sofosbuvir/velpatasvir / Generic mfg. - LARVOL DELTA

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

TREATMENT WITH DAA OF HCV INFECTION WITH HIGH INTRAMEDULLARY VIRAL REPLICATION IN SUBJECT WITH SEVERE MEDULLARY APLASIA (SIE 2025) - "The patient underwent immunosuppressive first-line treatment with Antilymphocyte Serum (horse ATG) (3200 mg iv for 4 days) and Cyclosporine 150 mg daily, associated with prophylactic therapy for the prevention of infectious complications...Also, after the start of the administration of Epclusa, the patient withdrew platelet and RBC transfusions...The eradication of HCV with antiviral therapy has de-fused the immune-mediated mechanisms responsible for the production reduction of central hematopoietic cells not targeted by viral infection with their consequent depletion in peripheral blood. The therapeutic success has brought a substantial benefit to the patient which is cured of HCV infection and of serious hematological disease."

Clinical • Aplastic Anemia • Cardiovascular • Diabetes • Hematological Disorders • Hepatitis C • Hepatology • Infectious Disease • Metabolic Disorders • Myocardial Infarction • Portal Hypertension • Pulmonary Arterial Hypertension • JAK2

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

Efficacy and safety of sofosbuvir-based therapies for treating HCV in children: observations from a real-world setting. (PubMed, Eur J Clin Microbiol Infect Dis) - "This study confirms the excellent efficacy and good tolerability of SOF-based regimens for the treatment of hepatitis C in children aged 5 to 17 years in real-life settings, supporting the inclusion of pediatric patients in national treatment policies."

Journal • Real-world evidence • Fatigue • Fibrosis • Hepatitis C • Immunology • Infectious Disease • Inflammation • Pain • Pediatrics

Treatment of refractory Giardiasis with quinacrine in a young refugee with HIV and HCV coinfection (EACS 2025) - "Serology revealed hepatitis C virus genotype 1b with an RNA viral load of 552,000 IU/mL (log 5.74) and occult hepatitis B (anti-core positive, HBsAg negative, undetectable HBV DNA).Antiretroviral therapy with BIC/TAF/FTC was initiated, achieving virologic suppression and improved CD4 counts. He was also treated for hepatitis C with sofosbuvir/velpatasvir, with sustained virological response...He received a single 2 g dose of tinidazole, followed by nitazoxanide 500 mg BID for 3 days, both without full clinical and parasitological response... This case highlights the importance of considering quinacrine as a safe and effective option for treating refractory giardiasis, particularly in immunocompromised patients. Though rarely used today, quinacrine remains a valuable therapeutic tool when conventional agents fail. It also underscores the need for comprehensive evaluation of gastrointestinal symptoms in patients with newly diagnosed HIV, especially in migrant populations."

Hepatitis B • Hepatitis C • Human Immunodeficiency Virus • Infectious Disease • CD4 • CD8

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

TROJAN-C: Transplant of Redeemed Organs by Judicious Administration of New Direct-Acting Antivirals for Hepatitis-C Heart Recipients (clinicaltrials.gov) - P2 | N=15 | Active, not recruiting | Sponsor: Baylor Research Institute | Trial completion date: Dec 2023 ➔ Dec 2025 | Trial primary completion date: Dec 2023 ➔ Dec 2025

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

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

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

CLINICAL OUTCOME OF HCV INFECTION IN CHILDREN: AN ANALYSIS BASED ON SIX CASES OF HCV INFECTED CHILDREN (AASLD 2025) - "Four patients received sofosbuvir and velpatasvir for 12 weeks, while the other two received ledipasvir and sofosbuvir for the same duration. This small, single-center clinical study confirms the need for early treatment of pediatric patients with HCV infection to prevent serious liver-related complications caused by long-term infection. There is an urgent need to establish an integrated pathway of screening, diagnostic, and treatment pathway for pediatric patients with HCV infection."

Clinical • Clinical data • Hepatitis C • Infectious Disease • Liver Cirrhosis • Pediatrics