Asclevir (ravidasvir) / Presidio Pharma, Ascletis, Pharco Pharmaceuticals - LARVOL DELTA

Multicenter, open-Label, randomized non-inferiority study comparing 8-week vs 12-week Sofosbuvir/Ravidasvir treatment for non-cirrhotic chronic hepatitis C patients (EASE trial) (EASL 2025) - P2/3 | "The 8-week sofosbuvir/ravidasvir treatment regimen demonstrated non-inferiorefficacy compared to the 12-week regimen, indicating that it could be a shorter, more cost-effective option for treating non-cirrhotic individuals with chronic HCV infection."

Clinical • Head-to-Head • Late-breaking abstract • Hepatitis C • Hepatology • Human Immunodeficiency Virus • Infectious Disease • Inflammation • Liver Cirrhosis • Musculoskeletal Pain • Pain

Time required to achieve optimum viral load suppression with Ravidasvir/sofosbuvir in chronic hepatitis C patients with or without compensated cirrhosis. (PubMed, Sci Rep) - "While the study demonstrates promising early viral suppression, it does not evaluate the efficacy of a shortened regimen. Further research is needed to assess whether shorter treatment durations maintain high SVR12 rates without compromising treatment success."

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

8- Versus 12-week of Sofosbuvir-ravidasvir Treatment of Chronic Hepatitis C (clinicaltrials.gov) - P2/3 | N=322 | Completed | Sponsor: Muhammad Radzi Abu Hassan | Recruiting ➔ Completed | Trial completion date: Dec 2022 ➔ Mar 2024

Trial completion • Trial completion date • Hepatitis C • Hepatology • Infectious Disease • Inflammation • CD4

Alternative Pharmaceutical Innovation Models in Competitive Markets: A Collaborative Approach to Develop a Novel Drug for Hepatitis C. (PubMed, Trop Med Infect Dis) - "However, the case also highlighted that strategic behavior by competing for-profit firms could pose significant challenges and that changing external conditions reduced the potential public health impact of the drug. Lessons from ravidasvir can inform future efforts to develop alternative innovation models for therapeutic areas with significant commercial interest."

Journal • Hepatitis C • Hepatology • Infectious Disease • Inflammation

INHIBITORS OF THE NON-STRUCTURAL PROTEIN 5A: FROM THE CONTROL OF HEPATITIS C TO THAT OF MALARIA? (EHA 2024) - "We have shownthat TD-6450, an NS5A inhibitor of hepatitis C virus (iNS5AHCV) kills the asexual stages, responsible forsymptoms and stiffens mature gametocytes of Plasmodium falciparum, responsible for transmission...The 3 NS5Ai (velpatasvir, elbasir, ravidasvir) are as effective on either P. falciparum artemisinin-sensitive (F-32TEM) and artemisinin-resistant (F32-ART) strains with IC50s lower than 2µM... All iNS5AHCV tested are active against P. falciparum (class effect). Ravidasvir, recently approved for thetreatment of hepatitis C in Indonesia (at a very low cost), is effective against the different stages of P. falciparum. If this multi-stage antimalarial activity is clinically confirmed, the addition of ravidasvir to combinedantimalarial treatments would generate multi-therapies that are resilient to resistance and effective intransmission blocking."

Hepatitis C • Hepatology • Infectious Disease • Inflammation • Malaria

Ravidasvir in combination with sofosbuvir for 12 or 24 weeks achieved high sustained virological response rates in genotype 3 chronic hepatitis C without or with compensated liver cirrhosis (EASL-ILC 2024) - "In chronic GT3 hepatitis C, the combination of ravidasvir and sofosbuvir for 12 weeks in patients without cirrhosis and 24 weeks in patients with CC achieved high SVR12/24 of 97.8% and 97.5%, respectively. There was a minimal impact of the presence of Y93H RAS at baseline on response rates and no evidence of treatment-emergent virologic resistance."

Combination therapy • Fibrosis • Gastroenterology • Hepatitis C • Hepatology • Human Immunodeficiency Virus • Immunology • Infectious Disease • Inflammation • Liver Cirrhosis

Population pharmacokinetics of ravidasvir in adults with chronic hepatitis C virus infection and impact of antiretroviral treatment. (PubMed, Antimicrob Agents Chemother) - "Sofosbuvir (SOF) plus RDV was demonstrated to be efficacious and safe in adults with active HCV infection, including those living with HIV (LWHIV), in the STORM-C-1 trial...Concomitant antiretroviral treatment (ART) increased RDV CL/F by 30%-60%, with efavirenz-based ART having the largest impact...While several covariates impact RDV CL/F and Vd/F, the effect on RDV exposures was not clinically relevant based on the efficacy data reported in this diverse Asian adult population. There were no meaningful drug-drug interactions in adults LWHIV on ART."

Journal • PK/PD data • Fibrosis • Hepatitis C • Hepatology • Human Immunodeficiency Virus • Immunology • Infectious Disease • Inflammation

Cost-Effectiveness of Ravidasvir Plus Sofosbuvir Compared to the Standard of Care in Patients with Chronic Hepatitis C in the Thai Healthcare Setting (ISPOR 2023) - "HCV treatment with ravidasvir plus sofosbuvir was dominant or cost-saving in Thailand compared to the standard-of-care treatment."

Clinical • Cost effectiveness • HEOR • Hepatitis C • Hepatology • Infectious Disease • Inflammation

All-oral, 12-week ravidasvir plus ritonavir-boosted danoprevir and ribavirin delivers 100% svr12 in treatment-naive non-cirrhotic hcv genotype 1 patients with resistance-associated substitutions of a phase 2/3 clinical trial in china (EASL-ILC 2019) - P2, P2/3; "For Chinese treatment-naïve non-cirrhotic GT1 HCV adult patients, there was no significant impact of baseline NS5A RASs on SVR12 with 12-week ravidasvir plus ritonavir-boosted danoprevir and ribavirin."

Clinical • P2/3 data • Fibrosis • Hepatitis C • Hepatology • Immunology

EFFICACY & SAFETY OF RAVIDASVIR + SOFOSBUVIR IN HEPATITIS C: STORM-C-1 FINAL RESULTS (CROI 2022) - "There were no significant drug-drug interactions requiring switching of anti-retroviral therapies. Ravidasvir with sofosbuvir is well tolerated with excellent safety and efficacy in HCV infection, including difficult to treat populations, making it suitable for implementation in public health settings."

Clinical • Late-breaking abstract • Acute Kidney Injury • Fibrosis • Hepatitis C • Hepatology • Human Immunodeficiency Virus • Infectious Disease • Inflammation • Nephrology • Renal Disease

Ravidasvir: equitable access through an alternative drug development pathway. (PubMed, Lancet Glob Health) - No abstract available

Journal

[VIRTUAL] Ravidasvir; Newer and Better DAA? (APDW 2021) - "Sponsored By Pharmaniaga"

fficacy and safety of Sofosbuvir plus Daclatasvir or Ravidasvir in patients with COVID-19, A Randomized Controlled Trial. (PubMed, J Med Virol) - "The results support the efficacy and safety of SOF-DCV as an add-on to SOC for treatment of moderate to severe COVID-19 infections."

Clinical • Journal • Infectious Disease • Novel Coronavirus Disease • Pain

Pharmacokinetics, safety and tolerability of ravidasvir, with and without danoprevir/ritonavir, in healthy subjects. (PubMed, Antimicrob Agents Chemother) - "Both single and multiple doses of RDV with or without DNVr were well tolerated. The favorable pharmacokinetic and safety results support ravidasvir's continued clinical development and treatment."

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

"Ravidasvir, sofosbuvir combo tested as HCV treatment https://t.co/jGatNf85hk @AASLDtweets @AmCollegeGastro" (@SWexner)

Hepatitis C

8- Versus 12-week of Sofosbuvir-ravidasvir Treatment for Chronic Hepatitis C (clinicaltrials.gov) - P2/3; N=316; Recruiting; Sponsor: Muhammad Radzi Abu Hassan

Clinical • New P2/3 trial • Hepatitis C • Hepatology • Infectious Disease • Inflammation • CD4

"Ravidasvir-Sofosbuvir Combo Shows Promise in Chronic Hep C Infection https://t.co/q6gQTQ6YYB via @Medscape #hepC #nohep #endhep @DNDi" (@LancetGastroHep)

Hepatitis C • Infectious Disease

Determination and structural characterization of ravidasvir metabolites by liquid chromatography coupled to triple quadrupole linear ion trap mass spectrometry: Application to pharmacokinetics and phase I metabolism in rats. (PubMed, Biomed Chromatogr) - "The most dominant metabolite in rat liver microsomal (RLM) samples was oxidative ravidasvir, where one O-demethylated metabolite and eight isomers of the oxidative ravidasvir metabolites were identified. The study provides essential data for proposing the metabolic pathway and successfully applied it to determine the pharmacokinetics of ravidasvir in rat plasma."

Journal • P1 data • PK/PD data • Preclinical • Hepatitis C • Hepatology • Infectious Disease

Efficacy and safety of ravidasvir plus sofosbuvir in patients with chronic hepatitis C infection without cirrhosis or with compensated cirrhosis (STORM-C-1): interim analysis of a two-stage, open-label, multicentre, single arm, phase 2/3 trial. (PubMed, Lancet Gastroenterol Hepatol) - P2/3 | "In this first stage, ravidasvir plus sofosbuvir was effective and well tolerated in this diverse adult population of patients with chronic HCV infection. Ravidasvir plus sofosbuvir has the potential to provide an additional affordable, simple, and efficacious public health tool for large-scale implementation to eliminate HCV as a cause of morbidity and mortality."

Clinical • Journal • P2/3 data • Fibrosis • Hepatitis C • Hepatology • Human Immunodeficiency Virus • Immunology • Infectious Disease • Pain • Respiratory Diseases

Ravidasvir hydrochloride for genotype 1 hepatitis C treatment. (PubMed, Drugs Today (Barc)) - "These direct-acting agents target a variety of HCV proteins, including HCV-NS5A (nonstructural protein 5A). Ravidasvir hydrochloride, a potent pan-genotypic HCV-NS5A inhibitor approved in Egypt for treatment of HCV genotype 4 (G4), demonstrated impressive efficacy, safety profiles and a high barrier to resistance in multiple clinical trials when used as a key component in combination with other direct-acting agents in treating patients with HCV-G1."

Journal • Gastroenterology • Gastrointestinal Disorder • Hepatitis C Virus • Hepatology • Infectious Disease

Binding and inhibitory effect of ravidasvir on 3CL of SARS-CoV-2: a molecular docking, molecular dynamics and MM/PBSA approach. (PubMed, J Biomol Struct Dyn) - "The binding free energy calculated using MM/PBSA method from the MD simulation trajectory was -190.3 ± 70.2 kJ/mol and -106.0 ± 26.7 kJ/mol for GROMOS96 54A7 and AMBER99SB-ILDN force field, respectively. This in silico studies suggesting ravidasvir might be a potential lead molecule against SARS-CoV-2 for further optimization and drug development to combat the life-threatening COVID-19 pandemic.Communicated by Ramaswamy H. Sarma."

Journal • Hepatitis C Virus • Hepatology • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Polymeric antigen BLSOmp31 formulated with class B CpG-ODN in a nanostructure (BLSOmp31/CpG-ODN/Coa-ASC16) administered by parenteral or mucosal routes confers protection against Brucella ovis in Balb/c mice. (PubMed, Res Vet Sci) - "Fecal antigen-specific IgA was slightly higher in mice immunized with BLSOmp31/CpG-ODN/Coa-ASC16 subcutaneously compared with the ocular route. These results indicate that BLSOmp31/CpG-ODN/Coa-ASC16 was a safe and effective vaccine against B. ovis in mice."

Journal • IL4

Self-assembled nanostructures of L-ascorbic acid alkyl esters support monomeric amphotericin B. (PubMed, Heliyon) - "Langmuir film visualisation supports spectrophotometric evidence, indicating that ASC16 allows the in-plane solubilisation of AmB. Coagels formed by ASC16 appear as promising for carrying AmB for dermal delivery."

Journal

[VIRTUAL] Comparison of the pharmacokinetic parameters of ASC18 tablets（ravidasvir and sofosbuvir fixed dose combination）with reference tablets (ravidasvir, sofosbuvir) for hepatitis treatment (APASL 2021) - No abstract available

PK/PD data • Hepatology

Strategic Transformation of the Market of HCV Treatments (clinicaltrials.gov) - P2/3; N=603; Active, not recruiting; Sponsor: Drugs for Neglected Diseases; Recruiting ➔ Active, not recruiting; Trial completion date: Dec 2023 ➔ Mar 2024; Trial primary completion date: Mar 2021 ➔ Aug 2021

Clinical • Enrollment closed • Trial completion date • Trial primary completion date • Fibrosis • Hepatitis C Virus • Hepatology • Human Immunodeficiency Virus • Immunology • Infectious Disease