Multiple-tablet Regimen Research Articles

Effectiveness, safety, and patient-reported outcomes of emtricitabine/tenofovir alafenamide-based regimens for the treatment of HIV-1 infection: Final 24-month results from the prospective German TAFNES cohort study.

Tenofovir alafenamide (TAF) was introduced in the European Union in 2015 as a novel prodrug of tenofovir showing similar efficacy in clinical trials and a more favorable safety profile than tenofovir disoproxil fumarate (TDF). The German TAFNES cohort study (2016-2019) was conducted to generate real-world evidence. Treatment-naïve (TN) and treatment-experienced (TE) people with HIV (PWH) receiving elvitegravir/cobicistat/emtricitabine/TAF (E/C/F/TAF), rilpivirine/F/TAF (R/F/TAF) or F/TAF + 3rd agent were included. Month (M) 24 outcomes included virologic effectiveness (HIV RNA <50 copies/mL), treatment persistence, adverse drug reactions (ADRs) and patient-reported outcomes, using the HIV Symptom Index (HIV-SI), 36-Item Short Form Health Survey (SF-36) and HIV Treatment Satisfaction (HIVTSQ) questionnaires. The study included 767 PWH (92% men, median age 46 years; 301 TN, 466 TE; E/C/F/TAF [n = 318], R/F/TAF [n = 192], F/TAF + 3rd agent [n = 257]). Among TN, 35% had late HIV diagnosis (CD4 < 350/μL and/or AIDS). Of TE, 95% were on suppressive antiretroviral therapy (ART) before switching. D:A:D (Data Collection on Adverse Effects of Anti-HIV Drugs) 5-year risks for chronic kidney disease were high for about 1 in 10 TN and 4 in 10 TE. Overall treatment persistence at M24 was 81% (E/C/F/TAF: 88%; R/F/TAF: 86%; F/TAF + 3rd agent: 70%, with ART simplification of multiple-tablet regimens in 13%). M24 viral suppression (missing = excluded) was 96% (479/501). Discontinuations due to virologic failure or ADRs were rare, 2% (12/767) and 4% (30/767), respectively. HIV-SI and SF-36 summary scores improved in TN; HIVTSQ change scores showed an improvement in treatment satisfaction in TE. Real-world data confirmed a favorable safety profile and high virologic effectiveness with high treatment satisfaction on F/TAF-based ART.

Long-Term Follow-Up of Persons Living with Perinatally Acquired HIV Infection at a Large HIV Treatment Clinic in Trinidad.

Data on persons with perinatally acquired HIV infection in the Caribbean are limited; thus, a chart review was conducted among these clients at an adult HIV treatment clinic in Trinidad over the period January 01, 2011-June 30, 2023. Sociodemographic, clinical, and laboratory data were extracted and analyzed using RStudio version 2021.09.0. Fifty-four study participants were followed up, age range 18-29 years, and there were 27 (50%) males. Eighteen participants (33.3%) were institutionalized until the age of 18 years, while 36 (66.7%) lived with caregivers/relatives and attended outpatient pediatric clinic. The transition from the sheltered environment of pediatric care to the adult HIV clinic was turbulent for some participants as they experienced HIV-related stigma, which may result in poor HIV outcomes. At the initial clinic visit, 28 (51.9%) study participants were virally suppressed (HIV viral load <1,000 copies/mL), which included 12 (66.7%) of 18 who were institutionalized as compared to 16 (44.4%) of 38 who lived with caregivers/relatives (p = 0.387). Data from their last clinic visit showed 31 (57.4%) participants were virally suppressed; 13 (24.1%) were lost to follow-up from care, and there were 6 (11.1%) deaths; 29 (53.7%) were on antiretroviral therapy single-tablet regimens (STRs) and 25 (46.3%) on complex multiple-tablet regimens (MTRs). Institutionalized clients and those on STRs were more likely to be virally suppressed than those living with relatives (p = 0.043) and those on MTR (p < 0.001), respectively. Reported deaths were higher among clients who lived with caregivers/relatives and those on MTR. Participants of younger age were less likely to achieve viral suppression (p = 0.02). Comprehensive programs that include STRs, the engagement of caregivers/relatives and health workers, life skills, and enhanced psychosocial interventions for youths living with perinatally acquired HIV are important to support the transition to adult care and reduce the complex challenges of living with a stigmatizing disease.

Non-adherence and non-persistence with antiretroviral treatment in Belgium: A real-world evaluation using a pharmacy database, 2018-2021.

To evaluate the real-world rates of non-adherence and non-persistence to antiretroviral therapy (ART) among treatment-naïve adult patients with HIV after a 12-month follow-up period in Belgium. A retrospective analysis of longitudinal pharmacy claims was conducted using the Pharmanet database from January 1, 2018, to December 31, 2021. Non-adherence was assessed over 12 months and reported as the proportion of days covered below the 80% threshold. Non-persistence was defined as the first 90-day gap in treatment between the two types of ART dispensed. Poisson regression with robust standard error and Cox proportional hazard models were used to assess the factors associated with non-adherence and non-persistence, respectively. Overall, 2999 patients were initiated on ART between 2018 and 2021. After a 12-month follow-up, the proportions of non-adherence and non-persistence were 35.6% and 15.9%, respectively in 2018, and decreased to 18.7% and 6.8%, respectively in 2021. Non-adherence was higher among women, Brussels residents, and those receiving multiple-tablet regimens (MTRs). Similarly, the prevalence of non-persistence was higher among women and MTR recipients. Among treatment-naïve adults with HIV in Belgium, non-adherence, and non-persistence to ART showed improvement over the study period but remained at high levels. Disparities were observed by sex and between geographical regions. Prioritizing strategies targeting women in Brussels and facilitating the transition from MTRs to single-tablet regimens should be emphasized optimize adherence to ART in Belgium.

1255. Single-tablet Regimens (STR) Offer Better Persistence and Adherence, with Lower Costs by Adherence Status, than Multiple-tablet Regimens (MTR) for People Living with HIV (PLWH) Enrolled in Medicaid

Abstract Background Pill burden associated with antiretroviral multiple-tablet regimens (MTR) can impact adherence. The shift to single-tablet regimens (STR) has lagged for people living with HIV (PLWH) covered by Medicaid. This study examines persistence, adherence, healthcare resource utilization (HCRU), and costs by STR or MTR use for new initiators and treatment-experienced PLWH over a 1-year study period. Methods A linked patient population was applied using data from IQVIA’s Prescription Claims (Rx), Professional Fee Claims (Dx), and Hospital Charge Data Master (CDM). A 6-month pre-index period was used to assess study eligibility and baseline characteristics. A 12-month post-index period was used to descriptively evaluate treatment patterns and HCRU/costs. Two mutually exclusive cohorts were created based on STR or MTR use during the selection window (01/2018-07/2019). For the STR cohort, date of the first STR claim during the selection window was termed the index date. For the MTR cohort, the date of the first MTR drug during the selection window was termed the index date. Results The final sample comprised 4,603 PLWH in the STR cohort and 2,728 in the MTR cohort (Table 1). The proportion persistent over the 1-year follow-up was higher among treatment experienced compared to new initiators, and higher for STR compared to MTR (Figure 1A). The proportion adherent was higher among treatment experienced compared to new initiators, and higher for STR compared to MTR (Figure 1B). HIV-specific per member per month (PMPM) pharmacy costs were higher among treatment experienced compared to new initiators, and higher for MTR compared to STR (Figure 2). Adherent PLWH had a lower proportion with ≥ 1 all-cause emergency room visit compared to non-adherent PLWH within a cohort/treatment status category; minimal differences in ≥ 1 all-cause hospitalization. Adherent PLWH had higher mean all-cause costs than non-adherent PLWH, driven by pharmacy costs. STR PLWH had lower mean all-cause total costs compared to MTR PLWH with the same adherence/treatment experience status (Figure 3). Conclusion PLWH enrolled in Medicaid are more persistent and adherent to STR than MTR. Among PLWH adherent to antiretroviral therapy, STR offer potential cost savings over MTR for appropriate patients. Disclosures Andrew P. Brogan, PhD, ViiV Healthcare: Employee, Salary|ViiV Healthcare: Stocks/Bonds Cindy Garris, MS, ViiV Healthcare: Employee|ViiV Healthcare: Stocks/Bonds Julie Priest, MSPH, ViiV Healthcare: Employee, Salary|ViiV Healthcare: Stocks/Bonds Victoria Divino, BA, IQVIA: Employee, Salary|ViiV Healthcare: Grant/Research Support Jing He, PhD, IQVIA: Employee, Salary|ViiV Healthcare: Grant/Research Support Justin Chen, MHS, IQVIA: Employee, Salary|ViiV Healthcare: Grant/Research Support Mitch DeKoven, MHSA, IQVIA: Employee, Salary|ViiV Healthcare: Grant/Research Support.

1254. An Increase in Single-tablet Regimen (STR) Utilization for People Living with HIV (PLWH) Enrolled in Medicaid had Minimal Impact on Pharmacy Costs

Abstract Background The shift to antiretroviral single-tablet regimens (STR) from multiple-tablet regimens (MTR) has lagged for people living with HIV (PLWH) covered by Medicaid. This study examines STR and MTR utilization and pharmacy costs over a 5-year period for PLWH enrolled in Medicaid. Methods This retrospective study used IQVIA’s Prescription Claims (Rx) data to identify two mutually exclusive cohorts based on STR or MTR use within each of 5 calendar years (2016-2020). For the STR cohort, the date of the first STR claim in each calendar year was termed the index date. For the MTR cohort, the date of the first MTR drug in the first observed complete MTR regimen in each calendar year was termed the index date; a window of 5 days between prescription fills for the agents used in an MTR regimen was allowed. The regimen received on the index date was used to assign the study cohort for each year and study measures were reported for each of the 5 calendar years. Additional eligibility criteria are provided in Table 1. Results The final STR cohort was 47,140 (14.5% of the initial sample) in 2016 and 73,111 (13.5%) in 2020 (Table 1). The final MTR cohort was 36,007 (15.5%) in 2016 and 20,264 (13.5%) in 2020. The distribution of PLWH with Medicaid Fee-For-Service (FFS) or Medicaid managed care was generally similar by year for both STR and MTR cohorts from 2016 to 2019 (Figure 1); Medicaid managed care enrollment for both cohorts increased in 2020 (62.4-62.9%). Among PLWH, STR use increased annually from 56.7% in 2016 to 78.3% in 2020 (Figure 2). Conversely, MTR use decreased from 43.3% to 21.7% over the same time period. The increase in STR utilization over time was consistent for both plan types. Mean HIV-specific per member per month (PMPM) pharmacy costs were similar across years for both STR and MTR cohorts, ranging from $2,016-$2,342 for STR cohorts and $2,247-$2,380 for MTR cohorts (Figure 3). Conclusion Between 2019 and 2020, PLWH enrolled in Medicaid shifted from FFS towards managed care. STR use among PLWH enrolled in Medicaid increased from 2016 to 2020 with minimal differences in PMPM pharmacy costs compared with PLWH enrolled in Medicaid receiving MTR. Disclosures Andrew P. Brogan, PhD, ViiV Healthcare: Employee, Salary|ViiV Healthcare: Stocks/Bonds Cindy Garris, MS, ViiV Healthcare: Employee|ViiV Healthcare: Stocks/Bonds Julie Priest, MSPH, ViiV Healthcare: Employee, Salary|ViiV Healthcare: Stocks/Bonds Victoria Divino, BA, IQVIA: Employee, Salary|ViiV Healthcare: Grant/Research Support Jing He, PhD, IQVIA: Employee, Salary|ViiV Healthcare: Grant/Research Support Justin Chen, MHS, IQVIA: Employee, Salary|ViiV Healthcare: Grant/Research Support Mitch DeKoven, MHSA, IQVIA: Employee, Salary|ViiV Healthcare: Grant/Research Support.

Treatment and comorbidity burden among people living with HIV: a review of systematic literature reviews

Background As the human immunodeficiency virus (HIV) treatment landscape continues to evolve, the prolonged life expectancy and long-term exposure to antiretroviral drugs have modified the burden associated with living with HIV. Objective To better understand the current treatment and comorbidity burden in people living with HIV (PLWH). Methods Peer-reviewed systematic literature reviews (SLRs) between 2017 and 2020 that included US studies and examined drug adherence/pill burden, resistance burden, or comorbidities in PLWH were identified. Methods and findings were extracted for the overall studies and examined in the subset of US studies. Results Among 665 publications identified, 47 met the inclusion criteria (drug adherence/pill burden: 5; resistance: 3; comorbidities: 40). While antiretroviral drug adherence levels varied across SLRs, single-tablet regimens (STR) were associated with higher adherence versus multiple-tablet regimens. STRs were also associated with lower risk of treatment discontinuation, higher cost-effectiveness, and lower risk of hospitalization. Longer survival resulted in a high comorbidity burden, with non-AIDS causes accounting for 47% of deaths among PLWH in the US. HIV doubled the risk of cardiovascular disease and was associated with other health problems, including bone and muscle diseases, depression, and cancers. Several antiretroviral regimens were associated with chronic diseases, including cardiometabolic conditions. Lifetime HIV costs are substantially increasing, driven by antiretroviral, adverse event, and comorbidity treatment costs cumulated due to longer survival times. Conclusions There is a considerable burden associated with HIV and antiretroviral treatment, highlighting the benefits of less complex and safer regimens, and the unmet need for effective preventative interventions.

Adherence and clinical outcomes of HIV patients switching to a fixed-dose combination regimen.

The efficacy of antiretroviral therapy (ART) is monitored using clinical markers such as viral load (VL) and CD4 counts. Adherence to ART has been associated with viral suppression and improved clinical outcomes. To determine the relationship between adherence status with multiple-tablet regimens (MTR) and fixed-dose combination (FDC) regimens, to weight, CD4 count and VL of patients living with HIV. An observational, descriptive study was conducted on a closed cohort of patients living with HIV and attending a primary health care clinic in Northern Cape in South Africa between 01 January 2013 and 31 December 2015. Patients were on an MTR and changed to an FDC regimen. Adherence was measured using the medicine possession ratio (MPR). Statistically significant differences exist between the mean MPR of the 30-day (p = 0.0308) and 28-day supply (p < 0.0001) of the MTR when compared to FDC regimen. No statistically significant differences could be found between adherence and clinical outcomes such as weight, CD4 count and VL for either MTR or FDC regimens. The suppressed VL values measured for MTR were n = 299 (89.25%) and n = 415 (93.05%) for FDC regimen. Adherence improved when patients were switched to FDC, but no statistically significant differences in clinical outcomes measured as weight, CD4 count and VL between adherence status and regimen type could be found. This study contributes to much-needed information about ART adherence and clinical outcomes (such as weight, CD4 count and VL) of adult HIV-positive patients in a public healthcare clinic in the Northern Cape, South Africa.

Real-world medication persistence among HIV-1 patients initiating integrase inhibitor-based antiretroviral therapy in Japan

IntroductionMedication persistence has rarely been studied for integrase strand transfer inhibitor (INSTI)-based regimens among patients living HIV (PLWH) in Asia. This study investigated medication persistence for newly prescribed INSTI-based regimens in Japan by comparing single-tablet regimens (STRs) versus multiple-tablet regimens (MTRs), based on the Medical Data Vision database. MethodsAdult PLWH with ≥2 claims for antiretroviral therapy (ART) of interest between 1 January 2017 and 30 June 2018 were included if they had a ≥3-month continuous enrolment prior to the index date and a ≥6-month follow-up after the index date. Medication persistence was measured as the duration from initiation to discontinuation of the prescribed INSTI-based regimen. ResultsOverall, 487 patients were included, with 220 in the STR cohort and 267 in the MTR cohort. Persistence was longer in the STR cohort than in the MTR cohort (mean days on the index regimens: 384.2 vs. 317.3, P < 0.001). MTRs were associated with a higher risk of discontinuation than STRs (hazard ratio [HR], 1.72; 95% confidence interval [CI], 1.18–2.52; P = 0.005). Other factors that were associated with discontinuation were backbone (emtricitabine/tenofovir disoproxil fumarate vs. emtricitabine/tenofovir alafenamide: HR, 5.64; 95% CI, 3.68–8.66; P < 0.001), third agent (raltegravir vs. elvitegravir/cobicistat: HR, 2.06; 95% CI, 1.10–3.86; P = 0.024), age (HR, 1.02; 95% CI, 1.01–1.03; P = 0.007), and the number of non-ART index medications (HR, 1.16; 95% CI, 1.12–1.21; P < 0.001). ConclusionsAmong PLWH newly prescribed an INSTI-based regimen in Japan, STRs were associated with longer persistence than MTRs.

Cumulative tenofovir diphosphate exposure in persons with HIV taking single- vs. multiple-tablet regimens.

We assessed cumulative antiretroviral exposure-using tenofovir diphosphate (TFV-DP) in dried blood spots (DBS)-in persons with HIV (PWH) receiving tenofovir disoproxil fumarate (TDF)-based antiretroviral therapy (ART) as single-tablet regimens (STR) or multiple-tablet regimens (MTR). Blood for DBS was prospectively collected in PWH on TDF during 1144 person visits (n=523). Linear mixed-effects models, adjusted for baseline characteristics, were used to compare TFV-DP in STR versus MTR. Models adjusted for ART regimen using either anchor drug class, pharmacokinetic booster status (unboosted [u/] or boosted [b/]), or a combined STR/MTR and booster categorical variable. In the anchor class-adjusted model, STR had 19% (95% confidence interval [CI]: 3%-37%; p=0.02) higher TFV-DP concentrations than MTR. However, in the booster-adjusted model, STR was not significantly higher than MTR (estimate 5%, 95% CI: -9% to 21%; p=0.48), although PWH on b/ART had 35% (95% CI: 16%-58%; p=0.0001) higher TFV-DP than u/ART. In the STR/MTR-boosted variable model, when compared to u/MTR, b/STR, b/MTR, and u/STR had 25% (95% CI: 7%-47%; p=0.005), 37% (95% CI: 17%-59%; p < 0.0001), and 7% (95% CI: -7% to 24%; p=0.34) higher TFV-DP, respectively. Compared with b/MTR, b/STR had 9% (95% CI: -31% to 10%; p=0.37) lower TFV-DP. In a sensitivity analysis of PWH with HIV viral load <20 copies/ml at all visits, b/STR and b/MTR had 34% (95% CI: 16%-55%; p < 0.0001) and 12% (95% CI: -2% to 27%; p=0.09) higher TFV-DP, respectively, compared with u/MTR, while u/STR had 4% (95% CI: -15% to 8%; p=0.50) lower TFV-DP. Compared with b/MTR, b/STR had 17% (95% CI: 2%-30%; p=0.03) higher TFV-DP. Persons with HIV on b/TDF-based ART had higher TFV-DP than u/ART, regardless of STR or MTR use. No significant differences in TFV-DP between regimens of the same boosting status (i.e., b/STR vs. b/MTR; u/STR vs. u/MTR) were observed in the full cohort. Future research should examine the clinical utility of these findings in patient-tailored ART selection.

Effect of single tablet regimen on prescription trends for treatment-na\xefve patients with HIV/AIDS in Korea

Single-tablet regimens (STRs) should be considered for patients with HIV/AIDS to increase medication compliance and improve clinical outcomes. This study compared variations in the prescription trends between STRs and multiple-tablet regimens (MTRs) for treatment-naïve patients with HIV/AIDS after the approval of the new STRs, a proxy indicator for improvement in medication adherence. The medical and pharmacy claim data were retrospectively obtained from the Health Insurance Review and Assessment service, which contains basic information on the patients’ sociodemographic characteristics and treatment information for the entire Korean population. From 2013 to 2018, a total of 6737 patients with HIV/AIDS were included. Most patients were men (92.8%, n = 6251) and insured through the National Health Insurance (95.1%, n = 6410). The mean number of pills in their antiretroviral treatment regimens decreased from 2.8 ± 1.2 in 2013 to 1.2 ± 1.0 in 2018. After the first STR (EVG/c/TDF/FTC) was approved in 2014, prescription transitions from MTR to STR were observed among more than 38% of patients. In 2018, most treatment-naïve patients were prescribed STRs (91.2%). There was a time lag for STR prescription trends in non-metropolitan hospitals compared with those in metropolitan cities. Our data provide a valuable perspective for evaluating ART regimen prescription patterns on a national scale.

Adherence after treatment switch from a multiple tablet antiretroviral regimen to a single tablet antiretroviral regimen

To evaluate adherence after treatment switch from a multiple-tablet regimen (MTR) to a single-tablet regimen (STR) in a national cohort of human immunodeficiency virus (HIV) patients. This retrospective observational cohort, with data spanning January 1,2000 to March1, 2019, consisted of HIV infected patients receiving treatment from the Veterans Affairs (VA) health system. Patients were required to have a complete MTR regimen after January1, 2006 and before December31, 2018 with at least 60 days of treatment. Medical and pharmacy data were analyzed from the Veterans Affairs Informatics and Computing Infrastructure (VINCI) database. Statistical analyses examined differences in adherence when patients switched to a STR. Patients who switched to a STR were propensity score matched to those who never switched. Descriptive statistics and multivariable linear mixed effects models were utilized to evaluate differences in adherence between MTR and STR treatment in both the matched and unmatched samples. A total of 5021 patients met the study criteria, 3906 patients in the MTR only cohort and 1115 patients in the switch to STR cohort. The unmatched cohorts were similar in terms of sex, index year, drug/alcohol abuse, and viral load but differed in terms of race, Charlson comorbidity and mental health conditions. The one to one propensity score matched cohort included 2230 patients, 1115 patients in each cohort. Among patients that switched from a MTR to STR, adherence increased on average from 65.9% to 78.12%. We find overall adherence is higher with STRs than with MTR HIV regimens in both the matched and unmatched sample and adherence declines with time for both STR and MTR regimens. Switching to a STR is associated with higher adherence compared to MTR among patients with HIV treated with antiretrovirals. However, adherence declines over time with both STR and MTR regimens.

Treatment Patterns and Predictors of Adherence in HIV Patients Receiving Single- or Multiple-Tablet Darunavir, Cobicistat, Emtricitabine, and Tenofovir Alafenamide.

PurposeDarunavir, cobicistat, emtricitabine, and tenofovir alafenamide can be used as a single-tablet regimen (STR, DRV/c/FTC/TAF) or multiple-tablet regimen (MTR, DRV/c+FTC/TAF) to treat patients with human immunodeficiency virus (HIV). This study described treatment patterns and predictors of adherence among patients with HIV initiated on DRV/c/FTC/TAF or DRV/c+FTC/TAF.Patients and MethodsA retrospective longitudinal study was conducted using linked claims and electronic medical records from Decision Resources Group’s Real World Data Repository (7/17/2017–6/1/2019). Treatment-naïve and treatment-experienced virologically suppressed adults with HIV-1 prescribed DRV/c/FTC/TAF or DRV/c+FTC/TAF (index date) were included. Six-month persistence (no treatment gaps >60 and >90 days) and adherence (proportion of days covered [PDC]) to the index regimen were evaluated among patients with ≥6 months of observation post-index. Predictors of low adherence (PDC<80%) were evaluated using a logistic regression model.ResultsAmong 2633 eligible patients (49.5 years old, 29% female, 37% African American/Black), 12% were treatment-naïve pre-index and 88% switched from a previous antiretroviral therapy; 84% initiated DRV/c/FTC/TAF and 16% initiated DRV/c+FTC/TAF. Among 822 DRV/c/FTC/TAF patients with ≥6 months of observation post-index, 80% and 86% had no >60- and >90-day gaps in DRV/c/FTC/TAF coverage, respectively, while among 204 DRV/c+FTC/TAF patients with ≥6 months of observation post-index, 69% and 75% had no >60- and >90-day gaps in DRV/c+FTC/TAF coverage, respectively. Mean (median) PDC for the index regimen was 81% (93%) for patients treated with DRV/c/FTC/TAF and 73% (83%) for patients treated with DRV/c+FTC/TAF. Predictors of low adherence included younger age (odds ratio [OR]=2.36, p=0.017), higher Quan-Charlson comorbidity index (OR=1.32, p=0.012), use of MTR regimen at index (OR=1.69, p=0.022), and prior low adherence (OR=2.56, p<0.001).ConclusionAmong patients initiating a DRV/c-based regimen, those initiating STR had higher 6-month adherence/persistence than those initiating MTR, highlighting the potential benefits of the STR formulation, particularly among younger patients with multiple comorbidities and prior low adherence.

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.

Does switching from multiple to single-tablet regimen containing the same antiretroviral drugs improve adherence? A group-based trajectory modeling analysis

ABSTRACT Combination Antiretroviral Therapy (cART) in single-tablet regimens (STR) is a simplification strategy that can potentially improve medication adherence and clinical outcomes. We conducted a retrospective cohort study of 1206 patients using efavirenz, tenofovir and lamivudine in multiple-tablet regimen who switched to the STR containing the same active ingredients in a southeast metropolis in Brazil. We measured adherence using the proportion of days covered (PDC≥95%) and evaluated this outcome before and after the switch using paired non-parametric statistics. Additionally, we used group-based trajectory modeling to identify adherence patterns to cART for each period and evaluate the migration behavior of patients between the trajectory groups. We observed a 14% increase in the proportion of adherent patients after switching to STR and a 6.2% increase in the proportion of patients with CD4 count>500 cells/μl (p < 0.001), without changes in viral load outcomes. We identified four adherence trajectories in each period. Most patients (60%, n = 722) migrated towards a group with better adherence trajectory or remained in the trajectory group with the highest probability of adherence after the switch. Our findings suggest that the implementation of the STR had a positive impact on adherence and CD4 count. This may potentially improve virologic outcomes later on treatment.

Antiretroviral therapy adherence among treatment-naive HIV-infected patients.

To determine the incidence of antiretroviral therapy (ART) adherence among treatment-naive HIV-infected patients and to evaluate the impact of single-tablet regimen (STR) on ART adherence among this population. Retrospective cohort study. We used a nationally representative sample of IQVIA LRx Lifelink individual level pharmacy claims database during 2011-2016, and defined adult patients with index date (first complete ART regimen prescription fill date) after 30 June 2011 as treatment naïve. We estimated ART adherence, measured as the proportion of days covered during 1 year following the index date. We conducted multivariable analysis to identify the factors associated with optimum adherence (≥90% proportion of days covered). We also compared adherence between patients prescribed STR and multiple-tablet regimens among those prescribed integrase strand transfer inhibitor-based or nonnucleoside reverse transcriptase inhibitor-based regimens. Overall 42.9% of the patients were optimally adherent. Adherence was significantly lower among blacks, Hispanics and patients in low-income communities. Adjusting for the covariates, patients on STR had higher incidence of optimum adherence compared with those on multiple-tablet regimens among patients on integrase strand transfer inhibitor-based regimens [49 vs. 24%, relative risk, 2.16 (95% confidence interval: 1.96-2.26)], but no significant difference was observed among those on nonnucleoside reverse transcriptase inhibitor-based regimen [45 vs. 45%, relative risk, 1.12 (95% confidence interval: 0.99-1.26)]. Low ART adherence observed among treatment-naive patients in this nationally representative study suggests the need for public health interventions to improve adherence among this population.

Accuracy of Antiretroviral Prescribing in a Community Teaching Hospital: A Medication Use Evaluation

Background: Medication errors account for nearly 250 000 deaths in the United States annually, with approximately 60% of errors occurring during transitions of care. Previous studies demonstrated that almost 80% of participants with human immunodeficiency virus (HIV) have experienced a medication error related to their antiretroviral therapy (ART). Objective: This retrospective chart review examines propensity and type of ART-related errors and further seeks to identify risk factors associated with higher error rates. Methods: Participants were identified as hospitalized adults ≥18 years old with preexisting HIV diagnosis receiving home ART from July 2015 to June 2017. Medication error categories included delays in therapy, dosing errors, scheduling conflicts, and miscellaneous errors. Logistic regression was used to examine risk factors for medication errors. Results: Mean age was 49 years, 76.5% were men, and 72.1% used hospital-supplied medication. For the primary outcome, 60.3% (41/68) of participants had at least 1 error, with 31.3% attributed to delays in therapy. Logistic regression demonstrated multiple tablet regimens (odds ratio [OR]: 3.40, 95% confidence interval [CI]: 1.22-9.48, P = .019) and serum creatinine (SCr) ≥1.5 mg/dL (OR: 8.87, 95% CI: 1.07-73.45, P = .043) were predictive for risk of medication errors. Regimens with significant drug–drug interactions (eg, cobicistat-containing regimens) were not significantly associated with increased risk of medication errors. Conclusions and Relevance: ART-related medication error rates remain prevalent and exceeded 60%. Independent risk factors for medication errors include use of multiple tablet regimens and SCr ≥1.5 mg/dL.

Adherence to HIV treatment regimens: systematic literature review and meta-analysis.

BackgroundAntiretroviral therapy (ART), when taken consistently, reduces morbidity and mortality associated with human immunodeficiency virus and viral transmission. Suboptimal treatment adherence is associated with regimen complexity and high tablet burden. Single-tablet regimens (STRs) provide a complete treatment regimen in a single tablet. This study examined the relationship between STRs (vs multiple-tablet regimens [MTRs]), treatment adherence, and viral suppression.MethodsA systematic review was conducted to identify studies investigating at least one of the following: (1) STR/MTR use and adherence; (2) levels of adherence and viral suppression; and (3) STR/MTR use and viral suppression. Meta-analysis was performed to assess the relationship between STR vs MTR use and adherence in observational settings at ≥95% and ≥90% adherence thresholds.ResultsIn total, 29 studies were identified across the three objectives; two studies were relevant for all objectives. STRs were associated with higher treatment adherence than MTRs in 10/11 observational studies: a 63% greater likelihood of achieving ≥95% adherence (95% CI=1.52–1.74; P<0.001) and a 43% increase in the likelihood of achieving ≥90% adherence (95% CI=1.21–1.69; P<0.001). Higher adherence rates were associated with higher levels of viral suppression in 13/18 studies. Results were mixed in five studies investigating the association between STR or MTR use and viral suppression.ConclusionAlthough the direct effect of STRs vs MTRs on viral suppression remains unclear, this study provided a quantitative estimate of the relationship between STRs and ART adherence, demonstrating that STRs are associated with significantly higher ART adherence levels at 95% and 90% thresholds. Findings from the systematic review showed that improved adherence results in an increased likelihood of achieving viral suppression in observational settings. Future research should utilize similar measures for adherence and evaluate viral suppression to improve assessment of the relationship between pill burden, adherence, and viral suppression.

Real-World Health Plan Data Analysis: Key Trends in Medication Adherence and Overall Costs in Patients with HIV.

Adherence to effective antiretroviral therapy (ART) is essential to achieve long-term viral suppression in patients with HIV-1. Single-tablet regimens (STRs) have improved adherence and decreased health care costs and hospitalizations, but previous study results suggest that the relationship between ART adherence and health care costs and utilization is complex. To assess ART adherence trends in patients with HIV-1 to determine if differences in utilization, demographics, and overall costs exist among patients with varying levels of medication adherence. This retrospective study analyzed medical and pharmacy claims data from an administrative claims database between January 1, 2007, and June 30, 2016, for Medicaid or commercially insured patients continuously enrolled for ≥ 6 months before and ≥ 15 months after the index date (date of first medical claim with an HIV diagnosis or pharmacy claim for HIV ART medication between July 1, 2007, and June 30, 2014). Qualifying patients were aged ≥ 18 years with a diagnosis of HIV-1 infection or at least 1 pharmacy claim for HIV ART at index and at least 2 pharmacy claims during the follow-up period. Patients were categorized on the basis of adherence as measured by proportion of days covered (PDC; ≥ 95%, highly adherent; < 95%, less adherent) and treatment with an STR or multiple-tablet regimen (MTR). Commercially insured patients were stratified by duration of follow-up data (< 3 or ≥ 3 years). There were not enough Medicaid patients for follow-up analysis. Outcomes of interest were ART adherence and annual medical and pharmacy utilization and costs. Descriptive statistics were generated, and health care resource utilization and costs were reported as annual averages. Chi-square and t-tests were used to examine differences between the cohorts. A total of 332 Medicaid patients and 1,698 patients insured commercially met inclusion criteria. Adherence to ART medication (mean PDC) during the first 15 months was lower in Medicaid patients (65%) versus commercial patients (79%; P < 0.0001). Patients treated with STRs comprised 47% and 37% of patients in the < 3-year and ≥ 3-year follow-up cohorts, respectively. More STR patients achieved ≥95% adherence than MTR patients (< 3-year follow-up, 53% vs. 39%; ≥ 3-year follow-up, 61% vs. 45%; P < 0.001). In both follow-up cohorts, less adherent patients had higher mean annual medical costs, and results were significant for patients with ≥ 3-year follow-up ($8,224 vs. $3,097; P = 0.0007). These results were largely driven by savings in mean annual inpatient costs among the highly adherent patients in both cohorts (< 3-year follow-up, -$2,525 [P = 0.0003]; ≥ 3-year follow-up, -$815 [P < 0.001]). Patients on STRs were more adherent than patients on MTRs regardless of length of follow-up. Better adherence was associated with significant inpatient cost savings. The relationship between adherence and total medical costs is nuanced depending on the duration of follow-up. This study was funded by ViiV Healthcare, which participated in protocol development, the analysis plan, and interpretation of results but did not have final approval on the decision to publish. Kangethe, Polson, Lord, and Evangelatos are employees of Magellan Rx Management, which was contracted by ViiV Healthcare to conduct the research for this study. Oglesby is an employee of ViiV Healthcare and owns stock in GlaxoSmithKline. Data from this study were previously presented at AMCP Nexus; October 16-19, 2017; Dallas, TX.

Effectiveness of antiretroviral therapy in the single-tablet regimen era.

ABSTRACTOBJECTIVE To evaluate the effectiveness of antiretroviral therapy and the associated factors according to the type of regimen used: Single Tablet Regimen or Multiple Tablet Regimen.METHODS Prospective cohort of 440 patients (male, 74.3%, median age, 36 years old) who initiated antiretroviral therapy between Jan/14 and Dec/15 at a referral service in Belo Horizonte. Efficacy was defined as viral suppression (viral load, VL < 50 copies/ml) and evaluated after six and twelve months of treatment. Sociodemographic, clinical and behavioral data were collected from clinical charts and from Information Systems. Multivariate analysis of overall effectiveness was performed by logistic regression.RESULTS Most patients initiated Multiple Tablet Regimen antiretroviral therapy (n = 255, 58%). At six months, overall viral suppression was 74.6%, being higher among patients who used Single Tablet Regimen (80.6%, p = 0.04). At twelve months, 83.2% of patients reached viral suppression, with no difference between groups (p = 0.93). Factors independently associated with viral suppression at six and twelve months varied, being negatively associated with effectiveness: VL ≥ 100,000 copies/ml, symptoms of AIDS, longer interval time between diagnosis and initiation of antiretroviral therapy, antiretroviral switching, smoking or current illicit drugs usage (p < 0.05). Factors positively associated with viral suppression included adherence to antiretroviral therapy and category of risk/exposure of men who have sex with men (p < 0.05). Reaching viral suppression at six months was the main predictor of effectiveness at one year (OR = 8.96 and p < 0.01).CONCLUSIONS Viral suppression was high and better results were achieved for patients who used Single Tablet Regimen regimens at six months. Clinical, behavioral, and antiretroviral therapy -related factors influence viral suppression and highlight the need for interventions to increase early diagnosis and initiation of antiretroviral therapy, patient’s adherence, and to reduce illicit drugs and cigarette smoking in this population.

Abacavir/lamivudine/dolutegravir single tablet regimen in patients with human immunodeficiency virus and end-stage renal disease on hemodialysis.

No single-tablet antiretroviral (ARV) regimens (STRs) are approved for patients with human immunodeficiency virus (HIV) and end-stage renal disease (ESRD) on hemodialysis (HD). Based on known pharmacokinetic (PK) properties, abacavir (ABC)/lamivudine (3TC)/dolutegravir (DTG) STR may represent a promising option. This case series presents the safety and efficacy of ABC/3TC/DTG STR in patients with HIV and ESRD on HD. Patients were included if they were HIV-positive, maintained on intermittent HD for ESRD, switched to an ARV regimen containing ABC/3TC/DTG, and had at least one set of virologic data before and after the switch. Average age (±standard deviation) was 59 (±8) years. The majority of patients were cis-gender male and non-Hispanic Black. Only one demonstrated clinically significant resistance at baseline. All were on multiple-tablet regimens prior to the switch. Five patients (83%) achieved undetectable HIV-RNA after the switch while only four patients (46%) were undetectable immediately prior. No decline in immune function was noted. ABC/3TC/DTG STR was well tolerated. Only one patient self-reported an adverse event (nausea), which resolved without drug discontinuation. Based on these data, it appears that ABC/3TC/DTG may be a safe and effective ARV-STR option for patients with HIV and ESRD on HD. A larger trial including a PK analysis is needed to confirm these findings.