34 results on '"Federico Hinestrosa"'
Search Results
2. Clinical outcomes of HIV-1 infected patients switched from complex multi-tablet regimens to tenofovir alafenamide based single-tablet regimens plus a boosted protease inhibitor in a real-world setting
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Charlotte-Paige Rolle, Vu Nguyen, Federico Hinestrosa, and Edwin DeJesus
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Simplification ,Multi-tablet regimens ,Highly treatment experienced ,Microbiology ,QR1-502 ,Public aspects of medicine ,RA1-1270 - Abstract
Background: Multi-tablet regimens (MTRs) are associated with increased adverse events and non-adherence. Single tablet regimens (STRs) plus boosted protease inhibitors (PIs) are a simplification option for MTR-treated patients; however, data is needed to validate this therapeutic strategy. Methods: This retrospective analysis included all HIV-1 infected patients seen at a single center from March 2016 to December 2017 who were switched from twice-daily (BID) regimens or regimens containing ≥ 3 pills daily to elvitegravir/cobicistat/emtricitabine/tenofovir-alafenamide (E/C/F/TAF) plus darunavir (DRV) or rilpivirine/emtricitabine/tenofovir-alafenamide (RPV/F/TAF) plus DRV boosted with ritonavir or cobicistat (DRV/r-c). Eligible patients had baseline HIV-1 RNA
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- 2020
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3. HIV/HCV therapy with ledipasvir/sofosbuvir after randomized switch to emtricitabine-tenofovir alafenamide-based single-tablet regimens.
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Gregory D Huhn, Moti Ramgopal, Mamta K Jain, Federico Hinestrosa, David M Asmuth, Jihad Slim, Deborah Goldstein, Shauna Applin, Julie H Ryu, Shuping Jiang, Stephanie Cox, Moupali Das, Thai Nguyen-Cleary, David Piontkowsky, Bill Guyer, Lorenzo Rossaro, and Richard H Haubrich
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Medicine ,Science - Abstract
IntroductionGuidelines advocate the treatment of HCV in all HIV/HCV co-infected individuals. The aim of this randomized, open-label study (ClinicalTrials.gov identifier: NCT02707601; https://clinicaltrials.gov/ct2/show/NCT02707601) was to evaluate the safety/efficacy of ledipasvir/sofosbuvir (LDV/SOF) co-administered with elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) or rilpivirine/F/TAF (R/F/TAF) in HIV-1/HCV co-infected participants.MethodsParticipants with HIV-1 RNA ResultsOf 150 participants, 148 received ≥1 dose of HIV study drug and 144 received LDV/SOF (72 in each F/TAF group; 83% GT1a, 94% HCV treatment-naïve, 12% cirrhotic). Overall, SVR12 was 97% (95% confidence interval: 93-99%). Black race did not affect SVR12. Of four participants not achieving SVR12, one had HCV relapse, one had HCV virologic non-response due to non-adherence, and two missed the post-HCV Week 12 visit. Of 148 participants, 96% receiving E/C/F/TAF and 95% receiving R/F/TAF maintained HIV suppression at Week 24; no HIV resistance was detected. No participant discontinued LDV/SOF or E/C/F/TAF due to adverse events; one participant discontinued R/F/TAF due to worsening of pre-existing hypercholesterolemia. Renal toxicity was not observed in either F/TAF regimen during LDV/SOF co-administration. In conclusion, high rates of HCV SVR12 and maintenance of HIV suppression were achieved with LDV/SOF and F/TAF-based regimens.ConclusionThis study supports LDV/SOF co-administered with an F/TAF-based regimen in HIV-1/HCV-GT1 co-infected patients.
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- 2020
- Full Text
- View/download PDF
4. Virologic outcomes of switching to dolutegravir functional mono- or dual therapy with a non-cytosine nucleoside analog: a retrospective study of treatment-experienced, patients living with HIV
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Edwin DeJesus, Vu Nguyen, Federico Hinestrosa, and Charlotte-Paige Rolle
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0301 basic medicine ,medicine.medical_specialty ,Dual therapy ,Pyridones ,030106 microbiology ,HIV Infections ,Single Center ,Gastroenterology ,Cytosine nucleoside ,Piperazines ,03 medical and health sciences ,chemistry.chemical_compound ,0302 clinical medicine ,Virology ,Internal medicine ,Oxazines ,HIV drug resistance ,Clinical endpoint ,Humans ,Medicine ,Pharmacology (medical) ,030212 general & internal medicine ,Retrospective Studies ,business.industry ,Research ,Nucleosides ,Retrospective cohort study ,Viral Load ,RC581-607 ,Resistance mutation ,Monotherapy ,Regimen ,Treatment Outcome ,chemistry ,Dolutegravir ,Molecular Medicine ,Immunologic diseases. Allergy ,business ,Heterocyclic Compounds, 3-Ring - Abstract
BackgroundDolutegravir (DTG) monotherapy results in virologic failure and the development of DTG resistance. Here, we evaluated virologic outcomes of patients switched to DTG functional mono- or dual therapy with a non-cytosine nucleoside analog (NA).MethodsThis retrospective, single center study included treatment-experienced patients switched to regimens containing ≥ 2 antiretrovirals between 8/13/13–11/22/14 who were later found to be on DTG functional mono- or dual therapy with a non-cytosine NA based on historical genotypes. Eligible patients were either suppressed or viremic at baseline and had ≥ 2 HIV-1 RNA measurements at least 4 weeks apart following switch. Demographics, laboratory values and clinical parameters were extracted from the charts of all eligible patients during study treatment until 12/31/2018 and were summarized using descriptive statistics. The primary endpoint was the proportion of patients with HIV-1 RNA ResultsOf 70 patients switched to DTG functional mono- or dual therapy, 39 were eligible; 19 (49%) were on DTG functional monotherapy and 20 (51%) were on DTG functional dual therapy with a non-cytosine NA. Historical genotypes indicated that all had an M184V/I, and 23 (59%) had an M184V/I and ≥ 1 additional NA mutation. The median duration of follow-up on study treatment was 50 weeks (range 12–244). Following switch, 32/39 (82%) patients achieved or maintained an HIV-1 RNA ConclusionsIn this real-world cohort, the majority of whom had virus with the M184V/I and ≥ 1 additional NA mutation, switching to DTG functional mono-or dual therapy with a non-cytosine NA resulted in persistent HIV-1 RNA ≥ 50 copies/mL in 18%. None with post-switch genotypes developed treatment-emergent resistance.
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- 2021
5. Treatment-related early discontinuations and adverse events among newly diagnosed people living with HIV initiating integrase inhibitors in a real-world setting
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Charlotte-Paige Rolle, Jamie Castano, Vu Nguyen, Kiran Patel, Federico Hinestrosa, and Edwin DeJesus
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Pharmacology ,Infectious Diseases ,Pharmacology (medical) - Abstract
Background Cohort studies suggest higher discontinuation rates with integrase strand transfer inhibitors (INSTIs) than are seen in clinical trials. We assessed discontinuations and adverse events (AEs) that were considered related to the initial INSTI in the first year following initiation among treatment-naïve people living with HIV (PLWH). Methods Newly diagnosed PLWH initiating raltegravir, elvitegravir/cobicistat, dolutegravir or bictegravir in combination with emtricitabine/tenofovir alafenamide or emtricitabine/tenofovir disoproxil fumarate between 10/2007 and 1/2020 at the Orlando Immunology Center were included. Unadjusted incidence rates (IRs) and incidence rate ratios (IRRs) were calculated for treatment-related discontinuations and AEs associated with the initial INSTI in the first year following initiation. Results Of 331 enrolled, 26 (8%) initiated raltegravir, 151 (46%) initiated elvitegravir/cobicistat, 74 (22%) initiated dolutegravir and 80 (24%) initiated bictegravir. Within the first year, treatment-related discontinuations occurred in 3 on elvitegravir/cobicistat (IR 0.02 per person-years (PPY)) and 5 on dolutegravir (IR 0.08 PPY); no treatment-related discontinuations occurred among those initiating raltegravir or bictegravir. Eleven treatment-related AEs occurred in 7 on raltegravir (IR 0.46 PPY), 100 treatment-related AEs occurred in 63 on elvitegravir/cobicistat (IR 0.72 PPY), 66 treatment-related AEs occurred in 37 on dolutegravir (IR 0.97 PPY) and 65 treatment-related AEs occurred in 34 on bictegravir (IR 0.88 PPY). Unadjusted IRRs did not reveal any significant difference between INSTIs in terms of early treatment-related discontinuations or AEs. Conclusions In our cohort, treatment-related AEs occurred in 43% initiating INSTIs but were responsible for early discontinuation in only 2% with no treatment-related discontinuations observed among those initiating RAL or BIC.
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- 2023
6. A Pragmatic, Randomized Controlled Trial of Oral Antivirals for the Treatment of Chronic Hepatitis C: The PRIORITIZE Study
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Patrick Horne, Anquenette P Sloan, K. Rajender Reddy, Mandana Khalili, Donna M. Evon, Juhi S Moon, Mark S. Sulkowski, Larry Michael, Scott Kixmiller, Michael W. Fried, David R. Nelson, Mitchell L. Shiffman, Meichen Dong, Monika Vainorius, Jama M. Darling, Jodi B Segal, Dawn Fishbein, Joy Peter, Paul W. Stewart, Summer Wadsworth, Kenneth E. Sherman, Brian L. Pearlman, Andrew J. Muir, Giuseppe Morelli, Federico Hinestrosa, Adrian M. Di Bisceglie, Prioritize Study Team, and Anna S. Lok
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Cyclopropanes ,Male ,Sofosbuvir ,Genotyping Techniques ,Sustained Virologic Response ,Administration, Oral ,Hepacivirus ,law.invention ,chemistry.chemical_compound ,Randomized controlled trial ,law ,2-Naphthylamine ,Medicine ,Anilides ,Aged, 80 and over ,Sulfonamides ,Dasabuvir ,Imidazoles ,Valine ,Middle Aged ,Drug Combinations ,Treatment Outcome ,Grazoprevir ,RNA, Viral ,Drug Therapy, Combination ,Female ,medicine.drug ,Ledipasvir ,Adult ,medicine.medical_specialty ,Elbasvir ,Adolescent ,Proline ,Lactams, Macrocyclic ,Antiviral Agents ,Young Adult ,Internal medicine ,Quinoxalines ,Ribavirin ,Humans ,Uracil ,Aged ,Benzofurans ,Fluorenes ,Hepatology ,business.industry ,Hepatitis C, Chronic ,Ombitasvir ,chemistry ,Paritaprevir ,Benzimidazoles ,business ,Follow-Up Studies - Abstract
Background and aims Multiple direct-acting antiviral (DAA) regimens are available to treat HCV genotype 1 infection. However, comparative effectiveness from randomized controlled trials of DAA regimens is unavailable. Approach and results We conducted a pragmatic randomized controlled trial (NCT02786537) to compare the effectiveness of DAAs for HCV genotype 1a or 1b on viral response, safety, tolerability, and medication nonadherence. Adults with compensated liver disease, HCV genotype 1, not pregnant or breastfeeding, and with health insurance likely to cover ledipasvir/sofosbuvir (LDV/SOF) were recruited from 34 US viral hepatitis clinics. Participants were randomized (± ribavirin) to LDV/SOF, elbasvir/grazoprevir (EBR/GZR), and paritaprevir/ritonavir/ombitasvir+dasabuvir (PrOD; treatment arm stopped early). Primary outcomes included sustained viral response at 12 weeks (SVR12), clinician-recorded adverse events, patient-reported symptoms, and medication nonadherence. Between June 2016 and March 2018, 1,609 participants were randomized. Among 1,128 participants who received ≥1 dose of EBR/GZR or LDV/SOF (± ribavirin), SVR12 was 95.2% (95% CI, 92.8%-97.6%) and 97.4% (95% CI, 95.5%-99.2%), respectively, with a difference estimate of 2.2% (-0.5% to 4.7%), falling within the "equivalence" interval (-5% to 5%). While most (56%) participants experienced adverse events, few were serious (4.2%) or severe (1.8%). In the absence of ribavirin, discontinuations due to adverse events were rare. Patient-reported symptoms and medication nonadherence were similar. Study limitations were dropout due to insurance denial and loss to follow-up after treatment, limiting the ability to measure SVR12. Conclusions This pragmatic trial demonstrated high SVR12 for participants treated with EBR/GZR and LDV/SOF with few adverse effects. Overall, the two regimens were equivalent in effectiveness. The results support current HCV guidelines that do not distinguish between ribavirin-free EBR/GZR and LDV/SOF.
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- 2021
7. Real-world efficacy and safety of switching to bictegravir/emtricitabine/tenofovir alafenamide in older people living with HIV
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Kiran Patel, Dan Cruz, Edwin DeJesus, Charlotte-Paige Rolle, Federico Hinestrosa, and Vu Nguyen
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Male ,safety ,medicine.medical_specialty ,real-world ,Pyridones ,efficacy ,Integrase inhibitor ,Observational Study ,HIV Infections ,Emtricitabine ,Tenofovir alafenamide ,Piperazines ,chemistry.chemical_compound ,Internal medicine ,medicine ,Humans ,Adverse effect ,Tenofovir ,older adults ,Aged ,Retrospective Studies ,Aged, 80 and over ,Alanine ,Bictegravir ,bictegravir ,business.industry ,Drug Substitution ,Retrospective cohort study ,General Medicine ,Middle Aged ,Drug Combinations ,Treatment Outcome ,chemistry ,Rilpivirine ,Cohort ,drug–drug interactions ,Female ,business ,medicine.drug ,Research Article - Abstract
Approximately 50% of people living with HIV (PLWH) in the United States are ≥50 years old. Clinical trials of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) demonstrated potent efficacy and favorable safety in older PLWH; however, real-world data would be useful to validate these results. Retrospective cohort study. We evaluated records from PLWH aged ≥50 years at the Orlando Immunology Center who were switched to B/F/TAF between February 2018 and August 2019. Eligible patients had baseline HIV-1 RNA
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- 2021
8. 889. Early Discontinuations and Adverse Events Among Treatment-Naïve Patients Initiating Integrase Inhibitors in a Real-world Setting
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Charlotte-Paige M Rolle, Jamie Castano, Vu Nguyen, Kiran Patel, Federico Hinestrosa, and Edwin DeJesus
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Infectious Diseases ,AcademicSubjects/MED00290 ,Oncology ,Poster Abstracts - Abstract
Background Cohort studies suggest higher rates of discontinuations (DCs) and adverse events (AEs) with integrase inhibitors (INSTIs) than is reported in clinical trials. Here, we assess DC of different INSTIs in combination with one of two tenofovir prodrugs in the first year following initiation defined as “early DC” in a real-world cohort of treatment-naïve patients. Methods This analysis evaluated treatment-naïve patients at a single center initiating raltegravir (RAL), elvitegravir/cobicistat (EVG/c), dolutegravir (DTG) or bictegravir (BIC) in combination with emtricitabine/tenofovir alafenamide (F/TAF) or emtricitabine/tenofovir disoproxil fumarate (F/TDF) between 10/2007-1/2020. Eligible patients had a minimum follow-up of 1 year. The primary endpoint was incidence of early INSTI DC. Secondary endpoints included AEs and risk factors for early INSTI DC and treatment-related AEs. Results 331 patients were included. Median age was 32 years, 89% were male, 43% were non-White, 8% started RAL-based therapy, 46% started EVG/c-based therapy, 22% started DTG-based therapy and 24% started BIC/F/TAF. 36 discontinued INSTI-based therapy early yielding an incidence rate of 0.17 DCs per person-years (PPY) among RAL patients, 0.14 DCs PPY among EVG/c patients, 0.22 DCs PPY among DTG patients, and 0 DCs PPY among BIC patients, p=0.006. Treatment-related AEs occurred in 27% of RAL patients, 42% of EVG/c patients, 50% of DTG patients, and 43% of BIC patients p=0.607; and were responsible for early DC rates of 0.022 in 3 EVG/c patients and 0.075 in 5 DTG patients. No treatment-related early DCs occurred among RAL or BIC patients. No evaluated factor was significantly associated with early INSTI DC, however DTG use was significantly associated with treatment-related AEs (aOR 3.46, 95% confidence interval: [1.20; 10.82]). Table 1. Risk factors for early integrase inhibitor discontinuation and treatment-related adverse events Conclusion In this cohort, early DCs occurred in 11% initiating INSTI-based therapy, however of these only 2% were treatment-related. These data support use of INSTI-based regimens as preferred options for treatment-naïve patients living with HIV due to their favorable safety and tolerability profiles. Disclosures Charlotte-Paige M. Rolle, MD MPH, Gilead Sciences (Grant/Research Support, Scientific Research Study Investigator, Speaker’s Bureau)Janssen Infectious Disease (Scientific Research Study Investigator, Advisor or Review Panel member)ViiV Healthcare (Grant/Research Support, Scientific Research Study Investigator, Advisor or Review Panel member, Speaker’s Bureau) Kiran Patel, PharmD, Gilead Sciences (Employee) Federico Hinestrosa, MD, AbbVie (Speaker’s Bureau)Gilead Sciences (Advisor or Review Panel member, Speaker’s Bureau)Theratechonologies (Advisor or Review Panel member)ViiV Healthcare (Advisor or Review Panel member, Speaker’s Bureau) Edwin DeJesus, MD, Gilead Sciences (Scientific Research Study Investigator, Advisor or Review Panel member)
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- 2021
9. Virologic Outcomes of Switching to Dolutegravir Functional Monotherapy, or Functional Dual Therapy With Dolutegravir Plus A Non-cytosine Nucleoside Analog: A Retrospective Study of Treatment-Experienced, HIV-1 Infected Patients
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Vu T. Nguyen, Federico Hinestrosa, Edwin DeJesus, and Charlotte-Paige Rolle
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Oncology ,medicine.medical_specialty ,business.industry ,Human immunodeficiency virus (HIV) ,Retrospective cohort study ,medicine.disease_cause ,Cytosine nucleoside ,Treatment experienced ,chemistry.chemical_compound ,chemistry ,Internal medicine ,Dolutegravir ,medicine ,Dual therapy ,business - Abstract
Background Dolutegravir (DTG) monotherapy results in unacceptable virologic failure rates and the development of DTG resistance. Here, we evaluated virologic outcomes of patients switched to DTG functional monotherapy, or functional dual therapy with DTG plus a non-cytosine nucleoside analog (NA).Methods This observational study included treatment-experienced patients switched to regimens containing ≥ 3 antiretrovirals later found to be on DTG functional monotherapy, or functional dual therapy with DTG plus a non-cytosine NA based on historical genotypes. Eligible patients were either suppressed or viremic at baseline and had ≥2 HIV-1 RNA measurements at least four weeks apart following switch. The primary endpoint was the proportion with HIV-1 RNAResults Thirty-nine patients were included, 19 (49%) were found to be on DTG functional monotherapy and 20 (51%) were found to be on functional dual therapy with DTG plus a non-cytosine NA. The median duration of follow-up was 50 weeks (range 12-244). Following switch, 32/39 (82%) patients achieved or maintained an HIV-1 RNAConclusions In this real-world cohort, the majority of whom had virus with the M184V/I and ≥ 1 additional NA mutation, switching to DTG functional monotherapy, or functional dual therapy with DTG plus a non-cytosine NA resulted in persistent HIV-1 RNA≥ 50 copies/mL in 18%. None with post-switch genotypes developed treatment-emergent resistance.
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- 2020
10. Clinical outcomes of once-daily darunavir in treatment-experienced patients with darunavir resistance-associated mutations through 48 weeks of treatment
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Omar Marquez, Edwin DeJesus, Federico Hinestrosa, Charlotte-Paige Rolle, and Vu Nguyen
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Adult ,Male ,medicine.medical_specialty ,Anti-HIV Agents ,HIV Infections ,Dermatology ,030312 virology ,Treatment experienced ,Drug Administration Schedule ,03 medical and health sciences ,Internal medicine ,Drug Resistance, Viral ,Medicine ,Humans ,Pharmacology (medical) ,In patient ,Darunavir ,0303 health sciences ,030306 microbiology ,business.industry ,Public Health, Environmental and Occupational Health ,HIV Protease Inhibitors ,Middle Aged ,Viral Load ,CD4 Lymphocyte Count ,Infectious Diseases ,Treatment Outcome ,Mutation ,HIV-1 ,RNA, Viral ,Once daily ,business ,medicine.drug - Abstract
Darunavir (DRV) is approved for once-daily use in patients with no DRV resistance-associated mutations (RAMs) and twice-daily use in those with DRV RAMs. Several studies suggest that once-daily DRV retains efficacy in the setting of 1–2 DRV RAMs whereas three or more DRV RAMs are needed for DRV resistance. There are few data to support the long-term use of once-daily DRV in patients with DRV RAMs. This observational study evaluated 48-week clinical outcomes of 22 treatment-experienced patients with ≥1 DRV RAMs switched to once-daily DRV between 2014 and 2017. The primary endpoint was HIV-1 RNA
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- 2020
11. HIV/HCV therapy with ledipasvir/sofosbuvir after randomized switch to emtricitabine-tenofovir alafenamide-based single-tablet regimens
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Mamta K. Jain, Deborah Goldstein, Julie H. Ryu, Thai Nguyen-Cleary, Shuping Jiang, Shauna Applin, Stephanie Cox, Moupali Das, Lorenzo Rossaro, Jihad Slim, Gregory D Huhn, Federico Hinestrosa, Moti Ramgopal, David M. Asmuth, Bill Guyer, Richard Haubrich, and David Piontkowsky
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RNA viruses ,Male ,Sofosbuvir ,Physiology ,HIV Infections ,Hepacivirus ,Urine ,Pathology and Laboratory Medicine ,Gastroenterology ,Biochemistry ,chemistry.chemical_compound ,0302 clinical medicine ,Immunodeficiency Viruses ,Medicine and Health Sciences ,Emtricitabine ,030212 general & internal medicine ,Multidisciplinary ,Alanine ,Elvitegravir ,Hepatitis C virus ,Coinfection ,Cobicistat ,Liver Diseases ,virus diseases ,Middle Aged ,Hepatitis C ,Body Fluids ,Drug Combinations ,Cirrhosis ,Medical Microbiology ,Rilpivirine ,Viral Pathogens ,Creatinine ,Viruses ,Medicine ,RNA, Viral ,030211 gastroenterology & hepatology ,Female ,Pathogens ,Anatomy ,medicine.drug ,Research Article ,Ledipasvir ,Adult ,medicine.medical_specialty ,Science ,Gastroenterology and Hepatology ,Tenofovir alafenamide ,Microbiology ,03 medical and health sciences ,Internal medicine ,Microbial Control ,Retroviruses ,Drug Resistance, Viral ,medicine ,Humans ,Tenofovir ,Microbial Pathogens ,Aged ,Pharmacology ,Treatment Guidelines ,Fluorenes ,Health Care Policy ,Flaviviruses ,business.industry ,Adenine ,Lentivirus ,Organisms ,Biology and Life Sciences ,HIV ,Hepatitis viruses ,Health Care ,Regimen ,chemistry ,HIV-1 ,Benzimidazoles ,Antimicrobial Resistance ,business ,Biomarkers - Abstract
IntroductionGuidelines advocate the treatment of HCV in all HIV/HCV co-infected individuals. The aim of this randomized, open-label study (ClinicalTrials.gov identifier: NCT02707601; https://clinicaltrials.gov/ct2/show/NCT02707601) was to evaluate the safety/efficacy of ledipasvir/sofosbuvir (LDV/SOF) co-administered with elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) or rilpivirine/F/TAF (R/F/TAF) in HIV-1/HCV co-infected participants.MethodsParticipants with HIV-1 RNA ResultsOf 150 participants, 148 received ≥1 dose of HIV study drug and 144 received LDV/SOF (72 in each F/TAF group; 83% GT1a, 94% HCV treatment-naïve, 12% cirrhotic). Overall, SVR12 was 97% (95% confidence interval: 93-99%). Black race did not affect SVR12. Of four participants not achieving SVR12, one had HCV relapse, one had HCV virologic non-response due to non-adherence, and two missed the post-HCV Week 12 visit. Of 148 participants, 96% receiving E/C/F/TAF and 95% receiving R/F/TAF maintained HIV suppression at Week 24; no HIV resistance was detected. No participant discontinued LDV/SOF or E/C/F/TAF due to adverse events; one participant discontinued R/F/TAF due to worsening of pre-existing hypercholesterolemia. Renal toxicity was not observed in either F/TAF regimen during LDV/SOF co-administration. In conclusion, high rates of HCV SVR12 and maintenance of HIV suppression were achieved with LDV/SOF and F/TAF-based regimens.ConclusionThis study supports LDV/SOF co-administered with an F/TAF-based regimen in HIV-1/HCV-GT1 co-infected patients.
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- 2020
12. Update of Hepatitis C in Colombia
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Oscar Santos, Juan Ignacio Marín, Federico Hinestrosa, Octavio Germán Muñoz Maya, and Juan Carlos Restrepo
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medicine.medical_specialty ,education.field_of_study ,business.industry ,Population ,Disease ,Hepatitis C ,medicine.disease ,03 medical and health sciences ,0302 clinical medicine ,Infectious Diseases ,030220 oncology & carcinogenesis ,Virologic response ,Epidemiology ,Tropical medicine ,medicine ,Immunology and Allergy ,030211 gastroenterology & hepatology ,Risk factor ,Intensive care medicine ,education ,business ,Disease burden - Abstract
The goal is to describe the epidemiology, disease burden and detection, available therapies, and current challenges to access care for people with chronic hepatitis C infection in Colombia. There are no detailed statistics about the prevalence of HCV in Colombia; nonetheless, majority of patients with hepatitis C are infected with genotype 1 and having received blood products before 1996 represents the main risk factor. The use of intravenous drugs has started to be recognized as a population at risk that is in increment. Direct-acting antivirals became available in 2016 in Colombia thanks to a centralized purchase program with the Pan American Health Organization. There are well-established guidelines for the use of available antivirals for all disease stages and genotypes and sustained virologic response (SVR) rates are 95 to 100%. Underdiagnosis, access and linkage to care, and disease stigmatization have contributed to a low number of patients that have actually completed their therapy.
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- 2018
13. Sofosbuvir‐velpatasvir with ribavirin for 24 weeks in hepatitis C virus patients previously treated with a direct‐acting antiviral regimen
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John McNally, Edward Gane, Giuseppe Morelli, Federico Hinestrosa, K.C. Huang, Gs-Us Investigators, Anu Osinusi, Alexander J. Thompson, Hadas Dvory-Sobol, Kyle Etzkorn, M. Davis, Diana M. Brainard, Mark S. Sulkowski, Mitchell L. Shiffman, John G. McHutchison, and Catherine A.M. Stedman
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Adult ,Male ,0301 basic medicine ,medicine.medical_specialty ,Sofosbuvir ,Voxilaprevir ,Hepatitis C virus ,Hepacivirus ,medicine.disease_cause ,Antiviral Agents ,Heterocyclic Compounds, 4 or More Rings ,Sofosbuvir/velpatasvir ,Gastroenterology ,03 medical and health sciences ,chemistry.chemical_compound ,0302 clinical medicine ,Internal medicine ,Drug Resistance, Viral ,Ribavirin ,medicine ,Humans ,Adverse effect ,Aged ,Hepatology ,business.industry ,Hepatitis C ,Hepatitis C, Chronic ,Middle Aged ,medicine.disease ,Drug Combinations ,Regimen ,030104 developmental biology ,chemistry ,Drug Therapy, Combination ,Female ,030211 gastroenterology & hepatology ,Carbamates ,business ,medicine.drug - Abstract
The optimal retreatment strategy for patients chronically infected with hepatitis C virus who experience virologic failure after treatment with direct-acting antiviral-based therapies remains unclear. In this multicenter, open-label, phase 2 study, we evaluated the efficacy and safety of a fixed-dose combination of sofosbuvir-velpatasvir (400 mg/100 mg) plus weight-adjusted ribavirin administered for 24 weeks in patients who did not achieve sustained virologic response after prior treatment with direct-acting antiviral regimens that included the nucleotide analogue nonstructural protein 5B inhibitor sofosbuvir plus the nonstructural protein 5A inhibitor velpatasvir with or without the nonstructural protein 3/4A protease inhibitor voxilaprevir. The primary efficacy endpoint was the proportion of patients achieving sustained virologic response at 12 weeks after the cessation of treatment. In total, 63 of 69 (91%; 95% confidence interval, 82%-97%) patients achieved sustained virologic response at 12 weeks, including 36 of 37 (97%; 95% confidence interval, 86%-100%) patients with hepatitis C virus genotype 1 infection, 13 of 14 (93%; 95% confidence interval, 66%-100%) patients with genotype 2 infection, and 14 of 18 (78%; 95% confidence interval, 52%-94%) patients with genotype 3 infection. Most adverse events were of mild or moderate severity. The most frequently reported adverse events were fatigue, nausea, headache, insomnia, and rash. One patient (1%) with genotype 1a infection discontinued all study drugs due to an adverse event (irritability).Retreatment of patients who previously failed direct-acting antiviral-based therapies with sofosbuvir-velpatasvir plus ribavirin for 24 weeks was well tolerated and effective, particularly those with hepatitis C virus genotype 1 or 2 infection. (Hepatology 2017;66:1083-1089).
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- 2017
14. 1012. Efficacy, safety and tolerability of switching to bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in HIV-1 infected virologically-suppressed older adults in a real-world setting
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Vu T. Nguyen, Edwin DeJesus, Federico Hinestrosa, Dan Cruz, Charlotte-Paige Rolle, and Kiran Patel
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Bictegravir ,business.industry ,Cobicistat ,Human immunodeficiency virus (HIV) ,medicine.disease_cause ,Tenofovir alafenamide ,Virology ,chemistry.chemical_compound ,AcademicSubjects/MED00290 ,Infectious Diseases ,Oncology ,Tolerability ,chemistry ,Rilpivirine ,Poster Abstracts ,medicine ,Ritonavir ,Adverse effect ,business ,medicine.drug - Abstract
Background Approximately 50% of people living with HIV (PLWH) in the United States are ≥50 years old. Efforts are ongoing to identify antiretrovirals associated with fewer drug-drug interactions (DDIs) and long-term side effects in this group. Clinical trials of B/F/TAF demonstrated favorable efficacy and safety in older adults, however, data from real-word settings are needed to validate these results. Methods This retrospective analysis evaluated records from PLWH aged ≥ 50 years at the Orlando Immunology Center who were switched to B/F/TAF between 2/7/2018 and 5/31/2019. Eligible patients had baseline HIV-1 RNA< 50 copies/mL and were followed for 48 weeks post-switch. The primary endpoint was maintenance of HIV-1 RNA< 50 copies/mL at week 48. The impact of switching to B/F/TAF on DDIs, adverse events (AEs) and safety parameters were analyzed throughout the study. Results 306 patients met inclusion criteria. 62 (20%) were female, 126 (41%) were non-white, median age was 58 years (range [r] 50-81), median duration of HIV infection was 19.5 years (r 2-40), median number of chronic co-morbid conditions was 5 (r 0-20), and median number of baseline concomitant medications was 4 (r 0-23). 159 (52%) patients were switched from regimens containing ritonavir or cobicistat. The most commonly documented reason for switch was simplification (Table 1). At Week 48, 287 (94%) patients maintained an HIV-1 RNA< 50 copies/ml and 19 (6%) had an HIV-1 RNA between 50-200 copies/mL (Figure 1). 1 patient discontinued due to lack of efficacy. A total of 123 potential DDIs were identified in 104 (34%) patients taking a boosting agent or rilpivirine at baseline (Table 2). At Week 48, there was a significant median decline in total cholesterol (15.5 mg/dL, 95% confidence interval [CI]: 9.5; 21.5), LDL cholesterol (9.5 mg/dL, 95% CI: 4; 15.5) and triglycerides (20 mg/dL, 95% CI: 9.5; 32.5), and median weight increased by 2.5 pounds (95% CI: 1.5; 3.5). Treatment-related AEs occurred in 33 (11%) patients (all Grade 1-2) and led to 7 (2%) discontinuations. Table 1-Baseline demographic and clinical characteristics Table 2-Avoidance of Drug-Drug Interactions (DDIs) following switch to B/F/TAF Figure 1-Subgroup analysis of virologic outcomes at Week 48 Conclusion In this real-world cohort, switching to B/F/TAF was associated with maintenance of virologic control, improvement in lipid parameters, and avoidance of DDIs in a large proportion of patients. These data support use of B/F/TAF as a treatment option in older PLWH. Disclosures Charlotte-Paige M. Rolle, MD MPH, Gilead Sciences (Grant/Research Support, Scientific Research Study Investigator, Speaker’s Bureau)Janssen Infectious Disease (Grant/Research Support)ViiV Healthcare (Grant/Research Support, Scientific Research Study Investigator, Advisor or Review Panel member, Speaker’s Bureau) Kiran Patel, PharmD, Gilead Sciences (Employee) Federico Hinestrosa, MD, AbbVie (Speaker’s Bureau)Gilead Sciences (Speaker’s Bureau)Merck (Speaker’s Bureau)Theratechnologies (Speaker’s Bureau) Edwin DeJesus, MD, Gilead Sciences (Advisor or Review Panel member)
- Published
- 2020
15. Clinical outcomes of HIV-1 infected patients switched from complex multi-tablet regimens to tenofovir alafenamide based single-tablet regimens plus a boosted protease inhibitor in a real-world setting
- Author
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Federico Hinestrosa, Vu Nguyen, Edwin DeJesus, and Charlotte-Paige Rolle
- Subjects
0301 basic medicine ,medicine.medical_specialty ,Epidemiology ,Immunology ,Emtricitabine ,Microbiology ,Gastroenterology ,Tenofovir alafenamide ,Simplification ,03 medical and health sciences ,chemistry.chemical_compound ,0302 clinical medicine ,Virology ,Internal medicine ,medicine ,030212 general & internal medicine ,Darunavir ,Original Research ,business.industry ,Elvitegravir ,Cobicistat ,Public Health, Environmental and Occupational Health ,Highly treatment experienced ,Multi-tablet regimens ,QR1-502 ,Regimen ,030104 developmental biology ,Infectious Diseases ,chemistry ,Rilpivirine ,Ritonavir ,Public aspects of medicine ,RA1-1270 ,business ,medicine.drug - Abstract
Background: Multi-tablet regimens (MTRs) are associated with increased adverse events and non-adherence. Single tablet regimens (STRs) plus boosted protease inhibitors (PIs) are a simplification option for MTR-treated patients; however, data is needed to validate this therapeutic strategy. Methods: This retrospective analysis included all HIV-1 infected patients seen at a single center from March 2016 to December 2017 who were switched from twice-daily (BID) regimens or regimens containing ≥ 3 pills daily to elvitegravir/cobicistat/emtricitabine/tenofovir-alafenamide (E/C/F/TAF) plus darunavir (DRV) or rilpivirine/emtricitabine/tenofovir-alafenamide (RPV/F/TAF) plus DRV boosted with ritonavir or cobicistat (DRV/r-c). Eligible patients had baseline HIV-1 RNA
- Published
- 2020
16. Daclatasvir + asunaprevir + beclabuvir ± ribavirin for chronic HCV genotype 1-infected treatment-naive patients
- Author
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K. Sims, Shu-Pang Huang, James M. Levin, David F. Gardiner, Vinod K. Rustgi, Tarek Hassanein, Zobair M. Younossi, Federico Hinestrosa, Gregory T. Everson, Trevor Hawkins, Norman Gitlin, Maribel Rodriguez-Torres, Howard J. Schwartz, Timothy Eley, Tadesse Desta, Dennis M. Grasela, Lynn R. Webster, Fiona McPhee, Paul J. Thuluvath, and Eric Lawitz
- Subjects
Adult ,Male ,medicine.medical_specialty ,Indoles ,Pyrrolidines ,Daclatasvir ,Nausea ,Hepacivirus ,Antiviral Agents ,Gastroenterology ,Drug Administration Schedule ,03 medical and health sciences ,chemistry.chemical_compound ,0302 clinical medicine ,Internal medicine ,Ribavirin ,Clinical endpoint ,medicine ,Humans ,030212 general & internal medicine ,NS5A ,Beclabuvir ,Aged ,Sulfonamides ,Hepatology ,business.industry ,Imidazoles ,virus diseases ,Valine ,Benzazepines ,Hepatitis C, Chronic ,Middle Aged ,Viral Load ,Isoquinolines ,Virology ,digestive system diseases ,Regimen ,Treatment Outcome ,chemistry ,Asunaprevir ,Drug Therapy, Combination ,Female ,030211 gastroenterology & hepatology ,Carbamates ,Drug Monitoring ,medicine.symptom ,business ,medicine.drug - Abstract
Background and Aims This phase-2b study examined the safety and efficacy of an all-oral, interferon-free combination of the NS5A replication complex inhibitor daclatasvir (DCV), the NS3 protease inhibitor asunaprevir (ASV), and the nonnucleoside NS5B polymerase inhibitor beclabuvir (BCV) with or without ribavirin in patients with HCV genotype (GT) 1 infection. Methods A total of 187 patients received 12 weeks of DCV 30 mg BID plus ASV 200 mg BID and BCV 150 mg BID (n = 86) or 75 mg BID with (n = 21) or without (n = 80) weight-based ribavirin BID. The primary endpoint was HCV RNA
- Published
- 2015
17. Sofosbuvir With Velpatasvir in Treatment-Naive Noncirrhotic Patients With Genotype 1 to 6 Hepatitis C Virus Infection
- Author
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John McNally, Lingling Han, Paul J. Thuluvath, William J. Towner, Raymond T. Chung, Federico Hinestrosa, Ronald Nahass, David L. Wyles, Kyle Etzkorn, Diana M. Brainard, Gregory T. Everson, Timothy R. Morgan, John G. McHutchison, Myron J. Tong, M. Davis, Tram T. Tran, Brian P. Doehle, and Mordechai Rabinovitz
- Subjects
Adult ,Male ,medicine.medical_specialty ,Genotype ,Sofosbuvir ,Hepatitis C virus ,Hepacivirus ,medicine.disease_cause ,Antiviral Agents ,Heterocyclic Compounds, 4 or More Rings ,Gastroenterology ,Sofosbuvir/velpatasvir ,Drug Administration Schedule ,Young Adult ,chemistry.chemical_compound ,Internal medicine ,Drug Resistance, Viral ,Internal Medicine ,medicine ,Humans ,Adverse effect ,Aged ,biology ,business.industry ,Ribavirin ,General Medicine ,Hepatitis C ,Hepatitis C, Chronic ,Middle Aged ,medicine.disease ,biology.organism_classification ,Virology ,Treatment Outcome ,chemistry ,Drug Therapy, Combination ,Female ,Carbamates ,business ,medicine.drug - Abstract
Background Effective, pangenotypic treatments for hepatitis C virus (HCV) infection are needed. Objective To assess the safety and efficacy of sofosbuvir with velpatasvir in patients infected with HCV genotypes 1 to 6. Design Randomized, phase 2, open-label study. (ClinicalTrials.gov: NCT01858766). Setting 48 U.S. sites. Patients 377 treatment-naive noncirrhotic patients. In part A, patients infected with HCV genotypes 1 to 6 were randomly assigned to sofosbuvir, 400 mg, with velpatasvir, 25 or 100 mg, for 12 weeks. In part B, patients with genotype 1 or 2 HCV infection were randomly assigned to sofosbuvir, 400 mg, and velpatasvir, 25 or 100 mg, with or without ribavirin for 8 weeks. Measurements Sustained virologic response at 12 weeks (SVR12). Results In part A, SVR12 rates were 96% (26 of 27) with velpatasvir, 25 mg, and 100% (28 of 28) with velpatasvir, 100 mg, for genotype 1; 93% (25 of 27) in both groups for genotype 3; and 96% (22 of 23) with velpatasvir, 25 mg, and 95% (21 of 22) with velpatasvir, 100 mg, for genotypes 2, 4, 5, and 6. In part B, for genotype 1, SVR12 rates were 87% (26 of 30) with velpatasvir, 25 mg; 83% (25 of 30) with velpatasvir, 25 mg, plus ribavirin; 90% (26 of 29) with velpatasvir, 100 mg; and 81% (25 of 31) with velpatasvir, 100 mg, plus ribavirin. For genotype 2, SVR12 rates were 77% (20 of 26) with velpatasvir, 25 mg; 88% (22 of 25) with velpatasvir, 25 mg, plus ribavirin; 88% (23 of 26) with velpatasvir, 100 mg; and 88% (23 of 26) with velpatasvir, 100 mg, plus ribavirin. Adverse events included fatigue (21%), headache (20%), and nausea (12%). One patient committed suicide. Limitation The study was open-label, no inferential statistics were planned, and sample sizes were small. Conclusion Twelve weeks of sofosbuvir, 400 mg, and velpatasvir, 100 mg, was well-tolerated and resulted in high SVR in patients infected with HCV genotypes 1 to 6. Primary funding source Gilead Sciences.
- Published
- 2015
18. Efficacy of Glecaprevir and Pibrentasvir in Patients With Genotype 1 Hepatitis C Virus Infection With Treatment Failure After NS5A Inhibitor Plus Sofosbuvir Therapy
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Mark S. Sulkowski, Mitchell L. Shiffman, Monika Vainorius, Joy Peter, Ira M. Jacobson, Lois Larsen, Larry Michael, Ira Willner, Anna S. Lok, Wenjing Lu, Gary P. Wang, Michael W. Fried, Giuseppe Morelli, Federico Hinestrosa, K. Rajender Reddy, David R. Nelson, Mohamed Hassan, Jens Kort, and Brian L. Pearlman
- Subjects
Male ,0301 basic medicine ,Pyrrolidines ,Sustained Virologic Response ,Sofosbuvir ,Hepacivirus ,Viral Nonstructural Proteins ,medicine.disease_cause ,Gastroenterology ,law.invention ,chemistry.chemical_compound ,0302 clinical medicine ,Randomized controlled trial ,law ,Medicine ,Treatment Failure ,Aged, 80 and over ,Sulfonamides ,virus diseases ,Hepatitis C ,Middle Aged ,Pibrentasvir ,Drug Combinations ,Hepatocellular carcinoma ,Drug Therapy, Combination ,Female ,030211 gastroenterology & hepatology ,medicine.drug ,Adult ,medicine.medical_specialty ,Genotype ,Hepatitis C virus ,Antiviral Agents ,03 medical and health sciences ,Drug Resistance, Multiple, Viral ,Quinoxalines ,Internal medicine ,Ribavirin ,Humans ,Aged ,Hepatology ,business.industry ,Glecaprevir ,Hepatitis C, Chronic ,medicine.disease ,digestive system diseases ,030104 developmental biology ,chemistry ,Benzimidazoles ,business - Abstract
Background & Aims Treatment options are limited for patients with hepatitis C (HCV) infection with treatment failure after sofosbuvir plus an NS5A inhibitor. There are some data for the efficacy of glecaprevir/pibrentasvir (G/P) in these patients. We performed a randomized trial of the safety and efficacy of 12 and 16 weeks of G/P, with or without ribavirin, in patients with HCV genotype 1 infection with treatment failure after sofosbuvir and an NS5A inhibitor. Methods We performed a phase 3b, open-label study of patients with chronic HCV genotype 1 infection who received previous treatment with sofosbuvir plus an NS5A inhibitor. Patients without cirrhosis were randomly assigned to groups that received G/P for 12 weeks (n = 78, group A) or 16 weeks (n = 49, group B). Patients with compensated cirrhosis were randomly assigned to groups that received G/P and ribavirin for 12 weeks (n = 21, group C) or G/P for 16 weeks (n = 29, group D). The primary end point was a sustained virologic response 12 weeks after treatment. Samples collected at baseline and at time of treatment failure were sequenced for resistance-associated substitutions in NS3 and NS5A. Results Of the 177 patients in the 4 groups, 81% were men, 79% had HCV genotype 1a infection, and 44% were black. Proportions of patients with sustained virologic response 12 weeks after treatment in groups A, B, C, and D were 90%, 94%, 86%, and 97%, respectively. The treatment failed in 13 (7.3%) patients with HCV genotype 1a infection, 6 (7.9%) in group A, 3 (6.1%) in group B, 3 (6.1%) in group C (6.1%), and 1 (3.4%) in group D. Most patients had baseline resistance-associated substitutions in NS5A. Treatment-emergent resistance-associated substitutions in NS3 and NS5A were observed in 9 and 10 patients with treatment failure, respectively. G/P was well tolerated. Ribavirin increased adverse events but did not increase efficacy. Conclusions In a randomized study of patients with chronic HCV genotype 1 infection who received previous treatment with sofosbuvir plus an NS5A inhibitor, 16 weeks treatment with G/P produced sustained virologic response 12 weeks after treatment in >90% of patients, including those with compensated cirrhosis. ClinicalTrials.gov , Number: NCT03092375 .
- Published
- 2019
19. 2486. Clinical Outcomes of Patients Treated with Dolutegravir Functional Monotherapy or Dolutegravir plus an Active Non-cytosine Nucleoside Analog: A Retrospective Observational Cohort Study of Treatment-Experienced Patients
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Maria Camila Castro, Vu Nguyen, Colton J Tucker, Edwin DeJesus, Federico Hinestrosa, Beth Bryant, and Charlotte-Paige Rolle
- Subjects
medicine.medical_specialty ,business.industry ,Treatment outcome ,Cytosine nucleoside ,Treatment experienced ,VIROLOGIC FAILURE ,Abstracts ,chemistry.chemical_compound ,Infectious Diseases ,Oncology ,chemistry ,Internal medicine ,Poster Abstracts ,Dolutegravir ,medicine ,business ,Adverse effect ,Cytosine ,Cohort study - Abstract
Background Dual dolutegravir (DTG)-containing regimens (DCRs) are currently approved for the treatment of antiretroviral (ARV) naïve and experienced patients with HIV-1 infection. DTG monotherapy has resulted in unacceptable rates of virologic failure and subsequent development of DTG resistance. Here, we evaluate the “real-world” efficacy and “barrier to resistance” of DCRs containing 0–1 active ARVs. Methods This is a retrospective observational study evaluating clinical outcomes of treatment-experienced patients on combination DCRs found to be on DTG functional monotherapy or DTG plus an active non-cytosine analog between 2013 and 2014. The primary endpoint was virologic suppression (HIV-1 RNA< 50 copies/mL) at week 48. Virologic failure (VF) was defined as confirmed HIV-1 RNA≥ 50 copies/mL 12 weeks after initiating DTG or any time after achieving HIV-1 RNA< 50 copies/mL. Adherence, adverse events (AEs) and laboratory parameters were analyzed throughout the study. Results Thirty-nine patients were included in the analysis, 19 (49%) were on DTG functional monotherapy and 20 (51%) were on DTG plus a non-cytosine nucleoside analog. The median age (range) was 53 (40–74) years, median baseline CD4+ count (range) was 564 (92–1217) cells/mm3, 22 (56%) had baseline HIV-1 RNA< 50 copies/mL, and 24 (62%) had previously used INSTIs (Table 1). At Weeks 48 and 96, virologic suppression was observed in 78.3% and 86% of patients respectively (Figures 1 and 2). Among 7 VFs (2 on DTG functional monotherapy, 5 on DTG plus a non-cytosine nucleoside analog), there was no evidence of treatment-emergent resistance to DTG. There was a significant median increase in CD4+ count from baseline to Week 48 (+90 cells/mm3, 95% confidence interval: [14.18, 165.9]). No significant changes in lipid parameters were observed. Treatment-related AEs occurred in 17/39 (44%) patients (all Grade 1–2) and 1 patient discontinued DCR treatment due to rash. Conclusion In this “real-world” cohort of treatment-experienced patients, we observed that DTG functional monotherapy and DTG plus a non-cytosine nucleoside analog maintained long-term virologic control and was well tolerated. These data supports use of DTG as a partner for dual DCRs given its high efficacy in patients with underlying ARV resistance. Disclosures All authors: No reported disclosures.
- Published
- 2019
20. 2482. Clinical Outcomes of Once-Daily Darunavir in Treatment-Experienced Patients with Darunavir Resistance Associated Mutations Through 48 Weeks of Treatment
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Federico Hinestrosa, Edwin DeJesus, Vu Nguyen, Charlotte-Paige Rolle, and Omar Marquez
- Subjects
medicine.medical_specialty ,business.industry ,Lipid-lowering therapy ,Treatment experienced ,Abstracts ,Infectious Diseases ,Oncology ,Internal medicine ,Poster Abstracts ,medicine ,LDL Cholesterol Lipoproteins ,Once daily ,Self report ,business ,Adverse effect ,Patient compliance ,Darunavir ,medicine.drug - Abstract
Background Darunavir (DRV) is a well-tolerated, potent protease inhibitor used once-daily in patients with no DRV resistance-associated mutations (RAMs) and twice-daily in those with DRV RAMs. Treatment guidelines encourage use of once-daily regimens to optimize patient adherence, convenience and tolerability. Several studies suggest that once-daily DRV retains efficacy in the setting of 1–2 DRV RAMs whereas 3 or more DRV RAMs (with multiple background PI RAMs) is needed for DRV resistance. Currently, there is little clinical data to support the long-term use of once-daily DRV in patients with DRV RAMs. Methods This is a retrospective study evaluating the 48-week clinical outcomes of 22 treatment-experienced patients with DRV RAMs switched to once-daily DRV between 2014 and 2017 at the Orlando Immunology Center. The primary endpoint was the proportion with virologic suppression (HIV-1 RNA< 50 copies/mL) at Week 48. Adherence, adverse events (AEs) and laboratory parameters were analyzed throughout the study. Results The median age (range) of the sample was 53 (21–77) years, median baseline CD4+ count was 609 cells/mm3, 18 (82%) had baseline HIV-1 RNA Conclusion Once-daily DRV maintained virologic control in this cohort of treatment-experienced patients with 1 or more baseline DRV RAMs and was safe and well-tolerated. This suggests that once-daily DRV may be effective in this population however further data are needed to validate this as a viable treatment option. Disclosures All authors: No reported disclosures.
- Published
- 2019
21. Daclatasvir plus Sofosbuvir for HCV in Patients Coinfected with HIV-1
- Author
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David L, Wyles, Peter J, Ruane, Mark S, Sulkowski, Douglas, Dieterich, Anne, Luetkemeyer, Timothy R, Morgan, Kenneth E, Sherman, Robin, Dretler, Dawn, Fishbein, Joseph C, Gathe, Sarah, Henn, Federico, Hinestrosa, Charles, Huynh, Cheryl, McDonald, Anthony, Mills, Edgar Turner, Overton, Moti, Ramgopal, Bruce, Rashbaum, Graham, Ray, Anthony, Scarsella, Joseph, Yozviak, Fiona, McPhee, Zhaohui, Liu, Eric, Hughes, Philip D, Yin, Stephanie, Noviello, Peter, Ackerman, and Atif, Zaman
- Subjects
Adult ,Male ,medicine.medical_specialty ,Pyrrolidines ,Daclatasvir ,Genotype ,Sofosbuvir ,Hepatitis C virus ,HIV Infections ,Hepacivirus ,Pharmacology ,medicine.disease_cause ,Antiviral Agents ,Gastroenterology ,Pharmacotherapy ,Internal medicine ,Drug Resistance, Viral ,Humans ,Medicine ,Adverse effect ,Aged ,business.industry ,Imidazoles ,Valine ,General Medicine ,Hepatitis C ,Hepatitis C, Chronic ,Middle Aged ,Viral Load ,medicine.disease ,Anti-Retroviral Agents ,Concomitant ,HIV-1 ,RNA, Viral ,Drug Therapy, Combination ,Female ,Carbamates ,Uridine Monophosphate ,business ,Viral load ,medicine.drug - Abstract
BACKGROUND The combination of daclatasvir, a hepatitis C virus (HCV) NS5A inhibitor, and the NS5B inhibitor sofosbuvir has shown efficacy in patients with HCV monoinfection. Data are lacking on the efficacy and safety of this combination in patients coinfected with human immunodeficiency virus type 1 (HIV-1). METHODS This was an open-label study involving 151 patients who had not received HCV treatment and 52 previously treated patients, all of whom were coinfected with HIV-1. Previously untreated patients were randomly assigned in a 2:1 ratio to receive either 12 weeks or 8 weeks of daclatasvir at a standard dose of 60 mg daily (with dose adjustment for concomitant antiretroviral medications) plus 400 mg of sofosbuvir daily. Previously treated patients were assigned to undergo 12 weeks of therapy at the same doses. The primary end point was a sustained virologic response at week 12 after the end of therapy among previously untreated patients with HCV genotype 1 who were treated for 12 weeks. RESULTS Patients had HCV genotypes 1 through 4 (83% with genotype 1), and 14% had compensated cirrhosis; 98% were receiving antiretroviral therapy. Among patients with genotype 1, a sustained virologic response was reported in 96.4% (95% confidence interval [CI], 89.8 to 99.2) who were treated for 12 weeks and in 75.6% (95% CI, 59.7 to 87.6) who were treated for 8 weeks among previously untreated patients and in 97.7% (95% CI, 88.0 to 99.9) who were treated for 12 weeks among previously treated patients. Rates of sustained virologic response across all genotypes were 97.0% (95% CI, 91.6 to 99.4), 76.0% (95% CI, 61.8 to 86.9), and 98.1% (95% CI, 89.7 to 100), respectively. The most common adverse events were fatigue, nausea, and headache. There were no study-drug discontinuations because of adverse events. HIV-1 suppression was not compromised. CONCLUSIONS Among previously untreated HIV–HCV coinfected patients receiving daclatasvir plus sofosbuvir for HCV infection, the rate of sustained virologic response across all genotypes was 97.0% after 12 weeks of treatment and 76.0% after 8 weeks. (Funded by Bristol-Myers Squibb; ALLY-2 ClinicalTrials.gov number, NCT02032888.)
- Published
- 2015
22. Daclatasvir plus Sofosbuvir for Previously Treated or Untreated Chronic HCV Infection
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Gregory T. Everson, Dennis Hernandez, K. Rajender Reddy, Dennis M. Grasela, Maribel Rodriguez-Torres, Paul J. Thuluvath, David R. Nelson, Min Gao, Federico Hinestrosa, William T. Symonds, Anna S. Lok, Eric Lawitz, David F. Gardiner, Claudio Pasquinelli, Fiona McPhee, Diane Sherman, Megan Wind-Rotolo, R. Hindes, Shu-Pang Huang, Timothy Eley, Tarek Hassanein, Ira M. Jacobson, Mark S. Sulkowski, and Howard J. Schwartz
- Subjects
Adult ,Male ,Simeprevir ,Ledipasvir ,Pyrrolidines ,Daclatasvir ,Genotype ,Sofosbuvir ,Hepacivirus ,Viral Nonstructural Proteins ,Antiviral Agents ,Telaprevir ,Young Adult ,chemistry.chemical_compound ,Boceprevir ,Ribavirin ,medicine ,Humans ,Protease Inhibitors ,Aged ,business.industry ,Imidazoles ,virus diseases ,Valine ,General Medicine ,Hepatitis C, Chronic ,Middle Aged ,Virology ,digestive system diseases ,Ombitasvir ,chemistry ,RNA, Viral ,Drug Therapy, Combination ,Female ,Carbamates ,Uridine Monophosphate ,business ,medicine.drug - Abstract
All-oral combination therapy is desirable for patients with chronic hepatitis C virus (HCV) infection. We evaluated daclatasvir (an HCV NS5A replication complex inhibitor) plus sofosbuvir (a nucleotide analogue HCV NS5B polymerase inhibitor) in patients infected with HCV genotype 1, 2, or 3.In this open-label study, we initially randomly assigned 44 previously untreated patients with HCV genotype 1 infection and 44 patients infected with HCV genotype 2 or 3 to daclatasvir at a dose of 60 mg orally once daily plus sofosbuvir at a dose of 400 mg orally once daily, with or without ribavirin, for 24 weeks. The study was expanded to include 123 additional patients with genotype 1 infection who were randomly assigned to daclatasvir plus sofosbuvir, with or without ribavirin, for 12 weeks (82 previously untreated patients) or 24 weeks (41 patients who had previous virologic failure with telaprevir or boceprevir plus peginterferon alfa-ribavirin). The primary end point was a sustained virologic response (an HCV RNA level of25 IU per milliliter) at week 12 after the end of therapy.Overall, 211 patients received treatment. Among patients with genotype 1 infection, 98% of 126 previously untreated patients and 98% of 41 patients who did not have a sustained virologic response with HCV protease inhibitors had a sustained virologic response at week 12 after the end of therapy. A total of 92% of 26 patients with genotype 2 infection and 89% of 18 patients with genotype 3 infection had a sustained virologic response at week 12. High rates of sustained virologic response at week 12 were observed among patients with HCV subtypes 1a and 1b (98% and 100%, respectively) and those with CC and non-CC IL28B genotypes (93% and 98%, respectively), as well as among patients who received ribavirin and those who did not (94% and 98%, respectively). The most common adverse events were fatigue, headache, and nausea.Once-daily oral daclatasvir plus sofosbuvir was associated with high rates of sustained virologic response among patients infected with HCV genotype 1, 2, or 3, including patients with no response to prior therapy with telaprevir or boceprevir. (Funded by Bristol-Myers Squibb and Pharmasset (Gilead); A1444040 ClinicalTrials.gov number, NCT01359644.).
- Published
- 2014
23. THU-182-The PRIORITIZE study: A pragmatic, randomized study of oral regimens for hepatitis C-transforming decision-making for patients, providers, and stakeholders
- Author
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Monika Vainorius, Rajender Reddy, Dawn Fishbein, Mandana Khalili, Donna M. Evon, Mark S. Sulkowski, Andrew J. Muir, Paul W. Stewart, Mitchell L. Shiffman, Brian L. Pearlman, Anna Lok, David R. Nelson, Michael Fried, Larry Michael, Summer Wadsworth, Federico Hinestrosa, Joy Peter, Adrian M. Di Bisceglie, Jama M. Darling, Jodi B Segal, Juhi Moon, and Kenneth E. Sherman
- Subjects
medicine.medical_specialty ,Hepatology ,Randomized controlled trial ,law ,business.industry ,Family medicine ,medicine ,Hepatitis C ,medicine.disease ,business ,law.invention - Published
- 2019
24. Efficacy of Sofosbuvir, Velpatasvir, and GS-9857 in Patients With Genotype 1 Hepatitis C Virus Infection in an Open-Label, Phase 2 Trial
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Federico Hinestrosa, Aasim Sheikh, Jenny C. Yang, Tram Tran, Hadas Dvory-Sobol, Sophia Lu, Robert Herring, Nancy Reau, Eugene R. Schiff, Ira M. Jacobson, Michael J. Bennett, Trevor Hawkins, K. Rajender Reddy, Ronald Nahass, Ziad Younes, Mitchell L. Shiffman, Mordechai Rabinovitz, Diana M. Brainard, Michael P. Curry, Brian L. Pearlman, Eric Lawitz, John G. McHutchison, and Luisa M. Stamm
- Subjects
Cyclopropanes ,Male ,Cirrhosis ,Aminoisobutyric Acids ,Sofosbuvir ,Hepacivirus ,Viral Nonstructural Proteins ,medicine.disease_cause ,NS5A ,Gastroenterology ,NS5B ,chemistry.chemical_compound ,0302 clinical medicine ,030212 general & internal medicine ,Aged, 80 and over ,Sulfonamides ,Middle Aged ,Drug Combinations ,Treatment Outcome ,030211 gastroenterology & hepatology ,Drug Therapy, Combination ,Female ,medicine.drug ,Adult ,medicine.medical_specialty ,Macrocyclic Compounds ,Adolescent ,Genotype ,Proline ,Voxilaprevir ,Hepatitis C virus ,Lactams, Macrocyclic ,Direct-Acting Antiviral Agent ,Sofosbuvir/velpatasvir ,Antiviral Agents ,Heterocyclic Compounds, 4 or More Rings ,Drug Administration Schedule ,03 medical and health sciences ,Young Adult ,Leucine ,Internal medicine ,Quinoxalines ,Ribavirin ,medicine ,Humans ,Adverse effect ,Aged ,Hepatology ,business.industry ,Hepatitis C, Chronic ,medicine.disease ,NS3/4A ,Surgery ,Regimen ,chemistry ,Carbamates ,Serine Proteases ,business - Abstract
Background & AimsThe best regimen to re-treat patients who do not respond to direct-acting antivirals (DAAs) and the feasibility of further shortening regimens is unclear. We assessed the efficacy and safety of the combination of the nucleotide polymerase inhibitor sofosbuvir, the NS5A inhibitor velpatasvir, and the NS3/4A protease inhibitor GS-9857 in patients with hepatitis C virus genotype 1 infection.MethodsWe performed an open-label trial at 32 sites in the United States and at 2 sites in New Zealand of 197 patients with genotype 1 hepatitis C virus infection, with or without compensated cirrhosis, who were treatment-naive or were treated previously with a DAA. Between March 2, 2015, and September 1, 2015, patients received sofosbuvir-velpatasvir (400 mg/100 mg in a fixed-dose combination) plus GS-9857 (100 mg) once daily for 6–12 weeks, plus ribavirin for 1 treatment group consisting of treatment-naive patients with cirrhosis. The primary end point was sustained virologic response 12 weeks after treatment (SVR12).ResultsAmong treatment-naive patients without cirrhosis, 71% (24 of 34; 95% confidence interval [CI], 53–85) achieved SVR12 after 6 weeks of treatment and 100% (36 of 36; 95% CI, 90%–100%) achieved SVR12 after 8 weeks of treatment. Among treatment-naive patients with cirrhosis, 94% (31 of 33; 95% CI, 80–99) achieved SVR12 after 8 weeks of treatment and 81% (25 of 31; 95% CI, 63–93) achieved SVR12 after 8 weeks of treatment with ribavirin. Among DAA-experienced patients treated for 12 weeks, 100% without cirrhosis (31 of 31; 95% CI, 89–100) and 100% with cirrhosis (32 of 32; 95% CI, 89–100) achieved SVR12. The most common adverse events were headache, diarrhea, fatigue, and nausea. One patient (
- Published
- 2016
25. A phase 3b, open-label, randomized, pragmatic study of glecaprevir/pibrentasvir +/− ribavirin (RBV) for HCV genotype 1 subjects who previously failed an NS5A Inhibitor + sofosbuvir (SOF) therapy
- Author
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Michael Fried, Larry Michael, Gary P. Wang, Yiran B Hu, Mitchell L. Shiffman, David R. Nelson, Robert H. Brown, Monika Vainorius, Anna S.F. Lok, Giuseppe Morelli, Federico Hinestrosa, Joy Peter, I. Willner, Jens Kort, M.S. Sulkowski, Mohamed Hassan, and Rajender Reddy
- Subjects
medicine.medical_specialty ,Hepatology ,Sofosbuvir ,business.industry ,Ribavirin ,Gastroenterology ,03 medical and health sciences ,chemistry.chemical_compound ,0302 clinical medicine ,chemistry ,Hcv genotype 1 ,Internal medicine ,Medicine ,030211 gastroenterology & hepatology ,030212 general & internal medicine ,Open label ,Glecaprevir / pibrentasvir ,business ,NS5A ,medicine.drug - Published
- 2018
26. Effectiveness of Simeprevir Plus Sofosbuvir, With or Without Ribavirin, in Real-World Patients With HCV Genotype 1 Infection
- Author
-
P. Pockros, Ira M. Jacobson, A. M. Di Bisceglie, Gregory T. Everson, Mark E. Mailliard, J.R. Spivey, H.E. Vargas, Thomas G. Stewart, C.A. Kerr, K.R. Reddy, H.A. Elbeshbeshy, Gyongyi Szabo, M.S. Sulkowski, Norah A. Terrault, Nezam H. Afdhal, P. Kwo, K. Rajender Reddy, T.N. Hawkins, Coleman Smith, Eugene R. Schiff, J. Lim, I.M. Jacobson, G. Morelli, Michael W. Fried, Lynn M. Frazier, Andrew J. Muir, Mohamed Hassan, Jordan J. Feld, Giuseppe Morelli, Federico Hinestrosa, Hugo E. Vargas, Mitchell L. Shiffman, Richard K. Sterling, Adrian M. Di Bisceglie, Imtiaz Alam, Nancy Reau, Ziv Ben-Ari, Mark S. Sulkowski, A. Williams, R.T. Chung, J. Darling, C. Trautwein, Josh Levitsky, Stefan Zeuzem, Jonathan M. Fenkel, J. Bredfeldt, Rolland C. Dickson, Kenneth E. Sherman, Ananthakrishnan Ramani, R.S. Brown, Jama M. Darling, M.W. Fried, A. Kuo, David R. Nelson, Joseph S. Galati, Jacqueline G. O'Leary, W. Harlan, D. Nelson, Joseph K. Lim, A.S. Lok, Michael P. Manns, Alexander Kuo, Robert S. Brown, Brian L. Pearlman, K. Watts, and S.C. Gordon
- Subjects
Simeprevir ,Male ,Time Factors ,Sofosbuvir ,Hepacivirus ,medicine.disease_cause ,Telaprevir ,chemistry.chemical_compound ,0302 clinical medicine ,030212 general & internal medicine ,Prospective Studies ,Aged, 80 and over ,Gastroenterology ,virus diseases ,Middle Aged ,Viral Load ,Hepatitis C ,Treatment Outcome ,RNA, Viral ,030211 gastroenterology & hepatology ,Drug Therapy, Combination ,Female ,medicine.drug ,Adult ,medicine.medical_specialty ,Genotype ,Hepatitis C virus ,Antiviral Agents ,Article ,03 medical and health sciences ,Young Adult ,Boceprevir ,Internal medicine ,Ribavirin ,medicine ,Humans ,Aged ,Hepatology ,business.industry ,digestive system diseases ,Discontinuation ,Regimen ,chemistry ,Immunology ,North America ,business ,Biomarkers - Abstract
Background & Aims The interferon-free regimen of simeprevir plus sofosbuvir was recommended by professional guidelines for certain patients with hepatitis C virus (HCV) genotype 1 infection based on the findings of a phase 2 trial. We aimed to evaluate the safety and efficacy of this regimen in clinical practice settings in North America. Methods We collected demographic, clinical, and virologic data, as well as reports of adverse outcomes, from sequential participants in HCV-TARGET—a prospective observational cohort study of patients undergoing HCV treatment in routine clinical care settings. From January through October 2014, there were 836 patients with HCV genotype 1 infection who began 12 weeks of treatment with simeprevir plus sofosbuvir (treatment duration of up to 16 weeks); 169 of these patients received ribavirin. Most patients were male (61%), Caucasian (76%), or black (13%); 59% had cirrhosis. Most patients had failed prior treatment with peginterferon and ribavirin without (46%) or with telaprevir or boceprevir (12%). The primary outcome was sustained virologic response (SVR), defined as the level of HCV RNA below quantification at least 64 days after the end of treatment (beginning of week 12 after treatment—a 2-week window). Logistic regression models with inverse probability weights were constructed to adjust for baseline covariates and potential selection bias. Results The overall SVR rate was 84% (675 of 802 patients, 95% confidence interval, 81%–87%). Model-adjusted estimates indicate patients with cirrhosis, prior decompensation, and previous protease inhibitor treatments were less likely to achieve an SVR. The addition of ribavirin had no detectable effects on SVR. The most common adverse events were fatigue, headache, nausea, rash, and insomnia. Serious adverse events and treatment discontinuation occurred in only 5% and 3% of participants, respectively. Conclusions In a large prospective observational cohort study, a 12-week regimen of simeprevir plus sofosbuvir was associated with high rates of SVR and infrequent treatment discontinuation. ClinicalTrials.gov: NCT01474811.
- Published
- 2015
27. Sofosbuvir/Velpatasvir in Combination with Ribavirin for 24 Weeks is Effective Retreatment for Patients who failed Prior NS5A Containing DAA Regimens: Results of the GS-US-342-1553 Study
- Author
-
K.C. Huang, Catherine A.M. Stedman, M.S. Sulkowski, Kyle Etzkorn, M. Davis, Hadas Dvory-Sobol, Giuseppe Morelli, Federico Hinestrosa, Alexander J. Thompson, John McNally, Mitchell L. Shiffman, D.M. Brainard, John G. McHutchison, A. Osinusi, and E.J. Gane
- Subjects
medicine.medical_specialty ,Hepatology ,business.industry ,Ribavirin ,Sofosbuvir/velpatasvir ,Gastroenterology ,03 medical and health sciences ,chemistry.chemical_compound ,0302 clinical medicine ,chemistry ,030220 oncology & carcinogenesis ,Internal medicine ,medicine ,030211 gastroenterology & hepatology ,NS5A ,business - Published
- 2016
28. High Efficacy of Sofosbuvir/Velpatasvir Plus GS-9857 for 12 Weeks in Treatment-Experienced Genotype 1-6 HCV-Infected Patients, Including Those Previously Treated with Direct-Acting Antivirals
- Author
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Ronald Nahass, M. Davis, J.C. Yang, Federico Hinestrosa, E.J. Gane, Robert Herring, Mindie H. Nguyen, R.T. Chung, Eugene R. Schiff, Maribel Rodriguez-Torres, Ziad Younes, Di An, Michael P. Curry, Kris V. Kowdley, David Pound, Paul Y. Kwo, D.M. Brainard, Nancy Reau, Kyle Etzkorn, T.T. Tran, L.M. Stamm, John G. McHutchison, K.R. Reddy, Ira M. Jacobson, M. Bennet, Hadas Dvory-Sobol, and Eric Lawitz
- Subjects
0301 basic medicine ,Hepatology ,business.industry ,DIRECT ACTING ANTIVIRALS ,Sofosbuvir/velpatasvir ,Virology ,Treatment experienced ,03 medical and health sciences ,030104 developmental biology ,0302 clinical medicine ,Genotype ,Medicine ,030211 gastroenterology & hepatology ,business ,Previously treated - Published
- 2016
29. Propionibacterium acnes as a cause of prosthetic valve aortic root abscess
- Author
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Svetolik Djurkovic, Michael A. Foltzer, Federico Hinestrosa, and Paul P. Bourbeau
- Subjects
Microbiology (medical) ,Aortic valve ,Male ,medicine.medical_specialty ,Pathology ,Prosthesis-Related Infections ,Virulence ,Late Prosthetic Valve Endocarditis ,Bacteremia ,Case Reports ,Propionibacterium acnes ,medicine ,Endocarditis ,Humans ,Prosthesis-Related Infection ,Abscess ,Gram-Positive Bacterial Infections ,biology ,Endocarditis, Bacterial ,Middle Aged ,medicine.disease ,biology.organism_classification ,Surgery ,medicine.anatomical_structure ,Aortic Valve ,Heart Valve Prosthesis - Abstract
Propionibacterium acnes isolates usually have relatively low virulence and are often classified as contaminants when isolated from blood and tissue cultures. We report a patient with Propionibacterium acnes bacteremia and late prosthetic valve endocarditis, complicated by an aortic root abscess.
- Published
- 2006
30. Severe Gastroenteritis and Hypovolemic Shock Caused by Grimontia ( Vibrio ) hollisae Infection
- Author
-
Paul P. Bourbeau, Federico Hinestrosa, and Robert G. Madeira
- Subjects
Adult ,Male ,Microbiology (medical) ,Moderate to severe ,biology ,business.industry ,Shock ,macromolecular substances ,Case Reports ,biology.organism_classification ,Vibrio ,Gastroenteritis ,Microbiology ,Vibrio Infections ,Shock (circulatory) ,Immunology ,Humans ,Medicine ,medicine.symptom ,business ,Grimontia hollisae - Abstract
Vibrio hollisae is a halophilic species that was recently reclassified as Grimontia hollisae . This organism is known to cause moderate to severe cases of gastroenteritis. We report a case of an individual who suffered a more severe form of this disease, presenting with profound hypotension and acute renal failure, secondary to hypovolemic shock.
- Published
- 2007
31. 1417 SUSTAINED VIROLOGIC RESPONSE WITH DACLATASVIR PLUS SOFOSBUVIR ± RIBAVIRIN (RBV) IN CHRONIC HCV GENOTYPE (GT) 1-INFECTED PATIENTS WHO PREVIOUSLY FAILED TELAPREVIR (TVR) OR BOCEPREVIR (BOC)
- Author
-
Anna S.F. Lok, Howard J. Schwartz, William T. Symonds, Maribel Rodriguez-Torres, Claudio Pasquinelli, G.T. Everson, David R. Nelson, D. Sherman, Dennis Hernandez, Paul J. Thuluvath, Timothy Eley, M.S. Sulkowski, E.J. Lawitz, Fiona McPhee, R. Hindes, Megan Wind-Rotolo, Dennis M. Grasela, Federico Hinestrosa, Shu-Pang Huang, M. Gao, K.R. Reddy, Tarek Hassanein, Ira M. Jacobson, and David F. Gardiner
- Subjects
Daclatasvir ,Hepatology ,Sofosbuvir ,business.industry ,Ribavirin ,Virology ,Telaprevir ,chemistry.chemical_compound ,chemistry ,Virologic response ,Boceprevir ,Genotype ,Medicine ,business ,medicine.drug - Published
- 2013
32. 1422 POTENT VIRAL SUPPRESSION WITH ALL-ORAL COMBINATION OF DACLATASVIR (NS5A INHIBITOR) AND GS-7977 (NS5B INHIBITOR), +/− RIBAVIRIN, IN TREATMENT-NAIVE PATIENTS WITH CHRONIC HCV GT1, 2, OR 3
- Author
-
Megan Wind-Rotolo, Howard J. Schwartz, Anna S.F. Lok, Timothy Eley, David F. Gardiner, Shu-Pang Huang, K.R. Reddy, B. Symonds, Maribel Rodriguez-Torres, Claudio Pasquinelli, Fiona McPhee, E.J. Lawitz, Mark S. Sulkowski, Federico Hinestrosa, Paul J. Thuluvath, M. Gao, R. Hindes, David R. Nelson, and Dennis M. Grasela
- Subjects
Daclatasvir ,Hepatology ,business.industry ,Ribavirin ,Virology ,Therapy naive ,chemistry.chemical_compound ,Regimen ,chemistry ,Virologic response ,Medicine ,Viral suppression ,NS5A ,business ,NS5B ,medicine.drug - Abstract
1421 HIGH SUSTAINED VIROLOGIC RESPONSE RATE IN TREATMENT-NAIVE HCV GENOTYPE 1A AND 1B PATIENTS TREATED FOR 12 WEEKS WITH AN INTERFERON-FREE ALL-ORAL QUAD REGIMEN: INTERIM RESULTS M. Sulkowski, M. Rodriguez-Torres, E. Lawitz, M. Shiffman, S. Pol, R. Herring, J. McHutchison, P. Pang, D. Brainard, D. Wyles, F. Habersetzer. Johns Hopkins University School of Medicine, Lutherville, MD, Fundacion de Investigacion de Diego, Santurce, PR, Alamo Medical Research, San Antonio, TX, Liver Institute of Virginia, Richmond, VA, USA; Hopital Necker, Paris, France; Nashville Gastrointestinal Specialists, Inc., Nashville, TN, Gilead Sciences, Inc., Foster City, University of California, San Diego, La Jolla, CA, USA; Hopitaux Universitaires de Strasbourg, Strasbourg, France E-mail: msulkowski@jhmi.edu
- Published
- 2012
33. 1151 CONTINUED HIGH VIROLOGIC RESPONSE RATES WITH ACH-1625 DAILY DOSING PLUS PEGIFN-ALPHA 2A IN A 28-DAY AND 12-WEEK PHASE 2A TRIAL
- Author
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Mitchell L. Shiffman, L. Robarge, Fred Poordad, Ira M. Jacobson, H. Robison, V. Araya, L. Hazan, M. Ryan, E. Godofsky, Reem Ghalib, Federico Hinestrosa, J. Lalezari, E. Olek, P.P. Michielsen, H. Van Vlierberghe, Pierre Deltenre, S.L. Flamm, M. Kankam, Bruce R. Bacon, and E.J. Lawitz
- Subjects
Hepatology ,business.industry ,Virologic response ,Alpha (ethology) ,Medicine ,Dosing ,Pharmacology ,business - Published
- 2012
34. OBESITY IS ASSOCIATED WITH IMPROVED SURVIVAL IN CRITICALLY ILL PATIENTS WITH BLOOD STREAM INFECTIONS
- Author
-
Alejandro M. Restrepo, Federico Hinestrosa, Marilyn Haupt, Svetolik Djurkovic, Craig G. Wood, and Luis C. Murillo
- Subjects
Pulmonary and Respiratory Medicine ,medicine.medical_specialty ,Critically ill ,business.industry ,medicine ,Improved survival ,Cardiology and Cardiovascular Medicine ,Critical Care and Intensive Care Medicine ,Intensive care medicine ,business ,medicine.disease ,Blood stream ,Obesity - Published
- 2006
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