scholarly journals Incidence and severity of drug interactions before and after switching antiretroviral therapy to bictegravir/emtricitabine/tenofovir alafenamide in treatment-experienced patients

2020 ◽  
Author(s):  
Jason J Schafer ◽  
Neha S Pandit ◽  
Agnes Cha ◽  
Emily Huesgen ◽  
Melissa Badowski ◽  
...  
Keyword(s):  
Antiretroviral Therapy ◽  
Drug Interactions ◽  
Potential Interaction ◽  
People Living With Hiv ◽  
Interaction Database ◽  
Before And After ◽  
Tenofovir Alafenamide ◽  
The University ◽  
Living With Hiv ◽  
Paired T Test

Abstract Background Switching antiretroviral therapy (ART) in people living with HIV (PLWH) can influence their risk for drug-drug interactions (DDIs). The purpose of this study was to assess changes in the incidence and severity of DDIs among PLWH who switched their ART to bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF). Methods This was a multicenter retrospective cohort study of PLWH on ART and at least one concomitant medication (CM) who switched to BIC/FTC/TAF between 3/2018 and 6/2019. Using the University of Liverpool’s HIV Drug Interaction Database, two DDI analyses were performed for each patient. The first assessed patients’ pre-switch ART regimens with their CM list. The second assessed the same CM list with BIC/FTC/TAF. Each ART-CM combination was given a score of zero (no or potential weak interaction), one (potential interaction), or two (contraindicated interaction). A paired t-test analyzed changes in total DDI scores following ART switches and linear regression examined factors contributing to DDI score reductions. Results Among 411 patients, 236 (57%) had at least one DDI present at baseline. On average, baseline DDI scores were 1.4 (SD 1.8) and decreased by 1-point (95% CI -1.1,-0.8) after patients switched to BIC/FTC/TAF (p < 0.0001). After adjusting for demographics, baseline ART and CM categories, switching to BIC/FTC/TAF led to significant DDI score reductions in patients receiving CMs for cardiovascular disease, neurologic/psychiatric disorders, chronic pain, inflammation, gastrointestinal/urologic conditions and conditions requiring hormonal therapy. Conclusion Treatment-experienced PLWH eligible to switch their ART, may experience significant declines in their number and severity of DDIs if switched to BIC/FTC/TAF.

scholarly journals 1044. The Incidence and Severity of Drug interactions Before and After Switching Antiretroviral Therapy to Bictegravir/Emtricitabine/Tenofovir Alafenamide in Treatment Experienced Patients

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S551-S552
Author(s):  
Jason J Schafer ◽  
Neha S Pandit ◽  
Agnes Cha ◽  
Emily Huesgen ◽  
Melissa E Badowski ◽  
...  
Keyword(s):  
Antiretroviral Therapy ◽  
Linear Regression ◽  
Drug Interactions ◽  
Regression Model ◽  
Panel Member ◽  
Potential Interaction ◽  
Research Support ◽  
Review Panel ◽  
Before And After ◽  
Tenofovir Alafenamide

Abstract Background Switching antiretroviral therapy (ART) in virally suppressed people with HIV (PWH) can simplify treatment, improve tolerability, and limit long-term toxicity. It can also influence the presence of drug interactions (DIs) in a positive or negative manner among patients receiving concomitant medications (CMs). The extent to which switching ART to bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) influences DIs in treatment-experienced PWH is unclear. The purpose of this study was to assess changes in the incidence and severity of DIs after switching to BIC/FTC/TAF. Methods This was a multicenter retrospective cohort study of PWH on ART and at least one prescription CM who switched to BIC/FTC/TAF between 3/2018 and 6/2019. Using the University of Liverpool’s HIV drug interaction checker, two DI analyses were performed for each patient. The first assessed patients’ pre-switch ART regimen with their CM list. The second assessed the same CM list with BIC/FTC/TAF. Each ART-CM combination was given a numerical score of 0 (no or potential weak interaction), 1 (potential interaction), or 2 (contraindicated interaction). Total DI scores for each patient, both before and after switching to BIC/FTC/TAF, were then calculated. A paired t-test analyzed changes in DI scores following ART switches and a linear regression model examined factors contributing to DI score reductions. Results A total of 411 patients were included in the analysis (Table 1) of which 236 (57%) had at least one DI present at baseline. On average, patients had a baseline DI score of 1.4 (SD 1.8) and experienced a 1 point reduction (95% CI -1.1,-0.8) after switching to BIC/FTC/TAF (p < 0.0001). After adjusting for demographic variables as well as baseline ART and CM categories in the regression model, switching to BIC/FTC/TAF led to significant DI score reductions in patients receiving CMs for the following conditions: cardiovascular disease, neurologic and psychiatric disorders, chronic pain, inflammation, gastrointestinal and urologic conditions and conditions requiring hormonal therapy (Table 2). Table 1. Descriptive Summary of Baseline Characteristics, n =411. Table 2. Linear Regression for the Difference of DI scores (post – pre), n =376. Conclusion Switching ART to BIC/FTC/TAF can reduce the incidence of DIs among treatment-experienced PWH who are receiving CMs for a broad range of comorbid conditions. Disclosures Jason J. Schafer, PharmD, MPH, Gilead (Research Grant or Support)Merck (Grant/Research Support, Advisor or Review Panel member)ViiV (Advisor or Review Panel member) Elizabeth Sherman, PharmD, Gilead (Grant/Research Support) Jennifer Cocohoba, PharmD, AAHIVP, BCPS, Viiv (Grant/Research Support)

Distinct Lipidomic Signatures in People Living With HIV: Combined Analysis of ACTG 5260s and MACS/WIHS

2021 ◽  
Author(s):  
Jennifer Jao ◽  
Lauren C Balmert ◽  
Shan Sun ◽  
Grace A McComsey ◽  
Todd T Brown ◽  
...  
Keyword(s):  
Antiretroviral Therapy ◽  
High Sensitivity ◽  
People Living With Hiv ◽  
Model Assessment ◽  
Metabolic Complications ◽  
Persons Living With Hiv ◽  
Before And After ◽  
Homeostatic Model Assessment ◽  
Positive Correlations ◽  
Living With Hiv

Abstract Context Disentangling contributions of HIV from antiretroviral therapy (ART) and understanding the effects of different ART on metabolic complications in persons living with HIV (PLHIV) has been challenging. Objective We assessed the effect of untreated HIV infection as well as different antiretroviral therapy (ART) on the metabolome/lipidome. Methods Widely targeted plasma metabolomic and lipidomic profiling was performed on HIV-seronegative individuals and people living with HIV (PLHIV) before and after initiating ART (tenofovir/emtricitabine plus atazanavir/ritonavir [ATV/r] or darunavir/ritonavir [DRV/r] or raltegravir [RAL]). Orthogonal partial least squares discriminant analysis was used to assess metabolites/lipid subspecies that discriminated between groups. Graphical lasso estimated group-specific metabolite/lipid subspecies networks associated with the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR). Correlations between inflammatory markers and metabolites/lipid subspecies were visualized using heat maps. Results Of 435 participants, 218 were PLHIV. Compared to HIV-seronegative individuals, ART-naive PLHIV exhibited higher levels of saturated triacylglycerols/triglycerides (TAGs) and 3-hydroxy-kynurenine, lower levels of unsaturated TAGs and N-acetyl-tryptophan, and a sparser and less heterogeneous network of metabolites/lipid subspecies associated with HOMA-IR. PLHIV on RAL vs ATV/r or DRV/r had lower saturated and unsaturated TAGs. Positive correlations were found between medium-long chain acylcarnitines (C14-C6 ACs), palmitate, and HOMA-IR for RAL but not ATV/r or DRV/r. Stronger correlations were seen for TAGs with interleukin 6 and high-sensitivity C-reactive protein after RAL vs ATV/r or DRV/r initiation; these correlations were absent in ART-naive PLHIV. Conclusion Alterations in the metabolome/lipidome suggest increased lipogenesis for ART-naive PLHIV vs HIV-seronegative individuals, increased TAG turnover for RAL vs ATV/r or DRV/r, and increased inflammation associated with this altered metabolome/lipidome after initiating ART. Future studies are needed to understand cardiometabolic consequences of lipogenesis and inflammation in PLHIV.

scholarly journals The Incidence and Severity of Drug Interactions Before and After Antiretroviral Therapy Simplification in Treatment-Experienced Patients With HIV Infection

2019 ◽  
Vol 54 (1) ◽  
pp. 36-42
Author(s):  
Nicholas V. Hastain ◽  
Aleena Santana ◽  
Jason J. Schafer
Keyword(s):  
Antiretroviral Therapy ◽  
Hiv Infection ◽  
Drug Interactions ◽  
Patient Adherence ◽  
Potential Interaction ◽  
Rank Test ◽  
Signed Rank ◽  
Before And After ◽  
Signed Rank Test

Background: Current guidelines advocate for antiretroviral therapy (ART) simplification in patients on complicated regimens. Simplifying ART improves patient adherence and quality of life, but changes in drug interactions (DIs) are uncertain. Objective: This study assessed changes in DIs following ART simplification in patients with HIV. Methods: This was an observational, retrospective cohort study of patients attending an urban HIV clinic. Patients were included if they had ART simplification (a decreased number of daily tablets) and ≥1 concomitant medication (CM). Total DI scores were generated for each patient pre–ART simplification and post–ART simplification using an online DI database. Each ART-CM pair labeled as “do not co-administer” was given a score of 2, “potential interaction” a score of 1, or “no interaction” a score of 0. Differences in total DI scores following simplification were analyzed with a Wilcoxon Signed-Rank test. Predictors of DI score reductions were examined with linear regression. Results: A total of 99 patients were included. Their median age was 54 years, and 79% were male. The median durations of HIV infection and ART were 16 and 10 years, respectively. Patients were receiving an average of 4.5 CMs. Median interaction scores presimplification and postsimplification were 3 (interquartile range [IQR], 1-6) and 1 (IQR, 0-2) respectively ( P < 0.001). Predictors of score reductions were the patient’s number of CMs, discontinuing a protease inhibitor, and switching to a dolutegravir-based regimen. Conclusion and Relevance: ART simplification decreased the incidence of DIs in this analysis of patients with advanced age who had ART experience and polypharmacy.

scholarly journals Lipids Changes After Switch from TDF to TAF in the OPERA Cohort: LDL-cholesterol and Triglycerides

2021 ◽  
Author(s):  
Patrick W G Mallon ◽  
Laurence Brunet ◽  
Jennifer S Fusco ◽  
Girish Prajapati ◽  
Andrew Beyer ◽  
...  
Keyword(s):  
Generalized Estimating Equations ◽  
Ldl Cholesterol ◽  
Low Density Lipoprotein ◽  
Density Lipoprotein ◽  
People Living With Hiv ◽  
Low Density Lipoprotein Cholesterol ◽  
Before And After ◽  
Tenofovir Alafenamide ◽  
Living With Hiv ◽  
Linear Splines

Abstract Background Increases in lipids have been observed in people living with HIV (PLWH) switching from tenofovir disoproxil fumarate (TDF) to tenofovir alafenamide (TAF). We assessed changes in low-density lipoprotein cholesterol (LDL-C) and triglycerides (TG) following a switch from TDF to TAF. Methods Adults with ≥1 lipid measure before and after switch from TDF-to-TAF were identified in the OPERA® cohort. Multivariable linear regression using generalized estimating equations were used to estimate predicted changes in lipids over time on TAF, modeled flexibly with linear splines. Results 6,451 PLWH switched from TDF-to-TAF, of whom 4,328 maintained all other agents. LDL-C increased significantly by 1.40 mg/dL/month over the first 3 months on TAF, by 0.33 mg/dL/month between 3-9 months and plateaued beyond 9 months. TG increased significantly by 3.52 mg/dL/month over the first 3 months of TAF, by 0.91 mg/mL/month between 3-9 months, and by 0.72 mg/mL/month between 9-16 months but decreased thereafter. Similar patterns were observed in analyses restricted to PLWH who switched from TDF-to-TAF but maintained all other agents. Discussion TDF-to-TAF switch was associated with LDL-C and TG increases over the first 9 to 16 months on TAF. The dynamic patterns observed cannot be attributed to changes in other agents.

scholarly journals Managing Pharmacotherapy in People Living With HIV and Concomitant Malignancy

2019 ◽  
Vol 53 (8) ◽  
pp. 812-832 ◽  
Author(s):  
Jacqueline L. Olin ◽  
Olga Klibanov ◽  
Alexandre Chan ◽  
Linda M. Spooner
Keyword(s):  
Antiretroviral Therapy ◽  
Drug Interactions ◽  
Medical Condition ◽  
Point Of Care ◽  
Multidisciplinary Care ◽  
Hiv Care ◽  
Chronic Medical Condition ◽  
People Living With Hiv ◽  
Age Related ◽  
Living With Hiv

Objective: To describe data with selected malignancies in people living with HIV (PLWH) and HIV in individuals affected by both conditions and to summarize drug-drug interactions (DDIs) with clinical recommendations for point-of-care review of combination therapies. Data Sources: Literature searches were performed (2005 to December 2018) in MEDLINE and EMBASE to identify studies of malignancies in PLWH in the modern era. Study Selection and Data Extraction: Article bibliographies and drug interaction databases were reviewed. Search terms included HIV, antiretroviral therapy, antineoplastic agents, malignancies, and drug interactions. Data Synthesis: In the pre–antiretroviral therapy (ART) era, malignancies in PLWH were AIDS-defining illnesses, and life expectancy was shorter. Nowadays, PLWH are living longer and developing malignancies, including lung, anal, and prostate cancers. Concurrently, the oncology landscape has evolved, with novel oral targeted agents and immunotherapies becoming routine elements of care. The increased need for and complexity with antineoplastics in PLWH has led to recommendations for multidisciplinary care of this unique population. Evaluation of DDIs requires review of metabolic pathways, absorption mechanisms, and various drug transporters associated with antineoplastics and ART. Relevance to Patient Care and Clinical Practice: This review summarizes available data of non–AIDS-defining malignancies, principles of HIV care in the patient with malignancy, and guidance for assessing DDIs between antineoplastics and ART. Summary DDI tables provide point-of-care recommendations. Conclusions: The availability of ART has transformed AIDS into a chronic medical condition, and PLWH are experiencing age-related malignancies. Pharmacists play an important role in the management of this patient population.

scholarly journals 925. Adverse Events Due to Inappropriate Prescribing in Older Adults Living with HIV

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S496-S496
Author(s):  
Mark Cinquegrani ◽  
M Gabriela Cabanilla ◽  
Keenan L Ryan ◽  
Catia Marzolini ◽  
Bernadette Jakeman
Keyword(s):  
Adverse Events ◽  
Drug Interactions ◽  
Inappropriate Prescribing ◽  
Panel Member ◽  
People Living With Hiv ◽  
Start Criteria ◽  
Age Related ◽  
Hiv Drugs ◽  
The University ◽  
Living With Hiv

Abstract Background People living with HIV (PLWH) are aging and experience age-related comorbidities as well as physiological changes leading to a higher risk for polypharmacy, drug-drug interactions, inappropriate prescribing and related adverse events (AE). Prior studies have highlighted a growing concern for inappropriate prescribing in older PLWH. The objective of this study was to examine the prevalence of AEs resulting from inappropriate prescribing in PLWH &gt; 65 years of age. Methods This was a retrospective chart review. PLWH followed-up at the outpatient HIV clinic at the University Hospital in New Mexico between 01/01/2015 and 08/21/ 2018 were eligible if they were &gt; 65 years of age and had &gt;1 potentially inappropriate prescriptions (PIP). PIP were identified using the Beers and STOPP/START criteria for inappropriate mediations in elderly, as well as drugs incorrectly dosed, and potentially deleterious drug-drug interactions (DDI). The University of Liverpool’s HIV interaction checker and Lexicomp’s interaction checker were used to screen for DDI between HIV and non-HIV drugs, and between non-HIV drugs. AEs related to PIPs were collected and their severity was classified using the WHO scale for grading of AEs. Results A total of 104 PLWH &gt;65 years of age fulfilled the eligibility criteria. Most patients were male (88.5%) with an average age of 69 years. The majority of patients were virologically suppressed (89%), with an average CD4 cell count of 650 cells/µL. Polypharmacy (&gt;5 non-HIV medications) was identified in all 104 patients; average number of non-HIV medications was 9.4 + 4.8. 30 (28.8%) patients experienced &gt;1 AE, with a total of 53 AEs identified. Of those, 20 (67%) presented with a serious AE. 14 patients (47%) had to seek treatment at an emergency department and 2 patients (7%) had to be hospitalized. The most common AEs included falls (27/53 events; 51%), bleeds (7/53 events; 13%), fractures (4/53 events; 8%). Risk for an AE was significantly associated with increasing number of medications (OR 1.16; 95% CI 1.05-1.29). Conclusion PIP and related AEs are common in older PLWH. Interventions to prevent harm including medication reconciliation, medication review, and medication prioritization according to the risks/benefits of individual patients are warranted. Disclosures Keenan L. Ryan, PharmD, PhC, Theravance (Advisor or Review Panel member)

scholarly journals EVALUATION ON THE NUMBER OF CD4 T CELLS AND ANTIRETROVIRAL SIDE EFFECTS IN PATIENTS WITH AIDS

2016 ◽  
Vol 3 (2) ◽  
pp. 96
Author(s):  
Siti Qamariyah Khairunisa ◽  
Irine Normalina ◽  
Nasronudin Nasronudin
Keyword(s):  
T Cells ◽  
Antiretroviral Therapy ◽  
Side Effects ◽  
Cd4 T Cells ◽  
Secondary Data ◽  
Antiretroviral Drugs ◽  
People Living With Hiv ◽  
Before And After ◽  
Record Card ◽  
Living With Hiv

Antiretroviral drug discovery has encouraged a revolution in the care of people living with HIV, although it has not been able to cure diseases and to increase the challenge in terms of drug side effects. Side effects of antiretroviral drugs are fairly common occurrences in HIV patients and generally occur within the first three months after initiation of antiretroviral therapy, although long-term side effects are also often found afterwards. This study aims to evaluate the number of CD4 T-cells in patients with AIDS before and after getting on ARV therapy and side effects arising during the taking of ARVs. Samples were collected from 10 patients infected by HIV/AIDS in a clinic in Surabaya. This study is an analytical survey. Data collection was conducted using secondary data obtained from the medical record card status on HIV paients in a clinic in Surabaya. Data results showed that the side effects that often occur in people with AIDS are appetite loss (90%), headache (80%), insomnia (80%) and nausea (70%). While many combinations of antiretroviral drugs have side effects such as a combination of AZT +3 TC + EFV, d4T +3 TC + followed by EFV and AZT +3 TC + NVP. The present study shows that combination antiretroviral therapy gives good results to the increased number of CD4 T-cellsin patients living with HIV, as shown by the tendency of an increase in the number of CD4 T-cells in 8 out of 10 AIDS patients who received a antiretroviral therapy.

scholarly journals EVALUATION ON THE EFFECT OF ANTIRETROVIRAL DRUGS ON CD4 T-CELL AND THE INCREMENT OF BODY WEIGHT AMONG HIV-AIDS PATIENTS IN SURABAYA

2016 ◽  
Vol 3 (2) ◽  
pp. 92
Author(s):  
Edith Frederika ◽  
Irine Normalina ◽  
Nasronudin Nasronudin ◽  
Rury Mega
Keyword(s):  
T Cells ◽  
Body Weight ◽  
Antiretroviral Therapy ◽  
Side Effects ◽  
Cd4 T Cells ◽  
Antiretroviral Drugs ◽  
People Living With Hiv ◽  
Antiretroviral Drug ◽  
Before And After ◽  
Living With Hiv

Antiretroviral drug discovery has encouraged a revolution in the care of people living with HIV, although it has not been able to cure diseases and to increase the challenge in terms of drug side effects. Side effects of antiretroviral drugs are fairly common occurrences in HIV patients and generally occurr within the first three months after initiation of antiretroviral therapy, although long-term side effects are also often found afterwards. This study aims to evaluate the number of CD4 T-cells in patients with AIDS before and after getting on ARV therapy, the side effects arising during the taking of ARVs are related to the increment of body weight among the HIVAIDS patients. Subjects were then narrowed down from 25 to 12 due to the incomplete data. The results showed that the top three most side effects which often occur in people with AIDS are appetite loss (20.0%), nausea (17.8%), and diarrhoea (15.6%). Meanwhile, about 58% of the subjects experienced increment of their body weight, and 42% were losing weight due to the side effects of the ARV therapy. Among those who lost their body weight, 50% were in the productive ages between 21–30 years old. The present study shows that combination antiretroviral therapy gives good results to the increased number of CD4 T-cells in patients living with HIV, as shown by the tendency of an increment in the number of CD4 T-cells in patients who received antiretroviral therapy. However, around 42% of those patients were losing weight because of the side effects of the therapy. Therefore, the importance of giving specific nutrient to overcome with the weight loss is needed to be given to the patients HIV instead of only giving the ARV treatment.

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