scholarly journals INCIDENCE AND RISK FACTORS OF RENAL IMPAIRMENT IN HIV-1 INFECTED PATIENTS RECEIVING TENOFOVIR BASED ANTIRETROVIRAL THERAPY IN A SOUTH INDIAN HOSPITAL

2017 ◽  
Vol 9 (5) ◽  
pp. 152
Author(s):  
A. Pramod Kumar ◽  
G. Parthasarathi ◽  
A. P. Sudheer ◽  
S. N. Mothi ◽  
V. H. T. Swamy ◽  
...  
Keyword(s):  
Risk Factors ◽  
Renal Impairment ◽  
Real Life ◽  
Transcriptase Inhibitor ◽  
People Living With Hiv ◽  
South Indian ◽  
Severe Impairment ◽  
Living With Hiv ◽  
Reverse Transcriptase Inhibitor ◽  
Hiv 1

Objective: To identify the incidence and risk factors of tenofovir (TDF) induced nephrotoxicity among People Living with HIV/AIDS (PLHA) receiving TDF-based anti-retroviral therapy (ART) in a South Indian Hospital.Methods: A retrospective cohort study was conducted among HIV-infected ART naïve patients taking TDF as part of either a first-line or second-line ART between July 2013 and June 2015 at Asha kirana Hospital Mysore, India.Results: A total of 380 patients have been initiated on TDF-based ART. Out of these, 335 patients were on tenofovir+lamivudine+efavirenz, 30 patients were on the tenofovir+lamivudine+nevirapine regimen and 25 patients were on tenofovir+lamivudine+atazanavir/ritonavir regimen. Renal impairment was documented for 35 patients with 9.21% incidence. 34% of renal impaired patients had a severe impairment with eGFR<30 ml/min. Elderly patients (>61 y) had higher chances of developing TDF toxicity compared to adult patients (P=0.0018). Other possible risk factors for TDF-induced renal impairment was CD4>200 (P=0.003). TDF was withdrawn and substituted with Nucleoside Reverse Transcriptase Inhibitor (NRTI) drug following the diagnosis of renal impairment.Conclusion: TDF-associated renal impairment was not uncommon in real-life practice and considered as a frequent complication during treatment with TDF. Risk factors for developing renal impairment include increasing age and CD4>200 cells.

scholarly journals Population Pharmacokinetic and Pharmacodynamic Analysis To Evaluate a Switch to Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate in People Living with HIV-1

2020 ◽  
Vol 64 (11) ◽  
Author(s):  
Pavan Vaddady ◽  
Bhargava Kandala ◽  
Ka Lai Yee
Keyword(s):  
Transcriptase Inhibitor ◽  
Population Pharmacokinetic ◽  
People Living With Hiv ◽  
Shift Trial ◽  
Treatment Naïve ◽  
Post Hoc ◽  
Living With Hiv ◽  
Reverse Transcriptase Inhibitor ◽  
Parameter Values ◽  
Hiv 1

ABSTRACT Doravirine is a non-nucleoside reverse transcriptase inhibitor for treatment of human immunodeficiency virus type 1 (HIV-1) infection. A population pharmacokinetic (PK) model for treatment-naive participants in doravirine clinical studies was updated with data from switch participants in the DRIVE-SHIFT trial and used to estimate individual post hoc PK parameter values and evaluate the efficacy exposure-response relationship. The results support the 100-mg dose for people living with HIV switching to a doravirine-based regimen (This study has been registered at ClinicalTrials.gov under ClinicalTrials registration no. NCT02397096.)

Profiles of 2-Drug Regimen in People Living with HIV-1 in A Real World Setting: A Large-Scale Medical Claim Database Analysis in Japan

2020 ◽  
Author(s):  
Daniel J. Ruzicka ◽  
Mayuko Kamakura ◽  
Naho Kuroishi ◽  
Nobuyuki Oshima ◽  
Miyuki Yamatani ◽  
...  
Keyword(s):  
Large Scale ◽  
Transcriptase Inhibitor ◽  
Treatment Patterns ◽  
Claim Database ◽  
People Living With Hiv ◽  
Medical Claim ◽  
Living With Hiv ◽  
Reverse Transcriptase Inhibitor ◽  
Medical Claim Database ◽  
Hiv 1

Abstract Background Regimen simplification to 2-drug antiretroviral therapy (2-ART) may address potential tolerability issues, increase adherence, and reduce toxicity and potential drug-drug-interactions among people living with HIV-1 (PLWH). However, real-world treatment patterns and patient profiles associated with 2-ART are unclear. Methods This retrospective observational cohort study employed a large-scale medical claim database of Japanese hospitals to extract data on 4,293 PLWH aged ≥18 years with diagnosis of HIV and treated with any ART regimens between April 2008 and April 2019. A 2-ART cohort was compared with a 3-drug antiretroviral therapy (3-ART) cohort in terms of patient characteristics, comorbid conditions, and treatment patterns. Treatment switching rates were calculated for each cohort followed by sensitivity analysis to confirm the robustness of the findings.Results There were 94 patients identified in the 2-ART cohort. Compared to the standard 3-ART cohort (n=3,993), the 2-ART cohort was older (mean age 54.4 vs 43.4 years), with a lower proportion of males (87.2% vs 93.8%), higher Charlson Comorbidity Index (CCI) (mean score 6.9 vs 5.3), more co-medications (mean 8.3 vs 5.0), and a higher percentage of AIDS-defining conditions (66.0% vs 42.8%). The most common 2-ART were protease inhibitor (PI) + integrase strand transfer inhibitor (INSTI) and non-nucleoside reverse transcriptase inhibitor (NNRTI) + INSTI (33.0% and 31.9%, respectively). Overall, most of the regimens were nucleoside reverse transcriptase inhibitor (NRTI)-sparing (71.3%), with a decreasing trend over time (76.2% to 70.2%). ART regimen switch occurred more often in the 2-ART cohort than in the 3-ART cohort (33.0% vs 21.2%). Conclusion The profiles of patients on 2-ART in Japan were demonstrated to be complex. Most patients were treated with NRTI-sparing regimens which may reflect an effort to reduce treatment-related toxicities.

scholarly journals Impact of HIV-1 Resistance-associated Mutations on Susceptibility to Doravirine: Analysis of Real-world Clinical Isolates

2021 ◽  
Author(s):  
Ernest Asante-Appiah ◽  
Johnny Lai ◽  
Hong Wan ◽  
Dongmei Yang ◽  
Elizabeth Anne Martin ◽  
...  
Keyword(s):  
Reverse Transcriptase ◽  
Transcriptase Inhibitor ◽  
Fold Change ◽  
Clinical Isolates ◽  
Transmitted Drug Resistance ◽  
People Living With Hiv ◽  
Relative Fold Change ◽  
Reverse Transcriptase Inhibitor ◽  
The Impact ◽  
Hiv 1

Background: Clinical management of human immunodeficiency virus type-1 (HIV-1) infection may be negatively impacted by either acquired or transmitted drug resistance. Here, we aim to extend our understanding of the impact of resistance-associated mutations (RAMs) on the susceptibility of clinical isolates to the non-nucleoside reverse transcriptase inhibitor (NNRTI) doravirine. Methods: Clinical isolates from people living with HIV-1 undergoing routine testing for susceptibility to doravirine and other approved NNRTIs (etravirine, rilpivirine, efavirenz, and nevirapine) were collected from August 2018 to August 2019. Susceptibility in the presence/absence of NNRTI and nucleos(t)ide reverse transcriptase inhibitor (NRTI) mutations was determined using cut-offs for relative fold-change in inhibition (ratio of the 50% inhibitory concentration [IC 50 ] of patient virus compared with the IC 50 of a wild-type reference strain). Biological cut-offs of 3- to 15-fold-change were investigated for doravirine, with pre-established cut-offs used for the other NNRTIs. Results: Of 4,070 clinical isolates, 42.9% had ≥1 NNRTI RAM. More isolates were susceptible to doravirine (92.5–96.7%) than to etravirine (91.5%), rilpivirine (89.5%), efavirenz (81.5%), or nevirapine (77.5%). Based on a 3-fold cut-off, doravirine susceptibility was retained in 44.7–65.8% of isolates resistant to another NNRTI and 28.5% of isolates resistant to all other tested NNRTIs. The presence of NRTI RAMs including thymidine analog mutations was associated with doravirine hypersusceptibility in some isolates, particularly in the absence of NNRTI RAMs. Conclusion: These results support the favorable resistance profile of doravirine, and are of particular importance given the challenge posed by both acquired and transmitted resistance.

Cerebrospinal fluid exposure to bictegravir/emtricitabine/tenofovir in HIV-1-infected patients with CNS impairment

2021 ◽  
Author(s):  
Thibaut Gelé ◽  
Antoine Chéret ◽  
Alicia Castro Gordon ◽  
Lionelle Nkam ◽  
Valérie Furlan ◽  
...  
Keyword(s):  
Real Life ◽  
Antiretroviral Drugs ◽  
People Living With Hiv ◽  
Hiv Cure ◽  
Crucial Component ◽  
Total Plasma Concentration ◽  
Tenofovir Alafenamide ◽  
Living With Hiv ◽  
Csf Concentration ◽  
Hiv 1

Abstract Objectives The penetration of antiretroviral drugs into deep compartments, such as the CNS, is a crucial component of strategies towards an HIV cure. This study aimed to determine CSF concentrations of bictegravir, emtricitabine and tenofovir in patients with HIV-related CNS impairment (HCI) enrolled in a real-life observational study. Methods Patients with HCI treated by optimized ART, including bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) for at least 1 month were enrolled. Plasma and CSF concentrations were measured by quality control-validated assays (LC-MS/MS). The inhibitory quotient (IQARV) was calculated as the ratio of unbound (bictegravir) or total (emtricitabine and tenofovir) concentration to half (or 90%) maximal inhibitory concentration for bictegravir (or emtricitabine and tenofovir). All numerical variables are expressed as median (range). Results Twenty-four patients (nine women) were enrolled. The age was 45 (26–68) years. Unbound bictegravir and total emtricitabine and tenofovir CSF concentrations were 4.4 (1.6–9.6), 84.4 (28.6–337.4) and 1.6 (0.7–4.3) ng/mL, respectively. The unbound bictegravir CSF fraction was 34% (15%–82%) versus 0.33% (0.11%–0.92%) in plasma. Three patients had an IQARV above unity for the three antiretrovirals. Factors positively associated with the CSF concentration (unbound for bictegravir) were age and total plasma concentration for the three antiretrovirals. Patients aged over 51 years had higher CSF concentrations (unbound for bictegravir). Conclusions We observed low CSF exposure to bictegravir, emtricitabine and tenofovir. These results suggest that BIC/FTC/TAF should be used with caution as first-line treatment for people living with HIV with HCI under 51 years of age.

scholarly journals Switching to a Bictegravir Single Tablet Regimen in Elderly People Living with HIV-1: Data Analysis from the BICTEL Cohort

Diagnostics ◽  
2021 ◽  
Vol 12 (1) ◽  
pp. 76
Author(s):  
Alessandro Lazzaro ◽  
Elio Gentilini Cacciola ◽  
Cristian Borrazzo ◽  
Giuseppe Pietro Innocenti ◽  
Eugenio Nelson Cavallari ◽  
...  
Keyword(s):  
T Cells ◽  
Real Life ◽  
Total Body Weight ◽  
P Value ◽  
People Living With Hiv ◽  
Single Tablet Regimen ◽  
Total Body ◽  
Tenofovir Alafenamide ◽  
Living With Hiv ◽  
Hiv 1

Bictegravir/emtricitabine/tenofovir alafenamide fumarate (BIC/FTC/TAF) is a recommended once-daily single tablet regimen for the treatment of people living with HIV-1 (PLWH). We aimed to assess efficacy, safety and tolerability of BIC/FTC/TAF among PLWH, with a specific focus on people older than 55 years. Thus, we recruited an observational retrospective real-life cohort including all PLWH who underwent a therapeutic switch to BIC/FTC/TAF, independently from the provenience treatment regimen. After 48 weeks of follow-up, 147 PLWH were included and 93 were older than 55 years. PLWH with HIV-RNA < 37 copies/mL increased from 140 to 146 (p < 0.033). Among the overall population, we observed an increase in CD4+ T cells count by 30.1% (p-value < 0.001), in CD8+ T cells count by 7.1% (p-value = 0.004) and in CD4+/CD8+ ratio by 21.5% (p-value < 0.001). Lipidic profile was characterized by decreasing total cholesterol/HDL ratio by 8% (p-value < 0.001) and LDL by 6.8% (p-value = 0.007). Total body weight increased by 1.8% (p-value = 0.014) and BMI by 4.2% (p-value < 0.001), even remaining within the healthy range. Hepatic and renal profile were not altered by the switch, nor were adverse events and/or discontinuations events detected. In conclusion, BIC/FTC/TAF is effective, safe and well tolerated in real life and among PLWH older than 55.

scholarly journals Risk and Cost Associated With Drug–Drug Interactions Among Aging HIV Patients Receiving Combined Antiretroviral Therapy in France

2019 ◽  
Vol 6 (3) ◽  
Author(s):  
Ludivine Demessine ◽  
Laure Peyro-Saint-Paul ◽  
Edward M Gardner ◽  
Jade Ghosn ◽  
Jean-Jacques Parienti
Keyword(s):  
Health Care ◽  
Drug Interactions ◽  
Reverse Transcriptase ◽  
Transcriptase Inhibitor ◽  
People Living With Hiv ◽  
Combined Antiretroviral Therapy ◽  
The Difference ◽  
The University ◽  
Living With Hiv ◽  
Reverse Transcriptase Inhibitor

Abstract Background We aimed to describe the frequency, risk factors, and costs attributable to drug–drug interactions (DDIs) among an aging French HIV population. Methods We conducted a retrospective cohort study using French nationwide health care e-records: the SNIIRAM database. People living with HIV (PLWH) aged &gt;65 years and receiving combined antiretroviral treatment (cART) during 2016 were included. A DDI was defined as “These drugs should not be co-administered,” represented by a red symbol on the University of Liverpool website. Attributable DDIs’ cost was defined as the difference between individuals with and without DDIs regarding all reimbursed health care acts. Results Overall, 9076 PLWH met the study criteria. Their baseline characteristics were: mean age, 71.3 ± 4.9 years; 25% female; median HIV duration (interquartile range [IQR]), 16.2 (9.5–20.3) years; median comorbidities (IQR), 2 (1–3). During 2016, they received a median (IQR) of 14 (9–21) comedications (non-cART), and 1529 individuals had at least 1 DDI (16.8%; 95% confidence interval [CI], 16.1–17.6). In multivariate analysis, raltegravir or dolutegravir plus 2 nucleoside reverse-transcriptase inhibitors (NRTIs) significantly and independently reduced the risk of DDIs (adjusted odds ratio [aOR], 0.02; 95% CI, 0.005–0.050; P &lt; .0001) compared with non-nucleoside reverse-transcriptase inhibitor plus 2 NRTIs, whereas cART with boosted agents (protease inhibitors or elvitegravir) significantly increased the risk (aOR, 4.12; 95% CI, 3.34–5.10; P &lt; .0001). Compared with propensity score–matched PLWH without DDIs, the presence of DDIs was associated with a $2693 additional cost per year (P &lt; .0001). Conclusions The presence of DDIs is frequent and significantly increases health care costs in the aging population of PLWH.

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