Viekira Pak (ombitasvir/paritaprevir/ritonavir/dasabuvir) / AbbVie, Enanta Pharma - LARVOL DELTA

Direct-Acting Antivirals Remain Cost-Effective Treatments for Chronic Hepatitis C in Australia Despite Changes to the Treated Population and the Availability of Retreatment: The Glecaprevir/Pibrentasvir (Maviret®) Example. (PubMed, Infect Dis Ther) - "Despite changes in demographics and disease characteristics of treated patients, and changes to the model structure to reflect retreatment in clinical practice in Australia, DAAs remain cost-effective in 2023."

Cost effectiveness • HEOR • Journal • Fibrosis • Hepatitis C • Hepatology • Immunology • 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

Discovery of HCV NS5A inhibitors ombitasvir (ABT-267) and pibrentasvir (ABT-530) and bromodomain and extra-terminal domain (BET) inhibitors mivebresib (ABBV-075) and ABBV-744 (ACS-Fall 2022) - "Our initial medicinal chemistry exploration of HCV NS5A resulted in the discovery of ombitasvir (ABT-267), the HCV NS5A inhibitor that is a key component of Viekira Pak, AbbVie’s 1st generation treatment for HCV. Further research culminated in the discovery of pibrentasvir (ABT-530), the HCV NS5A inhibitor that is a key component of Mavyret, AbbVie’s 2nd generation treatment for HCV...Structure-based drug design at AbbVie led to the discovery of a novel and potent pan BET inhibitor, mivebresib (ABBV-075, phase 1). Additional effort led to the discovery of the BD2 selective BET inhibitor ABBV-744 (phase 1)."

Hepatitis C • Hepatology • Infectious Disease • Inflammation • Oncology

Overcoming Bioavailability Challenges of Dasabuvir and Enabling a Triple-Combination Direct-Acting Antiviral HCV Regimen through a Salt of Very Weak Acid for Oral Delivery. (PubMed, Mol Pharm) - "The oral delivery of dasabuvir through the salt approach has enabled the commercialization of the triple-combination direct-acting antiviral HCV regimen, Viekira Pak. The methodologies and solutions identified in targeted studies to overcome technical challenges encountered along the way (i.e., incorporation of polymers to inhibit crystallization and disproportionation and species mapping to enable salt manufacturing process, etc.) can be applied to other insoluble compounds."

Journal • Hepatitis C • Hepatology • Infectious Disease • Inflammation

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

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

Twirla - a new contraceptive patch. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Long-acting Reversible Contraceptives

Viekira Pak or Mavyret Treatment for Patient With Chronic Kidney Disease and Hepatitis C (clinicaltrials.gov) - P4; N=24; Active, not recruiting; Sponsor: Massachusetts General Hospital; Trial primary completion date: Dec 2020 ➔ Jul 2021

Biomarker • Clinical • Trial primary completion date • Chronic Kidney Disease • Hepatitis C Virus • Hepatology • Infectious Disease • Nephrology • Renal 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

Viekira Pak or Mavyret Treatment for Patient With Chronic Kidney Disease and Hepatitis C (clinicaltrials.gov) - P4; N=24; Active, not recruiting; Sponsor: Massachusetts General Hospital; Recruiting ➔ Active, not recruiting; Trial completion date: Dec 2020 ➔ Dec 2021; Trial primary completion date: Dec 2019 ➔ Dec 2020

Biomarker • Clinical • Enrollment closed • Trial completion date • Trial primary completion date • Chronic Kidney Disease • Hepatitis C Virus • Hepatology • Infectious Disease • Nephrology • Renal Disease

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

[VIRTUAL] The impact of universal access to DAA and real-world treatment outcome amongst genotype 3 hepatitis C virus-infected prisoners (EASL-ILC-I 2020) - "GT3 HCV patients received either 12 weeks of sofosbuvir/daclatasvir and ribavirin (SOF/DAC/Riba) or 12-weeks of sofosbuvir/velpastavir (SOF/VEL). Genotype 1 (GT1) patients receive HARVONI, VIEKIRA PAK or SOF/VEL for 12 weeks... We demonstrated that GT3 HCV prisoner is no longer a difficult-to-treat cohort in the pan-genotypic DAA era, and high SVR12 can be achieved in the real-world setting. Our result shows that universal access to DAA among HCV prisoners is an impactful strategy for HCV micro-elimination in this cohort."

Clinical • HEOR • Real-World Evidence • Gastrointestinal Cancer • Hepatitis C Virus • Hepatocellular Cancer • Hepatology • Hypertension • Infectious Disease • Oncology • Portal Hypertension • Solid Tumor

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

PRIORITIZE: Study of Oral Treatments for Hepatitis C (clinicaltrials.gov) - P4; N=3750; Recruiting; Sponsor: University of Florida; Trial primary completion date: Feb 2021 ➔ Aug 2020

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

Potential for Drug-Drug Interactions between Antiretrovirals and HCV Direct Acting Antivirals in a Large Cohort of HIV/HCV Coinfected Patients. (PubMed) - "Significant potential drug-drug interactions are expected between cART and the currently available DAAs in the majority of HIV/HCV coinfected patients. Sofosbuvir/ledipasvir and sofosbuvir/daclatasvir with or without ribavirin appeared the most suitable combinations in our population. A close collaboration between hepatologists and HIV/AIDS specialists appears necessary for the management of HCV treatment concomitantly to cART."

Journal • Biosimilar • Hepatitis C Virus • Immunology • Inflammation

Express Scripts excludes 20 more drugs from 2016 coverage (Reuters) - "Express Scripts Holding Corp , the largest U.S. pharmacy benefit manager, said on Friday that it would exclude about 20 new medications in 2016 from insurance coverage...The 2016 formulary continues to exclude Gilead Sciences Corp's pricey hepatitis C treatments Harvoni and Sovaldi in favor of its nearest competitor, AbbVie Inc's Viekera Pak."

Reimbursement • Hepatitis C Virus

Effectiveness of Paritaprevir/Ritonavir - Ombitasvir, +/- Dasabuvir, +/- Ribavirin in Patients With Chronic Hepatitis C - An Observational Study in Belgium (clinicaltrials.gov) - P=N/A; N=440; Recruiting; Sponsor: AbbVie

New trial • Biosimilar • Hepatitis C Virus • Immunology • Inflammation

Cost-effectiveness of currently recommended direct-acting antiviral treatments in patients infected with genotypes 1 or 4 hepatitis C virus in the United States. (PubMed) - J Med Econ - "Among currently recommended treatments for GT1 and GT4 in the US, 3D±R (for GT1) and 2D+R (for GT4) have a favorable cost-effectiveness profile."

Journal • Biosimilar • Fibrosis • Gastrointestinal Cancer • Hepatitis C Virus • Hepatocellular Cancer • Immunology • Oncology

Factors affecting approval rates of direct acting antivirals (DAA) for hepatitis C infection: a single center experience (DDW 2016) - P=NA, N=94; "Though this study found no impact of disease stage, HIV co-infection or demographics on treatment denial rates, further larger studies are warranted to compare possible treatment effectiveness in the different insurance groups and better gauge the impact of the potential contributing obstacles to insurance approval."

Retrospective data • Hepatitis C Virus

Ombitasvir/Paritaprevir/Ritonavir With or Without Dasabuvir in Adults With Genotype 1a or Genotype 4 Chronic Hepatitis C Virus (HCV) Infection, With Severe Kidney Impairment or End Stage Kidney Disease (clinicaltrials.gov) - P3; N=40; Recruiting; Sponsor: AbbVie; Not yet recruiting ➔ Recruiting

Enrollment open • Biosimilar • Chronic Kidney Disease • Hepatitis C Virus • Immunology • Inflammation • Renal Disease

OPALE: The Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in France (clinicaltrials.gov) - P=N/A; N=700; Not yet recruiting; Sponsor: AbbVie

New trial • Biosimilar • Hepatitis C Virus • Immunology • Inflammation

Enanta Pharmaceuticals announces preliminary data from AbbVie’s phase 3b RUBY-I study in chronic hepatitis C patients with renal impairment presented at The International Liver Congress™ 2015 (Businesswire) - P3, N=40; NCT02207088; Sponsor: AbbVie; "Enanta Pharmaceuticals...announced today new preliminary safety and efficacy data from the first cohort of AbbVie’s ongoing, Phase 3b RUBY-I study...presented as a late-breaker today at The International Liver Congress™ (ILC) 2015...RUBY-I data showed no virologic failures to date.1 Preliminary safety analyses reported that patients experienced mainly mild or moderate adverse events...Additional Phase 3b studies from AbbVie presented at ILC 2015 included MALACHITE-I and MALACHITE-II data, and TOPAZ-I and TOPAZ-II study design."

Clinical protocol • Conference • P3 data • Hepatitis C Virus

AbbVie receives U.S. FDA approval of once-daily Viekira XR (dasabuvir, ombitasvir, paritaprevir and ritonavir) for the treatment of genotype 1 chronic hepatitis C (AbbVie Press Release) - "AbbVie...today announced that the U.S. Food and Drug Administration (FDA) has approved a New Drug Application (NDA) for VIEKIRA XR...for the treatment of patients with chronic genotype 1 (GT1) hepatitis C virus (HCV) infection, including those with compensated cirrhosis (Child-Pugh A)...not for people with decompensated cirrhosis...approval is supported by Phase 3 clinical trials for VIEKIRA PAK which include data that demonstrated 100 percent sustained virologic response 12 weeks..."

sNDA • Hepatitis C Virus

New drug appears to be curing some Islanders with hepatitis C (Guardian) - P=NA, N=60; "...32 patients have completed the program and are testing negative for the virus; however they must be retested 12 weeks after finishing the treatment to ensure the virus hasn’t come back. The final test results in October are expected to be very good as the drug has a cure rate of at least 95 percent."

Anticipated clinical data • Hepatitis C Virus