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Twenty six years have passed since the first cases of the acquired immune deficiency syndrome (AIDS) were recognized in the U.S. Since that time, over 25 million people have died worldwide. The Centers for Disease Control and Prevention estimates that 1.1 million individuals in the U.S. are living with human immunodeficiency virus (HIV) infection with or without AIDS. With the advent of effective antiretroviral treatment strategies, HIV infection has now become a chronic disease requiring lifelong therapy. Despite the advances made in treatment, drug resistance, long-term adverse effects, and high adherence requirements continue to represent challenges to patients and clinicians. This overview will provide a summary of current antiretroviral drugs, treatment strategies, and novel therapeutic agents presently in development.

Adverse drug reactions causing the early discontinuation of therapy are common in patients with HIV infection. Hypersensitivity consisting mainly of a maculopapular rash on the face, extremities and trunk has been observed at a rate higher than expected in patients treated with tenofovir at our clinics. We therefore examined nine patients with suspected tenofovir hypersensitivity reactions in two indigent care HIV clinics. Type I and type IV hypersensitivity may be involved as immunological mechanisms.

Background: Adherence to antiretroviral therapy (ART) is vital to achieve durable suppression of viral replication. Effective mechanisms to predict adherence can be difficult to implement in clinical practice settings. Self-administered questionnaires are a practical option for assessing patient adherence but may lack validation with objective measures of adherence., Objective: To examine the ability of a 2 item stage of change (SOC) questionnaire to predict medication adherence in indigent patients receiving ART., Methods: Patients participating in an ongoing study to examine adherence interventions were administered a 2 item SOC instrument to assess readiness for adherence behavior. The SOC instrument was given to patients prior to beginning ART and readministered after they had received 16 weeks of treatment. Electronic monitoring was used to examine the validity of the SOC instrument to predict patient readiness for adherence behavior., Results: Thirty-one patients completed the SOC questionnaire prior to beginning a new ART regimen. Most (87%) patients were male, had previously received antiretroviral therapy (77%), and had an AIDS diagnosis (77%). The SOC category determined at baseline was a poor predictor of adherence at 4 and 16 weeks; however, the SOC category determined after treatment onset (week 16) was a strong predictor of adherence at both time points (p < 0.001 for 4 and 16 weeks; one way ANOVA)., Conclusions: The SOC category determined at baseline correlated poorly with subsequent medication adherence in our indigent, HIV-infected patient population. Prediction of adherence based on SOC after treatment initiation may provide a better estimate of adherence behavior. Recognition of this limitation may help clinicians more accurately interpret predicted adherence behavior from self-report instruments.

Objective: The aim of this randomized, controlled pilot study was to examine the impact of a pharmacist operated adherence clinic on adherence to highly active antiretroviral therapy (HAART) and viral suppression in patients with HIV over 28 weeks., Methods: Consecutive eligible patients initiating HAART at an indigent-care clinic were randomized to an adherence clinic or to standard care (information provided by physician or nurse practitioner) for education and monitoring. Group assignment was stratified before randomization according to regimen complexity and potential tolerability. Adherence (electronic monitoring and patient self-report) and viral load (reverse-transcription polymerase chain reaction) were assessed at weeks 4, 16, and 28., Results: Thirty-three randomized patients (adherence clinic, n = 16; standard care, n = 17) comprised the intent-to-treat population. The groups were well-matched for demographics and antiretroviral regimen. The median age was 38.0 years in both groups. Most patients were male (85%), had previously used HAART (78%), and had an AIDS diagnosis (79%). Mean (SD) adherence at weeks 4, 16, and 28 was 86% (27%), 77% (28%), and 74% (31%) in the adherence clinic group versus 73% (32%), 56% (39%), and 51% (41%) in the standard care group (week-16 difference, 21% [90% CI, 1%-42%]; week-28 difference, 23% [90% CI, 1%-44%]). Sixty-nine percent of patients in the adherence clinic group took their medication on schedule versus 42% in the standard care group (P = 0.025); mean decline in adherence from weeks 4 to 28 was 12% in the adherence clinic group (P = 0.15) versus 22% in the standard care group (P = 0.002). HIV-1 RNA levels were <400 copies/mL at weeks 4, 16, and 28 in 63%, 100%, and 94% of the adherence clinic group and 29% (P = NS), 71% (P = 0.04), and 65% (P = NS) of the standard care group., Conclusions: In this preliminary trial, an adherence clinic model improved adherence to HAART and virologic response over 28 weeks in the patients studied.

Widespread dissemination of current interventions designed to improve HIV medication adherence is limited by several barriers, including additional time and expense burdens on the health care systems. Electronic interventions could aid in dissemination of interventions in the clinic setting. This study developed and tested the feasibility and acceptability of a computer-based adaption of an empirically supported face-to-face adherence promotion intervention. HIV-positive individuals (N= 92) on antiretroviral therapy with self-reported adherence <95% were randomized to the electronic intervention + treatment as usual (TAU) or TAU only. Study outcome variables which included treatment self-efficacy and self-reported medication adherence were assessed at baseline and follow-up. Time × condition interaction effects in mixed model analysis of variance (ANOVAs) examined the differences in patterns of change in the outcome variables over time between the two groups. Participants in the electronic intervention condition reported higher levels of self-efficacy to adhere to their medication at follow-up compared to the control condition. Although nonsignificant, levels of adherence tended to improve over time in the intervention condition, while TAU adherence remained constant. This was the first study to investigate a single-session, computer-based adherence intervention. Results suggest that electronic interventions are feasible and this method may be effective at increasing self-efficacy and adherence among patients reporting suboptimal adherence levels. [ABSTRACT FROM PUBLISHER]

Abstract: Objective:: The aim of this randomized, controlledpilot study was to examine the impact of a pharmacistoperated adherence clinic on adherence to highly active antiretroviral therapy (HAART) and viral suppression in patients with HIV over 28 weeks. Methods:: Consecutive eligible patients initiatingHAART at an indigent-care clinic were randomized to an adherence clinic or to standard care (information provided by physician or nurse practitioner) for education and monitoring. Group assignment was stratified before randomization according to regimen complexity and potential tolerability. Adherence (electronic monitoring and patient self-report) and viral load (reverse-transcription polymerase chain reaction) were assessed at weeks 4, 16, and 28. Results:: Thirty-three randomized patients (adherenceclinic, n = 16; standard care, n = 17) comprised the intent-to-treat population. The groups were well-matched for demographics and antiretroviral regimen. The median age was 38.0 years in both groups. Most patients were male (85%), had previously used HAART (78%), and had an AIDS diagnosis (79%). Mean (SD) adherence at weeks 4, 16, and 28 was 86% (27%), 77% (28%), and 74% (31%) in the adherence clinic group versus 73% (32%), 56% (39%), and 51% (41%) in the standard care group (week-16 difference, 21% [90% CI, 1%–42%]; week-28 difference, 23% [90% CI, 1%–44%]). Sixty-nine percent of patients in the adherence clinic group took their medication on schedule versus 42% in the standard care group (P = 0.025); mean decline in adherence from weeks 4 to 28 was 12% in the adherence clinic group (P = 0.15) versus 22% in the standard care group (P = 0.002). HIV-1 RNA levels were &#60;400 copies/mL at weeks 4, 16, and 28 in 63%, 100%, and 94% of the adherence clinic group and 29% (P = NS), 71% (P = 0.04), and 65% (P = NS) of the standard care group. Conclusions:: In this preliminary trial, an adherence clinic model improved adherence to HAART and virologic response over 28 weeks in the patients studied. [Copyright &y& Elsevier]