HIV blip synching: get the timing right.
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Antiretroviral Therapy, Highly Active↗
Biomedical subjects
James Hellinger
Publications and source records attributed to James Hellinger.
Racial and gender disparities in receipt of highly active antiretroviral therapy persist in a multistate sample of HIV patients in 2001.
BACKGROUND: National data from the mid-1990s demonstrated that many eligible patients did not receive highly active antiretroviral therapy (HAART) and that racial and gender disparities existed in HAART receipt. We examined whether demographic disparities in the use of HAART persist in 2001 and if outpatient care is associated with HAART utilization. METHODS: Demographic, clinical, and pharmacy utilization data were collected from 10 US HIV primary care sites in the HIV Research Network (HIVRN). Using multivariate logistic regression, we examined demographic and clinical differences associated with receipt of HAART and the association of outpatient utilization with HAART. RESULTS: In our cohort in 2001, 84% of patients received HAART and 66% had 4 or more outpatient visits during calendar year (CY) 2001. Of those with 2 or more CD4 counts below 350 cells/mm in 2001, 91% received HAART; 82% of those with 1 CD4 test result below 350 cells/mm received HAART; and 77% of those with no CD4 counts below 350 cells/mm received HAART. Adjusting for care site in multivariate analyses, age >40 years (adjusted odds ratio [AOR] = 1.13), male gender (AOR = 1.23), Medicaid coverage (AOR = 1.16), Medicare coverage (AOR = 1.73), having 1 or more CD4 counts less than 350 cells/mm (AOR = 1.33), and having 4 or more outpatient visits in a year (OR = 1.34) were significantly associated with an increased likelihood of HAART. African Americans (odds ratio [OR] = 0.84) and those with an injection drug use risk factor (OR = 0.86) were less likely to receive HAART. CONCLUSIONS: Although the overall prevalence of HAART has increased since the mid-1990s, demographic disparities in HAART receipt persist. Our results support attempts to increase access to care and frequency of outpatient visits for underutilizing groups as well as increased efforts to reduce persistent disparities in women, African Americans, and injection drug users (IDUs).
Adolescent↗
Hospital and outpatient health services utilization among HIV-infected adults in care 2000-2002.
BACKGROUND: Rapid changes in HIV epidemiology and antiretroviral therapy may have resulted in recent changes in patterns of healthcare utilization. OBJECTIVE: The objective of this study was to examine sociodemographic and clinical correlates of inpatient and outpatient HIV-related health service utilization in a multistate sample of patients with HIV. DESIGN: Demographic, clinical, and resource utilization data were collected from medical records for 2000, 2001, and 2002. SETTING: This study was conducted at 11 U.S. HIV primary and specialty care sites in different geographic regions. PATIENTS: In each year, HIV-positive patients with at least one CD4 count and any use of inpatient, outpatient, or emergency room services. Sample sizes were 13,392 in 2000, 15,211 in 2001, and 14,403 in 2002. MAIN OUTCOME MEASURES: Main outcome measures were number of hospital admissions, total days in hospital, and number of outpatient clinic/office visits per year. Inpatient and outpatient costs were estimated by applying unit costs to numbers of inpatient days and outpatient visits. RESULTS: Mean numbers of admissions per person per year decreased from 2000 (0.40) to 2002 (0.35), but this difference was not significant in multivariate analyses. Hospitalization rates were significantly higher among patients with greater immunosuppression, women, blacks, patients who acquired HIV through drug use, those 50 years of age and over, and those with Medicaid or Medicare. Mean annual outpatient visits decreased significantly between 2000 and 2002, from 6.06 to 5.66 visits per person per year. Whites, Hispanics, those 30 years of age and over, those on highly active antiretroviral therapy (HAART), and those with Medicaid or Medicare had significantly higher outpatient utilization. Inpatient costs per patient per month (PPPM) were estimated to be 514 dollars in 2000, 472 dollars in 2001, and 424 dollars in 2002; outpatient costs PPPM were estimated at 108 dollars in 2000, 100 dollars in 2001, and 101 dollars in 2002. CONCLUSION: Changes in utilization over this 3-year period, although statistically significant in some cases, were not substantial. Hospitalization rates remain relatively high among minority or disadvantaged groups, suggesting persistent disparities in care. Combined inpatient and outpatient costs for patients on HAART were not significantly lower than for patients not on HAART.
AIDS-Related Opportunistic Infections↗
Patient acceptance of self-injected enfuvirtide at 8 and 24 weeks.
PURPOSE: Enfuvirtide is the first of a new class of antiretrovirals called the fusion inhibitors. It is administered twice daily by self-injection. This study assessed patient acceptance of enfuvirtide self-injection. METHOD: Patients (n = 661, intent-to-treat [ITT]) in two ongoing phase 3 trials were surveyed at treatment Weeks 8 and 24 using the Subcutaneous Injection Survey. This validated instrument contains 18 items measuring patients' assessment of ease of injection, impact on daily functioning, and activities of daily living. RESULTS: The majority (65%-92%) of patients assessed all items relating to ease of injection as "very easy" or "easy" at both 8 and 24 weeks. Similarly, at both visits, the majority (69%-90%) of patients assessed their daily functioning as "not at all" or "a little" limited by enfuvirtide self-injection, and 96%-98% gave these assessments for impact on activities of daily living. CONCLUSION: These findings indicate that most patients taking enfuvirtide in clinical trials learn to integrate enfuvirtide dosing in their daily routines; with appropriate education and training, enfuvirtide self-injection becomes routine with relatively little subjective impact on daily functioning and activities of daily living. Patient acceptance of self-injected enfuvirtide is high and does not decline over 24 weeks of therapy.
Activities of Daily Living↗
Pilot study of saquinavir and lopinavir/ritonavir twice daily in protease inhibitor-naive HIV-positive patients.
PURPOSE: Protease inhibitor (PI)-naive patients may have limited reverse transcriptase inhibitor (RTI) options due to resistance and/or toxicity. Effective, well-tolerated nucleoside reverse transcriptase inhibitor (NRTI)-sparing regimens are therefore needed. METHOD: This prospective study evaluated the efficacy and safety of saquinavir/lopinavir/ritonavir (1000/400/100 mg bid) in PI-naive patients over 48 weeks. The regimen could be intensified with NRTIs if patients did not achieve virologic suppression by 12 weeks. The primary study endpoint was virologic suppression at 48 weeks. Additional study objectives included assessment of safety, CD4 cell counts, blood lipids, PI trough levels, and anthropometrics. RESULTS: Of the 20 PI-naive study participants, 16 completed 48 weeks of study treatment, with no discontinuations attributed to virologic failure. Fourteen of 16 patients achieved virologic suppression with only the PIs; 2 patients required tenofovir intensification to achieve complete suppression. Median CD4 counts increased significantly over 48 weeks. Adverse events were generally mild and manageable. Extreme lipid elevations were uncommon, although moderate lipid elevations occurred in the majority of patients. Most patients reported some degree of central fat accumulation. CONCLUSION: Our study demonstrates that saquinavir/lopinavir/ritonavir 1000/400/100 mg bid with tenofovir intensification is a potent nucleoside-sparing regimen for PI-naive patients, associated with durable HIV suppression and improved CD4 cell counts. Fat accumulation and metabolic changes observed in this study warrant confirmation from ongoing trials.
Adult↗