sofosbuvir/velpatasvir / Generic mfg. - LARVOL DELTA

STORC: Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy (clinicaltrials.gov) - P4 | N=100 | Recruiting | Sponsor: Catherine Anne Chappell | Trial primary completion date: Dec 2025 ➔ Apr 2026

Trial primary completion date • Hepatitis C • Infectious Disease • Inflammation

Histopathological features and eight-week split-tablet sofosbuvir/velpatasvir treatment in young children with acute hepatitis C: a case-series study. (PubMed, BMC Infect Dis) - No abstract available

Journal • Hepatitis C • Infectious Disease • Inflammation

Retreatment of Direct Acting Agents (DAAs) After Initial DAA Failure in Hepatitis C Patients. (PubMed, Hepatol Res) - "Retreatment with SOF/VEL + RBV, GLE/PIB for 12 weeks, or SOF/LDV achieved high SVR12 rates, indicating that effective viral eradication is feasible using currently available DAA regimens even after prior treatment failure."

Journal • Hepatitis C • Hepatology • Infectious Disease • Inflammation

Community-based integrated care for HIV, viral hepatitis and sexually transmitted infections, Thailand. (PubMed, Bull World Health Organ) - "Eligible participants with HCV infection received a 12-week course of sofosbuvir-velpatasvir...Community-based HCV treatment of people who use drugs in Thailand, within harm reduction settings, is safe and effective. Integration of this strategy into national programmes could enhance HCV elimination in people who use drugs."

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

TROJAN-C: Transplant of Redeemed Organs by Judicious Administration of New Direct-Acting Antivirals for Hepatitis-C Heart Recipients (clinicaltrials.gov) - P2 | N=15 | Recruiting | Sponsor: Baylor Research Institute | Active, not recruiting ➔ Recruiting | Trial completion date: Dec 2025 ➔ Dec 2026 | Trial primary completion date: Dec 2025 ➔ Dec 2026

Enrollment open • Trial completion date • Trial primary completion date • Cardiovascular • Heart Failure • Hepatitis C • Infectious Disease • Inflammation • Transplantation

Direct-Acting Antivirals as Primary Treatment for Hepatitis C Virus-Associated Indolent Non-Hodgkin Lymphomas: The BArT Study of the Fondazione Italiana Linfomi. (PubMed, J Clin Oncol) - "HCV eradication by DAAs was achieved in 100% of HCV-positive patients with indolent lymphomas not requiring immediate conventional treatment and resulted in non-negligible rate of lymphoma responses. Treatment with DAAs should be considered as the first-line therapy in this setting."

Journal • Hematological Disorders • Hematological Malignancies • Hepatitis C • Hepatology • Indolent Lymphoma • Infectious Disease • Inflammation • Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Sofosbuvir/Velpatasvir in Chronic Hepatitis C, Compensated and Decompensated Cirrhosis, and Retreatment Settings. (PubMed, Intern Med) - "Methods This multicenter prospective study enrolled 236 patients treated with SOF/VEL (with ribavirin for retreatment) at 21 Japanese institutions (chronic hepatitis, n=35; compensated cirrhosis, n=43; decompensated cirrhosis, n=134; undergoing DAA retreatment, n=24). Conclusion SOF/VEL has demonstrated high efficacy in all stages of hepatitis C, including patients with chronic hepatitis, compensated cirrhosis, decompensated cirrhosis, and prior DAA failure. The ability to achieve high efficacy at any stage of chronic hepatitis C is expected to improve the prognosis for a wide range of patients."

Journal • Fibrosis • Hepatitis C • Immunology • Infectious Disease • Inflammation • Liver Cirrhosis

Effectiveness of Sofosbuvir/Velpatasvir in a Patient with Ultra-Short Bowel Syndrome and Hepatitis C Virus Infection: A Case Report. (PubMed, Gastroenterol Hepatol) - No abstract available

Journal • Gastrointestinal Disorder • Hepatitis C • Infectious Disease • Inflammation • Short Bowel Syndrome

Virological and antifibrotic efficacy of antiviral treatment for hepatitis В+C in HIV-positive patients. (PubMed, Wiad Lek) - " In patients with HIV/HBV/HCV coinfection, interferon-free regimens that include two direct-acting antivirals, either alone or in combination with ribavirin, demonstrated 100 % virologic efficacy and the most beneficial effects on the liver reducing the degree of liver fibrosis."

Journal • Fibrosis • Hepatitis B • Hepatitis C • Human Immunodeficiency Virus • Immunology • Infectious Disease • Inflammation • Liver Cirrhosis

Shortening Hepatitis C Treatment in Correctional Facilities: Impact of Early Viral Response and Ribavirin Use in 8-Week Sofosbuvir/Velpatasvir (SOF/VEL) Regimens (ASHP 2025) - No abstract available

Hepatitis C • Hepatology • Infectious Disease • Inflammation

Hepatitis C Treatment During Pregnancy: Time for a Practice Change. (PubMed, Am J Obstet Gynecol MFM) - "Ledipasvir/sofosbuvir and sofosbuvir/velpatasvir currently have the most data available in pregnancy and should be included in conversations regarding HCV treatment in pregnancy. Multidisciplinary care between maternal-fetal medicine, infectious disease, and hepatology can help promote access to HCV treatment in pregnancy."

Journal • Review • Hepatitis C • Hepatology • Infectious Disease • Inflammation • Obstetrics

C-BEYOND: Efficacy and Safety of BEM/RZR vs. SOF/VEL in Subjects With Chronic HCV (clinicaltrials.gov) - P3 | N=880 | Active, not recruiting | Sponsor: Atea Pharmaceuticals, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Hepatitis C • Infectious Disease • Inflammation

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

Simplified monitoring of sofosbuvir/velpatasvir in Japanese patients with chronic hepatitis C based on a retrospective analysis of a prospective multicenter cohort. (PubMed, Sci Rep) - "Two patients were lost to follow-up; one who discontinued treatment achieved SVR12. This is the first Japanese real-world evaluation of DAA under simplified monitoring and supports low-burden pathways with high efficacy and safety."

Journal • Retrospective data • Fibrosis • Gastroenterology • Hepatitis C • Hepatology • Immunology • Infectious Disease • Inflammation • Liver Cirrhosis

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

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

Therapy for Hepatitis C Virus (HCV) in Primary Treatment Failure in Pakistan (clinicaltrials.gov) - P=N/A | N=318 | Enrolling by invitation | Sponsor: Queen Mary University of London | Trial completion date: Sep 2025 ➔ Sep 2027 | Trial primary completion date: Sep 2025 ➔ Sep 2027

Trial completion date • Trial primary completion date • Hepatitis C • Infectious Disease • Inflammation

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

Efficacy and Safety of Sofosbuvir Plus Velpatasvir Combination for Treatment of Patients with Chronic Hepatitis-C Infection (All Genotypes) and ESRD on Hemodialysis (KIDNEY WEEK 2025) - "Conclusion Treatment with a fixed-dose combination of sofosbuvir (400 mg) and velpatasvir (100 mg) for chronic Hepatitis C infection (all genotypes) in patients with end-stage renal disease on regular hemodialysis was safe and highly effective. No significant adverse events were observed during the period of treatment."

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

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

Resistance-Driven Treatment Failure: A Challenge to HCV Elimination in Pakistan (ISPOR-EU 2025) - "Patients treated with sofosbuvir/velpatasvir had a lower Y93H RAS rate (52%) than those treated with sofosbuvir/daclatasvir (73%). Patients with cirrhosis and subtype 3b have a higher prevalence of NS5A RASs, which contribute to treatment failure. In real-world settings like Pakistan, the presence of these RASs poses challenges for retreatment, potentially leading to increased healthcare costs and delays in achieving national HCV elimination goals."

Fibrosis • Gastroenterology • Hepatitis C • Hepatology • Immunology • Infectious Disease • Inflammation • Liver Cirrhosis

Sofosbuvir/Velpatasvir Causing Hepatotoxicity With Hepatocellular Pattern and Hemolytic Anemia (ACG 2025) - "Introduction: A case of sofosbuvir and velpatasvir, a treatment for hepatitis C, causing hepatocellular injury and hemolytic anemia.Case Description/ Patient is a 68 y.o. M with PMH of A-fib on Eliquis, HTN, HLD, DM, prostate cancer who was recently diagnosed with hepatitis C confirmed with liver biopsy that showed active hepatitis and stage I-II portal and periportal fibrosis who was initiated on sofosbuvir/velpatasvir 5 days prior to admission. In this patient, liver enzymes improved quickly within 24 hours of discontinuing Sofosbuvir/velpatasvir. Figure: MRCP shows slight prominence of the proximal common bile duct."

Anemia • CNS Disorders • Fibrosis • Genito-urinary Cancer • Hepatic Encephalopathy • Hepatitis B • Hepatitis C • Hepatology • Immunology • Infectious Disease • Liver Failure • Prostate Cancer • Solid Tumor

Vanishing Act: Spontaneous Regression of HCC After Starting HCV Treatment and Emergent TIPS Placement (ACG 2025) - "In January 2025, he was started on sofosbuvir/velpatasvir daily given his significantly decompensated disease...Pathology slides from explanted liver a. Liver explant showing well-developed cirrhosis with foci of HCC (H&E; X2) b. HCC, poorly differentiated, exhibiting tumor necrosis comprising 90% of the tumor mass (H&E; x4) c-e. The tumor cells are positive for arginase, hepPar1, and glypican 3 immunostains, respectively (IHC; x4)"

Cardiovascular • Fibrosis • Gastroenterology • Hepatitis C • Hepatocellular Cancer • Hepatology • Hypertension • Immunology • Infectious Disease • Portal Hypertension • Solid Tumor • GPC3

A Case of Acute Liver Failure Due to Hepatitis C Rescued by Direct-Acting Antivirals (ACG 2025) - "Her UDS was positive for amphetamines, cocaine, and fentanyl...Treatment with Sofosbuvir/Velpatasvir was initiated...A systematic review reports 3 other cases of Hep C-associated ALF prior to DAAs availability. This case illustrates that full recovery can be achieved with prompt DAA initiation in cases of ALF secondary to Hep C"

Clinical • Hematological Disorders • Hepatitis C • Hepatology • Infectious Disease • Inflammation • Liver Failure

Pharmacokinetics of Sofosbuvir and Velpatasvir for Hepatitis C Treatment in Pregnancy. (PubMed, Biomedicines) - "SOF/VEL was safe and well tolerated. These results add to the limited published experience prescribing antivirals in pregnancy and provide further support for a larger ongoing prospective study and other efforts to support HCV treatment in pregnancy."

Journal • PK/PD data • Hepatitis C • Infectious Disease • Inflammation