Impact of Medication Adherence on Virologic Failure in A5202: A Randomized, Partially Blinded, Phase 3B Study.
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SUBMITTER: Parker RA
PROVIDER: S-EPMC5434358 | biostudies-literature | 2017 Jun
REPOSITORIES: biostudies-literature
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Impact of Medication Adherence on Virologic Failure in A5202: A Randomized, Partially Blinded, Phase 3B Study.
Parker Robert A RA Rabideau Dustin J DJ Sax Paul E PE Tierney Camlin C Daar Eric S ES Collier Ann C AC Losina Elena E Freedberg Kenneth A KA
Clinical infectious diseases : an official publication of the Infectious Diseases Society of America 20170601 11
In AIDS Clinical Trials Group A5202, participants who reported missing their medication within the past month or not providing adherence reports at both 8 and 24 weeks had 5 times the hazard of virological failure compared to more adherent participants. Adherence interventions should focus on such patients. ...[more]
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Project description:To determine medication use and adherence among community-dwelling patients with heart failure (HF).Residents of Olmsted County, Minnesota, with HF were recruited from October 10, 2007, through February 25, 2009. Pharmacy records were obtained for the 6 months after enrollment. Medication adherence was measured by the proportion of days covered (PDC). A PDC of less than 80% was classified as poor adherence. Factors associated with medication adherence were investigated.Among the 209 study patients with HF, 123 (59%) were male, and the mean ± SD age was 73.7 ± 13.5 years. The median (interquartile range) number of unique medications filled during the 6-month study period was 11 (8-17). Patients with a documented medication allergy were excluded from eligibility for medication use within that medication class. Most patients received conventional HF therapy: 70% (147/209) were treated with ?-blockers and 75% (149/200) with angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers. Most patients (62%; 127/205) also took statins. After exclusion of patients with missing dosage information, the proportion of those with poor adherence was 19% (27/140), 19% (28/144), and 13% (16/121) for ?-blockers, angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers, and statins, respectively. Self-reported data indicated that those with poor adherence experienced more cost-related medication issues. For example, those who adhered poorly to statin therapy more frequently reported stopping a prescription because of cost than those with good adherence (46% vs 6%; P < .001), skipping doses to save money (23% vs 3%; P = .03), and not filling a new prescription because of cost (46% vs 6%; P < .001).Community-dwelling patients with HF take a large number of medications. Medication adherence was suboptimal in many patients, often because of cost.
| S-EPMC3068886 | biostudies-other
Project description:AimsHealth insurance claims (HIC) databases in the Netherlands capture unselected patient populations, which makes them suitable for epidemiological research on sex differences. Based on a HIC database, we aimed to reveal sex differences in heart failure (HF) outcomes, with particular focus on co-morbidities and medication.Methods and resultsThe Achmea HIC database included 14 517 men and 11 259 (45%) women with a diagnosis treatment code for chronic HF by January 2015. We related their sex, co-morbidities, and medication adherence (medication possession rate >0.8) with the primary endpoint (PE) of all-cause mortality or HF admission during a median follow-up of 3.3 years, using Cox regression. Median age of men and women was 72 and 76 years, respectively. Prevalence of co-morbidities and use of disease-modifying drugs was higher in men; however, medication adherence was similar. At the end of follow-up, 35.1% men and 31.8% women had reached the PE. The adjusted hazard ratio for men was 1.25 (95% confidence interval: 1.19-1.30). A broad range of co-morbidities was associated with the PE. Overall, these associations were stronger in women than in men, particularly for renal insufficiency, chronic obstructive pulmonary disease/asthma, and diabetes. Non-adherence to disease-modifying drugs was related with a higher incidence of the PE, with similar effects between sexes.ConclusionsIn a representative sample of the Dutch population, as captured in a HIC database, men with chronic HF had a 25% higher incidence of death or HF admission than women. The impact of co-morbidities on the outcome was sex dependent, while medication adherence was not.
| S-EPMC7835621 | biostudies-literature
Project description:BackgroundAdolescents living with human immunodeficiency virus (HIV) die owing to acquired immune deficiency syndrome (AIDS)-related causes more than adults. Although viral suppression protects people living with HIV from AIDS-related illnesses, little is known about viral outcomes of adolescents in sub-Saharan Africa where the biggest burden of deaths is experienced. This study aimed to identify the factors associated with viral load suppression among HIV-positive adolescents (10-19 years) receiving antiretroviral therapy (ART) in Uganda.MethodsWe conducted a cross-sectional study among school-going, HIV-positive adolescents on ART from August to September 2016. We recruited 238 adolescents who underwent ART at a public health facility and had at least one viral load result recorded in their medical records since 2015. We collected the data of patients' demographics and treatment- and clinic-related factors using existing medical records and questionnaire-guided face-to-face interviews. For outcome variables, we defined viral suppression as < 1000 copies/mL. We used multivariate logistic regression to determine factors associated with viral suppression.ResultsWe analyzed the data of 200 adolescents meeting the inclusion criteria. Viral suppression was high among adolescents with good adherence > 95% (adjusted odds ratio [AOR] 2.73, 95% confidence interval [95% CI, 1.09 to 6.82). However, 71% of all adolescents who did not achieve viral suppression were also sufficiently adherent (adherence > 95%). Regardless of adherence status, other risk factors for viral suppression at the multivariate level included having a history of treatment failure (AOR 0.26, 95% CI, 0.09 to 0.77), religion (being Anglican [AOR 0.19, 95% CI, 0.06 to 0.62] or Muslim [AOR 0.17, 95% CI, 0.05 to 0.55]), and having been prayed for (AOR 0.38, 95% CI, 0.15 to 0.96).ConclusionMore than 70% of adolescents who experienced virologic failure were sufficiently adherent (adherence > 95). Adolescents who had unsuppressed viral loads in their initial viral load were more likely to experience virologic failure upon a repeat viral load regardless of their adherence level or change of regimen. The study also shows that strong religious beliefs exist among adolescents. Healthcare provider training in psychological counseling, regular and strict monitoring of adolescent outcomes should be prioritized to facilitate early identification and management of drug resistance through timely switching of treatment regimens to more robust combinations.
| S-EPMC6337787 | biostudies-literature
Project description:BACKGROUND:Optimal antiretroviral therapy (ART) effectiveness depends on medication adherence, which is a complex behavior with many contributing factors, including neurocognitive function. Pharmacy refill records offer a promising and practical tool to assess adherence. METHODS:A substudy of the CHARTER (CNS HIV Anti-Retroviral Therapy Effects Research) study was conducted at the Johns Hopkins University (JHU) and the University of Washington. Pharmacy refill records were the primary method to measure ART adherence, indexed to a "sentinel" drug with the highest central nervous system penetration-effectiveness score. Standardized neuromedical, neuropsychological, psychiatric, and substance use assessments were performed at enrollment and at 6 months. Regression models were used to determine factors associated with adherence and relationships between adherence and changes in plasma and cerebrospinal fluid HIV RNA concentrations between visits. RESULTS:Among 80 (33 at JHU and 47 at University of Washington) participants, the mean adherence score was 86.4%, with no difference between sites. In the final multivariable model, better neurocognitive function was associated with better adherence, especially among participants who were at JHU, male, and HIV infected for a longer period of time. Worse performance in working memory tests was associated with worse adherence. Better adherence predicted greater decreases in cerebrospinal fluid HIV RNA between visits. CONCLUSIONS:Poorer global neurocognitive functioning and deficits in working memory were associated with lower adherence defined by a pharmacy refill record measure, suggesting that assessments of cognitive function, and working memory in particular, may identify patients at risk for poor ART adherence who would benefit from adherence support.
| S-EPMC3906725 | biostudies-literature
Project description:There is no consensus on a gold standard for monitoring adherence to antiretroviral therapy (ART). We compared different adherence monitoring tools in predicting virologic failure as part of a clinical trial. HIV-infected Thai and Cambodian children aged 1-12 years (N=207) were randomized to immediate-ART or deferred-ART until CD4% <15%. Virologic failure (VF) was defined as HIV-RNA >1000 copies/mL after ?6 months of ART. Adherence monitoring tools were: (1) announced pill count, (2) PACTG adherence questionnaire (form completed by caregivers), and (3) child self-report (self-reporting from children or caregivers to direct questioning by investigators during the clinic visit) of any missed doses in the last 3 days and in the period since the last visit. The Kappa statistic was used to describe agreement between each tool. The median age at ART initiation was 7 years with median CD4% 17% and HIV-RNA 5.0?log(10)copies/mL and 92% received zidovudine/lamivudine/nevirapine. Over 144 weeks, 13% had VF. Mean adherence by announced pill count before VF in VF children was 92% compared to 98% in children without VF (p=0.03). Kappa statistics indicated slight to fair agreement between tools. In multivariate analysis adjusting for gender, treatment arm ethnicity and caregiver education, significant predictors of VF were poor adherence by announced pill count (OR 4.56; 95%CI 1.78-11.69), reporting any barrier to adherence in the PACTG adherence questionnaire (OR 7.08; 95%CI 2.42-20.73), and reporting a missed dose in the 24 weeks since the last HIV-RNA assessment (OR 8.64; 95%CI 1.96-38.04). In conclusion, we recommend the child self-report of any missed doses since last visit for use in HIV research and in routine care settings, because it is easy and quick to administer and a strong association with development of VF.
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Project description:BackgroundOver the last 20 years, there have been marked improvements in the availability of effective medications for rheumatic conditions such as gout, osteoporosis and rheumatoid arthritis (RA), which have led to a reduction in disease flares and the risk of re-fracture in osteoporosis, and the slowing of disease progression in RA. However, medication adherence remains suboptimal, as treatment regimens can be complex and difficult to continue long term. Many trials have been conducted to improve adherence to medication. Core domains, which are the outcomes of most relevance to patients and clinicians, are a pivotal component of any trial. These core domains should be measured consistently, so that all relevant trials can be combined in systematic reviews and meta-analyses to reach conclusions that are more valid. Failure to do this severely limits the potential for trial-based evidence to inform decisions on how to support medication adherence. The Outcome Measures in Rheumatology (OMERACT) - Interventions for Medication Adherence study by the OMERACT-Adherence Group aims to develop a core domain set for interventions that aim to support medication adherence in rheumatology.Methods/designThis OMERACT-Adherence study has five phases: (1) a systematic review to identify outcome domains that have been reported in interventions focused on supporting medication adherence in rheumatology; (2) semi-structured stakeholder interviews with patients and caregivers to determine their views on the core domains; (3) focus groups using the nominal group technique with patients and caregivers to identify and rank domains that are relevant to them, including the reasons for their choices; (4) an international three-round modified Delphi survey involving patients with diverse rheumatic conditions, caregivers, health professionals, researchers and other stakeholders to develop a preliminary core domain set; and (5) a stakeholder workshop with OMERACT members to review, vote on and reach a consensus on the core domain set for interventions to support medication adherence in rheumatology.DiscussionEstablishing a core domain set to be reported in all intervention studies undertaken to support patients with medication adherence will enhance the relevance and the impact of these results and improve the lives of people with rheumatic conditions.
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Project description:To explore a potential role for spirituality in medication-related needs assessment for integrated care in chronically ill populations.A systematic literature review was conducted to explore the impact of faith beliefs on health and/or medication adherence in individuals with depression and/or HIV+/AIDS. Retrospective electronic medical record review of adult HIV+ patients of an urban primary care clinic with integrated mental health services was conducted, with Substance Abuse and Mental Illness Symptoms Screener (SAMISS), major depressive disorder (MDD) incidence over the preceding year, and history of contact with a spiritual advisor. A convenience sample was interviewed to qualitatively assess potential medication therapy management needs and medication-related problems. Another sample was examined utilizing the Daily Spiritual Experience Scale.The literature reports positive influence on health behaviors, coping and outcomes; and poor medication adherence and treatment decisions due to patient passivity or resistance. Spiritual advisor contact (not limited to a specific religion) was significantly associated with MDD absence (1.7% vs. 15.3%, P<0.005) and inversely related to SAMISS, depression, and poor health behaviors. Patient interviews reflected significance of faith in terms of insight and acceptance of illness, the role or need for medications, coping, and medication adherence. An illustrative model was designed based on the literature and data collection.Spiritual assessment may help identify positive or negative influence on health. Spiritual interventions could be beneficial in promoting adherence and positive health outcomes. Further research is recommended.
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Project description:BACKGROUND:Medication adherence improves outcomes for patients with heart failure, but adherence rates remain low. We examined the association between earlier postdischarge follow-up and medication adherence. METHODS AND RESULTS:We performed a retrospective cohort study of patients ?65 years who were hospitalized for heart failure, covered by Medicare Part D, and discharged alive from April 2006 to October 2012 using the Get With The Guidelines-Heart Failure Registry linked to Medicare claims. Patients were categorized into 4 groups by timing of first postdischarge follow-up visit: ?1, 1 to 2, 2 to 6, and >6 weeks. Medication adherence was defined by proportion of days covered of >80% at 90 days and 1-year posthospital discharge to 5 guideline-directed medical therapies (angiotensin-converting enzyme inhibitor/angiotensin receptor blocker, evidence-based ?-blocker, aldosterone antagonist, hydralazine/isosorbide dinitrate, and anticoagulation for atrial fibrillation). Among 9878 patients with heart failure, 73% had left ventricular ejection fraction ?40%, median age was 78 years (25th-75th percentile, 71-84), and 48% were male. Overall, 30% had a follow-up appointment within 1-week postdischarge and 25% >6 weeks. At 1 year, medication adherence was 53% for evidence-based ?-blockers, 48% for angiotensin-converting enzyme inhibitors/angiotensin receptor blockers, and 8% for hydralazine/isosorbide dinitrate. We found no significant association between timing of first follow-up visit and medication adherence at 1 year (1.04, 0.92-1.17) when comparing follow-up visits >6 weeks to the earliest ones. CONCLUSIONS:Posthospital heart failure discharge, overall adherence to medical therapies in Medicare beneficiaries was low. Early follow-up was not associated with increased medication adherence to guideline-directed medical therapy in the short or long term.
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Project description:ObjectiveTo evaluate associations between hair antiretroviral hair concentrations as an objective, cumulative adherence metric, with self-reported adherence and virologic outcomes.DesignAnalysis of cohort A of the ACTG-A5288 study. These patients in resource-limited settings were failing second-line protease inhibitor-based antiretroviral therapy (ART) but were susceptible to at least one nucleoside reverse transcriptase inhibitor (NRTI) and their protease inhibitor, and continued taking their protease inhibitor-based regimen.MethodsAntiretroviral hair concentrations in participants taking two NRTIs with boosted atazanavir (n = 69) or lopinavir (n = 112) were analyzed at weeks 12, 24, 36 and 48 using liquid-chromatography--tandem-mass-spectrometry assays. Participants' self-reported percentage of doses taken in the previous month; virologic failure was confirmed HIV-1 RNA at least 1000 copies/ml at week 24 or 48.ResultsFrom 181 participants with hair samples (61% women, median age: 39 years; CD4+ cell count: 167 cells/μl; HIV-1 RNA: 18 648 copies/ml), 91 (50%) experienced virologic failure at either visit. At 24 weeks, median hair concentrations were 2.95 [interquartile range (IQR) 0.49-4.60] ng/mg for atazanavir, 2.64 (IQR 0.73--7.16) for lopinavir, and 0.44 (IQR 0.11--0.76) for ritonavir. Plasma HIV-1 RNA demonstrated inverse correlations with hair levels (rs -0.46 to -0.74) at weeks 24 and 48. Weaker associations were seen with self-reported adherence (rs -0.03 to -0.24). Decreasing hair concentrations were significantly associated with virologic failure, the hazard ratio (95% CI) for ATV, LPV, and RTV were 0.69 (0.56-0.86), 0.77 (0.68-0.87), and 0.12 (0.06-0.27), respectively.ConclusionProtease inhibitor hair concentrations showed stronger associations with subsequent virologic outcomes than self-reported adherence in this cohort. Hair adherence measures could identify individuals at risk of second-line treatment failure in need of interventions.
| S-EPMC8243835 | biostudies-literature
Project description:PurposeTo assess possible changes in medication adherence to prostaglandin analog (PGA) regimens among patients with open-angle glaucoma (OAG) after the initial introduction of generic PGAs.DesignLongitudinal cohort analysis.ParticipantsPatients older than 40 years with OAG continuously enrolled in a nationwide managed-care network during 2009-2012 who used PGAs.MethodsMean adherence rates were calculated for topical PGA use during the 18 months before the introduction of generic latanoprost (September 2009-February 2011) and the 18 months after generic latanoprost became available (July 2011-December 2012). The rates were compared between persons who continued to use brand-name PGAs once generic latanoprost became available and others who switched to generic latanoprost. Multivariable logistic regression identified variables associated with an improvement or worsening of adherence of ≥25%.Main outcome measuresMean adherence rates and odds of 25% or more improved or worsened adherence (with 95% confidence intervals [CIs]).ResultsA total of 8427 patients met the study eligibility criteria. Compared with persons switching to generic latanoprost, patients who continued taking brand name PGAs were 28% less likely to have improved adherence (odds ratio [OR], 0.72; 95% CI, 0.55-0.94) and 39% more likely to have reduced adherence (OR, 1.39; 1.04-1.86) of ≥25%. Improved adherence after the generic drug's introduction was also associated with higher monthly medication copay in the pregeneric period (P = 0.02), lower copay after introduction of the generic drug (P < 0.0001), and black race (OR, 1.25; 95% CI, 1.04-1.50). Six-hundred twelve patients (7.3%) discontinued all antiglaucoma interventions when generic latanoprost became available.ConclusionsGiven that cost can significantly deter adherence, switching patients to generic medications may help improve patients' drug-regimen adherence. A considerable number of patients discontinued glaucoma drug use altogether when generic latanoprost became available. Ophthalmologists should work with insurers and pharmacists to prevent such discontinuation of use as generic forms of other PGA agents become available.
| S-EPMC4518849 | biostudies-literature