Franco Felizarta
- HIV/AIDS drug development and treatment
- Hepatitis C virus research
- HIV Research and Treatment
- Liver Disease Diagnosis and Treatment
- HIV/AIDS Research and Interventions
- Hepatitis B Virus Studies
- HIV-related health complications and treatments
- Systemic Lupus Erythematosus Research
- Chronic Lymphocytic Leukemia Research
- Immunodeficiency and Autoimmune Disorders
- Biochemical and Molecular Research
- Viral Infections and Immunology Research
- Liver physiology and pathology
- Diabetes and associated disorders
- Genetic and Kidney Cyst Diseases
- Herpesvirus Infections and Treatments
- Diabetes Treatment and Management
- HIV, Drug Use, Sexual Risk
- Pharmacological Effects and Toxicity Studies
- Liver Disease and Transplantation
- Hepatitis Viruses Studies and Epidemiology
- Pneumocystis jirovecii pneumonia detection and treatment
Bakersfield College
2012-2024
Instituut voor Tropische Geneeskunde
2019
Janssen (Belgium)
2017
Japan Breast Cancer Research Group
2017
Johnson Matthey (France)
2016
JDSU (United States)
2016
Northern Lithuania College
2016
European Uro Oncology Group
2016
BCS — The Chartered Institute for IT
2016
Ehlers-Danlos Society
2016
Glecaprevir and pibrentasvir are direct-acting antiviral agents with pangenotypic activity a high barrier to resistance. We evaluated the efficacy safety of 8-week 12-week courses treatment 300 mg glecaprevir plus 120 in patients without cirrhosis who had hepatitis C virus (HCV) genotype 1 or 3 infection.We conducted two phase 3, randomized, open-label, multicenter trials. Patients infection were randomly assigned 1:1 ratio receive once-daily glecaprevir-pibrentasvir for either 8 12 weeks....
The SINGLE study was a randomized, double-blind, noninferiority that evaluated the safety and efficacy of 50 mg dolutegravir + abacavir/lamivudine versus efavirenz/tenofovir/emtricitabine in 833 ART-naive HIV-1 participants. Of randomized participants, 71% arm 63% maintained viral loads <50 copies per milliliter through W144 (P = 0.01). Superior primarily driven by fewer discontinuations due to adverse events [dolutegravir arm, 16 (4%); 58 (14%)] [corrected]. No treatment-emergent integrase...
Although direct‐acting antiviral (DAA) therapies for chronic hepatitis C virus (HCV) infection have demonstrated high rates of sustained virologic response, failure may still occur, potentially leading to the emergence viral resistance, which can decrease effectiveness subsequent treatment. Treatment options patients who failed previous DAA‐containing regimens, particularly those with nonstructural protein 5A inhibitors, are limited and remain an area unmet medical need. This phase 2,...
Hepatitis C virus (HCV)–infected patients with cirrhosis are historically a difficult‐to‐treat population and at risk of hepatic decompensation. In the phase 2 COSMOS study that evaluated simeprevir (HCV NS3/4A protease inhibitor) + sofosbuvir nucleotide analogue NS5B polymerase ± ribavirin for 12 or 24 weeks in HCV genotype (GT)1–infected patients, high rates sustained virologic response after planned end treatment (SVR12) were achieved, including (METAVIR score F4). This 3, open‐label,...
Objective: To evaluate the efficacy and safety/tolerability of dolutegravir (DTG, S/GSK1349572), a potent inhibitor HIV integrase, through full 96 weeks SPRING-1 study. Design: ING112276 (SPRING-1) was 96-week, randomized, partially blinded, phase IIb dose-ranging Methods: Treatment-naive adults with received DTG 10, 25, or 50 mg once daily efavirenz (EFV) 600 (control arm) combined investigator-selected dual nucleos(t)ide reverse transcriptase backbone regimen (tenofovir/emtricitabine...
This study assessed the efficacy and safety of ribavirin‐free coformulated glecaprevir/pibrentasvir (G/P) in patients with hepatitis C virus genotype 3 infection prior treatment experience and/or compensated cirrhosis, a patient population limited options. SURVEYOR‐II, Part was partially randomized, open‐label, multicenter, phase study. Treatment‐experienced (prior interferon or pegylated ± ribavirin sofosbuvir plus therapy) without cirrhosis were randomized 1:1 to receive 12 16 weeks G/P...
•343 treatment-naïve patients with chronic HCV genotypes 1–6 and compensated cirrhosis.•Glecaprevir/pibrentasvir for 8 weeks achieved 99.7% virologic cure.•One patient experienced relapse at post-treatment week 4.•Efficacy did not depend on any pre-treatment or viral characteristics.•No drug-related serious adverse events discontinuations due to occurred. Background & AimsEight-week glecaprevir/pibrentasvir leads high rates of sustained virological response 12 (SVR12) across (GT) in without...
Patients with hepatitis C virus (HCV) who have virological failure (VF) after treatment containing a nonstructural protein 5A (NS5A) inhibitor limited retreatment options. MAGELLAN‐1 Part 2 was randomized, open‐label, phase 3 study to evaluate the efficacy and safety of ribavirin (RBV)‐free glecaprevir pibrentasvir (G/P; 300 mg/120 mg) in patients chronic HCV past VF on at least one NS3/4A protease and/or NS5A inhibitor‐containing therapy. compensated liver disease, or without cirrhosis,...
Hepatitis C virus (HCV)-infected patients with a history of injection drug use have low rates initiation and completion interferon-based therapies. This study evaluated efficacy, safety, pharmacokinetics 12-week all-oral regimen ombitasvir/paritaprevir/ritonavir dasabuvir+ribavirin in HCV genotype 1-infected on stable opioid replacement therapy.This was phase II, multicenter, open-label, single-arm treatment-naïve or peginterferon/ribavirin treatment-experienced methadone...
Darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) 800/150/200/10 mg was investigated through 96 weeks in EMERALD (NCT02269917). Virologically-suppressed, HIV-1-positive treatment-experienced adults (previous non-darunavir virologic failure [VF] allowed) were randomized (2:1) to D/C/F/TAF or boosted protease inhibitor (PI) plus emtricitabine/tenofovir-disoproxil-fumarate (F/TDF) over 48 weeks. At week 52 participants the PI arm offered switch (late-switch, 44 exposure). All...
GSK3640254 (GSK'254) is a next-generation human immunodeficiency virus type 1 (HIV-1) maturation inhibitor with pharmacokinetics (PK) supporting once-daily therapy.This phase IIa double-blind (sponsor-unblinded), randomized, placebo-controlled, adaptive study evaluated antiviral effect, safety, tolerability, and PK of GSK'254 monotherapy administered food (moderate-fat meal) in HIV-1-positive, treatment-naive adults. In part 1, participants received 10 or 200 mg for days. 2, 40, 80, 140 7...
Abstract Background Cabotegravir + rilpivirine (CAB RPV) administered via intramuscular gluteal injections is the first complete long-acting regimen for maintaining human immunodeficiency virus type 1 (HIV-1) virologic suppression. We present substudy results on short-term repeat CAB RPV thigh in participants with ≥3 years of experience administration during ATLAS–2M study. Methods Substudy phases included screening, injection (day 1–week 16), and return to (week 16–week 24). The schedule...
Abstract Background Long-acting (LA) formulations of cabotegravir, an HIV integrase inhibitor, and rilpivirine, NNRTI, are in development as monthly or 2 intramuscular (IM) injections for maintenance virological suppression. Objectives To evaluate cabotegravir rilpivirine CSF distribution HIV-1 RNA suppression plasma HIV-infected adults participating a substudy the Phase 2b LATTE-2 study (NCT02120352). Methods Eighteen participants receiving LA 400 mg + 600 IM [every 4 weeks (Q4W), n = 3]...
GSK2838232 is a second-generation, potent, small-molecule, oral human immunodeficiency virus type 1 (HIV-1) maturation inhibitor for once-daily administration boosted with pharmacoenhancer.The phase 2a, proof-of-concept study was an open-label, adaptive dose-ranging design. Safety, pharmacokinetics, and efficacy of by cobicistat were evaluated in individuals HIV-1 infection. The participants (N = 33) received once daily across range doses (20-200 mg) 150 mg 10 days.GSK2838232 safe well...