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View article: Weight and Metabolic Changes With Long-Acting Cabotegravir and Rilpivirine or Bictegravir/Emtricitabine/Tenofovir Alafenamide
Weight and Metabolic Changes With Long-Acting Cabotegravir and Rilpivirine or Bictegravir/Emtricitabine/Tenofovir Alafenamide Open
Background: Modest weight and lipid changes have been observed in cabotegravir plus rilpivirine long-acting (CAB + RPV LA) phase 3/3b studies. The SOLAR study included standardized evaluations of weight and metabolic changes in people livi…
View article: Implementation of long‐acting cabotegravir and rilpivirine: primary results from the perspective of staff study participants in the Cabotegravir And Rilpivirine Implementation Study in European Locations
Implementation of long‐acting cabotegravir and rilpivirine: primary results from the perspective of staff study participants in the Cabotegravir And Rilpivirine Implementation Study in European Locations Open
Introduction Cabotegravir plus rilpivirine (CAB + RPV) is the first complete long‐acting (LA) regimen recommended for maintaining HIV‐1 virological suppression. Cabotegravir And Rilpivirine Implementation Study in European Locations (CARIS…
View article: Cabotegravir + Rilpivirine Long-Acting: Overview of Injection Guidance, Injection Site Reactions, and Best Practices for Intramuscular Injection Administration
Cabotegravir + Rilpivirine Long-Acting: Overview of Injection Guidance, Injection Site Reactions, and Best Practices for Intramuscular Injection Administration Open
Background Cabotegravir (CAB) + rilpivirine (RPV) dosed monthly or every 2 months is a complete long-acting (LA) regimen for the maintenance of human immunodeficiency virus type 1 virologic suppression. Across the phase 3/3b trials, the mo…
View article: Asian participants' experience in phase 3/3b studies of long‐acting cabotegravir and rilpivirine: Efficacy, safety, pharmacokinetic, and virological outcomes through week 96
Asian participants' experience in phase 3/3b studies of long‐acting cabotegravir and rilpivirine: Efficacy, safety, pharmacokinetic, and virological outcomes through week 96 Open
Objectives Cabotegravir + rilpivirine (CAB + RPV) dosed monthly or every 2 months is the first complete long‐acting (LA) regimen recommended by treatment guidelines for the maintenance of HIV‐1 virological suppression. This post hoc analys…
View article: Efficacy, Safety, and Pharmacokinetics by Body Mass Index Category in Phase 3/3b Long-Acting Cabotegravir Plus Rilpivirine Trials
Efficacy, Safety, and Pharmacokinetics by Body Mass Index Category in Phase 3/3b Long-Acting Cabotegravir Plus Rilpivirine Trials Open
Background Cabotegravir plus rilpivirine (CAB + RPV) is a guideline-recommended long-acting (LA) injectable regimen for the maintenance of human immunodeficiency virus-1 (HIV-1) virologic suppression. This post hoc analysis summarizes CAB …
View article: 1587. SOLAR 12-Month North American Results: Randomized Switch Trial of CAB+RPV LA vs. Oral BIC/FTC/TAF
1587. SOLAR 12-Month North American Results: Randomized Switch Trial of CAB+RPV LA vs. Oral BIC/FTC/TAF Open
Background Cabotegravir + rilpivirine (CAB+RPV) administered monthly or every 2 months (Q2M) is the only complete long-acting (LA) regimen for maintaining HIV-1 suppression and may address challenges associated with daily oral therapy. In …
View article: Clinical burden of invasive Escherichia coli disease among older adult patients treated in hospitals in the United States
Clinical burden of invasive Escherichia coli disease among older adult patients treated in hospitals in the United States Open
Background Invasive extraintestinal pathogenic Escherichia coli disease (IED) can lead to severe outcomes, particularly among older adults. However, the clinical burden of IED in the U.S. has not been well characterized. Methods IED encoun…
View article: Economic burden of invasive <i>Escherichia coli</i> disease among older adult patients treated in hospitals in the United States
Economic burden of invasive <i>Escherichia coli</i> disease among older adult patients treated in hospitals in the United States Open
BACKGROUND: Although invasive Escherichia coli disease (IED) can lead to severe clinical outcomes, little is known about the associated medical resource use and cost burden of IED in US hospitals. OBJECTIVE: To comprehensively describe med…
View article: 1586. Phase 3/3b Experience with Long-Acting Cabotegravir and Rilpivirine: Efficacy and Safety Outcomes Through Week 96 by Race
1586. Phase 3/3b Experience with Long-Acting Cabotegravir and Rilpivirine: Efficacy and Safety Outcomes Through Week 96 by Race Open
Background Long-acting cabotegravir + rilpivirine (CAB + RPV LA) administered monthly or every 2 months is the first and only complete LA regimen recommended by treatment guidelines for the maintenance of HIV-1 virologic suppression. This …
View article: 1820. Clinical Characteristics of Invasive Extraintestinal Pathogenic Escherichia coli Disease Among Older Adult Patients Treated in Hospitals in the United States
1820. Clinical Characteristics of Invasive Extraintestinal Pathogenic Escherichia coli Disease Among Older Adult Patients Treated in Hospitals in the United States Open
Background The risk of invasive extraintestinal pathogenic Escherichia coli disease (IED) increases with age and can lead to severe outcomes, including sepsis and death. Aim To describe the clinical outcomes of IED in older adults in the U…
View article: Pregnancy outcomes and pharmacokinetics in pregnant women living with <scp>HIV</scp> exposed to long‐acting cabotegravir and rilpivirine in clinical trials
Pregnancy outcomes and pharmacokinetics in pregnant women living with <span>HIV</span> exposed to long‐acting cabotegravir and rilpivirine in clinical trials Open
Background Limited data exist on pregnant women living with HIV exposed to cabotegravir + rilpivirine (CAB + RPV). Outcomes in pregnant participants exposed to CAB + RPV, and pharmacokinetic washout data in those exposed to CAB + RPV long‐…
View article: Compassionate use of <scp>long‐acting</scp> cabotegravir plus rilpivirine for people living with <scp>HIV</scp>‐1 in need of parenteral antiretroviral therapy
Compassionate use of <span>long‐acting</span> cabotegravir plus rilpivirine for people living with <span>HIV</span>‐1 in need of parenteral antiretroviral therapy Open
Objectives Physicians could request compassionate use of oral and long‐acting (LA) cabotegravir + rilpivirine for people living with HIV‐1 under a single‐patient request programme supported by ViiV Healthcare and Janssen. Outcomes are repo…
View article: Low Incidence and Brief Duration of Gastrointestinal Adverse Events with Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Over 96 Weeks: Post hoc Analyses of AMBER and EMERALD
Low Incidence and Brief Duration of Gastrointestinal Adverse Events with Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Over 96 Weeks: Post hoc Analyses of AMBER and EMERALD Open
Gastrointestinal intolerance has been associated with ritonavir-boosted protease inhibitors. This post hoc analysis evaluated gastrointestinal adverse events of interest (AEOIs; diarrhea, nausea, abdominal discomfort, flatulence [MedDRAv21…
View article: 885. Pregnancy Outcomes and Pharmacokinetics in Pregnant Women Living with HIV Exposed to Long-Acting Cabotegravir and Rilpivirine in Clinical Trials
885. Pregnancy Outcomes and Pharmacokinetics in Pregnant Women Living with HIV Exposed to Long-Acting Cabotegravir and Rilpivirine in Clinical Trials Open
Background Limited data exist among women living with HIV who become pregnant while exposed to long-acting (LA) cabotegravir (CAB) and rilpivirine (RPV). We report outcomes in pregnant participants and LA pharmacokinetic (PK) tail data in …
View article: 877. North American Phase 3/3b Experience with Long-Acting Cabotegravir and Rilpivirine: Efficacy, Safety, and Virologic Outcomes
877. North American Phase 3/3b Experience with Long-Acting Cabotegravir and Rilpivirine: Efficacy, Safety, and Virologic Outcomes Open
Background Cabotegravir (CAB) plus rilpivirine (RPV) is the first complete long-acting (LA) regimen recommended by treatment guidelines for the maintenance of HIV-1 virologic suppression. CAB+RPV LA dosed every 4 weeks (Q4W) or every 8 wee…
View article: Week 96 subgroup analyses of the phase 3, randomized AMBER and EMERALD trials evaluating the efficacy and safety of the once daily darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) single-tablet regimen in antiretroviral treatment (ART)-naïve and -experienced, virologically-suppressed adults living with HIV-1
Week 96 subgroup analyses of the phase 3, randomized AMBER and EMERALD trials evaluating the efficacy and safety of the once daily darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) single-tablet regimen in antiretroviral treatment (ART)-naïve and -experienced, virologically-suppressed adults living with HIV-1 Open
D/C/F/TAF was effective with a high barrier to resistance and bone/renal safety benefits, regardless of demographic or clinical characteristics for treatment-naïve and treatment-experienced, virologically-suppressed adults.
View article: Less Bone Loss With Maraviroc- Versus Tenofovir-Containing Antiretroviral Therapy in the AIDS Clinical Trials Group A5303 Study
Less Bone Loss With Maraviroc- Versus Tenofovir-Containing Antiretroviral Therapy in the AIDS Clinical Trials Group A5303 Study Open
Background. There is a need to prevent or minimize bone loss associated with antiretroviral treatment (ART) initiation. We compared maraviroc (MVC)- to tenofovir disoproxil fumarate (TDF)–containing ART.
View article: Comparison of the Metabolic Effects of Ritonavir-Boosted Darunavir or Atazanavir Versus Raltegravir, and the Impact of Ritonavir Plasma Exposure: ACTG 5257
Comparison of the Metabolic Effects of Ritonavir-Boosted Darunavir or Atazanavir Versus Raltegravir, and the Impact of Ritonavir Plasma Exposure: ACTG 5257 Open
Background. Metabolic effects following combination antiretroviral therapy (cART) vary by regimen type. Changes in metabolic effects were assessed following cART in the AIDS Clinical Trials Group (ACTG) A5257 study, and correlated with pla…
View article: 1015. Gastrointestinal (GI) Adverse Events With Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Through Week 96: An AMBER Post Hoc Analysis
1015. Gastrointestinal (GI) Adverse Events With Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Through Week 96: An AMBER Post Hoc Analysis Open
Background Ritonavir boosted protease inhibitors have been associated with GI intolerance. A post hoc analysis was conducted to assess the GI profile of D/C/F/TAF in treatment naïve patients. Methods The phase 3 AMBER trial (ClinicalTrials…
View article: Week 48 Resistance Analyses of the Once-Daily, Single-Tablet Regimen Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) in Adults Living with HIV-1 from the Phase III Randomized AMBER and EMERALD Trials
Week 48 Resistance Analyses of the Once-Daily, Single-Tablet Regimen Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) in Adults Living with HIV-1 from the Phase III Randomized AMBER and EMERALD Trials Open
Darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) 800/150/200/10 mg is being investigated in two Phase III trials, AMBER (NCT02431247; treatment-naive adults) and EMERALD (NCT02269917; treatment-experienced, virologicall…
View article: Bioequivalence of the Once‐Daily Single‐Tablet Regimen of Darunavir, Cobicistat, Emtricitabine, and Tenofovir Alafenamide Compared to Combined Intake of the Separate Agents and the Effect of Food on Bioavailability
Bioequivalence of the Once‐Daily Single‐Tablet Regimen of Darunavir, Cobicistat, Emtricitabine, and Tenofovir Alafenamide Compared to Combined Intake of the Separate Agents and the Effect of Food on Bioavailability Open
The effect of food on the bioavailability of the components of the once‐daily, single‐tablet human immunodeficiency virus (HIV) type 1 regimen containing darunavir (DRV 800 mg), cobicistat (COBI 150 mg), emtricitabine (FTC 200 mg), and ten…
View article: Pharmacokinetics of once‐daily darunavir/ritonavir in <scp>HIV</scp>‐1–infected pregnant women
Pharmacokinetics of once‐daily darunavir/ritonavir in <span>HIV</span>‐1–infected pregnant women Open
Objectives HIV antiretroviral therapy during pregnancy is recommended to reduce the risk of mother‐to‐child transmission and for maternal care. Physiological changes during pregnancy can affect pharmacokinetics. The impact of pregnancy was…
View article: Effects of once-daily darunavir/ritonavir versus atazanavir/ritonavir on insulin sensitivity in HIV-infected persons over 48 weeks: results of an exploratory substudy of METABOLIK, a phase 4, randomized trial
Effects of once-daily darunavir/ritonavir versus atazanavir/ritonavir on insulin sensitivity in HIV-infected persons over 48 weeks: results of an exploratory substudy of METABOLIK, a phase 4, randomized trial Open
DRV/r and ATV/r displayed similar modest effects on insulin sensitivity using a euglycemic hyperinsulinemic clamp.