Exviera (dasabuvir) / AbbVie - LARVOL DELTA

3D conformation and crystal interaction insights into drug development challenges for HCV drug analogues via molecular simulations. (PubMed, Commun Chem) - "ABT-333 and ABT-072 are two potent non-nucleoside NS5B polymerase inhibitors designed for the treatment of the hepatitis C virus (HCV). Through this study, we establish the importance of end-to-end physics-based modeling, which involves explicit considerations of 3-D structure and crystal packing interactions. This approach provides structural and energetic insights into the physicochemical properties and drug development challenges faced when designing best-in-class drug molecules."

Journal • Hepatitis C • Infectious Disease • Inflammation

Understanding HCV Reinfection Rates in an Incarcerated Population After Cure With Interferon Free HCV Treatment (clinicaltrials.gov) - P4 | N=44 | Active, not recruiting | Sponsor: Nova Scotia Health Authority | Trial completion date: Oct 2023 ➔ Oct 2025 | Trial primary completion date: Oct 2023 ➔ Oct 2025

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

Failed sulfonamidation reaction as inspiration for the development of diverse Phosphorinane ligands (ACS-Sp 2024) - "To ensure robustness of the sulfonamidation reaction, a Cu-free synthesis of structurally similar biaryl ligands was explored. This led to the development of diverse phosphorinane ligands that have not only been successfully used in the synthesis of ABT-333 on 100-kilogram scale but have also been implemented in other Pd-catalyzed C–N couplings and C–O couplings."

MHH-HCV-NPM-Neuropsychiatric Manifestations of HCV-infection During and After Treatment With OBV/PTV/r and DSV (clinicaltrials.gov) - P4 | N=5 | Terminated | Sponsor: Hannover Medical School | N=30 ➔ 5 | Unknown status ➔ Terminated; The recruitment was stopped prematurely by the sponsor in accordance with the principal investigator because of the difficulties to recruit patients and to achieve the planned numbers of patients within a reasonable time frame.

Enrollment change • Trial termination • Hepatitis C • Hepatology • Infectious Disease • Inflammation • Psychiatry

ABT-333 (Dasabuvir) Increases Action Potential Duration and Provokes Early Afterdepolarizations in Canine Left Ventricular Cells via Inhibition of I. (PubMed, Pharmaceuticals (Basel)) - "ABT-333 reduced hERG-channel-mediated ion current in a concentration-dependent, partially reversible manner with a half-inhibitory concentration of 3.2 μM. As the therapeutic plasma concentration of ABT-333 is 1 nM, the arrhythmic risk of ABT-333 is very low, even in the case of drug overdose."

Journal • Atrial Fibrillation • Cardiovascular • Hepatitis C • Hepatology • Infectious Disease • Inflammation

Understanding HCV Reinfection Rates in an Incarcerated Population After Cure With Interferon Free HCV Treatment (clinicaltrials.gov) - P4 | N=44 | Active, not recruiting | Sponsor: Lisa Barrett | Unknown status ➔ Active, not recruiting | Trial completion date: Jun 2021 ➔ Oct 2023 | Trial primary completion date: Jun 2021 ➔ Oct 2023

Enrollment closed • Trial completion date • Trial primary completion date • Hepatitis C • Hepatology • Infectious Disease • Inflammation

TARGET3D: Treatment of Recently Acquired Hepatitis C With the 3D Regimen or G/P (clinicaltrials.gov) - P3 | N=83 | Completed | Sponsor: Kirby Institute | Recruiting ➔ Completed

Trial completion • Hepatitis C • Hepatology • Human Immunodeficiency Virus • Infectious Disease • Inflammation • CD4

Highlights from the center of catalysis at AbbVie (ACS-Fall 2022) - "For example, the combination of Pd2(dba)3 and novel biaryl phosphorinane ligands have been used to prepare an intermediate for ABT-333 as well as to catalyze several highly challenging C-N cross-coupling reactions...The substrate scope, kinetic and mechanistic studies will be discussed. Finally, a recent discovery of a simple and inexpensive ligand for Ni that can catalyze Suzuki coupling of Lewis basic partners will be discussed."

GEHEP: Efficacy and Safety of Therapy Against HCV Based on Direct-acting Antivirals in Real-life Conditions (clinicaltrials.gov) - P=N/A | N=1128 | Completed | Sponsor: Valme University Hospital | Unknown status ➔ Completed

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

ZIRCON: A Study to Evaluate Treatment of Hepatitis C Virus Infection in Pediatric Subjects (clinicaltrials.gov) - P2/3; N=64; Completed; Sponsor: AbbVie; Phase classification: P2 ➔ P2/3

Clinical • Phase classification • Hepatitis C • Hepatology • Infectious Disease • Inflammation • Pediatrics

DAAs Treatment for Chronic HCV/HBV Co-infection Patients(DASCO) (clinicaltrials.gov) - P2/3; N=23; Completed; Sponsor: Humanity and Health Research Centre; Recruiting ➔ Completed; Trial completion date: Dec 2020 ➔ Aug 2021; Trial primary completion date: Oct 2020 ➔ May 2021

Clinical • Trial completion • Trial completion date • Trial primary completion date • Hepatitis B • Hepatitis C • Hepatology • Infectious Disease • Inflammation

C-DIAMOND: Effectiveness and Safety of Direct-Acting Antiviral Agents for the Treatment of Chronic Hepatitis C (clinicaltrials.gov) - P; N=300; Recruiting; Sponsor: Qing XIe

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

TARGET3D: Treatment of Recently Acquired Hepatitis C With the 3D Regimen or G/P (clinicaltrials.gov) - P3; N=90; Recruiting; Sponsor: Kirby Institute; Trial completion date: Dec 2025 ➔ Dec 2024

Clinical • Trial completion date • Hepatitis C • Hepatology • Human Immunodeficiency Virus • Infectious Disease • Inflammation • CD4

TOPAZ-I: A Study to Evaluate Long-term Outcomes Following Treatment With ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (clinicaltrials.gov) - P3; N=1596; Completed; Sponsor: AbbVie; Active, not recruiting ➔ Completed

Clinical • Trial completion • Hepatitis C • Hepatology • Infectious Disease • Inflammation

TOPAZ II: A Study to Evaluate Long-term Outcomes Following Treatment With ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (clinicaltrials.gov) - P3; N=615; Completed; Sponsor: AbbVie; Active, not recruiting ➔ Completed

Clinical • Trial completion • Hepatitis C • Hepatology • Infectious Disease • Inflammation

TOPAZ II: A Study to Evaluate Long-term Outcomes Following Treatment With ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (clinicaltrials.gov) - P3; N=615; Active, not recruiting; Sponsor: AbbVie; Completed ➔ Active, not recruiting; Trial completion date: Nov 2020 ➔ Mar 2021; Trial primary completion date: Oct 2020 ➔ Mar 2021

Clinical • Enrollment closed • Trial completion date • Trial primary completion date • Hepatitis C Virus • Hepatology • Infectious Disease

TOPAZ II: A Study to Evaluate Long-term Outcomes Following Treatment With ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (clinicaltrials.gov) - P3; N=615; Completed; Sponsor: AbbVie; Active, not recruiting ➔ Completed; Trial completion date: May 2021 ➔ Nov 2020; Trial primary completion date: May 2021 ➔ Oct 2020

Clinical • Trial completion • Trial completion date • Trial primary completion date • Hepatitis C Virus • Hepatology • Infectious Disease

Real World Study: Genotype 1 Chronic Hepatitis C Virus Treatment and Evaluation of Real World SVR and PRO (clinicaltrials.gov) - P4; N=200; Completed; Sponsor: Kaiser Permanente; Active, not recruiting ➔ Completed

Clinical • Real-World Evidence • Trial completion • Hepatitis C Virus • Hepatology • Infectious Disease

PRIORITIZE: Study of Oral Treatments for Hepatitis C (clinicaltrials.gov) - P4; N=1275; Completed; Sponsor: University of Florida; Active, not recruiting ➔ Completed; Trial completion date: Feb 2022 ➔ Sep 2020

Clinical • Trial completion • Trial completion date • Hepatitis C Virus • Hepatology • Infectious Disease

ZIRCON: A Study to Evaluate Treatment of Hepatitis C Virus Infection in Pediatric Subjects (clinicaltrials.gov) - P2; N=64; Completed; Sponsor: AbbVie; Active, not recruiting ➔ Completed

Clinical • Trial completion • Hepatitis C Virus • Hepatology • Infectious Disease • Pediatrics

TARGET3D: Treatment of Recently Acquired Hepatitis C With the 3D Regimen or G/P (clinicaltrials.gov) - P3; N=90; Recruiting; Sponsor: Kirby Institute; Trial completion date: Dec 2022 ➔ Dec 2025; Trial primary completion date: Jun 2020 ➔ Mar 2021

Clinical • Trial completion date • Trial primary completion date • Hepatitis C Virus • Hepatology • Human Immunodeficiency Virus • Infectious Disease

"1) 👆🏼 2)Pediatrics/Pediatric Surgery 3)Basketball/Reading/Gaming 4)@hafaydeefe @Alexviera90 @Dany_Oceguera @Leonbmariana @lorainePoulain @majoglz91 @levivanquee @Rosalesede1 @sergioe1301" (@ccolunga)

Clinical • Pediatrics

A Follow up Study Designed to Obtain Long Term Data on Subjects Who Either Achieved a Sustained Virologic Response or or Did Not Achieve a Sustained Virologic Response in an Abbott Sponsored Hepatitis C Study (clinicaltrials.gov) - P3; N=500; Active, not recruiting; Sponsor: AbbVie (prior sponsor, Abbott); Enrolling by invitation -> Active, not recruiting

Enrollment closed • Biosimilar • Hepatitis C Virus • Immunology • Inflammation

Quantifying antiviral activity optimizes drug combinations against hepatitis C virus infection. (PubMed) - Proc Natl Acad Sci U S A - "From the calculated IIP of 15 anti-HCV drugs from different classes [telaprevir, danoprevir, asunaprevir, simeprevir, sofosbuvir (SOF), VX-222, dasabuvir, nesbuvir, tegobuvir, daclatasvir, ledipasvir, IFN-α, IFN-λ1, cyclosporin A, and SCY-635], we found that the nucleoside polymerase inhibitor SOF had one of the largest potentials to inhibit viral replication events. Our quantification analysis clearly indicated an advantage of triple-DAA treatments over double-DAA treatments, with triple-DAA treatments showing enhanced antiviral activity and a significantly lower probability for drug resistance to emerge at clinically relevant drug concentrations. Our framework provides quantitative information to consider in designing multidrug strategies before costly clinical trials."

Journal • Biosimilar • Hepatitis C Virus • Immunology

DAAs Treatment for Chronic HCV/HBV Co-infection Patients(DASCO) (clinicaltrials.gov) - P2/3; N=32; Recruiting; Sponsor: Humanity and Health Research Centre; Trial completion date: Dec 2017 ➔ Dec 2018; Trial primary completion date: Dec 2017 ➔ Dec 2018

Trial completion date • Trial primary completion date • Biosimilar • Hepatitis C Virus • Immunology