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

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

Treatment Failure of Sofosbuvir/Velpatasvir for Donor-Derived Hepatitis C Genotype 3 (ISHLT 2025) - "He received induction immunosuppression with basiliximab, followed by tacrolimus, mycophenolate, and steroid taper. On PTD 295, he started a 24-week course of sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX), with undetectable viral load as of PTD 407.Summary Organs from HCV-infected donors remain a viable option, but providers must consider predictors of treatment failure, particularly drug resistance, which is more common with genotype 3. Close monitoring for signs of failure and awareness of salvage therapy options are essential."

Cardiomyopathy • Cardiovascular • Congestive Heart Failure • Fibrosis • Heart Failure • Hepatitis C • Hepatology • Human Immunodeficiency Virus • Infectious Disease • Inflammation • Pain • Solid Organ Transplantation

Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir for the Retreatment of Chronic Hepatitis C Patients with DAA Relapse (APASL 2025) - "The impact of gender, age, cirrhosis status, genotype, and the addition of ribavirin during treatment on HCV RNA clearance rates was assessed...Additionally, among the 58 relapsed patients, 22 patients had previously been treated with SOF/VEL, and 18 patients had been treated with Glecaprevir/Pibrentasvir... SOF/VEL/VOX is an effective and safe retreatment option for HCV patients who relapse after DAA therapy, demonstrating excellent virological response rates and good tolerability."

Clinical • Fibrosis • Gastrointestinal Disorder • Hepatitis C • Hepatology • Infectious Disease • Inflammation

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

12-week treatment of sofosbuvir/velpatasvir plus ribavirin and sofosbuvir/velpatasvir/voxilaprevir for HCV patients with GT3b and compensated cirrhosis: a multicenter, randomized, open-label study in China (APASL 2025) - P4 | "Compared to SOF/VEL plus RBV treatment, 12 weeks of SOF/VEL/VOX treatment achieved a significantly higher SVR12 rate in DAAs treatment-naïve HCV patients with GT3b, compensated cirrhosis in China (NCT05467826). Table and Figure:Figure 1.Treatment response to SOF/VEL plus RBV and SOF/VEL/VOX. Figure 2.Characteristics of patients with virologic failure treated by SOF/VEL plus RBV."

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

Effectiveness and safety of sofosbuvir/velpatasvir/voxilaprevir as a salvage therapy for chronic hepatitis C patients with failed previous direct-acting antivirals treatment (APASL 2025) - "SOF/VEL/VOX was effective and well-tolerated for DAAs experienced CHC patients in China, including difficult-to-treat cases such as those with GT 3 and cirrhosis. Table and Figure:Figure 1. Figure 2."

Clinical • Fibrosis • Hepatitis C • Hepatocellular Cancer • Hepatology • Human Immunodeficiency Virus • Infectious Disease • Inflammation • Liver Cirrhosis • Oncology • Pain • Solid Tumor

Direct-Acting Antiviral Treatment Failure and Retreatment Strategies Following Hepatitis C-Positive Solid Organ Transplantation in Hepatitis C-Negative Recipients: A Multicenter Case Series. (PubMed, Transpl Infect Dis) - "Despite initial DAA failures, all HCV-negative SOT recipients achieved SVR following one or more courses of retreatment with DAAs."

Journal • Hepatitis C • Hepatology • Infectious Disease • Inflammation • Solid Organ Transplantation • Transplantation

Direct-acting antiviral treatment outcomes in people infected with endemic compared to epidemic hepatitis C virus subtypes in England. (PubMed, J Infect) - "This study provides further evidence that endemic HCV subtypes lead to sub-optimal DAA efficacy, which may impact global HCV elimination."

Journal • Hepatitis C • Hepatology • Infectious Disease • Inflammation

Analysis of the efficacy and safety profile of sofosbuvir/velpatasvir/voxilaprevir in the treatment of patients with chronic hepatitis C with failed DAAs therapy (PubMed, Zhonghua Gan Zang Bing Za Zhi) - "Objective: To explore the efficacy and safety profile of sofosbuvir/velpatasvir/voxilaprevir ± ribavirin (SOF/VEL/VOX±RBV) for salvage treatment of chronic hepatitis C patients who have failed direct-acting antivirals (DAAs). There were no serious adverse events, deaths, or interruptions of treatment due to adverse reactions. SOF/VEL/VOX is a safe and effective salvage treatment option for chronic hepatitis C patients who have failed DAAs therapy, and may be particularly beneficial to refractory populations infected with genotype 3 and combined with cirrhosis."

Journal • Retrospective data • Fatigue • Fibrosis • Hepatitis C • Hepatology • Human Immunodeficiency Virus • Immunology • Infectious Disease • Inflammation • Liver Cancer • Oncology • Pain • Solid Tumor

Integrating hepatitis C testing and treatment into routine HIV care in Cameroon is feasible. (PubMed, J Int AIDS Soc) - "Our study demonstrates the viability of integrating HCV testing and treatment into routine HIV care in Cameroon, yielding new HCV diagnoses and high cure rates. Cameroon can use this strategy to achieve HCV elimination goals, although improvements in testing uptake, diagnosis and treatment access, and laboratory capacity are needed."

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

Introducing Sofosbuvir/Velpatasvir + Ribavirin as a Generic Retreatment Regimen for Hepatitis C: Evaluation of a Government Program in Rwanda. (PubMed, Clin Infect Dis) - "Sofosbuvir/velpatasvir/voxilaprevir is recommended for hepatitis C virus (HCV) retreatment in those who fail initial treatment but is unavailable in resource-limited settings. Of 231 participants, 174 were cured (75.3% intention-to-treat analysis). SOF/VEL + RBV may be considered for HCV retreatment in resource-limited settings."

Journal • Hepatitis C • Hepatology • Infectious Disease • Inflammation

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

Direct Antivirals Can Achieve a Cure in All Patients With Chronic Hepatitis C due to Genotype 5: A French Multicentre Study. (PubMed, Liver Int) - "HCV-GT-5 patients treated with a DAA regimen had a 99% SVR12 in intention-to-treat (including initial therapy and retreatment) and 100% SVR12 per protocol. Sofosbuvir/ledipasvir, sofosbuvir/velpatasvir, and glecaprevir/pibrentasvir show very good efficacy in real-world HCV-GT-5 patients."

Journal • Hepatitis C • Hepatology • Infectious Disease • Inflammation

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

Table 3: Some drug interactions with DAAs for HCV infection. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Hepatitis C • Hepatology • Infectious Disease • Inflammation

Figure 1: Treatment of hepatitis C virus infection in treatment-naive adults. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Hepatitis C • Hepatology • Infectious Disease • Inflammation

Trends in Prescriber Characteristics of Hepatitis C Direct-Acting Antivirals in the United States (ACG 2024) - "Seven medications were included: branded and generic ledipasvir/sofosbuvir, branded and generic sofosbuvir/velpatasvir, sofosbuvir, sofosbuvir/velpatasvir/voxilaprevir, and glecaprevir/pibrentasvir. Between 2015 and 2021, 102,767 Medicare patients received DAAs. The annual number of patients receiving DAAs decreased from 45,697 in 2015 to 3,633 in 2021 (2015-2017: APC -50.7, 95% CI -57.4 to -39.4, p< 0.001; 2017-2021: APC -25.6, 95% CI -30.8 to -13.9, p< 0.001)."

Hepatitis C • Hepatology • Infectious Disease • Inflammation

TRANSPLANTING HEPATITIS C NAT POSITIVE SOLID ORGANS INTO HCV NEGATIVE RECIPIENTS; AN ADVANCED PRACTICE PROVIDER (APP) LED CLINIC, 4-YEAR REAL WORLD OUTCOMES (AASLD 2024) - "Patient was re-treated with SOF/VEL/VOX/RBV for 16w and achieved SVR12... This real-world cohort demonstrates a successful long-term APP-led Hepatitis C clinic focused on treating patients who received NAT positive organs with a high treatment success rate. Relapses when they occurred were successfully retreated. Treatment was well tolerated, and drug to drug interactions were manageable."

Clinical • Metastases • Real-world • Real-world evidence • Fibrosis • Hepatitis C • Hepatology • Infectious Disease • Inflammation • Solid Organ Transplantation • Transplantation

MEDICARE PART D COVERAGE RESTRICTIONS FOR DRUGS COMMONLY PRESCRIBED FOR HEPATITIS C TREATMENT, 2019-2024 (AASLD 2024) - "For most brand name formulations- Sovaldi, Epclusa, Harvoni, Vosevi and Mavyret, the trend became increasingly restrictive over the years, with a higher proportion of plans imposing quantity limits each year. Over the 6-year study period, access to hepatitis C treatments via Medicare Part D plans remained restrictive, with all plans requiring a prior authorization, and most plans placing these drugs on higher cost sharing tiers. Over the years, a higher proportion of plans imposed quantity limits for brand name hepatitis C formulations. With our findings, we highlight the need for urgent advocacy, legislative efforts, and policy initiatives to ensure affordable, equitable, and timely access to treatment for Part D beneficiaries with Hepatitis C."

Medicare • Reimbursement • US reimbursement • Hepatitis C • Hepatology • Infectious Disease • Inflammation

Improving Response to Immunotherapy in Patients With Advanced Hepatocellular Carcinoma and Chronic Hepatitis C Virus Infection With Direct-Acting Antiviral Therapy (clinicaltrials.gov) - P4 | N=2 | Terminated | Sponsor: M.D. Anderson Cancer Center | N=15 ➔ 2 | Trial completion date: Oct 2026 ➔ Aug 2024 | Recruiting ➔ Terminated; PI Request

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

Cutting-edge pharmacotherapy for hepatitis C virus infection: a comprehensive review. (PubMed, Expert Opin Pharmacother) - "Using the first-line GLE/PIB and SOF/VEL can eradicate HCV in more than 95% of DAA-naïve patients across different populations. The viral cure usually exceeds 95% when using the rescue SOF/VEL/VOX regimen for prior DAA failures."

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

Treatment outcomes of sofosbuvir/velpatasvir/voxilaprevir in direct-acting antiviral-experienced hepatitis c virus patients (IDDF 2024) - "The study outcomes were SVR12 and treatment-related adverse effects, with subgroup analysis performed based on genotype, cirrhosis, HCC, prior SOF/VEL exposure, and region. We identified and analyzed data from 24 studies (2877 DAA-experienced CHC patients); 17.2% had prior SOF/VEL exposure, 25% received ribavirin with SOF/VEL/VOX, and 42% had pre-treatment resistance-associated substitution (RAS) testing performed. In summary, SOF/VEL/VOX is efficacious and safe for retreatment in DAA-experienced CHC patients, even with RAS mutation. Our findings support SOF/VEL/VOX as a first-line rescue treatment for DAA-experienced CHC patients."

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

Direct-Acting Antiviral Agents in Prevention of Maternal-Fetal Transmission of Hepatitis C Virus in Pregnancy. (PubMed, Pathogens) - "Prior to the Food and Drug Administration approval of ledipaspavir/sofosbuvir (Harvoni®) in 2014, the treatment of hepatitis C was interferon plus or minus ribavirin. The treatment of pregnant women with direct-acting antivirals is important because the treatment of pediatric patients cannot begin until three years of age and does not always occur prior to the symptom development of hepatitis C. This review article will include glecaprevir/pibrentasvir (Mayvret®), sofosbuvir/velpatasvir (Epclusa®), and sofosbuvir/velpatasvir plus voxilaprevir (Vosevi®). We aim to review the teratogenic risk of direct-acting antivirals as well as currently published clinical trials and ongoing research on direct-acting antiviral hepatitis C treatment in pregnancy in this publication."

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

TRENDS IN MEDICAID SPENDING FOR HEPATITIS C TREATMENT FROM 2012-2021 (DDW 2024) - "In 0 1 the highest average spending per claim was seen with Harvoni ($30 941) followed by Sovaldi ($ 7 47) Vosevi ($ 3 877) and Epclusa ($ 917). In the same year Mavyret had the greatest number of claims at 51 500 followed by generic sofosbuvir-velpatasvir (50 115) Epclusa (11 437) and Vosevi ( 177)...Despite the number of claims declining from 01 to 0 1 the average spending has increased due to the significant cost of HCV medications on Medicaid spending. The highest spending was noted to be with originator medications while generic formulations had the highest number of claims. Understanding the trends in spending on HCV medications can help guide insurance coverage changes for those depending on Medicaid."

Medicaid • Reimbursement • US reimbursement • Hepatitis C • Hepatology • Infectious Disease • Inflammation

Breakthrough Hepatitis C Virus (HCV) Infections in HCV Viremic Donors to HCV Negative Kidney Transplant Recipients (KTRS) Following an Ultra-Short Duration of Direct Acting Anti-Viral (DAA) Prophylaxis (ATC 2024) - "All patients received induction with rabbit anti-thymocyte globulin followed by maintenance tacrolimus, mycophenolate and steroids...All patients were successfully treated with 12 weeks of DAA therapy (7 patients received glecaprevir-pibrentasvir and one patient received Sofosbuvir-Velpatasvir-Voxilaprevir)... Our data suggest that an ultra-short duration of DAA prophylaxis with 7 days of SOF/VEL is successful in preventing HCV transmission in a majority of HCV D+/R- KTRs. Due to absence of resistance testing on donor blood, we are unable to ascertain whether drug resistance was already present or developed due to the prophylaxis strategy. We identified that a missed pre-operative dose of SOF/VEL was a major risk factor for an increased risk of viral transmission."

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