Brief Report: Virologic Monitoring Can Be a Cost-Effective Strategy to Diagnose Treatment Failure on First-Line ART.
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ABSTRACT:
SUBMITTER: Vandormael AM
PROVIDER: S-EPMC4767659 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Electrographic status epilepticus (ESE) in critically ill children is associated with unfavorable functional outcomes, but identifying candidates for ESE management requires resource-intense EEG monitoring. A cost-effectiveness analysis was performed to estimate how much ESE identification and management would need to improve patient outcomes to make EEG monitoring strategies a good value.A decision tree was created to examine the relationships among variables important to deciding whether to perform EEG monitoring. Variable costs were estimated from their component parts, outcomes were estimated in quality-adjusted life-years, and incremental cost-effectiveness ratios were calculated to compare the relative values using four alternative EEG monitoring strategies that varied by monitoring duration.Forty-eight hours of EEG monitoring would be worth its cost if ESE identification and management improved patient outcomes by ?7%. If ESE identification and management improved patient outcomes by 3% to 6%, then 24 or 48 hours of EEG monitoring would be worth the cost depending on how much decision makers were willing to pay per quality-adjusted life-year gained. If ESE identification and management improved outcomes by as little as 3%, then 24 hours of EEG monitoring would be worth the cost.EEG monitoring has the potential to be cost-effective if ESE identification and management improves patient outcomes by as little as 3%.
| S-EPMC4668222 | biostudies-literature
Project description:Background:Viral load (VL) monitoring is standard of care in HIV-infected persons initiated on antiretroviral therapy (ART). We evaluated the predictive value of VL measurements at 6 and 12 months after initiation of firstline ART to estimate the future risk of virologic failure (VF). Methods:HIV-infected persons with VL measurements at 6 and 12 months post-ART initiation and at least 2 additional VL measurements thereafter were assessed for risk of future VF, defined per World Health Organization guidelines. VL at 6 or 12 months post-ART was categorized into <400, 400-1000, 1001-2000, and >2000 copies/mL. Cox proportional hazard models were used to compare VF incidence associated with 6-month, 12-month, and a composite of 6- and 12-month VL prediction indicators. Results:Overall, 1863 HIV-infected adults had a 6- and 12-month VL measurement, and 1588 had at least 2 additional VLs thereafter for predicting future VF. The majority (67%) were female (median age: females 33 years and males 37 years). At 12 months post-ART, 90% had VL<400 copies/mL (cumulative incidence of VF at 1.5%), 3% had 400-1000 copies/mL (VF 12%), 2% had 1001-2000 copies/mL (VF 22%), and 5% had >2000 copies/mL (VF 71%). The predictive value of the 12-month VL measurement was comparable to the composite of both the 6- and 12-month VL measurements and better than the 6-month VL measurement. Conclusions:At 12 months after ART initiation, 90% of patients were virally suppressed with a low likelihood of future VF. VL measurement at 12 months post-ART initiation predicts risk of VF and could inform differentiated virologic monitoring strategies.
| S-EPMC6176337 | biostudies-literature
Project description:OBJECTIVES:To assess the cost-effectiveness of frequently used monitoring strategies for vestibular schwannoma (VS). DESIGN:A state transition model was developed to compare six monitoring strategies for patients with VS: lifelong annual monitoring; annual monitoring for the first 10 years after diagnosis; scanning at 1-5, 7, 9, 12, 15 years after diagnosis and subsequently every 5 years; a personalised monitoring strategy for small and large tumours; scanning at 1, 2 and 5 years after diagnosis and no monitoring. Input data were derived from literature and expert opinion. Quality-adjusted life years (QALYs) and healthcare costs of each strategy were modelled over lifetime. Net monetary benefits (NMBs) were calculated to determine which strategy provided most value for money. Sensitivity analyses were performed to address uncertainty. RESULTS:Omitting monitoring is least effective with 18.23 (95% CI 16.84-19.37) QALYs per patient, and lifelong annual monitoring is most effective with 18.66 (95% CI 17.42-19.65) QALYs. Corresponding costs were €6526 (95% CI 5923-7058) and €9429 (95% CI 9197-9643) per patient, respectively. Lifelong annual monitoring provided the best value with a NMB of €363 765 (339 040-383 697), but the overall probability of being most cost-effective compared to the other strategies was still only 23%. Sensitivity analysis shows that there is large uncertainty in the effectiveness of all strategies, with largely overlapping 95% confidence intervals for all strategies. CONCLUSIONS:Due to the largely overlapping 95% confidence intervals of all monitoring strategies for VS, it is unclear which monitoring strategy provides most value for money at this moment.
| S-EPMC6850121 | biostudies-literature
Project description:BACKGROUND:Residual systemic inflammation persists despite suppressive antiretroviral therapy (ART) and is associated with non-AIDS clinical outcomes. We aimed to evaluate the association between ART adherence and inflammation in Ugandans living with HIV who were predominantly receiving nevirapine-based ART with a thymidine analog backbone and were virologically suppressed by conventional assays. METHODS:Plasma concentrations of interleukin-6 (IL-6), D-dimer, soluble (s)CD14, sCD163, and the kynurenine/tryptophan ratio, in addition to CD8 T-cell activation, were measured at baseline and 6 months after ART initiation in treatment-naive adults who achieved an undetectable plasma HIV RNA (<400 copies/mL) at their 6-month visit. Adherence was measured through medication event monitoring system and calculated as the ratio of observed/prescribed device openings per participant. We fit adjusted linear regression models to estimate the association between ART adherence and the log-transformed plasma concentrations of inflammatory biomarkers. RESULTS:We evaluated 282 participants (median age, 35 years; 70% women). The median (interquartile range) adherence was 93% (84-98). In the adjusted analyses, for every 10% increase in average ART adherence, we found a 15% [P < 0.0001; 95% confidence interval (CI), -21.0 to -7.9], 11% (P = 0.017; 95% CI, -18.3 to -2.0), and 3% (P = 0.028; 95% CI, -5.0 to -0.3) decrease in IL-6, D-dimer, and sCD14, respectively. CONCLUSIONS:Higher ART adherence was associated with lower levels of biomarkers of inflammation, immune activation, and coagulopathy among Ugandans living with HIV who achieved viral suppression shortly after ART initiation. This suggests that ART adherence could have biological consequences beyond viral suppression. Whether ART adherence optimization in virologically suppressed individuals could reduce residual inflammation remains unknown.
| S-EPMC5844840 | biostudies-literature
Project description:IntroductionThe "greying" of the HIV epidemic necessitates a better understanding of the healthcare needs of older HIV-positive adults. As these individuals age, it is unclear whether comorbidities and their associated therapies or the ageing process itself alter the response to antiretroviral therapy (ART). In this study, HIV treatment outcomes and corresponding risk factors were compared between older ART initiators and those who were younger using data from the Caribbean, Central and South America Network for HIV Epidemiology (CCASAnet).MethodsHIV-positive adults (?18 years) initiating ART at nine sites in Argentina, Brazil, Chile, Haiti, Honduras, Mexico and Peru were included. Patients were classified as older (?50 years) or younger (<50 years) based on age at ART initiation. ART effectiveness was measured using three outcomes: death, virologic failure and ART treatment modification. Cox regression models for each outcome compared risk between older and younger patients, adjusting for other covariates.ResultsAmong 26,311 patients initiating ART between 1996 and 2016, 3389 (13%) were ?50 years. The majority of patients in both ?50 and <50 age groups received a non-nucleoside reverse transcriptase inhibitor-based regimen (89% vs. 87%), did not have AIDS at baseline (63% vs. 62%), and were male (59% vs. 58%). Older patients had a higher risk of death (adjusted hazard ratio (aHR) 1.64; 95% confidence intervals (CI): 1.48 to 1.83) and a lower risk of virologic failure (aHR: 0.73; 95% CI: 0.63 to 0.84). There was no difference in risk of ART modification (aHR: 1.00; 95% CI: 0.94 to 1.06). Risk factors for death, virologic failure and treatment modification were similar for each group.ConclusionsOlder age at ART initiation was associated with increased mortality and decreased risk of virologic failure in our cohort of more than 26,000 ART initiators in Latin America and the Caribbean. To the best of our knowledge this is the first study from the region to evaluate ART outcomes in this growing and important population. Given the complexity of issues related to ageing with HIV, a greater understanding is needed in order to properly respond to this shifting epidemic.
| S-EPMC5864576 | biostudies-literature
Project description:ObjectiveTo determine whether brief interventions promoting physical activity are cost-effective in primary care or community settings.DesignSystematic review of economic evaluations.Methods and data sourcesWe searched MEDLINE, EMBASE, PsycINFO, CINAHL, EconLit, SPORTDiscus, PEDro, the Cochrane library, National Health Service Economic Evaluation Database and the Cost-Effectiveness Analysis Registry up to 20 August 2014. Web of Knowledge was used for cross-reference search. We included studies investigating the cost-effectiveness of brief interventions, as defined by National Institute for Health and Care Excellence, promoting physical activity in primary care or the community. Methodological quality was assessed using Drummond's checklist for economic evaluations. Data were extracted from individual studies fulfilling selection criteria using a standardised pro forma. Comparisons of cost-effectiveness and cost-utility ratios were made between studies.ResultsOf 1840 identified publications, 13 studies fulfilled the inclusion criteria describing 14 brief interventions. Studies varied widely in the methods used, such as the perspective of economic analysis, intervention effects and outcome measures. The incremental cost of moving an inactive person to an active state, estimated for eight studies, ranged from £96 to £986. The cost-utility was estimated in nine studies compared with usual care and varied from £57 to £14?002 per quality-adjusted life year; dominant to £6500 per disability-adjusted life year; and £15?873 per life years gained.ConclusionsBrief interventions promoting physical activity in primary care and the community are likely to be inexpensive compared with usual care. Given the commonly accepted thresholds, they appear to be cost-effective on the whole, although there is notable variation between studies.
| S-EPMC4819643 | biostudies-literature
Project description:BackgroundInterventions based around objective measurement of adherence to antiretroviral drugs for HIV have potential to improve adherence and to enable differentiation of care such that clinical visits are reduced in those with high adherence. It would be useful to understand the approximate upper limit of cost that could be considered for such interventions of a given effectiveness in order to be cost effective. Such information can guide whether to implement an intervention in the light of a trial showing a certain effectiveness and cost.MethodsAn individual-based model, calibrated to Zimbabwe, which incorporates effects of adherence and resistance to antiretroviral therapy, was used to model the potential impact of adherence monitoring-based interventions on viral suppression, death rates, disability adjusted life years and costs. Potential component effects of the intervention were: enhanced average adherence when on ART, reduced risk of ART discontinuation, and reduced risk of resistance acquisition. We considered a situation in which viral load monitoring is not available and one in which it is. In the former case, it was assumed that care would be differentiated based on the adherence level, with fewer clinic visits in those demonstrated to have high adherence. In the latter case, care was assumed to be primarily differentiated according to viral load level. The maximum intervention cost required to be cost effective was calculated based on a cost effectiveness threshold of $500 per DALY averted.FindingsIn the absence of viral load monitoring, an adherence monitoring-based intervention which results in a durable 6% increase in the proportion of ART experienced people with viral load < 1000 cps/mL was cost effective if it cost up to $50 per person-year on ART, mainly driven by the cost savings of differentiation of care. In the presence of viral load monitoring availability, an intervention with a similar effect on viral load suppression was cost-effective when costing $23-$32 per year, depending on whether the adherence intervention is used to reduce the level of need for viral load measurement.ConclusionThe cost thresholds identified suggest that there is clear scope for adherence monitoring-based interventions to provide net population health gain, with potential cost-effective use in situations where viral load monitoring is or is not available. Our results guide the implementation of future adherence monitoring interventions found in randomized trials to have health benefit.
| S-EPMC5157976 | biostudies-literature
Project description:IntroductionWhen protease inhibitor (PI)-based second-line ART fails, guidelines recommend drug resistance testing and individualized third-line treatment. However, PI-resistant viral strains are rare and drug resistance testing is costly. We investigated whether less costly PI-exposure testing can be used to select those patients who would benefit most from drug resistance testing.MethodsWe performed a retrospective analysis of South African adults living with HIV experiencing failure of ritonavir-boosted-lopinavir (LPV/r)-based second-line ART for whom drug resistance testing results were available. We included patients who received plasma-based drug resistance testing at a central South African reference laboratory in 2017 and patients who received dried blood spots (DBS)-based drug resistance testing at a rural South African clinic between 2009 and 2017. PI-exposure testing was performed on remnant plasma or DBS using liquid chromatography mass spectrometry (LCMS). Additionally, a low-cost immunoassay was used on plasma. Population genotypic drug resistance testing of the pol region was performed on plasma and DBS using standard clinical protocols.ResultsSamples from 544 patients (494 plasma samples and 50 DBS) were included. Median age was 41.0 years (IQR: 33.3 to 48.5) and 58.6% were women. Median HIV-RNA load was 4.9 log10 copies/mL (4.3 to 5.4). Prevalence of resistance to the NRTI-backbone was 70.6% (349/494) in plasma samples and 56.0% (28/50) in DBS. Major PI-resistance mutations conferring high-level resistance to LPV/r were observed in 26.7% (132/494) of plasma samples and 12% (6/50) of DBS. PI-exposure testing revealed undetectable LPV levels in 47.0% (232/494) of plasma samples and in 60.0% (30/50) of DBS. In pooled analysis of plasma and DBS samples, detectable LPV levels had a sensitivity of 90% (84% to 94%) and a negative predictive failure of 95% (91% to 97%) for the presence of major LPV/r resistance.ConclusionsPI-exposure testing revealed non-adherence in half of patients experiencing failure on second-line ART and accurately predicted the presence or absence of clinically relevant PI resistance. PI-exposure testing constitutes a novel screening strategy in patients with virological failure of ART that can differentiate between different underlying causes of therapy failure and may allow for more effective use of limited resources available for drug resistance testing.
| S-EPMC7282495 | biostudies-literature
Project description:BackgroundContemporary data on the immunologic, haematologic and virologic responses and predictors of virologic failure after initiation of free antiretroviral treatment in Cameroon are needed to evaluate the current treatment-monitoring algorithm and to complement efforts to scale-up and improve on the management of HIV infections.MethodsThis was a cross-sectional study conducted between October 2010 and June 2012. A total of 951 participants aged 18-74 years were recruited from selected approved HIV treatment centres of the Northwest and Southwest regions. This comprised 247 males and 704 females. Demographic, self-reported risk behaviours and socioeconomic data were obtained using a structured questionnaire. Full blood and CD4 + T-cell counts were done using standard automated techniques. Determination of viral load (VL) was done using Abbott RealTime HIV-1 m2000™ system. Data was analysed using SPSS version 17. The statistical significance level was P < 0.05.ResultsThe median duration of antiretroviral therapy (ART) was 24 months. The population mean CD4 + T-cell count was 255.3 cells/μL [95% CI, 236.8 - 273.9]. Overall, 45.9%, 43.8% and 10.2% of the participants had CD4 + T-cell counts of < 200 cells/μL, 200-499 cells/μL and > 500 cells/μL respectively. Anaemia was present in 26.2% of the participants with 62.3%, 25.7% and 12% described as mild, moderate and severe anaemia respectively. Virologic failure occurred in 23.2% of the participants with 12.3% having VL > 10,000 RNA copies/mL. Meanwhile 76.8% of patients attained adequate viral suppression with 40.8% having undetectable viral load. The age group 18-29 years (p = 0.024), co-infection with tuberculosis (p = 0.014), anaemia (p = 0.028) and distance from the treatment centre (p = 0.011) independently predicted virologic failure.ConclusionThe majority of the participants achieved adequate viral suppression after ≥ 6 months of ART. Despite these favourable immuno-haematologic and virologic outcomes, the National AIDS Control Program should step-up efforts to improve on antiretroviral drug distribution, as well as proper assessment and management of anaemia, foster early diagnosis and treatment of tuberculosis and enhance treatment adherence counselling especially in younger patients.
| S-EPMC3922096 | biostudies-literature
Project description:Background: Identifying pre-ART factors associated with the emergence of HIV-1 drug resistance is critical for optimizing strategies to prevent virologic failure. A previous study reported that lower pre-ART HIV-1 pol diversity was associated with higher risk of virologic failure in HIV-1-infected children. To investigate this association in adults, we measured HIV-1 diversity with deep sequencing in pre-ART samples from adults with well-characterized virologic outcomes in a study (A5142) of initial ART conducted by the AIDS Clinical Trials Group (ACTG).Methods: We identified 22 cases in ACTG A5142 who experienced virologic failure with drug resistance mutations in RT and 44 matched controls who did not experience virologic failure. cDNA was synthesized from plasma HIV-1 RNA. Each cDNA molecule was tagged with a unique primer ID and RT codons 41-103 were amplified and deep sequenced. Sequences with the same tag were aligned and a consensus was generated to reduce PCR and sequencing errors. Diversity was calculated by measuring average pairwise distance (APD) of the consensus sequences. An exact conditional logistic regression model with percent APD as the risk factor estimated the odds ratio for VF and the corresponding 95% confidence interval.Results: Consensus single-genome sequences and diversity estimates of pol were obtained for pre-ART samples from 21 cases and 42 controls. The median (IQR) pre-ART percent APD was 0.71 (0.31-1.13) in cases and 0.58 (0.32-0.94) in controls. A possible trend was found for higher diversity being associated with greater risk of virologic failure in adults (OR = 2.2 per one percent APD increase, 95% CI = [0.8, 7.2]; p = 0.15).Conclusions: This study in adults suggests there is a positive association between higher pre-ART pol diversity and the risk of virologic failure in adults rather than an inverse relationship reported in children.
| S-EPMC5784902 | biostudies-literature