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Background and Objective Many people living with HIV (PLWH) on stable tenofovir disoproxil fumarate (TDF)-containing regimens have switched to tenofovir alafenamide (TAF), despite the potential lipid-lowering effect of TDF. We aimed to assess the impact of switching from TDF to TAF on lipids in real-world clinical practice. Methods PLWH prescribed TDF for ≥ 4 weeks who switched to TAF were identified in the OPERA cohort. Patterns of dyslipidemia were compared before and after switch based on NCEP ATPIII guidelines. Elevated 10-year risk of atherosclerotic cardiovascular disease (ASCVD ≥ 7.5%) and statin use were assessed. Results Among 6423 PLWH switched from TDF to TAF, the proportion with dyslipidemia/severe dyslipidemia observed after switch from TDF to TAF increased statistically significantly (p < 0.0001) with total cholesterol (5–10%), low-density lipoprotein cholesterol (16–23%), and triglycerides (21–27%), but decreased statistically significantly with high-density lipoprotein cholesterol (35–30%, p < 0.0001). These patterns of dyslipidemia persisted in sensitivity analyses restricted to PLWH who maintained all other antiretrovirals (N = 4328) or stratified by pharmaco-enhancer use before and after switch. An elevated ASCVD risk was detected in 29% before and 31% after switch. As many as 59% of PLWH with an elevated ASCVD risk were not prescribed a statin after switch from TDF to TAF. Conclusions In this large, diverse population of PLWH in the USA, the switch from TDF to TAF was associated with development of less favorable lipid profiles, regardless of pharmaco-enhancers or third-agent use. Statins remained underutilized after a switch from TDF to TAF.

To describe the burden of comorbid conditions and comedications among people living with HIV (PLWH) vs. people living without HIV (PLWoH). This was a case–control study conducted among insured patients using administrative claims data. Adult PLWH were identified by antiretroviral therapy (ART) claims or HIV/AIDS diagnosis codes from 1 January 2018 to 31 December 2018 (index date was set by the earliest claim). Continuous enrollment was required for ≥12 months pre-index (baseline) and ≥30 days post-index (follow-up). Patients were required to have ≥1 HIV diagnosis during baseline or follow-up. Those with only HIV prophylaxis were excluded. PLWoH were matched 2:1 to PLWH on demographic characteristics. Study outcomes were compared using z-tests with robust standard errors in an ordinary least squares regression or Rao–Scott tests. The study included 20,256 PLWH and 40,512 matched PLWoH, mean age 52 years. PLWH vs. PLWoH had higher mean (SD) Charlson comorbidity index scores (0.93 [1.59] vs. 0.61 [1.28]; p < .001) and a greater proportion had ≥1 comorbidity (69.1% vs. 54.5%, p < .001). The most prevalent comorbidities included hypertension (33.9% vs. 32.2%; p < .001), hyperlipidemia (29.4% vs. 24.6%; p < .001), chronic kidney disease (13.6% vs. 9.4%, p < .001), depression (13.1% vs. 7.3%, p < .001) and substance abuse (12.8% vs. 7.1%, p < .001). Mean (SD) non-ART prescription fills were higher among PLWH vs. PLWoH (11.9 [10.1] vs. 9.2 [9.4]; p < .001). Multimorbidity and polypharmacy were more prevalent among PLWH vs. matched PLWoH. Findings support the need to consider comorbidities and comedications when choosing ART and to minimize drug–drug interactions and adverse events to improve patient outcomes.

Background Increases in lipids have been observed in people with HIV (PWH) switching from tenofovir disoproxil fumarate (TDF) to tenofovir alafenamide (TAF). We assessed changes in low-density lipoprotein cholesterol (LDL-C) and triglycerides (TG) following a switch from TDF to TAF. Methods Adults with ≥1 lipid measure before and after switch from TDF to TAF were identified in the OPERA cohort. Multivariable linear regression using generalized estimating equations was used to estimate predicted changes in lipids over time on TAF, modeled flexibly with linear splines. Results A total of 6451 PWH switched from TDF to TAF, of whom 4328 maintained all other agents. LDL-C increased significantly by 1.40 mg/dL/mo over the first 3 months on TAF, by 0.33 mg/dL/mo between 3 and 9 months and then plateauing beyond 9 months. TG increased significantly by 3.52 mg/dL/mo over the first 3 months of TAF, by 0.91 mg/mL/mo between 3 and 9 months and by 0.72 mg/mL/mo between 9 and 16 months, but decreased thereafter. Similar patterns were observed in analyses restricted to PWH who switched from TDF to TAF but maintained all other agents. Conclusions TDF-to-TAF switch was associated with LDL-C and TG increases over the first 9 to 16 months on TAF. The dynamic patterns observed cannot be attributed to changes in other agents.

Objectives: This study compared healthcare utilization and costs associated with switching the first-line protease inhibitor (PI) or non-nucleoside reverse transcriptase inhibitor (NNRTI) based ant...

Introduction Although weight gain has been reported with the use of integrase strand transfer inhibitors (InSTI), concurrent use of tenofovir alafenamide (TAF) has been implicated in recent studies. This study examined weight changes in people living with HIV (PLWH) who switched from tenofovir disoproxil fumarate (TDF) to TAF, to clarify the relative contribution to weight gain of core agents versus TDF to TAF switch. Methods Antiretroviral‐experienced, virologically suppressed PLWH in the U.S. OPERA cohort were included if they switched from TDF to TAF (5NOV2015‐28FEB2019) and either maintained all other antiretrovirals or switched from a non‐InSTI to an InSTI. Linear mixed models were used to assess weight changes before/after the switch to TAF (restricted cubic splines on time) and rates of change over time (linear splines on time, based on the shape of the weight change curves). Changes in weight on TDF or TAF were assessed among those who maintained other antiretrovirals (overall, by core class), and those who maintained an InSTI or switched to an InSTI (by core agent). All models were adjusted for age, sex, race, (age‐sex, race‐sex interactions), BMI, CD4 cell count, endocrine disorders and concurrent medications that could affect weight. Results A total of 6908 PLWH were included, with 5479 maintaining all other antiretrovirals (boosted protease inhibitor: 746, non‐nucleoside reverse transcriptase inhibitor: 1452, InSTI: 3281) and 1429 switching from a non‐InSTI to an InSTI (elvitegravir/cobicistat: 1120, dolutegravir: 174, bictegravir: 129). In adjusted models, modest weight gain was observed over time on TDF for most (0.24 to 0.71 kg/year); raltegravir was the exception with weight loss. Switching to TAF was associated with early, pronounced weight gain for all (1.80 to 4.47 kg/year). This effect with TAF switch was observed both in PLWH maintaining other antiretrovirals and those switching to an InSTI, regardless of which InSTI agent was used. Weight gain tended to slow down or plateau approximately nine months after switch to TAF. Conclusions In this large, diverse U.S. cohort of PLWH, switching from TDF to TAF was associated with pronounced weight gain immediately after switch, regardless of the core class or core agent, suggesting an independent effect of TAF on weight gain.

Background Advances in antiretroviral therapies (ART) have resulted in people living with HIV (PLWH) living longer with higher risk for age-related comorbid conditions and polypharmacy. The aim of this study was to describe trends in comorbidity and comedication burden in PLWH over a 5-year time period. Methods A retrospective analysis of commercial and Medicare Advantage enrollees from the Optum Research Database was conducted. Annual cohorts of PLWH were constructed for each calendar year from 2014-2018 and included adults (≥ 18 years) with ≥ 1 pharmacy claim for an ART or medical claim with an HIV/AIDS diagnosis code (index date=earliest claim date in each calendar year). Continuous health plan enrollment of 12 months prior to (baseline), and 30 days after index date was required for each annual cohort. Comorbidities were identified using ICD-9/10 diagnosis codes from medical claims during baseline period and comedications from pharmacy/medical claims in the 90-days prior to index using National Drug Codes. Charlson Comorbidity Index (CCI) was computed excluding HIV/AIDS. P-for-trend values accounting for clustering by patients across calendar years were assessed. Results Overall, 14,222 - 20,249 PLWH who were enrolled in commercial (80.7%-65.4%) or Medicare Advantage (19.3%-34.6%) plans were identified in 2014 - 2018 calendar years. Notable trends in demographics of PLWH were observed across years, including increases in mean age (48.9 to 52.4 years), proportion of females (17.2% to 20.3%) and Black race (25.9% to 29.0%), all p-trend< 0.001. Mean CCI scores increased across years (0.72 to 0.93), p-trend< 0.001. Multimorbidity (≥2 non-HIV conditions) and polypharmacy (≥ 5 non-ART medications) prevalence increased over 5 years (Figure 1). Hypertension, hyperlipidemia, neuropsychiatric conditions and Type 2 diabetes mellitus were the most prevalent comorbid conditions with statistically significant upward trends in prevalence across years (Figure 1). Conclusion Multimorbidity and polypharmacy are common in PLWH and have been increasing in prevalence over the past 5 years. Study findings highlight the importance of an individualized approach to care for a diverse PLWH population, in order to minimize drug-drug interactions and adverse events and thereby improve patient outcomes. Figure 1. Comorbidity and Comedication Trends by Index Year among People Living with HIV Disclosures Misti Paudel, PhD, Merck (Other Financial or Material Support, This study was funded by Merck & Co.) Girish Prajapati, M.B.B.S., MPH , Merck & Co., Inc. (Employee, Shareholder) Erin K. Buysman, MS, Merck & Co., Inc. (Other Financial or Material Support, I am an employee of Optum, which was contracted by Merck to complete the research described in this abstract) Jianbin Mao, PhD, Merck & Co. (Employee, Shareholder) Kimberly McNiff, MPH, Merck (Other Financial or Material Support, Merck funded the research project) Princy N. Kumar, MD, Amgen (Consultant)Eli Lilly (Grant/Research Support)Gilead (Consultant, Grant/Research Support, Shareholder)GSK (Consultant, Grant/Research Support, Shareholder)Merck (Consultant, Grant/Research Support, Shareholder, Honoraria)

Background Among the 1.2 million people living with HIV (PLWH) in the U.S., many are covered by Medicare, a federally funded health insurance program for elderly (≥65 years) and disabled (< 65 years) individuals. Medicare has emerged as a major source of HIV care for PLWH. Given limited research in this population, a better understanding of patient characteristics, comorbidities, and comedication use among PLWH in the Medicare program is needed to help optimize clinical care. Methods A retrospective claims analysis of a national cross-sectional sample of fee-for-service (FFS) Medicare beneficiaries with continuous medical and prescription coverage in 2018 was conducted using 100% Medicare administrative claims. The PLWH group included individuals with ≥1 HIV diagnosis code in medical claims and ≥1 pharmacy claim for an anchor antiretroviral (ARV) drug (i.e., NNRTI, PI or InSTI) in 2018. The comparison group included a random sample of Medicare beneficiaries without HIV (PLWoH). Sociodemographic characteristics, comorbidities, and medication use were compared between PLWH and PLWoH. Results The study sample included 86,856 PLWH and 552,645 PLWoH. PLWH were more likely to be younger (mean age: 57.4 vs 71.1 years and < 65 years: 72% vs 18%), male (75% vs 42%), Black (42% vs 10%), eligible for Medicare due to disability (83% vs 27%) and receiving full low-income subsidies (77% vs 31%); all p< 0.001. Prevalence of >3 comorbidities was high in PLWH (70.2%) and only slightly lower than in PLWoH (71.7% p< 0.001). Prevalence of neuropsychiatric conditions, chronic kidney disease, liver disease, COPD, hepatitis B, and hepatitis C were higher in PLWH (Figure 1). The mean hierarchical condition categories risk score was higher in PLWH vs PLWoH (1.81 vs. 1.32; p< 0.001). On average, polypharmacy was higher among PLWH vs PLWoH (annual number of unique medications: 12.6 vs. 9.4 for all drugs and 10.3 vs. 9.4 for non-ARV drugs, both p< 0.001). Figure 1. Percentage of PLWH and PLWoH with multimorbidity and selected comorbid conditions. Abbreviations: COPD=chronic obstructive pulmonary disease; GI=gastrointestinal; PLWH=people living with HIV; PLWoH=people living without HIV All p-values Conclusion In the Medicare FFS population, multimorbidity and polypharmacy were highly prevalent in PLWH despite their substantially younger age compared to PLWoH. Our findings highlight the need to consider comorbidities and comedications in HIV management including ARV regimens to minimize medication burden and drug interactions, which might improve clinical outcomes. Disclosures Pengxiang Li, PhD, Avalon Health Economics LLC (Consultant)COVIA Health Solutions (Consultant)Healthstatistics, LLC (Consultant) Jianbin Mao, PhD, Merck (Employee)Merck (Shareholder) Girish Prajapati, M.B.B.S., MPH , Merck & Co., Inc. (Employee, Shareholder) Robert Gross, MD, MSCE, Pfizer (Other Financial or Material Support, Serve on DSMB for drug unrelated to HIV) Jalpa A. Doshi, PhD, Acadia (Consultant, Advisor or Review Panel member)Allergan (Advisor or Review Panel member)Biogen (Grant/Research Support)Boehringer Ingelheim (Other Financial or Material Support, Scientific lecture)Catabasis (Consultant)Humana (Grant/Research Support)Janssen, Inc. (Consultant, Grant/Research Support)MeiraGTX (Consultant)Merck (Grant/Research Support, Advisor or Review Panel member)Novartis (Grant/Research Support)Otsuka (Advisor or Review Panel member)Regeneron (Grant/Research Support)SAGE Therapeutics (Consultant)Sanofi (Grant/Research Support)Shire (Advisor or Review Panel member)The Medicines Company (Advisor or Review Panel member)

OBJECTIVES The aim of the study was to assess the validity of an easy-to-calculate chronic kidney disease (CKD) risk score developed by the Data Collection on Adverse Events of Anti-HIV Drugs (D:A:D) group in a longitudinal observational study of people living with HIV (PLWH) in the USA. METHODS PLWH (2002-2016) without prior exposure to potentially nephrotoxic antiretroviral agents and with at least three estimated glomerular filtration rate (eGFR) test results were identified in the Observational Pharmaco-Epidemiology Research and Analysis (OPERA® ) cohort. Three samples were drawn independently using the same eligibility criteria but each using a different eGFR equation, specifically the Cockcroft-Gault (C-G), Modification of Diet in Renal Disease (MDRD) or Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) eGFR estimation method. Full and short D:A:D risk scores were applied. CKD was defined as a confirmed decrease in eGFR to < 60 mL/min/1.73 m2 (stages 3-5). Poisson models estimated the association between CKD incidence and a one-point increase in the continuous risk score. The incidence rate ratio (IRR), adjusted IRR (aIRR), and Harrell's discrimination statistic were used to assess validity. RESULTS There were 19 444, 22 727 and 22 748 PLWH in the OPERA C-G, CKD-EPI and MDRD samples, respectively. The median (minimum-maximum) follow-up duration was 6.1 (0.3-9.1) years in the D:A:D cohort and ranged from 3.2 to 3.5 (0.2-15.5) years in the OPERA validation samples. The observation time for the majority of PLWH in the D:A:D cohort began prior to 2006, in stark contrast to the OPERA validation samples, where the majority of PLWH were observed after 2011. The CKD incidence ranged from 7.3 per 1000 person-years [95% confidence interval (CI) 6.8, 7.9 per 1000 person-years] in OPERA C-G to 11.0 (95% CI 10.4, 11.6 per 1000 person-years) in OPERA MDRD. In OPERA samples, IRRs by risk group and adjusted IRRs (full risk score) were similar to those in the D:A:D derivation cohort (adjusted IRR 1.3; 95% CI 1.3, 1.3). Harrell's c-statistic ranged from 0.87 to 0.92 in the OPERA samples, comparable to that in the derivation cohort (0.92). Results for short scores were similar. CONCLUSIONS The findings support the validity of the D:A:D risk scoring method for assessing CKD (stages 3-5) probability in an exclusively USA-based sample regardless of eGFR method.

In this prospective, observational, multicentre study using data from five countries (Columbia, The Philippines, Portugal, Taiwan and Thailand), the clinical impact of extended-spectrum β-lactamase (ESBL)-producing organisms on hospitalised patients with community-acquired complicated intra-abdominal infections (CA-cIAIs) was compared with that of non-ESBL-producing organisms during the period April 2010 to December 2011. Adult patients (aged ≥18 years) requiring surgery or percutaneous drainage were enrolled and were followed during the first hospitalisation course. An unadjusted statistical comparison of risk factors for ESBL-positive and ESBL-negative patients was performed. Multivariate regression analyses were performed to assess whether length of stay (LOS) in hospital, clinical cure rate and some important clinical characteristics were associated with ESBL positivity. During the study period, a total of 105 adult patients from five countries were enrolled, of whom 17 (16.2%) had CA-cIAI due to ESBL-positive organisms and 88 (83.8%) had CA-cIAI due to ESBL-negative organisms. Escherichia coli was isolated in 73.3% of all samples. Infections were cured in 8 (47.1%) of the patients with CA-cIAI due to ESBL-positive organisms and in 59 (67.0%) of the patients with CA-cIAI due to ESBL-negative organisms (P=0.285). The median LOS was 11.6 days for patients with infections due to ESBL-negative organisms and 17.6 days for patients with infections due to ESBL-positive organisms (P=0.011). Multivariate logistic regression analysis revealed that pre-existing co-morbidities, but not ESBL positivity, were adversely associated with clinical cure of CA-cIAIs. In contrast, duration of hospitalisation was longer for patients with CA-cIAI due to ESBL-positive organisms.

OBJECTIVE: To quantify the health-related quality of life (HRQoL) burden of hepatitis C virus (HCV) infection among a broad sample of adults in Brazil, particularly among those 40 years of age and older. METHODS: This was a retrospective observational study of data from the 2011 Brazil National Health and Wellness Survey, a large (n = 12 000) cross-sectional survey that includes information on medical conditions and health outcomes, including the Medical Outcomes Study Short-form 12 health questionnaire, version 2 (SF-12v2). Respondents who reported a physician diagnosis of HCV infection were compared with those who reported never experiencing HCV on the Mental (MCS) and Physical (PCS) Component Summary scores and SF-6D health utility scores. Unadjusted comparisons were conducted with chi-square tests for categorical variables and t-tests for continuous variables. Regression was used to adjust outcomes for potential confounds. Subgroup analyses were conducted on those 40 years of age and older. RESULTS: Unadjusted comparisons between respondents infected with HCV (n = 100) and controls (n = 11 694) revealed similar MCS and PCS scores, but HCV patients had lower SF-6D utility scores (0.70 vs. 0.73, P < 0.05). Regressions adjusting for demographic and health characteristics provided similar results to unadjusted comparisons. Subgroup analyses of respondents 40 years of age and older revealed decrements in both MCS (45.95 vs. 49.72, P < 0.05) and SF-6D (0.71 vs. 0.76, P < 0.05). PCS scores were comparable in HCV patients and controls. CONCLUSIONS: HCV infection in Brazil causes significant HRQoL burden, especially among the older population. Prevention measures to curtail the spread of the virus in Brazil should provide societal benefits in terms of quality of life, in addition to preventing morbidity and mortality from chronic infection.

Background People living with HIV (PLWH) have been observed to have twice the risk for atherosclerotic cardiovascular disease (ASCVD) as the general population. Increases in total and low-density lipoprotein cholesterol have been observed in PLWH switching from tenofovir disoproxil fumarate (TDF) to tenofovir alafenamide (TAF). Changes in regimens represent an opportunity for healthcare providers to assess health markers and address clinical concerns. Current guidelines recommend initiating statin therapy in individuals with an elevated ASCVD risk. Failure to initiate statins in PLWH with an ASCVD ≥ 7.5% at switch represents a missed opportunity for statin initiation. We aimed to assess missed opportunities for statin therapy in PLWH switching from TDF to TAF-containing antiretroviral therapy. Methods Adults switching from TDF to TAF with ≥1 lipid measure on TDF ≤6 months prior to switch and ≥1 lipid measure ≥7 days after switch to TAF were identified in the OPERA® cohort (84 clinics in 18 US states/territories). The proportion of PLWH prescribed statins pre- and post-switch was stratified by ASCVD risk (recommended threshold: ASCVD ≥ 7.5%). The ASCVD score was imputed using the limit value for components out of the pre-specified range. Results 6,451 PLWH switched from TDF to TAF (Figure 1); over 90% had ASCVD scores available pre- (n = 5801) and post-switch (n = 5881). High ASCVD risk (≥7.5%) was more likely post-switch (34.1) than pre-switch (32.1%, P = 0.02; Figure 2). Of those with high ASCVD risk, only 31% and 41% were prescribed statins pre- vs. post-switch, respectively (Figure 3), representing a considerable missed opportunity for ASCVD prevention, with 59% of PLWH with an elevated risk of ASCVD not prescribed statins after switch from TDF to TAF. ASCVD scores were imputed for those outside the range of the score (e.g., patients < 40 years of age) to evaluate the entire population. Comparable results were obtained when the analysis was limited to PLWH who did not require ASCVD score imputation. Conclusion Despite a switch from TDF to TAF being associated with higher numbers of PLWH with elevated ASCVD risk, most did not receive a statin, representing considerable missed opportunities to reduce risk of cardiovascular disease in this at-risk population. Disclosures All authors: No reported disclosures.

Background Raltegravir has been used to treat HIV infection for over a decade. In 2017, a 1200 mg, once-daily, formulation of raltegravir (RALQD) was approved. We sought to characterize the utilization and effectiveness of RALQD in ART-experienced, virologically suppressed, HIV+ adults in a real-world cohort of patients treated in the United States. Methods HIV+ adults, suppressed to = 200 copies/mL or 1 VL ≥ 200 copies + RALQD discontinuation. Kaplan–Meier methods were used to describe VF. Results The study eligible population (n = 121) was older (median 54 years, IQR: 44, 61) than the overall ART experienced OPERA population (median 47 years, IQR: 35, 55), equally as likely to be male (84% vs. 83%), or African American (38%), but more likely to be Hispanic (23% vs. 20%) and receiving care in the southern United States (61% vs. 56%). RALQD initiators were also more likely to be heavily treatment experienced (≥3 lines ART) than the overall ART experienced OPERA population (57% vs 43%). They were also more likely to have at least one comorbid condition complicating their care (88% vs. 72%), most frequently hyperlipidemia (50%), hypertension (47%), anemia (26%), anxiety disorders (25%) and diabetes (22%). Half of all RALQD initiators had ≥3 comorbidities at the time of RALQD initiation. Two-thirds of RALQD initiators had baseline CD4 cell counts >500 cells/µL. Median (IQR) time on RALQD was 57 weeks (43–65); 89% of RALQD initiators had ≥1 VL test result during follow-up. Among these patients, VF occurred in 3 patients at a rate of 2.7 (0.9, 8.4) per 100 person years of observation. Figure 1 depicts Kaplan–Meier curves. Conclusion RALQD was found to be an effective treatment option in ART experienced patients who are virologically suppressed at initiation, and who often face challenges associated with managing comorbid conditions. Disclosures All authors: No reported disclosures.

Poor adherence to antiretroviral therapies (ARTs) in human immunodeficiency virus (HIV)-infected patients increases the risk of incomplete viral suppression, development of viral resistance, progression to acquired immune deficiency syndrome and death. This study assesses the impact of specific treatment-related adverse events (AEs) on adherence to ART in the adult HIV patient population. A systematic review of studies involving adult HIV-infected patients aged ≥ 16 years that reported an odds ratio (OR) for factors affecting adherence to ART was conducted through a search of the EMBASE(®) and Medline(®) databases. Database searches were complemented with a search of titles in the bibliographies of review papers. Studies conducted in populations limited to a particular demographic characteristic or behavioural risk were excluded. To qualify for inclusion into a meta-analysis, treatment-related AEs had to be defined similarly across studies. Also, multiple ORs from the same study were included where study sub-groups were distinct. Random effects models were used to pool ORs. In total, 19 studies and 18 ART-related AEs were included in meta-analyses. Adherence to ART was significantly lower in patients with non-specific AEs than in patients who did not experience AEs [OR = 0.623; 95% confidence interval (CI): 0.465-0.834]. Patients with specific AEs such as fatigue (OR = 0.631; 95% CI: 0.433-0.918), confusion (OR = 0.349; 95% CI: 0.184-0.661), taste disturbances (OR = 0.485; 95% CI: 0.303-0.775) and nausea (OR = 0.574; 95% CI: 0.427-0.772) were significantly less likely to adhere to ART compared to patients without these AEs. Knowledge of specific treatment-related AEs may allow for targeted management of these events and a careful consideration of well-tolerated treatment regimens to improve ART adherence and clinical outcomes.

Hepatitis C virus (HCV) infection is widespread and associated with high economic costs and reduced quality of life, but the impact of untreated HCV infection on patient outcome is not well understood. To estimate the impact of untreated HCV infection on work productivity, daily activity, healthcare use, economic costs, and health-related quality of life (HRQoL). Respondents to the 2010 US National Health and Wellness Survey (n = 75,000) reporting physician diagnosis of HCV infection but not current or previous treatment (patients) were matched to respondents without HCV infection (controls) by use of propensity scores. Those reporting infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV) were excluded. Self-reported work impairment, activity impairment, healthcare resource use, and HRQoL were compared between patients and controls. Indirect and direct costs were estimated. A total of 306 patients met inclusion criteria. Patients were more impaired at work than controls, with overall work impairment of 26 % versus 15 %, respectively (P

Background Raltegravir (RAL) 400 mg twice-daily (RAL BID) has been an integral part of antiretroviral therapy (ART) in both ART naïve and experienced HIV-1 infected patients for the last decade. In 2017, RAL 1,200 mg (2 × 600 mg), a once-daily formulation (RAL QD) was approved. The objective of this study was to characterize the early utilization of RAL QD in the United States. Methods This is an ongoing cohort study of HIV-1 infected adults with ≥1 prescription for RAL QD in the OPERA® Observational Database, the product of a collaboration of HIV caregivers in 84 clinics across 17 states following over 80,000 people living with HIV through their prospectively collected electronic medical records. Baseline demographic, clinical and laboratory characteristics of patients who initiated RAL QD between July 1 and December 31, 2017 (study window) were analyzed using descriptive statistics. Results A total of 175 patients were prescribed RAL QD during the study window; 57.1% of whom were ≥50 years of age, 80.6% male, 41.1% African American, and 20.0% Hispanic (Figure 1). RAL QD was most often given with emtricitabine/tenofovir (TDF or TAF): 56.0%, abacavir/lamivudine: 8.0%, and darunavir/cobicistat: 4.6%. Twelve patients (7%) were ART naïve, 45 (26%) switched from non-RAL-based regimens, and 118 patients (67%) were previously on RAL BID, most of whom (86%) had no other regimen changes other than switching to RAL QD. A majority (80%) of patients initiated RAL QD with a viral load 350 cells/mm3; 64.0% >500 cells/mm3. Overall, a third of patients had a history of an AIDS-defining illness. Eighty-one percent of patients had at least one of the comorbidities depicted in Figure 2; 45.7% with hypertension, 42.9% hyperlipidemia, 26.7% anxiety disorders, 26.3% anemia and 19.4% with diabetes. The median number of prescriptions for concomitant medications prescribed with RAL QD regimens was 5 (IQR: 4–8). Conclusion Early initiators of RAL QD are primarily treatment-experienced individuals, older than 50 years of age with virologic and immunologic control, significant comorbid conditions and the burden of medications that treat those conditions. Disclosures J. Fusco, Epividian, Inc.: Employee, Salary. Merck & Co.: Merck contracted research with my employer, Epividian, Inc., Employer received funding for research. J. M. Arduino, Merck Sharp & Dohme Corp: Employee and Shareholder, Salary. G. Prajapati, Merck & Co., Inc.: Employee and Shareholder, Salary. G. Fusco, Epividian, Inc.: Employee, Salary. Merck & Co.: Merck research contract with Epividian, employer received funding to perform analysis.

Background Initial antiretroviral therapy (ART) is modified for non-virologic failure reasons in many patients, and the healthcare resource utilization (HRU) and costs associated with these switches in the real world is not well understood. Methods Administrative claims data from the Optum Research and Impact National Benchmark Databases were utilized. Adult patients (≥18 years) with HIV-1 diagnosis code, and claim for an anchor agent of the protease inhibitor (PI) or non-nucleoside reverse transcriptase inhibitor (NNRTI) class in first-line ART between July 1, 2006 and December 31, 2015 were identified (see Figure 1 for addl. criteria). Patients with a claim for an anchor agent (PI or NNRTI) different from that in first-line ART were defined as switchers, with index date as date of first claim for new anchor agent. Switchers were matched to patients who did not switch (non-switchers) at 1:3 ratio using propensity score matching on patient and first-line ART characteristics. For non-switchers, date following corresponding duration of first-line ART in matched switcher was assigned as index date. Per-patient-per-month (PPPM) all-cause HRU and costs (US$) during switch period (±15 days of index date) were compared descriptively. Results 11,302 patients met study criteria. After matching, switcher (1,204) and non-switcher (3,612) groups were comparable on mean age (41.9 vs. 41.7 years), percent male (85.8% vs. 82.6%), percent commercial enrollee (96.0% vs. 95.8%), mean Quan-Charlson comorbidity index score (both 0.4), and mean ART pill burden (both 2.2) with standard difference less than absolute value of 10%. During switch period, switchers had higher mean PPPM ambulatory visits (2.30 vs. 1.26), emergency room visits (0.12 vs. 0.06), inpatient stays (0.04 vs. 0.01), and pharmacy fills (4.52 vs. 3.01) than non-switchers (all P < 0.001). Switchers also incurred greater mean PPPM costs during switch than non-switchers, with an additional $2,261/month total cost, and $1,031/month pharmacy cost (Figure 2). Conclusion The study gives a more complete view of the burden of switching initial ART with pharmacy costs driving this burden. Assuming some patients will switch regardless of the regimen selected, less expensive initial ART could reduce this burden further. Disclosures M. Johnson, Merk & Co: Research Contractor, research funded by Merk; J. Mcpheeters, Merck & Co.: Research Contractor, Sarary from Optum; G. Prajapati, Merck & Co., Inc.: Employee, Salary; A. Beyer, Merck & Co., Inc: Employee and Shareholder, Salary

To quantify the health-related quality of life (HRQoL) burden of hepatitis C virus (HCV) infection among a broad sample of adults in Brazil, particularly among those 40 years of age and older.This was a retrospective observational study of data from the 2011 Brazil National Health and Wellness Survey, a large (n = 12 000) cross-sectional survey that includes information on medical conditions and health outcomes, including the Medical Outcomes Study Short-form 12 health questionnaire, version 2 (SF-12v2). Respondents who reported a physician diagnosis of HCV infection were compared with those who reported never experiencing HCV on the Mental (MCS) and Physical (PCS) Component Summary scores and SF-6D health utility scores. Unadjusted comparisons were conducted with chi-square tests for categorical variables and t-tests for continuous variables. Regression was used to adjust outcomes for potential confounds. Subgroup analyses were conducted on those 40 years of age and older.Unadjusted comparisons between respondents infected with HCV (n = 100) and controls (n = 11 694) revealed similar MCS and PCS scores, but HCV patients had lower SF-6D utility scores (0.70 vs. 0.73, P0.05). Regressions adjusting for demographic and health characteristics provided similar results to unadjusted comparisons. Subgroup analyses of respondents 40 years of age and older revealed decrements in both MCS (45.95 vs. 49.72, P0.05) and SF-6D (0.71 vs. 0.76, P0.05). PCS scores were comparable in HCV patients and controls.HCV infection in Brazil causes significant HRQoL burden, especially among the older population. Prevention measures to curtail the spread of the virus in Brazil should provide societal benefits in terms of quality of life, in addition to preventing morbidity and mortality from chronic infection.

Discussion Those tested for HIV were all Non – Reactive; shows the effectiveness of PEP services. We are finding obstacles on follow up tracking like “I am much aware about the risk, stigma of HIV Positivity, negligence for follow up and confidentiality issues at the workplace etc.” that prevent the HCP for PEP and increase the risk of transmission. Practice and regular sensitization with UPW has increased the awareness among HCP for reducing HIV infection risk and transmission and prevention through PEP. Published: 11 May 2010

Background To share our experience in second line Anti Retroviral Therapy (ART) at State AIDS Clinical Expert Panel (SACEP) Clinic, Centre of Excellence (CoE), ART Centre, B. J. Medical College, Civil Hospital, Ahmedabad, Gujarat, India. Methods First line treatment failure Patients (as per Indian National ART Guidelines) were referred to SACEP Clinic for further evaluation and if eligible as per Indian National 2 Line ART Guidelines; enrolled and followed up for initiation of 2 Line ART at our institute.

Discussion The clinical goals of HIV treatment are optimally accomplished through consistent high-level adherence to Highly Active Anti Retroviral Therapy (HAART) and sustained virological suppression through cost effective regimen (2NRTIs+1NNRTI). At the end of more than 4 years total suspected IF patients are only 73 (2.13%) of which only 49 (1.70%) has actual virological failure; shows the efficacy of the 1 Line ART. Failure to access care and discontinuation of or non-adherence to ART are the most important factors associated with the progression of HIV disease. Published: 11 May 2010

Background Few studies have examined the impact of Hepatitis C virus (HCV) infection on patient reported outcomes in Europe. This study was conducted to assess the burden of HCV infection in terms of work productivity loss, activity impairment, health-related quality of life, healthcare resource utilization, and associated costs. Methods The 2010 European National Health and Wellness Survey (n = 57,805) provided data. Patients reporting HCV infection in France, Germany, the UK, Italy, and Spain were matched to respondents without HCV using propensity scores. Outcome measures included the Work Productivity and Activity Impairment (WPAI) questionnaire and the Medical Outcomes Study Short Form-12 (SF-12v2) questionnaire. Subgroup analyses focused on treatment-naïve patients. Results HCV Patients (n = 286) had more work impairment (30% vs. 18%, p p p p p n = 139) also reported higher work impairment (29% vs. 15%, p p p p Conclusion HCV infection in Europe is associated with considerable economic and humanistic burden. This is also true of diagnosed patients who have never been treated for HCV.

Background: The societal impact of current HCV infections is expected to rise as patients develop liver cirrhosis and cancer. This study assessed productivity loss, healthcare resource utilization, and health related quality of life (HRQoL) in treatment naive HCV patients in the EU. Methods: Adult subjects without HBV or HIV infection in the 2010 wave of the EU National Health and Wellness Survey, conducted by Kantar Health, were analyzed. Propensity score was used to match untreated physician diagnosed HCV patients with individuals without HCV. The study cohort was assessed for work productivity [percentage of work time missed (absenteeism) and percentage of impairment experienced while at work (presenteeism) because of one’s health in past seven days] and activity impairment; indirect costs [annual lost wages due to absenteeism and presenteeism]; healthcare resource utilization [outpatient and ER visits, hospitalization in past 6 months]; and HRQoL [MOS-SF12v2 based Physical and Mental Component Summary (PCS and MCS), and Health Utility score]. Comparisons were made using chi-square for categorical, and t-tests and Mann-Whitney-U non-parametric tests for continuous outcomes. Results: Of 57,172 survey respondents, 139 reported a diagnosis of HCV infection with no treatment history [France (26), Germany (26), the UK (19), Italy (48), and Spain (20)] and 139 matched controls were selected from non-HCV subjects from same countries in equal numbers. The mean age of HCV patients was 55.1 years and 62% were male. Non-HCV individuals were, on average, 53.1 years old and 54% were male. HCV patients versus matched non-HCV subjects had higher presenteeism (24.84% vs. 12.86%; P = 0.006) and overall work impairment (28.65% vs. 14.75%; P = 0.004), on average, greater indirect costs (€6201.83 vs. €3447.32; P = 0.009), more provider visits (19.54 vs. 12.06; P = 0.001), and lower PCS score (43.49 vs. 45.99; P = 0.048). When compared to non-HCV individuals, HCV patients also had higher absenteeism and activity impairment, more frequent ER visits and hospitalizations, and poorer mean MCS and SF6D Utility scores. However, the differences did not reach statistical significance (all P > 0.05). Conclusion: In the absence of treatment, HCV infection was associated with greater work productivity loss and related indirect costs, poorer physical health, and greater outpatient services utilization.

Methods All the ICTC confirmed HIV Positive Patients were registered and initiated with FDC ART at ART Center of the Institute as per Indian National ART Guidelines; recommends the use of 2 NRTIs (ZDV/d4T + 3TC) + 1 NNRTI (EFV/NVP). Baseline parameters like CD4 count, necessary laboratory investigations, TB Workup and adherence counseling were carried out and on follow up. Depending on the level of hemoglobin NRTIs were chosen.