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 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.)

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 Comorbidities associated with HPV and HSV infections among people living with HIV-1 in the Southeastern US: a retrospective clinical cohort study

2019 ◽  
Author(s):  
Yuanfan Ye ◽  
Greer A. Burkholder ◽  
Howard W. Wiener ◽  
Russell Griffin ◽  
Stella Aslibekyan ◽  
...  
Keyword(s):  
Large Scale ◽  
White Women ◽  
Incidence Rates ◽  
People Living With Hiv ◽  
Anogenital Warts ◽  
Gender And Race ◽  
Clinical Cohort ◽  
Southeastern Us ◽  
Living With Hiv ◽  
Hiv 1

Abstract Background The southeastern US is a domestic epicenter for incident HIV with high prevalence of human papillomavirus (HPV) and herpes simplex virus (HSV) co-infections. However, epidemics of HPV and HSV- associated clinical conditions (CC) among people living with HIV-1 infection (PLWH) are not fully known. Methods Electronic medical records (EMR) of PLWH attending one of the leading HIV clinics in the southeastern US between 2006 and 2018 were reviewed and analyzed. The retrospective study was nested within the University of Alabama at Birmingham HIV clinical cohort, which has electronically collected over 7000 PLWH’s clinical and sociobehavioral data since 1999. Incidence rates of HPV-related CC including anogenital warts, penile, anal, cervical, and vaginal/vulvar low- and high-grade squamous intraepithelial lesions (LSIL and HSIL) and HSV- related CC including anogenital herpetic ulcers were estimated in per 10000 person years. Joinpoint regressions were performed to examine temporal changes in the trends of incident CC. All rates and trends were stratified by gender and race. Results Of the 4,484 PLWH eligible individuals (3,429 men, 1,031 women, and 24 transgender), we observed 1,038 and 425 patients with HPV-and HSV-related CC respectively, and 163 patients with both conditions. The mean log10 viral load (VL) was higher in all of the case groups than the non-cases with neither conditions (5.0) (whereas the median nadir CD4 counts (cells/uL) was higher in the non-cases than in any of the case groups (P<0.05). Anogenital warts, anal LSIL, HSIL, and cancer were more likely to be diagnosed among HIV-infected men than women. White men presented more frequently with anal LSIL and anal and penile cancers than black men (P<0.03). White women were also more likely to be diagnosed with cervical HSIL (P=0.023) and cancer (P=0.037) than black women By contrast, herpetic ulcers were more frequent in women than men. Conclusions There were significant differences between gender and race with incidence of HPV- and HSV-related CC among HIV patients. EMR-based studies provide insights on understudied epidemics; however, large-scale studies in other regions are needed to generalize current findings and draw public health attention to co-infection induced non-AIDS defining comorbidities among PLWH.

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.

scholarly journals Comorbidities associated with HPV infection among people living with HIV-1 in the Southeastern US: a retrospective clinical cohort study

2020 ◽  
Author(s):  
Yuanfan Ye ◽  
Greer A. Burkholder ◽  
Howard W. Wiener ◽  
Russell Griffin ◽  
Stella Aslibekyan ◽  
...  
Keyword(s):  
Large Scale ◽  
White Women ◽  
Incidence Rates ◽  
People Living With Hiv ◽  
Anogenital Warts ◽  
Gender And Race ◽  
Clinical Cohort ◽  
Southeastern Us ◽  
Living With Hiv ◽  
Hiv 1

Abstract Background: The southeastern US is an epicenter for incident HIV in the US with high prevalence of human papillomavirus (HPV) co-infections. However, epidemiologies of HPV-associated clinical conditions (CC) among people living with HIV-1 infection (PLWH) are not fully known. Methods: Electronic medical records (EMR) of PLWH attending one of the leading HIV clinics in the southeastern US between 2006 and 2018 were reviewed and analyzed. The retrospective study was nested within the University of Alabama at Birmingham HIV clinical cohort, which has electronically collected over 7000 PLWH’s clinical and sociobehavioral data since 1999. Incidence rates of HPV-related CC including anogenital warts, penile, anal, cervical, and vaginal/vulvar low- and high-grade squamous intraepithelial lesions (LSIL and HSIL) were estimated per 10000 person years. Joinpoint regressions were performed to examine temporal changes in the trends of incident CC. All rates and trends were stratified by gender and race. Results: Of the 4,484 PLWH included in the study (3,429 men, 1,031 women, and 24 transgender), we observed 1,038 patients with HPV-related CC. The median nadir CD4 count (cells/uL) was higher in the HPV-condition free group than the case groups (P<0.0001). Anogenital warts, anal LSIL, HSIL, and cancer were more likely to be diagnosed among HIV-infected men than women. White men presented more frequently with anal LSIL and anal and penile cancers than black men (P<0.03). White women were also more likely to be diagnosed with cervical HSIL (P=0.023) and cancer (P=0.037) than black women Conclusions: There were significant differences between gender and race with incidence of HPV-related CC among HIV patients. EMR-based studies provide insights on understudied HPV-related anogenital conditions in PLWH; however, large-scale studies in other regions are needed to generalize current findings and draw public health attention to co-infection induced non-AIDS defining comorbidities among PLWH.

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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