Mavyret (glecaprevir/pibrentasvir) / AbbVie, Enanta Pharma - LARVOL DELTA

Drug-induced headache reports: a comprehensive disproportionality and time-to-onset pharmacovigilance study using the FAERS database (2018-2024). (PubMed, Front Pain Res (Lausanne)) - "The drugs with the highest headache risk based on ROR included glecaprevir/pibrentasvir (ROR = 10.445), sofosbuvir/velpatasvir (ROR = 9.729), and eptinezumab-jjmr (ROR = 6.775). Top frequently reported drugs were apremilast, treprostinil, and adalimumab...Early-onset headaches (≤7days) were particularly associated with ofatumumab and fingolimod. Late-onset headaches (>90days) were linked to treprostinil and infliximab-dyyb. This large-scale pharmacovigilance study identifies multiple drugs and therapeutic classes with significant associations to headache as an ADR. These findings highlight the need for proactive headache monitoring, particularly during early treatment phases, and warrant further prospective investigations to understand mechanisms and preventive strategies."

Adverse events • Journal • Pain

Hepatitis C virus microelimination program in hemodialysis patients: success of a multi-stakeholder partnership based on a national eradication strategy. (PubMed, Medicina (B Aires)) - "A multi-stakeholder partnership model (Fresenius Medical Care, physicians, insurance companies and Ministry of Health), implemented as a national microelimination strategy, has demonstrated increased treatment rates for HCV in dialysis units, exhibiting acceptable effectiveness."

Journal • Licensing / partnership • Fibrosis • Hepatitis C • Immunology • Infectious Disease • Inflammation • Renal Disease

Recently acquired hepatitis C virus infection in people with HIV - what have we learned? (PubMed, Curr Opin HIV AIDS) - "Treatment of RAHCV, especially among key populations living with HIV, is a cornerstone of HCV elimination attempts. Recent studies might help reinvigorate these efforts."

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

Epidemiologic Characteristics Determining the Choice of Direct-Acting Antiviral Therapy in HCV Patients: An Italian Real-World Evidence Study. (PubMed, Pathogens) - "In Italy, sofosbuvir/velpatasvir (SOF/VEL) and glecaprevir/pibrentasvir (GLE/PIB) are available. SOF/VEL was often used for older, frailer patients, likely due to a more favourable DDI profile. These prescribing trends highlight the importance of tailoring pDAA choice to patient comorbidity profiles, ensuring appropriate and individualized HCV treatment."

HEOR • Journal • Real-world evidence • Cardiovascular • CNS Disorders • Diabetes • Hepatitis C • Hypertension • Infectious Disease • Inflammation • Mental Retardation • Metabolic Disorders • Oncology • Psychiatry

Consideration of ledipasvir/sofosbuvir as an alternative to glecaprevir/pibrentasvir based upon on-treatment FIB-4 changes and sustained virologic response at 12 weeks in hepatitis C genotype 1 and 2 infections: A propensity score-matched study. (PubMed, Medicine (Baltimore)) - "Fixed doses of LDV/SOF and GLE/PIB are effective for treating HCV GT-1 and GT-2 infections. There were no significant differences between the 2 regimens in on-treatment FIB-4 changes upon reaching SVR 12."

Clinical • Journal • Observational data • Retrospective data • Fibrosis • Hepatitis C • Immunology • Infectious Disease • Inflammation

A phase IIIb study of 8-week glecaprevir/pibrentasvir treatment in adults with acute hepatitis C. (PubMed, J Hepatol) - P3 | "An 8-week glecaprevir/pibrentasvir regimen was efficacious and well-tolerated in patients with acute HCV. These results support glecaprevir/pibrentasvir use in HCV test-and-treat models, potentially streamlining the care cascade, reducing transmission, and supporting HCV elimination."

Journal • P3 data • Hepatitis C • Human Immunodeficiency Virus • Infectious Disease • Inflammation • Liver Failure

Pangenotypic Glecaprevir/Pibrentasvir Therapy for Chronic Hepatitis C in Children. (PubMed, Pediatr Infect Dis J) - "Eight-week GLE/PIB therapy in children is well tolerated and highly effective in all age ranges regardless of gender. Its use in routine clinical practice will bring the ambitious goal of eliminating HCV worldwide a step closer."

Journal • Asthma • Fibrosis • Genetic Disorders • Hepatitis C • Hepatology • Immunology • Infectious Disease • Inflammation • Nephrology • Obesity • Pediatrics • Pulmonary Disease • Renal Disease • Respiratory Diseases

A cost-utility analysis of Glecaprevir/Pibrentasvir versus Sofosbuvir/Daclatasvir and Sofosbuvir/Velpatasvir for treatment of hepatitis C in Iran. (PubMed, Cost Eff Resour Alloc) - "The results showed that GLE/PIB is cost-effective compared with the two common medication regimens in Iran, SOF/DCV and SOF/VEL, consistent with Iran's national willingness-to-pay threshold based on one time the GDP per capita, making it a good treatment option for patients with hepatitis C."

HEOR • Journal • Hepatitis C • Hepatology • Infectious Disease • Inflammation

Effectiveness and Safety of Glecaprevir/Pibrentasvir Combination Therapy in Patients Diagnosed with Chronic Hepatitis C. (PubMed, J Clin Pract Res) - "The GLE/PIB combination is an effective and safe treatment option in the treatment of HCV infection. Due to the high EVR rates, more comprehensive studies need to be conducted to keep the duration of GLE/PIB treatment shorter in some patient groups in patients diagnosed with CHC."

Journal • Fatigue • Hepatitis C • Infectious Disease • Inflammation

Successful Antiviral Treatment of Hepatitis C Virus-Associated Polyarteritis Nodosa with Resolution of Dialysis-Dependent Kidney Failure (KIDNEY WEEK 2025) - "Thrice weekly HD was commenced, 60 mg prednisolone daily with gradual weaning, glecaprevir + pibrentasvir thrice daily for 23 weeks, and entecavir 0.5 mg once weekly for prevention of HBV reactivation. Discussion This is the first report of HCV-associated PAN requiring dialysis treated with glecaprevir + pibrentasvir that was able to successfully discontinue HD and achieve vasculitis remission following complete resolution of HCV viremia. The patient now has stage 3 CKD and remains on a SGLT2 inhibitor."

Cardiovascular • Chronic Kidney Disease • Hepatitis B • Hepatitis C • Hepatology • Human Immunodeficiency Virus • Hypertension • Immunology • Infectious Disease • Inflammation • Inflammatory Arthritis • Rare Diseases • Renal Disease • Vasculitis

Rare Case of Dual Pathology: Methamphetamine-Associated Acute Interstitial Nephritis and HIV/Hepatitis C Virus-Associated Fibrillary Glomerulonephritis (KIDNEY WEEK 2025) - "The patient received a 2-week course of 20 mg oral prednisone. Antiviral therapies (bictegravir/emtricitabine/tenofovir and glecaprevir/pibrentasvir) were initiated...His IVDA status could be linked to both methamphetamine AIN and HCV/HIV-related GN. This case highlights the diagnostic and therapeutic challenges in patients with dual renal pathology and coexisting infections."

Clinical • Cardiovascular • Glomerulonephritis • Hepatitis C • Hepatology • Human Immunodeficiency Virus • Infectious Disease • Inflammation • Lupus Nephritis • Nephrology • Renal Disease

Membranoproliferative Glomerulonephritis from Hepatitis C: Managing Treatment with Brain Lesions and Latent Tuberculosis (KIDNEY WEEK 2025) - "KDIGO recommends direct-acting antivirals like glecaprevir/pibrentasvir for first-line therapy to improve renal function and reduce proteinuria. Rituximab addresses autoimmune issues, especially in cryoglobulinemic flare or rapidly progressive glomerulonephritis. Treatment aims for sustained virologic response. This case underscores management complexity due to comorbidities and social challenges like access to care and treatment adherence."

Cardiovascular • Diabetes • Diabetic Nephropathy • Glomerulonephritis • Hepatitis C • Hepatology • Human Immunodeficiency Virus • Hypertension • Immunology • Infectious Disease • Inflammation • Lupus Nephritis • Metabolic Disorders • Nephrology • Renal Disease • Respiratory Diseases • Tuberculosis • Vasculitis

Management of HCV-Infection in Pediatric Patients Undergoing HCT: A Single-Center Experience (ASH 2024) - "Four patients received myeloablative conditioning consisting of TBI + etoposide and busulfan + cyclophosphamide + thiotepa for 3 and 1 patient, respectively. One patient received a reduced-intensity conditioning regimen consisting of fludarabine + cyclophosphamide...DAAs were started after discontinuation of immunosuppressive therapy, for 4/5 patients.The combination of drugs used was : glecaprevir + pibrentasvir (2 patients), sofosbuvir + velpatasvir and ledipasvir + sofosbuvir...Two patients developed CMV-reactivation and required pre-emptive therapy with valganciclovir...No data are currently available regarding the possibility of viral reactivation in patients receiving treatment before transplant. Larger studies are needed to assess the right timing of treatment based on clinical evaluations."

Clinical • Acute Lymphocytic Leukemia • Anemia • Aplastic Anemia • Bone Marrow Transplantation • Fibrosis • Graft versus Host Disease • Hematological Disorders • Hematological Malignancies • Hepatology • Immunology • Infectious Disease • Leukemia • Liver Cirrhosis • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Pediatrics • T Cell Non-Hodgkin Lymphoma

Recent Advances in the Treatment of Chronic Hepatitis C (PubMed, Korean J Gastroenterol) - "Pan-genotypic regimens, including sofosbuvir/velpatasvir and glecaprevir/pibrentasvir, provide simplified, short-duration, and highly effective therapy. Sofosbuvir/velpatasvir/voxilaprevir is reserved for patients with prior DAA treatment failure...This review summarizes the current therapeutic updates for chronic hepatitis C, with a focus on pan-genotypic regimens, treatment duration, and strategies for special populations. Strengthening screening programs, optimizing retreatment, and expanding access are crucial for achieving the World Health Organization's goal of eliminating hepatitis C by 2030."

Journal • Review • Chronic Kidney Disease • Fibrosis • Hepatitis C • Hepatocellular Cancer • Hepatology • Human Immunodeficiency Virus • Immunology • Infectious Disease • Inflammation • Liver Failure • Nephrology • Oncology • Renal Disease • Solid Tumor • Transplantation

High Rate of HCV Reinfection and the Efficacy of Standard Regimens in Men Who Have Sex with Men Living with HIV. (PubMed, J Infect Chemother) - "Among the reinfection cases, two individuals without prior DAA treatment received sofosbuvir/ledipasvir for 12 weeks, while five with prior treatment received glecaprevir/pibrentasvir for 8 weeks. These findings support the need to reframe HCV as a recurrent sexually transmitted infection. To ensure sustainable control in high-risk populations, healthcare systems must evolve to allow HCV treatment to be accessible, affordable, and repeatable, as is the case with the management of other common STIs."

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

Glecaprevir/Pibrentasvir Versus Sofosbuvir/Velpatasvir for Hepatitis C Virus Genotype 6: A Systematic Review and Meta-Analysis. (PubMed, Rev Med Virol) - "GLE/PIB and SOF/VEL are clinically equivalent to treating HCV GT6, achieving near-universal cure rates with excellent safety profiles. Regimen selection should consider practical factors such as GLE/PIB's shorter 8-week duration, comorbidities like cirrhosis, drug interaction profiles, and local cost-effectiveness, rather than minor efficacy differences."

Clinical • Journal • Retrospective data • Review • Fibrosis • Hepatitis C • Immunology • Infectious Disease • Inflammation

Glecaprevir/pibrentasvir in patients aged 3-17 years with chronic hepatitis C: Real-life data from the POLAC project. (PubMed, J Pediatr Gastroenterol Nutr) - "Our study confirms that 8 weeks of therapy with GLE/PIB in children with chronic hepatitis C is highly effective and safe."

Journal • Dermatology • Fatigue • Fibrosis • Hepatitis C • Hepatology • Immunology • Infectious Disease • Inflammation • Pain • Pediatrics • Pruritus

CHARACTERISTICS OF 930 PATIENTS WITH CHRONIC HEPATITIS C: A 7-YEAR REAL-WORLD COHORT FROM A TERTIARY CENTER IN GREECE (AASLD 2025) - "Sofosbuvir/velpatasvir (39%), glecaprevir/pibrentasvir (19.5%), and elbasvir/grazoprevir (13.2%) were the most used regimens. PWID and non-PWID with HCV infection in Greece display distinct clinical profiles that do not affect SVR rates but may influence long-term management. Non-PWID are older, have more features of metabolic syndrome, and demonstrate more advanced liver fibrosis at baseline. The number of patients with advanced liver disease and metabolic syndrome raise the importance of surveillance for hepatocellular carcinoma during next years."

Clinical • Real-world • Real-world evidence • Cardiovascular • Diabetes • Fibrosis • Hepatitis C • Hepatocellular Cancer • Hepatology • Hypertension • Immunology • Infectious Disease • Inflammation • Liver Cirrhosis • Metabolic Disorders • Solid Tumor

THE MAJORITY OF PATIENTS WITH HEPATITIS C NOT ACHIEVING SVR CAN BE SUCCESSFULLY RETREATED WITH FIRST-LINE REGIMENS: RESULTS: FROM A MULTIDISCIPLINARY TEAM APPROACH TO GUIDE TREATMENT DECISIONS (AASLD 2025) - "A total of 263 retreatments were given, 176 (66.9%) 1st line (103 glecaprevir/pibrentasvir, 28 sofosbuvir/velpatasvir, 20 grazoprevir/elbasvir, 18 sofosbuvir/ledipasvir, 7 others) and 87 (33.1%) 2nd line (76 sofosbuvir/velpatasvir/voxilaprevir, 11 others).98 (37.2%) had documented risk factors for reinfection. An MDT approach to treatment failure, combined with resistance testing where available, allows for the majority of patients to be retreated with 1st line DAA regimen, with comparable rates of SVR to those treated with 2nd line regimens."

Clinical • Hepatitis C • Hepatology • Infectious Disease • Inflammation

To treat or not to treat young children with hepatitis C?--real-life experience. (PubMed, Eur J Pediatr) - "This study confirms both the efficacy and tolerability of DAAs for the treatment of hepatitis C in children aged 3-6 years in a clinical setting. Qualification for treatment in this age group should be made individually on the basis of the child's ability and willingness to swallow medications."

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

REAL-WORLD EXPERIENCE WITH PANGENOTYPIC GLECAPREVIR/PIBRENTASVIR THERAPY FOR CHRONIC HEPATITIS C IN CHILDREN (AASLD 2025) - "Eight-week GLE/PIB therapy in children is well tolerated and highly effective in all age ranges and regardless of gender. Its use in routine clinical practice will bring the ambitious goal of eliminating HCV worldwide a step closer."

Clinical • Real-world • Real-world evidence • Asthma • Fibrosis • Genetic Disorders • Hepatitis C • Hepatology • Immunology • Infectious Disease • Inflammation • Nephrology • Obesity • Pediatrics • Renal Disease • Respiratory Diseases

TIMING IS EVERYTHING: ECONOMIC IMPLICATIONS OF IMMEDIATE VERSUS DELAYED HEPATITIS C CARE (AASLD 2025) - P3 | "A recent study demonstrated the efficacy of 8-week glecaprevir/pibrentasvir (G/P) therapy in acute HCV. We evaluated the cost-effectiveness of treating newly diagnosed HCV patients with G/P vs waiting to determine chronicity to treat with sofosbuvir/velpatasvir (SOF/VEL)... Treating HCV at first diagnosis with 8-week G/P therapy regardless of chronicity is projected to be a QALY- and cost-saving strategy compared to delaying treatment with SOF/VEL until confirmed HCV chronicity. This highlights the importance of therapies effective in treating HCV at the time of diagnosis, as it enables a more efficient use of finite healthcare resources, and lowers the transmission risk and time to cure."

Hepatitis C • Hepatology • Infectious Disease • Inflammation

REAL-WORLD IMPLICATIONS OF THE NEW AASLD/IDSA HCV "TEST AND TREAT" ALGORITHM: FOCUS ON CARDIOVASCULAR COMEDICATIONS IN HEPATITIS C VIRUS (HCV) PATIENTS RECEIVING DIRECT-ACTING ANTIVIRALS (DAAS) (AASLD 2025) - " We leveraged the IQVIA PharMetrics Plus claims database (July 2015-June 2023) to evaluate the co-administration of statins and antihypertensive drugs with pDAAs, specifically sofosbuvir/velpatasvir (SOF/VEL) or glecaprevir/pibrentasvir (GLE/PIB), in US patients...All 321 contraindications among statin users were associated with GLE/PIB, specifically involving atorvastatin, lovastatin, and simvastatin. For antihypertensives, olmesartan, prazosin, and enalapril were the most common comedications posing a clinically significant DDI risk. Applying the new AASLD/IDSA algorithm, especially when statins or antihypertensives are co-administered with pDAAs, would necessitate specialist consultation for a significant number of patients due to DDI risk. This potential barrier to rapid "test and treat" implementation could be substantially reduced by carefully selecting the DAA regimen based on individual patient DDI risk profiles."

Clinical • Real-world • Real-world evidence • Cardiovascular • Hepatitis C • Hepatology • Infectious Disease • Inflammation

MODELING SUGGESTS THAT UNDETECTABLE HCV RNA AT WEEKS 1 OR 2 OF DAA THERAPY COULD IDENTIFY ADULTS WITH RECENT HCV FOR SHORTER TREATMENT DURATION (AASLD 2025) - "Mathematical modeling suggested that most people with recent HCV treated with GLE-PIB will have undetectable HCV RNA by week 1 or 2 and could have their treatment duration reduced by 2-4 weeks. This could improve treatment access, facilitate HCV elimination, and reduce cost, particularly in key populations most affected by HCV, such as PWID."

Clinical • Hepatitis C • Hepatology • Infectious Disease • Inflammation

EFFECTIVE RE-ENGAGEMENT OF HEPATITIS C PATIENTS: A MULTICENTER STUDY BASED ON LABORATORY RECORDS IN ARGENTINA (AASLD 2025) - "Among re-engaged patients, 167 initiated treatment with Sofosbuvir/Velpatasvir (70.08%) or Glecaprevir/Pibrentasvir (29.92%) (p = 0.12). This program successfully re-engaged HCV patients lost to follow-up, achieving high SVR12 rates and demonstrating the utility of SVR4 as an early predictor of treatment success. A significant proportion of patients were unaware of their diagnosis, available treatments, or disease progression. The majority of treated patients had advanced fibrosis, highlighting the need for proactive strategies targeting high-risk populations."

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