Vosevi (sofosbuvir/velpatasvir/voxilaprevir) / Gilead - LARVOL DELTA

Third Time's the Charm: Virologic Suppression After 2 Consecutive DAA Failures in Chronic Hepatitis C (ACG 2026) - "Introduction: Direct-acting antivirals achieve sustained virologic response (SVR) in over 95% of patients with chronic hepatitis C virus (HCV) infection, so sequential failure of multiple regimens is rare, and evidence guiding retreatment after sofosbuvir/velpatasvir/voxilaprevir failure is limited and extrapolated from small studies.[1] We present a non-cirrhotic genotype 1a patient with an NS5A L31M resistance-associated variant (RAV) who failed two sequential regimens but achieved on-treatment suppression with an extended course plus ribavirin...L31M was classified as conferring possible resistance to daclatasvir, elbasvir, ledipasvir, and ombitasvir, but no determinable impact on velpatasvir or pibrentasvir...Third, the recommendation for this extended regimen after voxilaprevir failure rests on a retrospective study of only four patients, so each real-world case adds to a thin evidence base. Suppression after two failed courses suggests extended duration and..."

Cardiovascular • Fibrosis • Hepatitis C • Hepatology • Immunology • Infectious Disease • Inflammation • Orthopedics • Portal Hypertension

Real-world efficacy and safety of sofosbuvir/velpatasvir/voxilaprevir in treatment-naive and treatment-experienced chronic hepatitis c patients: a single-center study. (PubMed, BMC Gastroenterol) - "This real-world study demonstrate that the SOF/VEL/VOX combination achieved a 100% SVR12 rate with excellent tolerability in both treatment-naive and treatment-experienced CHC patients. These findings support the use of SOF/VEL/VOX as a first-line option for treatment-naive patients, particularly in settings where alternative pangenotypic regimens are unavailable, while providing high virological efficacy and promoting rapid resolution of hepatic necroinflammation."

Journal • Observational data • Real-world evidence • Retrospective data • Cardiovascular • Diabetes • Fibrosis • Hepatitis C • Hypertension • Immunology • Infectious Disease • Inflammation • Liver Cirrhosis • Metabolic Disorders

Real-world effectiveness of sofosbuvir/velpatasvir retreatment in people living with HIV and recurrent hepatitis C (AIDS 2026) - "Although international guidelines recommend sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) or glecaprevir/pibrentasvir for retreatment, these regimens are unavailable in Colombia. SOF/VEL retreatment in DAA-experienced PLWH achieved clinically meaningful SVR12, although lower than rates reported for guideline-recommended salvage regimens. Outcomes were primarily influenced by behavioral and host factors rather than virological resistance. Advancing HCV micro-elimination in PLWH with recurrent infection in resource-limited settings will require integrated strategies combining optimal HIV suppression, adherence support, sexual-health interventions, and harm-reduction programs."

Clinical • Real-world • Real-world effectiveness • Real-world evidence • Hepatitis C • Hepatology • Human Immunodeficiency Virus • Infectious Disease • Inflammation

Sofosbuvir/Velpatasvir/Voxilaprevir Salvage Therapy in Hepatitis C Patients Who Relapsed After DAA Treatment (clinicaltrials.gov) - P=N/A | N=200 | Active, not recruiting | Sponsor: Xiangya Hospital of Central South University

New trial • Hepatitis C • Infectious Disease • Inflammation

Evaluation of Treatment Response in Chronic Hepatitis C Patients Receiving Sofosbuvir/Velpatasvir/Voxilaprevir: A Multicenter Real-World Experience from Türkiye (APASL 2026) - No abstract available

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

A post-authorization study to evaluate the safety and efficacy of sofosbuvir/velpatasvir/voxilaprevir in the retreatment of chronic hepatitis C patients in Taiwan (APASL 2026) - No abstract available

Clinical • Hepatitis C • Hepatology • Infectious Disease • Inflammation

Efficacy and Safety of Sofosbuvir/Velpatasvir/Voxilaprevir for the Retreatment of Chronic Hepatitis C Patients Relapsed after DAA Treatment (APASL 2026) - No abstract available

Clinical • Hepatitis C • Hepatology • Infectious Disease • Inflammation

Sofosbuvir/Velpatasvir/Voxilaprevir in Chronic Hepatitis C: A Systematic Review and Meta-Analysis (APASL 2026) - No abstract available

Retrospective data • Review • Hepatitis C • Hepatology • Infectious Disease • Inflammation

Real-world effectiveness of sofosbuvir/velpatasvir, glecaprevir/pibrentasvir, and sofosbuvir/velpatasvir/voxilaprevir against genotype 3 hepatitis C virus infection: a systematic review and meta-analysis. (PubMed, Front Gastroenterol (Lausanne)) - "However, limited data are available on the antiviral effect of sofosbuvir (SOF) + velpatasvir (VEL) ± ribavirin (RBV), SOF + VEL + voxilaprevir (VOX), and glecaprevir (GLE) + pibrentasvir (PIB) in treating patients infected with HCV GT3 in a real-world setting. SOF+VEL ± RBV, GLE+PIB, and SOF+VEL+VOX had good antiviral effectiveness for chronic HCV-GT3 infection in real-world settings. Factors such as cirrhosis and treatment experience, especially previous DAA treatment failure, may influence the SVR rate."

Journal • Real-world evidence • Retrospective data • Review • Fibrosis • Hepatitis C • Hepatology • Immunology • Infectious Disease • Inflammation • Liver Cirrhosis

Sustained Virologic Response Following a Shortened Course of Direct-Acting Antiviral Therapy in an HIV/HCV Co-Infected Patient With Previous Treatment Experience: A Case Report. (PubMed, J Pharm Pract) - "We describe a 47-year-old treatment-experienced African-American man co-infected with human immunodeficiency virus (HIV) and chronic hepatitis C virus (HCV) who took sofosbuvir-velpatasvir-voxilaprevir (SOF/VEL/VOX) for approximately 4 weeks and achieved sustained virologic response 12 weeks post-treatment (SVR12)...This case report illustrates that SVR12 may be achieved in treatment-experienced patients living with HIV/HCV who complete a shortened duration of triple-direct acting antiviral therapy. Healthcare professionals should consider obtaining an HCV-RNA to assess if SVR12 was achieved prior to re-initiating treatment in patients lost to follow-up or who did not complete therapy."

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

Hepatitis C Virus (HCV) Recurrence and Death After Viral Clearance in an HCV-Viremic Donor to HCV-Negative Kidney Recipient. (PubMed, Kidney Med) - "Sofosbuvir/velpatasvir was reinitiated with a plan to transition to sofosbuvir/velpatasvir/voxilaprevir...Fatal recurrence is rare in HCV NAT+/- kidney transplant recipients after completion of DAA regimen. HCV recurrence should be considered with abnormal liver chemistries in the absence of alternative explanations."

Journal • Diabetes • Hepatitis C • Hepatology • Infectious Disease • Inflammation • Liver Failure • Metabolic Disorders • Solid Organ Transplantation • Transplantation • Type 2 Diabetes Mellitus

Sofosbuvir/Velpatasvir/Voxilaprevir Versus Sofosbuvir/Velpatasvir Plus Ribavirin in Patients With Hepatitis C Virus Genotype 3b and Compensated Cirrhosis: A Multicentre Randomized Controlled Trial. (PubMed, J Med Virol) - P4 | "Both regimens were well tolerated, with one serious adverse event in arm A. Compared to sofosbuvir/velpatasvir plus ribavirin, 12 weeks of sofosbuvir/velpatasvir/voxilaprevir treatment suggests a higher SVR proportion in DAA-naïve patients with HCV GT3b with compensated cirrhosis. Clinical Trial Number: NCT05467826."

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

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

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

IS SVR4 TESTING AN ACCEPTABLE ALTERNATIVE MEASURE OF HCV CURE IN RE-TREATED PATIENTS FOLLOWING DAA FAILURE? A SVR4/12 CONCORDANCE EVALUATION FROM THE POLARIS CLINICAL TRIALS (AASLD 2025) - "For this reason, we evaluate the SVR4/12 concordance of sofosbuvir/velpatasvir/voxilaprevir (S/V/V) in randomized clinical trials (RCTs)... HCV treatment with S/V/V can be infrequent in the real world and achieving SVR4 is highly predictive of HCV cure. This earlier time point to confirm HCV cure may be particularly important in persons at high-risk to be LTFU."

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

RE-ENGAGEMENT TO RESCUE THERAPY WITH SOFOSBUVIR/VELPATASVIR/VOXILAPREVIR IN HEPATITIS C AFTER DIRECT-ACTING ANTIVIRAL FAILURE (AASLD 2025) - "The introduction of SOF/VEL/VOX in Korea enabled the re-engagement of patients lost to follow-up after DAA failure and facilitated successful rescue therapy."

Hepatitis C • Hepatology • Infectious Disease • Inflammation

Efficacy of Sofosbuvir-Velpatasvir-Ribavirin Regimen for Retreatment of Chronic Hepatitis C in Patients With Prior DAA Failure: A Retrospective Study From a National Treatment Center. (PubMed, Int J Hepatol) - "In resource-limited settings where second-line DAAs (such as SOF/VEL/VOX) may be unavailable, optimizing first-line treatments is essential...Prior to retreatment, 27 patients had received a 12-week regimen of sofosbuvir and daclatasvir, while only three had been treated with the sofosbuvir-velpatasvir regimen... First-line DAAs are highly effective to treat naïve patients. In the absence of second-line options, retreatment with first-line DAAs (SOF/VEL plus ribavirin) is a viable alternative."

Journal • Retrospective data • Hepatitis C • Infectious Disease • Inflammation

Trends in Use of Direct-Acting Antivirals for Treatment of Hepatitis C Virus Infection in Australia 2016-2024. (PubMed, J Viral Hepat) - "Glecaprevir/pibrentasvir (pan-genotypic regimen) has maintained an average market share of 34% since its introduction in August 2018. Sofosbuvir/velpatasvir/voxilaprevir, listed on the PBS in April 2019, and used for salvage therapy, has had a smaller average market share of 4% since listing...Increasing retreatment rates underscore the need for ongoing monitoring and real-world evaluations. Future head-to-head comparisons may support optimal regimen selection."

Journal • Retrospective data • Fatigue • Hepatitis C • Infectious Disease • Inflammation

ACCESS+: Access to Hepatitis C Treatment in Cameroon: Comparison of a Simplified Test and Treat Strategy to a Standard Strategy (clinicaltrials.gov) - P4 | N=576 | Not yet recruiting | Sponsor: ANRS, Emerging Infectious Diseases

New P4 trial • Hepatitis C • Infectious Disease • Inflammation

HCV Cure Rates in the THINKER-NEXT Trial of Transplanting Kidneys from HCV-Infected Donors into HCV-Negative Recipients (WTC 2025) - P2 | "Patients who failed S/V received Sofosbuvir/Velpatasvir/Voxilaprevir (S/V/V).* From 9/27/2021-1/5/2025, 201 HCV-negative patients were transplanted with a kidney from an HCV-RNA+ donor...196 received 12 weeks of S/V per protocol, while four patients underwent a modified protocol: a) S/V for 26 days due to the development of a perforated duodenal ulcer with prolonged NPO status (n=1); b) 8 weeks of Glecaprevir/Pibrentasvir (G/P) on post-KT day 3 due to initiation of amiodarone immediately post-transplant (n=1); and c) switch from S/V to G/P after initiating amiodarone within the first three weeks of KT (n=2)... In this multi-center trial of transplanting kidneys from HCV-RNA+ donors into HCV-negative recipients, we have demonstrated that with early initiation of HCV treatment within three days of KT, the cure rate with initial treatment is nearly 100%, and to date, all patients have been cured with first or second-line therapy. These data confirm that HCV cure rates..."

Late-breaking abstract • Hepatitis C • Hepatology • Infectious Disease • Inflammation • Peptic Ulcer • Transplantation

Evaluation of Treatment Response in Chronic Hepatitis C Patients Receiving Sofosbuvir/Velpatasvir/Voxilaprevir: A Multicenter Real-World Experience from Türkiye. (PubMed, Viruses) - "Mild adverse events included pruritus (2.1%, n = 3), fatigue (2.1%, n = 3), and nausea (1.4%, n = 2). The SOF/VEL/VOX combination is a highly effective and well-tolerated treatment option in treatment-naïve CHC patients, achieving an SVR12 rate of 97.5%."

Journal • Observational data • Real-world evidence • Retrospective data • Dermatology • Fatigue • Hepatitis C • Infectious Disease • Inflammation • Pruritus

Real-World Treatment Efficacy and Safety Profile of Sofosbuvir- and Velpatasvir-Based HCV Treatment in South Korea: Multicenter Prospective Study. (PubMed, Viruses) - "In this first prospective real-world study in South Korea, SOF/VEL-based regimens demonstrated excellent efficacy and safety, achieving 100% SVR12 in the per-protocol population, including patients with cirrhosis and prior treatment failure."

HEOR • Journal • Observational data • Real-world evidence • Fibrosis • Hepatitis C • Immunology • Infectious Disease • Inflammation

A global comparison of hepatitis B & C drug pricing. (PubMed, Ann Hepatol) - "HBV and HCV originator medications cost significantly more in the US compared to seven other major industrial countries. However, the introduction of HBV generic medications has lowered the cost of treatment for patients in the US. Future adoption of international reference pricing may help bridge remaining pricing disparities."

Journal • Pricing • Hepatitis B • Hepatitis C • Infectious Disease • Inflammation

RISK OF HEPATOCELLULAR CARCINOMA AFTER RECEIVING DIRECT ANTI-VIRAL AGENTS FOR THE TREATMENT OF HEPATITIS C VIRUS: MULTICENTRIC RETROSPECTIVE STUDY (DDW 2025) - "Subgroup analyses were performed for specific DAAAs combinations (Epclusa, Harvoni, Mavyret, Vosevi, and Zepatier). The findings highlight the importance of early DAAAs treatment in reducing the long-term complications of HCV. Further prospective studies with longer follow-up durations are warranted to confirm these associations."

Retrospective data • Hepatitis C • Hepatocellular Cancer • Hepatology • Human Immunodeficiency Virus • Infectious Disease • Oncology • Solid Tumor

Hepatobiliary disorders and direct-acting antiviral (DAA) therapies: real-world evidence and insights from the EudraVigilance database. (PubMed, Expert Opin Drug Saf) - "Harvoni® showed a statistically significant lower frequency of reporting for the hepatobiliary disorders SOC when compared to Epclusa® and Vosevi® (ROR, 0.33; 95% CI [0.26 - 0.41], and ROR 0.31; 95% CI [0.19 - 0.48], respectively). Harvoni® showed a lower reporting frequency of hepatobiliary disorders and fewer drug ineffectiveness reports, suggesting it may be preferred over Epclusa® and Vosevi® in patients with preexisting liver or biliary conditions."

HEOR • Journal • Real-world evidence • Hepatology • Infectious Disease • Inflammation