A retrospective study of HIV antiretroviral treatment persistence in a commercially insured population in the United States.

This study examined factors associated with persistence (time from initiation to discontinuation of treatment) on initial antiretroviral (ARV) therapy in commercially insured HIV patients in the United States, a population not well researched. This retrospective analysis of US health insurance claims data from 1 January 2003 to 30 June 2008 included treatment-naive patients aged 18-65 years with an HIV diagnosis receiving ARV therapy consisting of at least two individual nucleoside reverse transcriptase inhibitors (NRTIs) or one fixed-dose combination NRTI, plus at least one nonnucleoside reverse transcriptase inhibitor (NNRTI) or one protease inhibitor (PI), with or without ritonavir. Descriptive statistics, Kaplan-Meier survival estimation, and Cox proportional hazards regression models were completed. Patients were considered persistent until any component of the regimen was modified or there was a gap in treatment >90 days. A total of 2460 patients met full inclusion criteria (1388 NNRTI and 1072 PI). Mean (SD) time to discontinuation for NNRTI- vs PI-based regimens was 370 (346) vs 295 (338) days (p<0.001). Female sex, substance use, low comorbidity score, index year before 2007, geographical region, and taking a lopinavir/ritonavir regimen predicted discontinuation. Relative to NNRTI-based regimens, PI-based regimens demonstrated a greater risk of discontinuation (hazard ratio [HR], 1.32; p<0.001). The fixed-dose efavirenz/emtricitabine/tenofovir combination yielded the lowest risk of discontinuation (HR, 0.39; p<0.001). HIV treatment persistence was longer with NNRTI-based regimens than PI-based regimens. The fixed-dose regimen of once-daily efavirenz/emtricitabine/tenofovir had the lowest risk of discontinuation.

Factors associated with complete adherence to HIV combination antiretroviral therapy.

PURPOSE: To assess factors associated with adherence, particularly pill burden, to combination antiretroviral therapy (cART) using multivariate models. METHOD: A cross-sectional survey of US adults with a self-reported diagnosis of HIV/AIDS was conducted between April and May 2007. Respondents on a cART regimen of at least 2 nucleoside reverse transcriptase inhibitors plus at least 1 protease inhibitor or non-nucleoside reverse transcriptase inhibitor (n = 461) were included in the analytic sample. Multiple logistic regression models determined independent predictors of complete adherence (defined as never missing or skipping an antiretroviral dose). RESULTS: Fifty-four percent of respondents reported complete adherence to cART. Adherent respondents reported a lower percentage of hospitalizations (11% vs 28%; P < .0001) and emergency room visits (26% vs 34%; P < .09). Respondents taking the single tablet efavirenz/emtricitabine/tenofovir fixed-dose regimen were significantly more likely to have complete adherence than respondents taking other cART regimens (odds ratio [OR] 2.1, P < .05), and higher imputed daily HIV pill count was associated with lower likelihood of complete adherence (OR 0.93, P < .05). CONCLUSION: This study shows the negative impact of higher pill burden on medication adherence, an important factor associated with treatment outcomes in patients with HIV/AIDS.

Medication persistence in the treatment of HIV infection: a review of the literature and implications for future clinical care and research.

Persistence, continuous treatment with a prescribed medication or intervention, is an important, but underrecognized aspect of medication treatment, especially for HIV. In contrast to adherence, which measures the percentage of patient behavior to a prescribed therapy, persistence measures the duration during which a patient remains on a prescribed therapy. Decreased persistence for HIV treatment, or shorter duration on therapy, is associated with increased rates of virological failure, development of antiretroviral resistance, and increased morbidity and mortality. Additionally, frequency and duration of nonpersistent episodes rather than adherence may be a better predictor of clinical outcomes in HIV-infected patients on certain regimens. In this review, we codify the constructs of persistence and adherence, and further define persistence as either patient or regimen persistence. Furthermore, current literature on the clinical consequences of and factors associated with suboptimal persistence is summarized. Finally, methods to measure persistence as well as interventions that may improve persistence and clinical outcomes are suggested.

Patient-reported outcomes in virologically suppressed, HIV-1-Infected subjects after switching to a simplified, single-tablet regimen of efavirenz, emtricitabine, and tenofovir DF.

A randomized, open-label, multicenter study was conducted to evaluate the therapeutic switch to a single-tablet formulation of efavirenz/emtricitabine/tenofovir DF (EFV/FTC/TDF) among virologically suppressed, HIV-1-infected subjects. Eligible subjects on stable antiretroviral therapy (ART) with HIV-1 RNA less than 200 copies per milliliter for 3 months or more were stratified by prior protease inhibitor (PI)- or non-nucleoside reverse transcriptase inhibitor (NNRTI)-based therapy and randomized (2:1) to EFV/FTC/TDF or to stay on their baseline regimen (SBR). Patient-reported measures were quality of life (QOL; SF-36 [version 2]), treatment adherence (visual analogue scale), preference of medication (POM), perceived ease of the regimen for condition (PERC), and a 20-item HIV symptom index. Overall, 203 subjects were randomized to EFV/FTC/TDF and 97 to SBR. Fifty-three percent of subjects had previously received a PI-based regimen; 47% an NNRTI-based therapy. Throughout the study, SF-36 summary scores did not differ significantly from baseline, regardless of previous ART or treatment allocation. Adherence was 96% or more in both groups at baseline and all subsequent study visits. At study conclusion, the EFV/FTC/TDF regimen was considered easier to follow than prior regimens by 97% and 96% of subjects previously receiving PI-based and NNRTI-based therapies, respectively. Overall, 91% of subjects switched to EFV/FTC/TDF indicated a preference over their prior therapy. Switching to EFV/FTC/TDF was associated with transient worsening/emergence of dizziness and sustained improvements in several other HIV-related symptoms. In conclusion, switching virologically suppressed, HIV-1-infected subjects from PI-based or NNRTI-based regimens to EFV/FTC/TDF was associated with maintained QOL and treatment adherence, and improved ease of use and treatment satisfaction.

Virologic suppression, treatment adherence, and improved quality of life on a once-daily efavirenz-based regimen in treatment-Naïve HIV-1-infected patients over 96 weeks.

PURPOSE: This study evaluated the long-term efficacy, safety, adherence, and quality of life (QoL) of a once-daily efavirenz-based antiretroviral regimen in two 96-week prospective open-label single-arm studies of treatment-naïve HIV-1-infected patients. METHODS: Patients received once-daily efavirenz 600 mg and lamivudine 300 mg with either enteric-coated didanosine 400 mg (Daily Antiretroviral Therapy trial [DART] I) or extended-release stavudine 100 mg (DART II). The primary efficacy outcome measure was HIV RNA <400 copies/mL at Week 48. RESULTS: In an intent-to-treat (ITT) analysis, HIV RNA level <400 (<50) copies/mL was reached by 82%(80%) and 74% (72%) of patients at Week 48 in DART I and II. At Week 96, the corresponding values were 74% (68%) and 55% (54%), respectively. Both regimens were well tolerated. There were no discontinuations for virologic failure. Medication adherence assessed by pill counts was above 80% in 90% of the patients in DART I and more than 80% of patients in DART II. Treatment produced a significant improvement in overall QoL. CONCLUSION: Once-daily efavirenz-based antiretroviral therapy was effective, durable, and well tolerated. In this study, a high level of adherence was achieved with improvement in overall QoL.

Randomization to once-daily stavudine extended release/lamivudine/efavirenz versus a more frequent regimen improves adherence while maintaining viral suppression.

BACKGROUND: In antiretroviral (ARV) therapy, pill burden, dosing frequency, and regimen complexity adversely affect adherence. We sought to evaluate the effect of regimen simplification on maintenance of virologic suppression and treatment adherence. METHOD: In this 48-week, open-label, randomized study, 320 HIV-1-infected adult patients with a viral load of <50 copies/mL on a twice-daily or more frequent ARV regimen were either switched to a once-daily regimen of efavirenz, extended-release stavudine, and lamivudine (QD arm) or continued on existing therapy (BID+ arm). Medication Event Monitoring System (MEMS) caps, AIDS Clinical Trials Group (ACTG)-validated questionnaire, and pill counts were used to evaluate adherence. Treatment satisfaction and preference were also evaluated. RESULTS: The QD arm was noninferior to the BID+ arm in the primary efficacy measure (proportion of patients who maintained virologic suppression at Week 48; QD arm, 80.0% vs. BID+ arm, 75.8%). Adherence and treatment satisfaction significantly favored the QD arm, in which 91.0% of patients preferred the simpler regimen. Overall, the majority of adverse events were mild to moderate in severity and resulted in a low rate of treatment discontinuations. CONCLUSIONS: Simplifying twice-daily or more frequent ARV therapy to a once-daily efavirenz-containing regimen in virologically suppressed HIV-1-infected patients maintains virologic suppression while improving adherence and patient satisfaction.