Role of Visit Modality in the HIV-Related No-Shows During the COVID-19 Pandemic: A Multisite Retrospective Cohort Study.

The emergence of the COVID-19 pandemic necessitated rapid expansion of telehealth as part of healthcare delivery. This study compared HIV-related no-shows by visit type (in-person; video; telephone) during the COVID-19 pandemic (April 2020-September 2021) from the Data for Care Alabama project. Using all primary care provider visits, each visit's outcome was categorized as no-show or arrived. A logistic regression model using generalized estimating equations accounting for repeat measures in individuals and within sites calculated odds ratios (OR) and their accompanying 95% confidence interval (CI) for no-shows by visit modality. The multivariable models adjusted for sociodemographic factors. In-person versus telephone visits [OR (95% CI) 1.64 (1.48-1.82)] and in-person versus video visits [OR (95% CI) 1.53 (1.25-1.85)] had higher odds of being a no-show. In-person versus telephone and video no-shows were significantly higher. This may suggest success of telehealth visits as a method for HIV care delivery even beyond COVID-19.

Assessing the Impact of COVID-19 on Retention in HIV Primary Care: A Longitudinal Multisite Analysis.

We compared retention in care outcomes between a pre-COVID-19 (Apr19-Mar20) and an early-COVID-19 (Apr20-Mar21) period to determine whether the pandemic had a significant impact on these outcomes and assessed the role of patient sociodemographics in both periods in individuals enrolled in the Data for Care Alabama project (n = 6461). Using scheduled HIV primary care provider visits, we calculated a kept-visit measure and a missed-visit measure and compared them among the pre-COVID-19 and early-COVID-19 periods. We used logistic regression models to calculated odds ratios (OR) and accompanying 95% confidence intervals (CI). Overall, individuals had lowers odds of high visit constancy [OR (95% CI): 0.85 (0.79, 0.92)] and higher odds of no-shows [OR (95% CI): 1.27 (1.19, 1.35)] during the early-COVID-19 period. Compared to white patients, Black patients were more likely to miss an appointment and transgender people versus cisgender women had lower visit constancy in the early-COVID-19 period.

Factors Associated with Missed Psychiatry Visits in an Urban HIV Clinic.

Psychiatric co-management is often required in HIV primary care. While rates and clinical impact of linkage and retention in HIV are well explored, fewer investigations focus specifically on linkage to psychiatry. In this investigation, we evaluate factors associated with linkage to psychiatric services using a retrospective cohort study of HIV-infected patients during a two-year observation period. Descriptive statistics depict patient characteristics, and logistic regression models were fit to evaluate factors associated with failure to establish care at the co-located psychiatry clinic following referral from HIV provider. Of 370 referred, 23 % did not attend a scheduled psychiatry appointment within 6 months of initial referral. In multivariable analysis, Non-white race, younger age, non-suppressed viral load, and increased wait time to appointment (in days) were associated with failure to attend. Further exploration of barriers that contribute to disparate linkage to psychiatric care may inform future interventions to improve HIV outcomes in this population.

Exploration of an automated approach for receiving patient feedback after outpatient acute care visits.

BACKGROUND: To improve and learn from patient outcomes, particularly under new care models such as Accountable Care Organizations and Patient-Centered Medical Homes, requires establishing systems for follow-up and feedback. OBJECTIVE: To provide post-visit feedback to physicians on patient outcomes following acute care visits. DESIGN: A three-phase cross-sectional study [live follow-up call three weeks after acute care visits (baseline), one week post-visit live call, and one week post-visit interactive voice response system (IVRS) call] with three patient cohorts was conducted. A family medicine clinic and an HIV clinic participated in all three phases, and a cerebral palsy clinic participated in the first two phases. Patients answered questions about symptom improvement, medication problems, and interactions with the healthcare system. PATIENTS: A total of 616 patients were included: 142 from Phase 1, 352 from Phase 2 and 122 from Phase 3. MAIN MEASURES: Primary outcomes included: problem resolution, provider satisfaction with the system, and comparison of IVRS with live calls made by research staff. KEY RESULTS: During both live follow-up phases, at least 96% of patients who were reached completed the call compared to only 48% for the IVRS phase. At baseline, 98 of 113 (88%) patients reported improvement, as well as 167 of 196 (85%) in the live one-week follow-up. In the one-week IVRS phase, 25 of 39 (64%) reported improvement. In all phases, the majority of patients in both the improved and unimproved groups had not contacted their provider or another provider. While 63% of providers stated they wanted to receive patient feedback, they varied in the extent to which they used the feedback reports. CONCLUSIONS: Many patients who do not improve as expected do not take action to further address unresolved problems. Systematic follow-up/feedback mechanisms can potentially identify and connect such patients to needed care.

Gamification as a tool for enhancing graduate medical education.

INTRODUCTION: The last decade has seen many changes in graduate medical education training in the USA, most notably the implementation of duty hour standards for residents by the Accreditation Council of Graduate Medical Education. As educators are left to balance more limited time available between patient care and resident education, new methods to augment traditional graduate medical education are needed. OBJECTIVES: To assess acceptance and use of a novel gamification-based medical knowledge software among internal medicine residents and to determine retention of information presented to participants by this medical knowledge software. METHODS: We designed and developed software using principles of gamification to deliver a web-based medical knowledge competition among internal medicine residents at the University of Alabama (UA) at Birmingham and UA at Huntsville in 2012-2013. Residents participated individually and in teams. Participants accessed daily questions and tracked their online leaderboard competition scores through any internet-enabled device. We completed focus groups to assess participant acceptance and analysed software use, retention of knowledge and factors associated with loss of participants (attrition). RESULTS: Acceptance: In focus groups, residents (n=17) reported leaderboards were the most important motivator of participation. Use: 16 427 questions were completed: 28.8% on Saturdays/Sundays, 53.1% between 17:00 and 08:00. Retention of knowledge: 1046 paired responses (for repeated questions) were collected. Correct responses increased by 11.9% (p<0.0001) on retest. Differences per time since question introduction, trainee level and style of play were observed. Attrition: In ordinal regression analyses, completing more questions (0.80 per 10% increase; 0.70 to 0.93) decreased, while postgraduate year 3 class (4.25; 1.44 to 12.55) and non-daily play (4.51; 1.50 to 13.58) increased odds of attrition. CONCLUSIONS: Our software-enabled, gamification-based educational intervention was well accepted among our millennial learners. Coupling software with gamification and analysis of trainee use and engagement data can be used to develop strategies to augment learning in time-constrained educational settings.

A qualitative assessment of internal medicine resident perceptions of graduate medical education following implementation of the 2011 ACGME duty hour standards.

BACKGROUND: In 2011, the Accreditation Council of Graduate Medical Education implemented updated guidelines for medical resident duty hours, further limiting continuous work hours for first-year residents. We sought to investigate the impact of these restrictions on graduate medical education among internal medicine residents. METHODS: We conducted eight focus groups with internal medicine residents at the University of Alabama at Birmingham in 06/2012-07/2012. Discussion questions included, "How do you feel the 2011 ACGME work hour restrictions have impacted your graduate medical education?" Transcripts of the focus groups were reviewed and themes identified using a deductive/inductive approach. Participants completed a survey to collect demographic information and future practice plans. RESULTS: Thirty-four residents participated in our focus groups. Five themes emerged: decreased teaching, decreased experiential learning, shift-work mentality, tension between residency classes, and benefits and opportunities. Residents reported that since implementation of the guidelines, teaching was often deferred to complete patient-care tasks. Residents voiced concern that PGY-1 s were not receiving adequate clinical experience and that procedural and clinical reasoning skills are being negatively impacted. PGY-1 s reported being well-rested and having increased time for independent study. CONCLUSIONS: Residents noted a decline in teaching and are concerned with the decrease in "hands-on" clinical education that is inevitably impacted by fewer hours in the hospital, though some benefits were also reported. Future studies are needed to further elucidate the impact of decreased resident work hours on graduate medical education.

Closing the feedback loop: an interactive voice response system to provide follow-up and feedback in primary care settings.

In primary care settings, follow-up regarding the outcome of acute outpatient visits is largely absent. We sought to develop an automated interactive voice response system (IVRS) for patient follow-up with feedback to providers capable of interfacing with multiple pre-existing electronic medical records (EMRs). A system was designed to extract data from EMRs, integrate with the IVRS, call patients for follow-up, and provide a feedback report to providers. Challenges during the development process were analyzed and summarized. The components of the technological solution and details of its implementation are reported. Lessons learned include: (1) Modular utilization of system components is often needed to adapt to specific clinic workflow and patient population needs (2) Understanding the local telephony environment greatly impacts development and is critical to success, and (3) Ample time for development of the IVRS questionnaire (mapping all branching paths) and speech recognition tuning (sensitivity, use of barge-in tuning, use of "known voice") is needed. With proper attention to design and development, modular follow-up and feedback systems can be integrated into existing EMR systems providing the benefits of IVRS follow-up to patients and providers across diverse practice settings.

Patient reported outcomes in routine care: advancing data capture for HIV cohort research.

INTRODUCTION: Computerized collection of standardized measures of patient reported outcomes (PROs) provides a novel paradigm for data capture at the point of clinical care. Comparisons between data from PROs and Electronic Health Records (EHR) are lacking. We compare EHR and PRO for capture of depression and substance abuse and their relationship to adherence to antiretroviral therapy (ART). METHODS: This retrospective study includes HIV-positive patients at an HIV clinic who completed an initial PRO assessment April 2008-July 2009. The questionnaire includes measures of depression (PHQ-9) and substance abuse (ASSIST). Self-reported ART adherence was modeled using separate logistic regression analyses (EHR vs PRO). RESULTS: The study included 782 participants. EHR vs PRO diagnosis of current substance abuse was 13% (n = 99) vs 6% (n = 45) (P < .0001), and current depression was 41% (n = 317) vs 12% (n = 97) (P < .0001). In the EHR model, neither substance abuse (OR = 1.25; 95% CI = 0.70-2.21) nor depression (OR = 0.93; 95% CI = 0.62-1.40) was significantly associated with poor ART adherence. Conversely, in the PRO model, current substance abuse (OR = 2.78; 95% CI = 1.33-5.81) and current depression (OR = 1.93; 95% CI = 1.12-3.33) were associated with poor ART adherence. DISCUSSIONS: The explanatory characteristics of the PRO model correlated best with factors known to be associated with poor ART adherence (substance abuse; depression). The computerized capture of PROs as a part of routine clinical care may prove to be a complementary and potentially transformative health informatics technology for research and patient care.

Temporal trends in presentation for outpatient HIV medical care 2000-2010: implications for short-term mortality.

BACKGROUND: Many newly diagnosed patients present to outpatient care with advanced HIV infection. More timely HIV diagnosis and initiation of care has the potential to improve individual health outcomes and has public health implications. OBJECTIVE: To assess temporal trends in late presentation for outpatient HIV medial care as measured by CD4 count <200 cells/mm(3) and the implications on short-term (1-year) mortality. DESIGN: We conducted a cohort study nested in a prospective HIV clinical cohort including patients establishing initial outpatient HIV treatment between 2000-2010. Time series regression analysis evaluated temporal trends in late presentation for care measured by the proportion of patients with a CD4 count <200 cells/mm(3) or an opportunistic infection at enrollment, and also evaluated trends in short-term mortality. PARTICIPANTS: Patients establishing initial outpatient HIV treatment between 2000-2010 at an academic HIV clinic. MAIN MEASURES: The proportion of patients with a CD4 count <200 cells/mm(3) or an opportunistic infection at initial presentation and short-term (1-year) mortality following clinic enrollment. KEY RESULTS: Among 1121 patients, 41% had an initial CD4 count <200 cells/mm(3), 25% had an opportunistic infection and 2.4% died within 1-year of their initial visit. Time series regression analysis demonstrated significant reductions in late presentation for HIV care and decreases in short-term mortality with temporal improvement preceding updated CDC HIV testing recommendations. CONCLUSION: We observed a significant decline in the number of patients presenting for outpatient HIV care with advanced disease, particularly in 2006-2010. A significant trend in improved short-term survival among patients establishing HIV care was also observed, likely related to more timely presentation for outpatient care in more recent years.

Routine, self-administered, touch-screen, computer-based suicidal ideation assessment linked to automated response team notification in an HIV primary care setting.

BACKGROUND: Human immunodeficiency virus (HIV) and AIDS continue to be associated with an underrecognized risk for suicidal ideation, attempted suicide, and completed suicide. Suicidal ideation represents an important predictor for subsequent attempted and completed suicide. We sought to implement routine screening of suicidal ideation and associated conditions using computerized patient-reported outcome (PRO) assessments. METHODS: Two geographically distinct academic HIV primary care clinics enrolled patients who attended scheduled visits from December 2005 through February 2009. Touch-screen, computer-based PRO assessments were implemented into routine clinical care. Substance abuse, alcohol consumption, depression, and anxiety were assessed. The 9-item Patient Health Questionnaire assesses the frequency of suicidal ideation in the preceding 2 weeks. A response of "nearly every day" triggered an automated page to predetermined clinic personnel, who completed more detailed self-harm assessments. RESULTS: Overall, 1216 patients (740 from the University of Alabama at Birmingham and 476 from the University of Washington) completed the initial PRO assessment during the study period. Patients were predominantly white (646 [53%]) and male (959 [79%]), with a mean age (+/- standard deviation) of 44 +/- 10 years. Among surveyed patients, 170 (14%) endorsed some level of suicidal ideation, whereas 33 (3%) admitted suicidal ideation nearly every day. In multivariable analysis, suicidal ideation risk was lower with advancing age (odds ratio [OR], 0.74 per 10 years; 95% confidence interval [CI], 0.58-0.96) and was increased with current substance abuse (OR, 1.88; 95% CI, 1.03-3.44) and more-severe depression (OR, 3.91 for moderate depression [95% CI, 2.12-7.22] and 25.55 for severe depression [95% CI, 12.73-51.30]). DISCUSSION: Suicidal ideation was associated with current substance abuse and depression. The use of novel technologies to incorporate routine self-reported screening for suicidal ideation and other health domains allows for timely detection and intervention for this life-threatening condition.

Maraviroc observational study: the impact of expanded resistance testing and clinical considerations for antiretroviral regimen selection in treatment-experienced patients.

Maraviroc (MVC) use has trailed that of other post-2006 antiretroviral therapy (ART) options for treatment-experienced patients. We explored the impact of free tropism testing on MVC utilization in our cohort and explored barriers to MVC utilization. The Maraviroc Outcomes Study (MOS) is an investigator-initiated industry-sponsored trial where consecutive ART-experienced patients receiving routine care with viral loads ≥1,000 copies/ml, and whose provider requested resistance testing and received standardized resistance testing (SRT; phenotype, genotype, coreceptor/tropism). Sociodemographic, clinical, and ART characteristics of those receiving SRT were compared to a historical cohort (HC). Subsequently, providers were surveyed regarding factors influencing selection of salvage ART therapy. The HC (n=165) had resistance testing 7/08-9/09, while prospective SRT (n=83) patients were enrolled 9/09-8/10. In the HC, 92% had genotypes, 2% had tropism assays, and 62% (n=102) changed ART after resistance testing (raltegravir 37%, etravirine 25%, darunavir 24%, MVC 1%). In the SRT cohort, 57% (n=48) changed regimens after standardized resistance testing (darunavir 48%, raltegravir 40%, and etravirine 19%). CCR5-tropic virus was identified in 43% of the SRT group, and MVC was used in 10% [or 20% of R5 tropic patients who underwent a subsequent regimen change (n=25)], a statistically significant (p=0.01) increase in utilization. The factors most strongly influencing utilization were unique patient circumstances (60%), clinical experience (55%), and potential side effects (40%). The addition of routine tropism testing to genotypic/phenotypic testing was associated with increased MVC utilization, raising the possibility that tropism testing may present a barrier to MVC use; however, additional barriers exist, and merit further evaluation.

Effect of persistency of first-line HIV antiretroviral therapy on clinical outcomes.

Persistency is the time from initiation to discontinuation of therapy. Previous research has described factors that affect the persistency of initial antiretroviral therapy (ART); however, the impact of persistency on clinical outcomes is unknown. A retrospective study was conducted of treatment-naive HIV patients initiating ART between January 1, 2000 and December 31, 2010 at an academic medical center. Descriptive statistics and Cox proportional hazards regression models with persistency as a time-varying covariate were fit for (1) immunologic failure (subsequent CD4 lower than initial CD4); (2) development of an opportunistic infection (OI) or malignancy; and (3) mortality. Analyses were repeated with an interaction term of persistency (per 180 days) and time (before and after 1 year of ART). Among 879 patients who started ART, the mean age was 38 years (±10) and most patients were racial/ethnic minority (59%), males (80%), and with baseline CD4 <200 cells/mm(3) (52%). There were 100 deaths, 94 OIs/malignancy, and 183 immunologic failures; the mean persistency=723 days. In multivariable modeling, increased persistency decreased the overall and long-term hazard for immunologic failure (0.84 per 180 additional days; 0.70-1.00; 0.045). Increased persistency exhibited a potential trend toward decreased hazard for the occurrence of OI/malignancy (0.91; 0.80-1.03; 0.124) overall and after 1 year. Persistency exhibited a trend toward less risk of mortality in the first year of ART (0.42; 0.17-1.06; 0.067). In this study of the relationship between initial ART persistency and clinical outcomes, increased persistency was associated with a decreased hazard for the development of immunologic failure, a trend toward a decreased hazard for OI/malignancy, and a trend toward a decreased risk of first year mortality. Given these findings, the relationship between persistency and clinical outcomes merits further study.

Telephone follow-up in primary care: can interactive voice response calls work?

UNLABELLED: Follow-up calls after ambulatory visits are not routinely done, yet they can potentially detect and mitigate unresolved problems. Automated calls via an Interactive Voice Response System (IVRS) are an innovative way to conduct follow-up, but patients' attitudes toward follow-up calls are unknown. This study assessed 1) patient perceptions about follow-up calls after visits; 2) differences in perceptions between human and IVRS calls; and 3) association between follow-up calls and patient satisfaction with care. Post-visit follow-up calls in two ambulatory care setting were done in two phases. Phase 1 used a human caller and phase 2 used IVRS. Patient satisfaction questionnaires were completed after each phase. Results showed that 88% of patients favor the idea of the calls and those receiving them found them helpful. There were no differences in attitudes between patients receiving calls from clinic staff or from an IVRS. Patients receiving calls had higher patient satisfaction scores than those not called. CONCLUSION: Patients value follow-up calls and they are associated with patient satisfaction with care. IVRS is an innovative way to conduct post-visit follow-up.

Short communication routine HIV testing in the emergency department: assessment of patient perceptions.

The CDC released revised HIV testing guidelines in 2006 recommending routine, opt-out HIV testing in acute care settings including emergency departments (ED). Patient attitudes have been cited as a barrier to implementation of routine HIV testing in the ED. We assessed patients' perceptions of HIV testing in the ED through a contextual qualitative approach. The study was conducted during a 72-h period. All adults presenting to the ED without life-threatening trauma or psychiatric crisis completed a standardized questionnaire. The questionnaire explored HIV testing history, knowledge of testing resources, and qualitative items addressing participant perceptions about advantages and disadvantages to ED testing. After completion of the interview, participants were offered a free, confidential, rapid HIV test. Among 329 eligible individuals approached, 288 (87.5%) completed the initial interview. Participants overwhelmingly (n=247, 85.8%) reported support for testing and identified increased knowledge (41%), prevention (12.5%), convenience (11.8%), and treatment (4.9%) among the advantages. Fear and denial about one's HIV status, reported by <5% of patients, were identified as the most significant barriers to ED testing. Bivariate analysis determined race and ethnicity differences between individuals completing the interview and those who refused (p<0.05). Among individuals consenting for testing (n=186, 64.6%), no positives were detected. Most patients support HIV testing in the ED, noting knowledge of status, prevention, convenience, and linkage to early treatment as distinct advantages. These data are of particular benefit to decision makers considering the addition of routine HIV testing in EDs.

The role of toxicity-related regimen changes in the development of antiretroviral resistance.

In an effort to evaluate factors associated with the development of antiretroviral (ARV) resistance, we assessed the prevalence of toxicity-related regimen changes and modeled its association to the subsequent development of ARV resistance in a cohort of treatment-naive individuals initiating ARV therapy (ART). A retrospective analysis of patients initiating ART was conducted at the UAB 1917 Clinic from 1 January 2000 to 30 September 2007. Cox proportional hazards models were fit to identify factors associated with the development of resistance to ≥1 ARV drug class. Among 462 eligible participants, 14% (n=64) developed ARV resistance. Individuals with ≥1 toxicity-related regimen change (HR=3.94, 95% CI=1.09-14.21), initiating ART containing ddI or d4T (4.12, 1.19-14.26), and from a minority race (2.91, 1.16-7.28) had increased risk of developing resistance. Achieving virologic suppression within 12 months of ART initiation (0.10, 0.05-0.20) and higher pretreatment CD4 count (0.85 per 50 cells/mm(3), 0.75-0.96) were associated with decreased hazards of resistance. Changes in ART due to drug intolerance were associated with the subsequent development of ARV resistance. Understanding the role of ARV drug selection and other factors associated with the emergence of ARV resistance will help inform interventions to improve patient care and ensure long-term treatment success.

Underutilization of the AIDS Drug Assistance Program: associated factors and policy implications.

BACKGROUND: The AIDS Drug Assistance Program (ADAP) provides antiretroviral medications to low-income individuals with HIV infection. METHODS: A prospective cohort study of ADAP utilization, measured using medication possession ratio (MPR), was conducted during the 2008 calendar year at the University of Alabama at Birmingham 1917 HIV Clinic. Multivariable ordinal logistic regression evaluated factors associated with ADAP utilization. RESULTS: Among 245 patients, MPR quartiles (Q) were the following: Q1<69 percent, Q2=69-83 percent, Q3=84-93 percent, Q4>93 percent. In ordinal logistic regression, younger age (OR=0.59 per 10 years; 95 percent CI=0.44-0.79), nonwhite males (2.18; 1.18-4.04), lower CD4 count (2.79 for <200 cells/mm(3) ; 1.44-5.43), and a history of alcohol abuse (2.11; 1.02-4.37) were associated with poor ADAP utilization. CONCLUSIONS: One quarter of ADAP enrollees had MPR below 69 percent, a level well below that associated with optimal HIV treatment outcomes, indicating a need for programmatic interventions to improve ADAP utilization.

From access to engagement: measuring retention in outpatient HIV clinical care.

Engagement in HIV care is increasingly recognized as a crucial step in maximizing individual patient outcomes. The recently updated HIV Medicine Association primary HIV care guidelines include a new recommendation highlighting the importance of extending adherence beyond antiretroviral medications to include adherence to clinical care. Beyond individual health, emphasis on a "test and treat" approach to HIV prevention highlights the public health importance of engagement in clinical care as an essential intermediary between the putative benefits of universal HIV testing ("test") followed by ubiquitous antiretroviral treatment ("treat"). One challenge to administrators, researchers and clinicians who want to systematically evaluate HIV clinical engagement is deciding on how to measure retention in care. Measuring retention is complex as this process includes multiple clinic visits (repeated measures) occurring longitudinally over time. This article provides a synthesis of five commonly used measures of retention in HIV care, highlighting their methodological and conceptual strengths and limitations, and suggesting situations where certain measures may be preferred over others. The five measures are missed visits, appointment adherence, visit constancy, gaps in care, and the Human Resources and Services Administration HIV/AIDS Bureau (HRSA HAB) performance measure for retention in HIV care. As has been noted for antiretroviral medication adherence, there is no gold standard to measure retention in care, and consideration of the advantages and limitations of each measure, particularly in the context of the desired application, should guide selection of a retention measure.

Antiretroviral prescribing patterns in treatment-naïve patients in the United States.

Numerous antiretroviral therapy (ART) regimens are recommended for first-line and subsequent HIV care, but regimen selection for clinical use may not represent the full range of options. We hypothesized that despite an increase in available antiretrovirals, clinical trial data on regimen efficacy and fixed-dose combination options have lead to uniformity in initial ART. We evaluated regimen selection for ART-naïve patients at the University of Alabama at Birmingham (UAB) 1917 Clinic between January 2000 and December 2007. The annual number of unique initial regimens was quantified. Initial regimen variability was expressed as regimens per 100 patients. Subsequent ART regimens were characterized for complexity via regimen sequence trees detailing the first three generations of regimens for patients starting the two most common initial combinations. Four hundred eighty-two ART-naïve patients were treated with 39 unique initial regimens (8.0 regimens per 100 patients). Variability in initial regimen selection was highest in the first 6 years (14.9-24.4 regimens per 100 patients). A sharp decline was observed in 2006 (16.1 regimens per 100 patients) and 2007 (6.5 regimens per 100 patients). The most dramatic shift in drug selection involved an increase in emtricitabine plus tenofovir plus efavirenz, from 0% in 2003 to 85% in 2007. During the study period, 205 of 482 (43%) patients required a change in initial therapy. Of these, 156 of 205 (76%) had a unique sequence of regimens. A shift toward homogeneity of initial ART was observed (85% of patients received the same first-line regimen in 2007). In contrast, regimen sequencing beyond the first regimen remained complex. These shifts in ART prescribing patterns may have implications for collaborative HIV care.

Darunavir outcomes study: comparative effectiveness of virologic suppression, regimen durability, and discontinuation reasons for three-class experienced patients at 48 weeks.

Several new antiretroviral (ARV) agents for treatment experienced HIV-infected patients have been approved since June 2006, including darunavir (DRV) and raltegravir (RAL). While efficacious in clinical trials, the effectiveness, durability, and tolerability of these new ARVs remains understudied in the context of routine clinical care. The Darunavir Outcomes Study is a prospective cohort study of three-class ARV-experienced patients changing regimens at the 1917 Clinic after 1/7/2006. All treatment decisions were at the discretion of primary providers. Multivariate (MV) logistic regression for 48 week VL < 400c/ml and Cox models for regimen durability were completed. Propensity score methods controlled for sociodemographics. Among 108 patients, mean age of 46, 48% were white, 80% male, with prior exposure to a mean 10.5 ARVs. Overall, 64% of patients achieved 48-week VL < 400 c/ml. In MV modeling DRV/rll (OR = 5.77;95%CI = 1.62-20.58) and RAL (OR = 3.84;95%CI = 1.23-11.95) use increased odds of 48-week suppression. Use of these agents exhibited a trend towards prolonged regimen durability in Cox models. Among those highly ARV-experienced, regimens containing DRV/r and/or RAL were more likely to achieve 48-week VL < 400 c/ml and exhibited a trend towards prolonged durability. New agents have transformed the treatment landscape for ARV-experienced patients, with effectiveness in routine clinical care mirroring efficacy in clinical trials.

Early virologic suppression with three-class experienced patients: 24-week effectiveness in the darunavir outcomes study.

OBJECTIVE: To evaluate 24-week virologic effectiveness of novel antiretroviral regimens for treatment of three-class experienced adult patients in a clinical practice setting following the US Food and Drug Administration approval of darunavir (DRV) for this population. DESIGN: A prospective cohort study. SETTING: A single-center, academic HIV clinic. PARTICIPANTS: Three-class antiretroviral-experienced patients changing regimens between July 2006 and May 2008. Sociodemographic, psychosocial, and clinical characteristics were collected at baseline and during prospective follow-up. OUTCOME MEASURES: Plasma HIV viral load below 50 copies/ml and change in CD4 cell count at 24 weeks following regimen change. The Stanford Genotype Database was used to analyze HIV genotype resistance results and determine the number of active drugs in each regimen. Multivariate models and propensity score methods were employed to assess outcome measures. RESULTS: Among 109 three-class experienced patients, who previously received an average of 10.5 prior antiretrovirals, 55% achieved viral load below 50 copies/ml at 24 weeks. Treatment strategy was classified as nonprotease inhibitor (n = 25), DRV/ritonavir (DRV/r) (n = 51), or other protease inhibitor (n = 33). The number of active drugs was not significantly different across strategies (P = 0.24). In multivariate analysis, patients treated with DRV/r (65%, odds ratio = 4.24 vs. nonprotease inhibitor strategy, 95% confidence interval = 1.28-14.06), raltegravir (65%, odds ratio = 3.10, 95% confidence interval = 1.12-8.62), or both were more likely to achieve viral load below 50 copies/ml. CONCLUSION: Among antiretroviral-experienced patients changing regimens, those treated with DRV/r, raltegravir, or both were more likely to achieve a viral load below 50 copies/ml at 24 weeks. The effectiveness of these agents in routine clinical care mirrors their efficacy in clinical trials and has ushered in a new era in the therapy of three-class experienced patients.