Multi-tablet Regimens Research Articles

Health care resource utilization and costs for treatment-experienced people with HIV switching or restarting antiretroviral regimens since 2018.

There is a need to understand health care resource utilization (HCRU) and costs associated with treatment-experienced people with HIV (PWH) switching treatment regimens. To describe HCRU and cost during lines of antiretroviral therapy (ART) for treatment-experienced PWH switching to or restarting guideline-recommended, integrase strand transfer inhibitor (INSTI)-based multitablet regimens and single-tablet regimens. This retrospective claims study used data from Optum Research Database (January 1, 2010, to March 31, 2020) to identify lines of therapy (LOTs) for treatment-experienced adults who switched to or restarted INSTI-based regimens between January 1, 2018, and December 31, 2019. The first LOT during the study period was included in the analysis. We examined all-cause HCRU and costs and HIV-related HCRU and combined costs to the health plan and direct patient costs by site of service and compared between INSTI-based regimens: bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (single tablet) vs dolutegravir/abacavir/lamivudine (DTG/ABC/3TC) (single tablet), dolutegravir + emtricitabine/tenofovir alafenamide (DTG+FTC/TAF) (multitablet), and dolutegravir + emtricitabine/tenofovir disoproxil fumarate (DTG+FTC/TDF) (multitablet). Analysis of HCRU by site of service was conducted following inverse probability treatment weighting. Multivariable regression was conducted using a generalized linear model with stepwise covariate selection to estimate HIV-related medical costs and control for remaining differences after inverse probability treatment weighting. 4,251 PWH were identified: B/F/TAF (n = 2,727; 64.2%), DTG/ABC/3TC (n = 898; 21.1%), DTG+FTC/TAF (n = 539; 12.7%), and DTG+FTC/TDF (n = 87; 2.1%). PWH treated with DTG+FTC/TAF had a significantly higher mean of all-cause ambulatory visits than PWH treated with B/F/TAF (1.8 vs 1.6, P < 0.001). A significantly smaller proportion of PWH treated with DTG/ABC/3TC had an all-cause ambulatory visit vs PWH treated with B/F/TAF (90.6% vs 93.9%, P < 0.001). All-cause total costs were not significantly different between regimens. Mean (SD) medical HIV-related costs per month during the LOT were not significantly different between B/F/TAF $699 (3,602), DTG/ABC/3TC $770 (3,469), DTG+FTC/TAF $817 (3,128), and DTG+FTC/TDF $3,570 (17,691). After further controlling for unbalanced measures, HIV-related medical costs during the LOT were higher (20%) but did not reach statistical significance for DTG/ABC/3TC (cost ratio = 1.20, 95% CI = 0.851-1.694; P = 0.299), 49% higher for DTG+FTC/TAF (cost ratio = 1.489, 95% CI = 1.018-2.179; P = 0.040), and almost 11 times greater for DTG+FTC/TDF (cost ratio = 10.759, 95% CI = 2.182-53.048; P = 0.004) compared with B/F/TAF. HIV-related medical costs during the LOT were lowest for PWH treated with INSTI-based single-tablet regimens. Simplifying treatment regimens may help PWH maintain lower health care costs.

First-line antiretroviral therapy initiation for newly diagnosed people with HIV in the Netherlands: A retrospective analysis from 2016 to 2020.

HIV treating physicians in the Netherlands follow the guidelines of the Department of Health and Human Services (DHHS). Most of these recommended initial regimens are single-tablet regimens (STRs), which incur higher costs. By the end of 2017, generic NRTI backbones had become widely available, offering a potentially cheaper multi-tablet regimen. This study aimed to evaluate guideline compliance in people with HIV who started antiretroviral therapy (ART), the uptake of generic multi-tablet regimens (gMTRs), and associated medication costs. This retrospective cohort study used data from the Dutch HIV Monitoring Foundation to determine the proportion of treatment-naïve people entering care who initiated ART according to the DHHS and type of ART regimens prescribed between January 2016 and December 2020. We analyzed ART prescriptions, both at the national level and per individual HIV treatment centers. We calculated the monthly ART costs based on Dutch medicine prices listed on www.medicijnkosten.nl for each calendar year. In 2016, an integrase inhibitor-containing regimen was initiated in 77.3% which increased to 87.8% in 2020. The compliance rate to DHHS-recommended initial regimens ranged from 82.8% in 2016 to 90.9% in 2020. Most patients received single-tablet regimens, 81.3% in 2016 to 60.3% in 2020. After the introduction the gMTRs showed a steady increase from 17.8% in 2018 to 37.8% in 2020. The cost of the first-line regimen per patient decreased by 22.9% in 2020 compared with 2017. The decrease was larger in centers where treatment-naïve individuals with HIV were preferentially initiated on a gMTR. There was a high compliance to the "DHHS-recommended initial regimens for most people with HIV" in the Netherlands. Most people who initiated ART received STRs, although the percentage of people who started on STRs gradually decreased over time. The use of gMTRs increased over time and was associated with lower medication costs.

ART-related medication errors in hospitalized people with HIV in the INSTI-era: analysis from 2 health systems in South Georgia, U.S.

ABSTRACT ART-related medication errors occur at high rates in hospitalized people with HIV (PWH), but few studies included modern regimens. As such, we evaluated ART-related medication errors in hospitalized PWH in an era where use of INSTI-based regimens dominate. This multi-center, retrospective cohort included PWH at least 18 years hospitalized in South Georgia, U.S. between March 2016 and March 2018. Of those eligible for inclusion, 400 were randomly selected and included. Three hundred sixty-three inpatient ART-related medication errors occurred in 203 patients during the study period due to incorrect scheduling (44%), an incorrect or incomplete regimen (27%), and drug–drug interactions (27%). Approximately 25% of errors persisted to discharge. Medication errors were more likely to occur in patients receiving NNRTI- or PI-containing multi-tablet regimens, whereas those receiving INSTI-containing multi-tablet regimens were less likely to experience a medication error. ART-related medication errors are less likely in patients receiving INSTI-containing multi-tablet regimens. Ensuring appropriate transition of ART throughout hospitalization remains an area in need of significant improvement.

Environmentally sustainable computationally spectrophotometric resolution strategy for analysis single-tablet regimens of antihypertension with overlapped spectra

Single tablet regimens (STRs) for hypertension suppression improve patient satisfaction, quality of life, medication and adherence compared to multi-tablet regimens (MTRs). Development of simple cost effective and at the same time green an ecofriendly method for analysis and resolution of multicomponent and complex mixtures is an increasingly important issue in the field of pharmaceutical industry in general and analytical chemistry in specific. Thus, the presented research deals with two main goals, the first one is concerned with developing and applying a fully validated resolution plan using numerical data of signals on manipulated spectra for successive extraction of parent spectra of drugs in single-tablet Regimens (STRs) used in antihypertensive treatment. The STRs contains three drugs with deconvoluted spectra, Atenolol (ATL), Amiloride (AMD) and Chlortalidone (CLN). The resolution plan encompasses two simple and affordable spectrophotometric methods employing resolving spectra either normalized spectrum (NS) or factorized spectrum (FS) which acts as a master key for unlocking the overlapped spectra of ternary mixture with no need for any preliminary physical separation, sample pretreatment or pH adjustment. These two main methods namely, dual amplitude difference (DAD) and derivative ratio transformation (DDT). The presented approaches required a simple spectrophotometer with its built-in program using primitive mathematical operations to restore the parent spectrum for individually drug cited in the mixture understudy. The proposed methods validity was checked and evaluated through the ICH guidelines and displayed linearity within concentration range 4.0-40.0μg/mL for ATL, 3.0-20.0μg/mL for both AMD and CLN. While the specificity evaluation was performed via assaying the three drugs accurately and precisely in their synthetic mixtures and in their STRs. Generally, these methods could be recruited for the fast and effective analysis and determination of the purity index for AMD, CLN and ATL in bulk materials and available market formulation, Teklo ® tablets.The second main goal of the research was the evaluation of the methods greenness and whiteness where the applied UV-methods and the reported HPLC one had significantly different greenness scores when compared using three metrics: the Green Certificate Classification (GCC), the Complex Green Analytical Procedure Index (Complex-GAPI), and the Analytical Greenness metric approach (AGREE).Also, the whiteness scores, which reflected the degree of the achieved sustainability for the HPLC reported technique and the produced UV ones were done by using the ideologies of the white analytical chemistry (WAC) tool. All the differences between the four aforementioned metrics are discussed in this study.

Patient-reported outcomes among people living with HIV on single- versus multi-tablet regimens: Data from a real-life setting.

BackgroundThe use of single-tablet regimens (STRs) in HIV treatment is ubiquitous. However, reintroducing the (generic) components as multi-tablet regimens (MTRs) could be an interesting cost-reducing strategy. It is essential to involve patient-reported outcome measures (PROs) to examine the effects of such an approach. Hence, this study compared PROs of people living with HIV taking an STR versus a MTR in a real world setting.Materials and methodsThis longitudinal study included 188 people living with HIV. 132 remained on a MTR and 56 switched to an STR. At baseline, months 1-3-6-12-18 and 24, participants filled in questionnaires on health-related quality of life (HRQoL), depressive symptoms, HIV symptoms, neurocognitive complaints (NCC), treatment satisfaction and adherence. Generalized linear mixed models and generalized estimation equations mixed models were built.ResultsClinical parameters and PROs of the two groups were comparable at baseline. Neurocognitive complaints and treatment satisfaction did differ over time among the groups. In the STR-group, the odds of having NCC increased monthly by 4,1% as compared to the MTR-group (p = 0.035). Moreover, people taking an STR were more satisfied with their treatment after 6 months: the median change score was high: 24 (IQR 7,5–29). Further, treatment satisfaction showed a contrary evolution in the groups: the estimated state score of the STR-group increased by 3,3 while it decreased by 0,2 in the MTR-group (p = 0.003). No differences over time between the groups were observed with regard to HRQoL, HIV symptoms, depressive symptoms and adherence.ConclusionsNeurocognitive complaints were more frequently reported among people on an STR versus MTR. This finding contrasts with the higher treatment satisfaction in the STR-group over time. The long-term effects of both PROs should guide the decision-making on STRs vs. (generic) MTRs.

Trends in Antiretroviral Regimen Complexity Among Medicare Beneficiaries With HIV, 2014-2018

Little is known about antiretroviral therapy (ART) patterns among Medicare beneficiaries with Human Immunodeficiency Virus (HIV). ART has significant implications for spending in Medicare Part D as use of single-tablet regimens (STR) grows, generic availability remains low, and price increases for branded therapies consistently exceed inflation. The objective of this study is to detail patterns of STR utilization among Medicare beneficiaries with HIV. We conducted a retrospective trend analysis using a 5% sample of Medicare Chronic Conditions Data Warehouse, 2014-2018. We included each person-month that fee-for-service beneficiaries with HIV had Parts A, B, and D coverage. Trends in annual prevalence of STR overall, by ART class, and by age, sex, and race subgroups were estimated. The study included 9,509 beneficiaries who contributed 345,708 person-months to the analysis. The prevalence of STR increased from 21.8% (95%CI, 21.5-22.1) in 2014 to 44.6% (95%CI, 44.3-45.0) in 2018 (p <0.0001), an increase of 104.6%. Integrase strand transfer inhibitors (INSTI) saw the largest increase in utilization between 2014 (4.4% [95%CI 4.2-4.5]) and 2018 (35.1% [95%CI 34.8-35.4]) (p<0.0001), a 701.8% increase. All sociodemographic subgroups experienced similar growth in STR use between 2014 and 2018. STR and INSTI utilization increased significantly over the study period, suggesting increased ART spending under Part D. Although increasing availability of generic multi-tablet ART regimens (MTR) may offer cost-savings, further research is needed comparing generic MTR to branded STR with regards to patient preferences, adherence, healthcare resource utilization, and total costs in the growing population of Medicare beneficiaries with HIV.

Factors Associated with Treatment Satisfaction Among People Living with HIV in Japan and Other Selected Countries: Examination of the Intertwined Roles of Medication, Patient, and Provider Characteristics

We examined satisfaction and perceived challenges with antiretroviral therapy (ART) among people living with HIV (PLHIV) in Japan vs three other Asian countries (China, Taiwan, South Korea), and 21 non-Asian countries, using data from the 2019 Positive Perspectives Study (pooled sample size from all 25 countries = 2389). Participants in other Asian countries were more likely than those in Japan to report they missed ART ≥ 1 time in the past month because they were depressed/overwhelmed (57.4%[89/155] vs 32.0%[24/75]), had privacy concerns (56.8%[88/155] vs 30.7%[23/75]), were concerned about the potential long-term negative impacts of ART (46.5%[72/155] vs 26.7%[20/75]), or just wanted to forget about HIV (45.8%[71/155] vs 22.7%[17/75]). ART satisfaction however did not differ significantly between surveyed PLHIV in Japan (54.7%[41/75]) vs those in other Asian countries (47.7%[74/155]). The percentage who felt that daily ART dosing limited their lives was 36.0%[27/75] among participants from Japan, 48.4%[75/155] among participants from other Asian countries, and 27.3%[589/2159] among those from non-Asian countries. Within a structural equation model using pooled data from all 25 countries, positive correlations were seen between ART satisfaction and “provider engagement” (β = 0.35), high perceived control over ART dosing schedule (β = 0.28), and the belief that ART prevents HIV transmission (β = 0.16). Conversely, negative correlations were seen between ART satisfaction and experience of ART side-effects (β = − 0.24), high “ART anxiety” (β = − 0.20); and being on multi-tablet regimens (β = − 0.13). Those ART-satisfied reported higher self-rated health and greater ART adherence. These findings underscore the need for patient-centered care to enhance treatment satisfaction and improve ART adherence.

Retrospective analysis of adherence to HIV treatment and healthcare utilization in a commercially insured population

Aims: Single-tablet regimens (STRs) can improve antiretroviral therapy (ART) adherence; however, the relationship between long-term adherence and patient healthcare resource utilization (HRU) is unclear. The objective of this study was to assess long-term ART adherence among people living with HIV (PLHIV) using STRs and multi-tablet regimens (MTRs) and compare HRU over time by adherence. Materials and methods: This retrospective study analyzed medical and pharmacy claims (Optum Clinformatics® Data Mart Database). Included PLHIV were aged ≥18 years, had ≥1 medical claim with an HIV diagnosis, and had pharmacy claims for a complete STR or MTR. Adherence was analyzed as proportion of days covered (PDC), stratified as ≥95%, very high; 90–95%, high; 80–90%, moderate; <80%, low. Cumulative all-cause and HIV-related HRU were calculated across 4 years. Among PLHIV with ≥4-year follow-up, HRU was assessed by adherence. Results: Among 15,153 PLHIV included, 63% achieved PDC ≥90% during Year 1. Among the subgroup of PLHIV with ≥4-year follow-up (N = 3,818), the proportion maintaining PDC ≥90% fell from 67% in Year 1 to 54% by Year 4. Difference from Years 1 to 4 in the proportion of PLHIV with PDC ≥90% was 13% and 17% in the STR and MTR groups, respectively. Cumulative HRU across the 4-year follow-up was higher in PLHIV with low vs high adherence (27% with low adherence had ≥1 emergency room visit vs 17% for very high, p < 0.0001; 15% with low adherence had ≥1 inpatient stay vs 7% for very high, p < 0.0001). Conclusions: ART adherence showed room for improvement, particularly over the long-term. PLHIV receiving STRs exhibited higher adherence vs those receiving MTRs; this difference increased over time. The proportion of PLHIV with higher HRU was significantly higher among those with lower adherence, and became greater over time. Interventions and alternative therapies to improve adherence among PLHIV should be explored.

1036. Persistence of Guideline-Recommended Antiretroviral Therapy Regimens among Persons Living with HIV Newly Initiating Treatment in the US

BackgroundDiscontinuation of first-line antiretroviral therapy (ART) may lead to poor outcomes for persons living with HIV (PLWH). While single-tablet regimens (STRs) have been associated with greater persistence compared to multi-tablet regimens (MTRs), few real-world studies have assessed persistence with current guideline-recommended ART regimens. The study aims to assess persistence among treatment-naïve PLWH initiating guideline-recommended ART regimensMethodsLongitudinal pharmacy claims were extracted from IQVIA’s US LRx database for PLWH initiating ART between Jan 1, 2016 - Jul 31, 2019 (index period), with the observational period up to Jan 31, 2020. Index date was defined as the date of the first ART claim for STRs, or the date of the last filled drug of 1st set of claims for MTRs. Persistence was measured as the number of days until treatment discontinuation (≥ 90-day gap in therapy) and presented via Kaplan-Meier curves. Risk of discontinuation was assessed via Cox proportional hazards models, with BIC/FTC/TAF used as the reference ART regimen.ResultsOverall, 90,949 PLWH initiated STRs and 20,737 initiated MTRs. Average (SD) age was 43 (14) years, 75% were male, and 75% had commercial insurance. At 6 months of follow-up, 71% of PLWH initiating STRs and 56% initiating MTRs remained on their ART regimen. The proportion remaining on their index regimen at 6 months of follow-up was 79% for BIC/FTC/TAF, 73% for EVG/COBI/FTC/TAF, 71% for DTG/ABC/3TC, 69% for DTG + FTC/TAF, 67% for EFV/FTC/TDF, 62% for EVG/COBI/FTC/TDF, and 38% for DTG + FTC/TDF. Risk of discontinuation was higher for MTRs compared to STRs (hazard ratio [HR]: 1.63, 95% CI: 1.61 - 1.66). Compared to the referent BIC/FTC/TAF, risk of discontinuation was higher for EVG/COBI/FTC/TAF (HR: 1.54, 95% CI: 1.48 - 1.60), DTG/ABC/3TC (HR: 1.58, 95% CI: 1.52, 1.65), DTG + FTC/TAF (HR: 1.83, 95% CI: 1.74 - 1.93), EFV/FTC/TDF (HR: 2.31, 95% CI: 2.21 - 2.41), EVG/COBI/FTC/TDF (HR: 2.58, 95% CI: 2.47 - 2.70), and DTG + FTC/TDF (HR: 6.20, 95% CI: 5.83 - 6.59).Table 1. Persistence with ART by regimen for STR and MTR Figure 1. Forest Plot of Hazard Ratios for Treatment Discontinuation ConclusionAmong US adult PLWH, STRs were associated with longer persistence on first-line therapy compared to MTRs. Among STRs, persistence was highest for BIC/FTC/TAF.Disclosures All Authors: No reported disclosures

Clinical outcomes of HIV-1 infected patients switched from complex multi-tablet regimens to tenofovir alafenamide based single-tablet regimens plus a boosted protease inhibitor in a real-world setting

BackgroundMulti-tablet regimens (MTRs) are associated with increased adverse events and non-adherence. Single tablet regimens (STRs) plus boosted protease inhibitors (PIs) are a simplification option for MTR-treated patients; however, data is needed to validate this therapeutic strategy. MethodsThis retrospective analysis included all HIV-1 infected patients seen at a single center from March 2016 to December 2017 who were switched from twice-daily (BID) regimens or regimens containing ​≥ ​3 pills daily to elvitegravir/cobicistat/emtricitabine/tenofovir-alafenamide (E/C/F/TAF) plus darunavir (DRV) or rilpivirine/emtricitabine/tenofovir-alafenamide (RPV/F/TAF) plus DRV boosted with ritonavir or cobicistat (DRV/r-c). Eligible patients had baseline HIV-1 RNA<200 copies/mL and were followed for 48 weeks. The primary endpoint was HIV-1 RNA≥50 copies/mL at Week 48. Adherence and safety data were recorded throughout the study. ResultsOf 61 patients included, median age was 53 years, the median number of pills taken daily (range) was 5 (3–9), 80% were taking BID regimens, 97% had baseline HIV-1 RNA<50 copies/mL, 56 (92%) were switched to E/C/F/TAF plus DRV and 5 (8%) to RPV/F/TAF plus DRV/r-c. At Week 48, 2 patients (3%) had HIV-1 RNA≥ 50 copies/mL, both were treated with E/C/F/TAF plus DRV and neither had evidence of treatment-emergent resistance. Fifty-nine (97%) had an HIV-1 RNA<50 copies/mL. Adverse drug reactions (ADRs) occurred in 3/61 (5%) (all Grade 2) leading to 3/61 (5%) ADR-related discontinuations. ConclusionIn this real-world cohort of MTR-treated patients, switching to a TAF-based STR plus boosted PI maintained virologic control in 97% and was well-tolerated, supporting potential use of this strategy for regimen simplification.

PIN87 PATIENT ENGAGEMENT IN HIV CARE MANAGEMENT: BEHAVIOR ECONOMICS OF ART ADHERENCE AND ESTABLISHING CARE VISITS

Despite available potent and efficacious anti-retroviral therapy(ART), optimal treatment outcomes remain challenging with HIV patients and cannot be achieved without high levels of patient engagement. We explore whether patient implicit decision-making in valuing ongoing care can be elicited through observable engaged behavior—ART adherence and clinic appointments. Electronic health records (EHR) and pharmacy dispensing data within a single health care system were linked at individual patient levels. The relationship between adherence behavior (Proportion of Days Covered [PDC]) and “no show” office visit rates was examined as a proxy for patient valuation of engaged behavior in HIV management. Adults (18+ years) with newly established HIV care and initiating on once-daily ART between January 2009 and October 2019 were included. PDC was calculated using ART dispensed dates and days of supplies during their initiated regimen. Appointment status was categorized as completed, canceled, and “no show”. Patient demographics and regimen characteristics (e.g., copay, single- and multi-tablet regimen) were evaluated as covariates. GEE regression model was fitted with PDC as the dependent variable. Analyses were conducted using SAS 9.4. 53 patients were included in analysis-- 44 (83.0%) male; mean age=35.2 years at the time of establishing HIV care. 45 (84.9%) and 8 (15.1%) initiated single and multi-tablet regimens, respectively. Mean PDC for first-line therapy was 0.718; mean individual “no show” rate was 0.144, and 22 (41.5%) never had a “no show” event. PDC was lower with a higher “no show” rate (r= -0.380; p=0.005) and higher with older age (r=0.276; p=0.045). In the GEE regression model, having any “no show” event and age were predictors for PDC (beta_hat= -0.153 and 0.0056; p<0.05, respectively). Highly correlated patterns between ART adherence and appointment status may reflect an implicit decision-making process in the valuation of ongoing HIV care, as "No show” behavior predicts adherence behavior.

PIN4 IMPACT OF ADHERENCE ON VIRAL SUPPRESSION IN PATIENTS WITH HIV RECEIVING BICTEGRAVIR OR DOLUTEGRAVIR REGIMENS

Previous real-world studies have shown (1) reduced adherence with more complex, multi-tablet regimens (MTR) relative to simple, single-tablet regimens (STR) and (2) reduced virologic control with decreased regimen adherence. This study evaluated adherence and virologic suppression with second-generation integrase inhibitors (INSTIs) bictegravir (BIC) and dolutegravir (DTG) in patients with HIV. EMR, prescription and dispensing data for 2,217 patients initiating STR BIC/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) or DTG/abacavir/lamivudine (DTG/ABC/3TC) or MTR DTG + tenofovir disoproxil fumarate/emtricitabine (DTG+TDF/FTC) or DTG+TAF/FTC between August 2013 - August 2019 were collected from 5 US practices. Adherence was defined as proportion of days covered (PDC) at 6 months. To determine treatment effects on adherence, we used (1) multiple imputation with predictive posterior matching for missing baseline measures, (2) mixed effects logistic regression to adjust for source heterogeneity, and (3) propensity score matching (PSM) using imputed baseline labs and demographics, allowing for squares and first order interactions between all included predictors. In addition to adherence, we assessed viral suppression (<200 copies/mL) in a subset of 655 patients at 6 months (-1 week to + 2 months). In observed data, 80% PDC was significantly higher (p<0.01) with STR BIC/FTC/TAF compared to any dolutegravir-regimen and with STR DTG/ABC/3TC in comparison to MTR DTG+TDF/FTC or DTG+TAF/FTC (p<0.01). After PSM, adherence was only significantly different with STR BIC/FTC/TAF compared to MTR DTG+TDF/FTC or DTG+TAF/FTC (p<0.01). Viral suppression at 6 months for patients with measures (n=655) was favorably impacted by PDC ≥80% (OR 2.27 [1.26-4.07] p<0.01). Consistent with studies of legacy regimens, these data suggest that simplifying 2nd generation INSTI-containing regimens to a single tablet aids in adherence and greater adherence improves virologic outcomes.

Real-world adherence and persistence for newly-prescribed HIV treatment: single versus multiple tablet regimen comparison among US medicaid beneficiaries

BackgroundOnce-daily, single-tablet regimens (STRs) have been associated with improved patient outcomes compared to multi-tablet regimens (MTRs). This study evaluated real world adherence and persistence of HIV antiretroviral therapy (ART), comparing STRs and MTRs.MethodsAdult Medicaid beneficiaries (aged ≥ 18 years) initiating ART with ≥ 2 ART claims during the identification period (January 1, 2015–December 31, 2016) and continuous health plan enrollment for a 12-month baseline period were included. For STRs, the first ART claim date was defined as the index date; for MTRs, the prescription fill claim date for the last drug in the regimen was defined as the index date, and prescription fills were required to occur within a 5-day window. Adherence was assessed in 30-day intervals over a 6-month period, with adherence defined as having less than a 5-day gap between fills. Persistence was evaluated as median number of days on therapy and percent persistence at 12 months. Cox Proportional Hazard models were used to evaluate risk of discontinuation, controlling for baseline and clinical characteristics.ResultsA total of 1,744 (STR = 1290; MTR = 454) and 2409 (STR = 1782; MTR = 627) patients newly prescribed ART had available data concerning adherence and persistence, respectively. Average age ranged 40–42 years. The patient population was predominantly male. Adherence assessments showed 22.7% of STR initiators were adherent to their index regimens over a 6-month period compared to 11.7% of MTR initiators. Unadjusted persistence analysis showed 36.3% of STR initiators discontinued first-line therapy compared to 48.8% for MTR initiators over the 2-year study period. Controlling for baseline demographic and clinical characteristics, MTR initiators had a higher risk of treatment discontinuation (hazard ratio [HR] = 1.6, p < 0.0001). Among STRs, compared to the referent elvitegravir(EVG)/cobicistat(COBI)/emtricitabine(FTC)/tenofovir alafenamide(TAF), risk of discontinuation was higher for efavirenz(EFV)/FTC/tenofovir disoproxil fumarate(TDF) (HR = 3.6, p < 0.0001), EVG/COBI/FTC/TDF (HR = 2.8, p < 0.0001), and abacavir (ABC)/lamivudine (3TC)/dolutegravir (DTG) (HR = 1.8, p = 0.004). Among backbones, FTC/TAF was associated with lower risk of discontinuation than FTC/TDF (HR = 4.4, p < 0.0001) and ABC/3TC (HR = 2.2, p < 0.0001).ConclusionsAmong patients newly prescribed ART, STR initiators were significantly less likely to discontinue therapy and had greater adherence and persistence compared to MTR initiators. Regimens containing FTC/TAF as a backbone had higher persistence than those consisting of other backbones.

2512. Decreasing Adherence to Antiretroviral Therapy over 4 Years of Follow-up in a Commercially-Insured Population of Patients with HIV

BackgroundThis study compared yearly and longer term antiretroviral (ARV) adherence among HIV patients overall and by single-tablet regimens (STRs) vs. multi-tablet regimens (MTRs).MethodsA retrospective study using Optum Clinformatics US-based claims data was conducted. Patients with an HIV-1 diagnosis during 2011–2017, age ≥ 18 years at index (date of first complete ARV regimen during the study period), and continuous enrollment for ≥ 3 months before index (baseline) and ≥ 12 months after index (observation) were included. MTRs were required to be comprised of 3 or more agents across at least 2 classes. Adherence was measured as the proportion of days covered (PDC) and compared using a Chi-square test. PDC was examined in the 1-year observation period for the overall analysis, and each year following index among patients with at least 4 years of continuous data. A subgroup analysis was conducted among patients with index during 2014–2016 to evaluate modern ARV adherence.ResultsAmong the 15,153 included patients, median age was 45 years, the majority were male (88%), and 53% were in the South. At baseline, 58% (n = 8,715) were receiving an STR and 43% (n = 6,438) an MTR. Compared with STR patients, MTR patients had higher prevalence of hyperlipidemia (36% vs. 29%), cardiovascular disease (27% vs. 21%), and hypertension (25% vs. 20%). During year 1, the proportion of patients with PDC ≥ 0.90 was 63% overall (Table 1), and greater for STR than MTR (67% vs. 58%, P < .001). Among patients with at least 4 years of observation, PDC ≥ 0.90 decreased over time (from 67% in year 1 to 53% in year 4). In the subgroup of patients with index during 2014–2016 (Table 2), similar but slightly worse trends were observed, with PDC ≥ 0.90 for 57% of patients overall, and decreasing over time for those patients with at least 3 years of observation (59% in year 1 to 42% in year 3).ConclusionAdherence in this population of patients with HIV showed room for improvement in the first year of observation overall and in the modern ARV era, with those receiving STRs having higher adherence when compared with those receiving MTRs. For the patients with 4 years of follow-up, adherence tended to decrease year on year. Maintaining high rates of ARV adherence is a critically important aspect of therapy for patients with HIV. Disclosures All authors: No reported disclosures.

Desimplification to multi-tablet antiretroviral regimens in human immunodeficiency virus-type 1 infected adults: A cohort study.

BACKGROUNDHighly active antiretroviral therapy (HAART) is provided free of charge to all human immunodeficiency virus (HIV) positive residents in Italy. As fixed dose coformulations (FDCs) are often more expensive in comparison to the same drugs administered separately in a multi-tablet regimen (MTR), we considered a cost-effective strategy involving patients in the switch from their FDCs to corresponding MTRs including generic antiretrovirals.AIMTo verify if this would affect the virological and immunological response in comparison to maintaining the FDC regimens.METHODSFrom January 2012 to December 2013, we assessed the eligibility of all the HIV-1 positive adults on stable HAART being treated at our hospital-based outpatient clinic in Treviso, Italy. Participants who accepted to switch from their FDC regimen to the corresponding MTR joined the MTR group, while those who maintained a FDC regimen joined the FDC group. Clinical data, including changes in HAART regimens, respective reasons why and adverse effects, were recorded at baseline and at follow-up visits occurring at weeks 24, 48 and 96. All participants were assessed for virological and immunological responses at baseline and at weeks 24, 48 and 96.RESULTSTwo hundred and forty-three eligible HIV-1 adults on HAART were enrolled: 163 (67%) accepted to switch to a MTR, joining the MTR group, while 80 (33%) maintained their FDCs, joining the FDC group. In a parallel analysis, there were no significant differences in linear trend of distribution of HIV-RNA levels between the two groups and there were no significant odds in favour of a higher level of HIV-RNA in either group at any follow-up and on the overall three strata analysis. In a before-after analysis, both FDC and MTR groups presented no significant differences in distribution of HIV-RNA levels at either weeks 48 vs 24 and weeks 96 vs 24 cross tabulations. A steady increase of mean CD4 count was observed in the MTR group only, while in the FDC group we observed a slight decrease (-23 cells per mmc) between weeks 24 and 48.CONCLUSIONInvolving patients in the switch from their FDC regimens to the corresponding MTRs for economic reasons did not affect the effectiveness of antiretroviral therapy in terms of virological response and immunological recovery

Impact of an Antiretroviral Stewardship Team on the Care of Patients With Human Immunodeficiency Virus Infection Admitted to an Academic Medical Center.

BackgroundInterdisciplinary antiretroviral stewardship teams, comprising a human immunodeficiency virus pharmacist specialist, an infectious diseases physician, and associated learners, have the ability to assist in identification and correction of inpatient antiretroviral-related errors.MethodsElectronic medical records of patients with antiretroviral orders admitted to our hospital were evaluated for the number of interventions made by the stewardship team, number of admissions with errors identified, risk factors for occurrence of errors, and cost savings. Risk factors were analyzed by means of multivariable logistic regression. Cost savings were estimated by the documentation system Clinical Measures.ResultsA total of 567 admissions were included for analysis in a 1-year study period. Forty-three percent of admissions (245 of 567) had ≥1 intervention, with 336 interventions in total. The following were identified as risk factors for error: multitablet inpatient regimen (odds ratio, 1.834; 95% confidence interval, 1.160–2.899; P = .009), admission to the intensive care unit (2.803; 1.280–6.136; P = .01), care provided by a surgery service (1.762; 1.082–2.868; P = .02), increased number of days reviewed (1.061; 1.008–1.117; P = .02), and noninstitutional outpatient provider (1.375; .972–1.946; P = .07). The 1-year cost savings were estimated to be $263 428.ConclusionsAntiretroviral stewardship teams optimize patient care through identification and correction of antiretroviral-related errors. Errors may be more common in patients with multitablet inpatient regimens, admission to the intensive care unit, care provided by a surgery service, and increased number of hospital days reviewed. Once antiretroviral-related errors are identified, the ability to correct them provides cost savings.

Which antiretroviral regimen is associated with higher adherence in Brazil? A comparison of single, multi, and dolutegravir-based regimens.

We evaluated adherence to highly active antiretroviral therapy (HAART) and its associated factors according to the type of regimen in patients initiating treatment in Belo Horizonte, Minas Gerais State, Brazil. We measured adherence using the eight items Morisky Therapeutic Adhesion Scale (MMAS-8) and compared the use of "backbone" tenofovir/lamivudine plus efavirenz one tablet once-daily (STR) or dolutegravir in multi-tablet once-daily (MTR-DTG), or other multi-tablet regimens (MTR-other). We conducted a multivariate logistic regression analysis to address factors associated with adherence. A total of 393 patients were included, 254 used STR, 106 MTR-DTG, and 33 MTR-other. The overall adhesion rate was 44.8% (95%CI: 39.4; 50.1), 50% for MTR-DTG, 43.3% for STR and 39.4% for MTR-other. Multivariate analysis showed a higher chance of adherence among patients using MTR-DTG, those who received and understood counseling about their treatment and with a higher quality of life. Prior use of illicit drugs in the lifetime was associated with poorer adherence. Overall adherence was low, highlighting the need for strategies focusing on counseling about medicines and substance use. Pill burden was not an issue for patients using MTR-DTG once-daily, who achieved better results.

550. Adherence and Persistency With Modern Single vs. Multi-Tablet Antiretroviral (ARV) Regimens in First Treatment of HIV in Clinical Practice

550. Adherence and Persistency With Modern Single vs. Multi-Tablet Antiretroviral (ARV) Regimens in First Treatment of HIV in Clinical Practice

A meta-analysis comparing 48-week treatment outcomes of single and multi-tablet antiretroviral regimens for the treatment of people living with HIV

ObjectivesTo compare outcomes with single tablet regimens (STR) versus multi-tablet regimens (MTR) for human immunodeficiency virus (HIV) treatment using published data.DesignSystematic review and random-effects meta-analysis of literature on approved and investigational HIV regimens.MethodsThe research followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Single or un-blinded studies reporting a direct comparison between STR and MTR were eligible for the meta-analysis. Double-blinded studies were excluded due to lack of difference in pill burden between cohorts. The key outcomes of interest included: adherence rates/proportion meeting target, efficacy, safety/tolerability, non-clinical and economic outcomes.ResultsAfter screening 63 full-text articles and posters, 14 studies were eligible for the meta-analysis. The analysis showed that patients taking STR had improved outcomes over those taking MTR. Patients were significantly more adherent regardless of daily dosing frequency (odds ratio [OR]: 1.96, p < 0.001) and were more likely to achieve virological suppression (relative risk [RR]: 1.05, p = 0.002). There was a trend toward a lower discontinuation risk in the STR cohort, together with reported higher therapy satisfaction, better symptom control, improved health status, reduced healthcare resource utilization and demonstrated cost-effectiveness compared to MTR. There were no differences in CD4 cell count increase (at 48 weeks) or safety outcomes.ConclusionsThe findings of this study confirm previously reported preliminary findings of the advantages of STR over MTR for HIV treatment in adherence, therapy continuation, viral suppression, tolerability, quality of life improvement, cost-effectiveness and healthcare resource utilization.

Medication nonadherence, multitablet regimens, and food insecurity are key experiences in the pathway to incomplete HIV suppression.

To identify potential pathways by which a variety of factors act to lead to unsuppressed viral load. A prospective cohort of HIV-HCV co-infected adults receiving care from 18 HIV clinics across Canada was followed every 6 months between November 2012 and October 2015. Participants with at least two visits while receiving combined antiretroviral treatment (cART) were included. A path analysis was conducted on the basis of ordered sequences of multivariate logistic regressions using generalized estimating equations. The first regression model used incomplete viral suppression (viral load >50 copies/ml) as the outcome of interest and all other variables (i.e. nonadherence, food insecurity, treatment attributes, and other sociodemographic, behavioural, and clinical factors) as potential predictors. Any variable determined to be a statistically significant predictor of incomplete viral suppression was then used as the next outcome of interest in the subsequent regression, until all predictors of each selected outcome were purely explanatory variables. A total of 566 participants had at least two visits. Drivers of incomplete viral suppression included injection drug use, age 45 years or less, living alone, poor health status, longer duration of HIV infection and baseline CD4 cell count less than 200 cells/μl. Nonadherence, food insecurity, and the use of multitablet regimens mediated the effects of these factors on incomplete viral suppression. Our results suggest that nonadherence, multitablet regimens, and food insecurity are key points in the pathway to incomplete HIV suppression. These are potentially amenable intervention targets that would not be revealed using traditional regression analyses.