + daclatasvir being the preferred treatment. With 89% of all HCV infections in LMIC, immediate access to generic versions of the latest drugs is needed to achieve the global elimination targets. The high-income countries have been very proactive in treating their HCV infected populations and removing all restrictions."

Clinical • Hepatitis C • Hepatology • Infectious Disease • Inflammation

Hepatectomy In A Patient With Hepatocellular Carcinoma (ASA 2023) - "He has history of hepatitis C virus with sustained virologic response (SVR) after a course of treatment with ledipasvir/sofosbuvir, and hepatocellular carcinoma that recurred despite treatment with transarterial chemoembolization (TACE)...What is elbasvir/grazoprevir?...The nurse inquires if you need blood products for this case.7) What is your vascular access of choice?8) Will you place an arterial line?9) Will you place a central venous catheter?10) Do you need to measure central venous pressure (CVP) during the procedure?11) Does the position of the tumor alter your anesthetic plan?12) Do you need blood products for this case?You place an 18-gauge IV in the holding area and sedate the patient with 2 mg of midazolam...You perform a spinal anesthetic with 250 micrograms of preservative free morphine then perform a smooth induction of anesthesia with propofol, lidocaine, fentanyl and rocuronium. You then place an arterial line, a 16 Ga IV, and initiate maintenance of..."

Clinical • Anesthesia • Gastroenterology • Gastroesophageal Reflux Disease • Gastrointestinal Cancer • Hepatitis C • Hepatocellular Cancer • Hepatology • Infectious Disease • Oncology • Pain • Pulmonary Disease • Solid Tumor

Hepatectomy In A Patient With Hepatocellular Carcinoma (ASA 2023) - "He has history of hepatitis C virus with sustained virologic response (SVR) after a course of treatment with ledipasvir/sofosbuvir, and hepatocellular carcinoma that recurred despite treatment with transarterial chemoembolization (TACE)...What is elbasvir/grazoprevir?...The nurse inquires if you need blood products for this case.7) What is your vascular access of choice?8) Will you place an arterial line?9) Will you place a central venous catheter?10) Do you need to measure central venous pressure (CVP) during the procedure?11) Does the position of the tumor alter your anesthetic plan?12) Do you need blood products for this case?You place an 18-gauge IV in the holding area and sedate the patient with 2 mg of midazolam...You perform a spinal anesthetic with 250 micrograms of preservative free morphine then perform a smooth induction of anesthesia with propofol, lidocaine, fentanyl and rocuronium. You then place an arterial line, a 16 Ga IV, and initiate maintenance of..."

Clinical • Anesthesia • Gastroenterology • Gastroesophageal Reflux Disease • Gastrointestinal Cancer • Hepatitis C • Hepatocellular Cancer • Hepatology • Infectious Disease • Oncology • Pain • Pulmonary Disease • Solid Tumor

Reported adverse events related to use of hepatitis C virus direct-acting antivirals with opioids: 2017-2021. (PubMed, Harm Reduct J) - "Treating people with hepatitis C virus (HCV) infection who use drugs is key to achieving HCV elimination. Low numbers of DAA AE reports with opioids may provide reassurance to prioritize HCV treatment in this population. These data contribute to evidence supporting the continued scale-up of DAA treatment among people who use drugs to achieve HCV elimination goals."

Adverse events • Journal • Addiction (Opioid and Alcohol) • CNS Disorders • Hepatitis C • Hepatology • Infectious Disease • Inflammation • Psychiatry • Substance Abuse

Glecaprevir-pibrentasvir for 4 weeks among people with recent HCV infection: The TARGET3D study. (PubMed, JHEP Rep) - P3 | "There were four cases of virological failure (relapse); three received retreatment with 12 weeks sofosbuvir-velpatasvir or grazoprevir-elbasvir (SVR, n = 2; loss to follow-up, n = 1). Baseline HCV RNA appeared to impact response, with higher efficacy among participants with lower baseline HCV RNA (≤6 log; SVR12 100% ITT, 12/12). While most achieved SVR, the efficacy of 4 weeks of glecaprevir-pibrentasvir was below that seen with longer treatment durations (≥6 weeks)."

Journal • Hepatitis C • Hepatology • Human Immunodeficiency Virus • Infectious Disease • Inflammation

Pembrolizumab With or Without Elbasvir/Grazoprevir and Ribavirin in Treating Patients With Advanced Refractory Liver Cancer (clinicaltrials.gov) - P2 | N=12 | Completed | Sponsor: M.D. Anderson Cancer Center | Active, not recruiting ➔ Completed | Trial completion date: Dec 2022 ➔ Aug 2023 | Trial primary completion date: Dec 2022 ➔ Aug 2023

Metastases • Trial completion • Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Hepatitis C • Hepatocellular Cancer • Hepatology • Infectious Disease • Liver Cancer • Oncology • Solid Tumor

The SHELTER Trial of Transplanting Hepatitis C Virus-Infected Lungs Into Uninfected Recipients. (PubMed, Transplant Direct) - P1/2 | "Nine patients received elbasvir/grazoprevir, whereas 1 patient received sofosbuvir/velpatasvir. We detected no clinically important differences in forced expiratory volume in 1 s between the HCV-RNA lung recipients versus matched comparators. SHELTER adds important evidence regarding the safety of transplanting HCV-RNA lungs into uninfected recipients and suggests QOL benefits."

Journal • Chronic Obstructive Pulmonary Disease • Hepatitis C • Hepatology • Immunology • Infectious Disease • Inflammation • Pulmonary Disease • Respiratory Diseases • Transplantation