Scleroderma in a Patient on Capecitabine: Is this a Variant of Hand-Foot Syndrome?

Drug-induced scleroderma is a rare adverse effect of some chemotherapeutic drugs, such as taxanes and bleomycin. Capecitabine, an oral fluoropyrimidine approved for the treatment of metastatic breast and colon cancer, commonly causes cutaneous side effects including the hand-and-foot syndrome (HFS). Scleroderma-like skin changes associated with HFS associated with capecitabine is rare. However, diffuse scleroderma has never before been reported. We report a case of capecitabine-induced diffuse/systemic scleroderma in an 86-year-old female treated with capecitabine for metastatic colorectal cancer. She developed progressive skin and visceral sclerosis involving the lungs. We discuss the association between chemotherapy and scleroderma. We believe this is the first case of diffuse/systemic capecitabine-induced scleroderma without the presence of HFS. Early diagnosis is essential as fibrosis might be prevented in early stages. The capecitabine should be discontinued as early as possible.

Prevalence of Parental Misconceptions About Antibiotic Use.

BACKGROUND: Differences in antibiotic knowledge and attitudes between parents of Medicaid-insured and commercially insured children have been previously reported. It is unknown whether understanding has improved and whether previously identified differences persist. METHODS: A total of 1500 Massachusetts parents with a child <6 years old insured by a Medicaid managed care or commercial health plan were surveyed in spring 2013. We examined antibiotic-related knowledge and attitudes by using χ(2) tests. Multivariable modeling was used to assess current sociodemographic predictors of knowledge and evaluate changes in predictors from a similar survey in 2000. RESULTS: Medicaid-insured parents in 2013 (n = 345) were younger, were less likely to be white, and had less education than those commercially insured (n = 353), P < .01. Fewer Medicaid-insured parents answered questions correctly except for one related to bronchitis, for which there was no difference (15% Medicaid vs 16% commercial, P < .66). More parents understood that green nasal discharge did not require antibiotics in 2013 compared with 2000, but this increase was smaller among Medicaid-insured (32% vs 22% P = .02) than commercially insured (49% vs 23%, P < .01) parents. Medicaid-insured parents were more likely to request unnecessary antibiotics in 2013 (P < .01). Multivariable models for predictors of knowledge or attitudes demonstrated complex relationships between insurance status and sociodemographic variables. CONCLUSIONS: Misconceptions about antibiotic use persist and continue to be more prevalent among parents of Medicaid-insured children. Improvement in understanding has been more pronounced in more advantaged populations. Tailored efforts for socioeconomically disadvantaged populations remain warranted to decrease parental drivers of unnecessary antibiotic prescribing.

Use of glomerular filtration rate estimating equations for drug dosing in HIV-positive patients.

BACKGROUND: Current HIV treatment guidelines recommend using the Cockcroft-Gault equation for drug dosing adjustments. The use of newer glomerular filtration rate (GFR) estimating equations for drug dosing and the appropriateness of physician antiretroviral dosing based on estimated kidney function have not been studied in an HIV-positive population. METHODS: We evaluated concordance between measured and estimated GFR for the assignment of kidney function categories designated by the US Food and Drug Administration (FDA) Guidance for industry for pharmacokinetic studies, and appropriateness of physician antiretroviral drug dosing for level of kidney function in 200 HIV-positive patients on stable antiretroviral therapy. Estimated kidney function was determined using the Chronic Kidney Disease-Epidemiology collaboration (CKD-EPI), Modification of Diet in Renal Disease (MDRD) Study and Cockcroft-Gault equations. RESULTS: For assignment of FDA-designated kidney function categories, concordance rates between measured and estimated GFR using the CKD-EPI, MDRD Study and Cockcroft-Gault equations were 79%, 71% and 77%, respectively. This pattern was consistent across most subgroups. When actual prescribed dosages were compared with recommended dosages based on the level of estimated kidney function, 3-19% of study participants were prescribed higher than recommended dosages. The largest discordance between prescribed and recommended dosages was observed for the Cockcroft-Gault equation. CONCLUSIONS: The CKD-EPI equation has the highest concordance with measured GFR for the assignment of FDA-designated kidney function categories. Its use may lead to lower dosing-related errors in HIV-infected US adults on stable antiretroviral therapy. More education is required with respect to dose adjustment for level of kidney function.

Performance of creatinine and cystatin C GFR estimating equations in an HIV-positive population on antiretrovirals.

OBJECTIVE: To evaluate the performance of Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine, cystatin C, and creatinine-cystatin C estimating equations in HIV-positive patients. METHODS: We evaluated the performance of the Modification of Diet in Renal Disease (MDRD) Study and CKD-EPI creatinine 2009, CKD-EPI cystatin C 2012, and CKD-EPI creatinine-cystatin C 2012 glomerular filtration rate (GFR) estimating equations compared with GFR measured using plasma clearance of iohexol in 200 HIV-positive patients on stable antiretroviral therapy. Creatinine and cystatin C assays were standardized to certified reference materials. RESULTS: Of the 200 participants, median (IQR) CD4 count was 536 (421) and 61% had an undetectable HIV viral load. Mean (SD) measured GFR (mGFR) was 87 (26) mL/min per 1.73 m. All CKD-EPI equations performed better than the MDRD Study equation. All 3 CKD-EPI equations had similar bias and precision. The cystatin C equation was not more accurate than the creatinine equation. The creatinine-cystatin C equation was significantly more accurate than the cystatin C equation, and there was a trend toward greater accuracy than the creatinine equation. Accuracy was equal or better in most subgroups with the combined equation compared to either alone. CONCLUSIONS: The CKD-EPI cystatin C equation does not seem to be more accurate than the CKD-EPI creatinine equation in patients who are HIV-positive, supporting the use of the CKD-EPI creatinine equation for routine clinical care for use in North American populations with HIV. The use of both filtration markers together as a confirmatory test for decreased estimated GFR based on creatinine in individuals who are HIV-positive requires further study.

Antiviral activity, pharmacokinetics, and safety of BMS-488043, a novel oral small-molecule HIV-1 attachment inhibitor, in HIV-1-infected subjects.

BMS-488043 is a novel and unique oral small-molecule inhibitor of the attachment of human immunodeficiency virus type 1 (HIV-1) to CD4(+) lymphocytes. The antiviral activity, pharmacokinetics, viral susceptibility, and safety of BMS-488043 were evaluated in an 8-day monotherapy trial. Thirty HIV-1-infected study subjects were randomly assigned to sequential, safety-guided dose panels of 800 and 1,800 mg BMS-488043 or a matched placebo in a 4:1 ratio, and the drug was administered every 12 h with a high-fat meal for 7 days and on the morning of day 8. Dose-related, albeit less-than-dose-proportional, increases in plasma BMS-488043 concentrations were observed. Mean plasma HIV-1 RNA decreases from the baseline for the BMS-488043 800- and 1,800-mg dose groups on day 8 were 0.72 and 0.96 log(10) copies/ml, respectively, compared with 0.02 log(10) copies/ml for the placebo group. A lower baseline BMS-488043 50% effective concentration (EC(50)) in the active-treatment groups was predictive of a greater antiviral response. Although absolute drug exposure was not associated with an antiviral response, the trough concentration (C(trough)), adjusted by the baseline EC(50) (C(trough)/EC(50)), was associated with antiviral activity. During dosing, four subjects experienced >10-fold reductions in viral susceptibility to BMS-488043, providing further support of the direct antiviral mechanism of BMS-488043. BMS-488043 was generally safe and well tolerated. These results suggest that further development of this novel class of oral HIV-1 attachment inhibitors is warranted.

Contemporary costs of HIV healthcare in the HAART era.

BACKGROUND: The delivery of HIV healthcare historically has been expensive. The most recent national data regarding HIV healthcare costs were from 1996-1998. We provide updated estimates of expenditures for HIV management. METHODS: We performed a cross-sectional review of medical records at 10 sites in the HIV Research Network, a consortium of high-volume HIV care providers across the United States. We assessed inpatient days, outpatient visits, and prescribed antiretroviral and opportunistic illness prophylaxis medications for 14 691 adult HIV-infected patients in primary HIV care in 2006. We estimated total care expenditures, stratified by the median CD4 cell count obtained in 2006 (≤50, 51-200, 201-350, 351-500, >500 cells/µl). Per-unit costs of care were based on Healthcare Cost and Utilization Project (HCUP) data for inpatient care, discounted average wholesale prices for medications, and Medicare physician fees for outpatient care. RESULTS: Averaging over all CD4 strata, the mean annual total expenditures per person for HIV care in 2006 in three sites was US $19 912, with an interquartile range from US $11 045 to 22 626. Average annual per-person expenditures for care were greatest for those with CD4 cell counts 50 cell/µl or less (US $40 678) and lowest for those with CD4 cell counts more than 500 cells/µl (US $16 614). The majority of costs were attributable to medications, except for those with CD4 cell counts 50 cells/µl or less, for whom inpatient costs were highest. CONCLUSION: HIV healthcare in the United States continues to be expensive, with the majority of expenditures attributable to medications. With improved HIV survival, costs may increase and should be monitored in the future.

HIV-1 protease mutations and protease inhibitor cross-resistance.

The effects of many protease inhibitor (PI)-selected mutations on the susceptibility to individual PIs are unknown. We analyzed in vitro susceptibility test results on 2,725 HIV-1 protease isolates. More than 2,400 isolates had been tested for susceptibility to fosamprenavir, indinavir, nelfinavir, and saquinavir; 2,130 isolates had been tested for susceptibility to lopinavir; 1,644 isolates had been tested for susceptibility to atazanavir; 1,265 isolates had been tested for susceptibility to tipranavir; and 642 isolates had been tested for susceptibility to darunavir. We applied least-angle regression (LARS) to the 200 most common mutations in the data set and identified a set of 46 mutations associated with decreased PI susceptibility of which 40 were not polymorphic in the eight most common HIV-1 group M subtypes. We then used least-squares regression to ascertain the relative contribution of each of these 46 mutations. The median number of mutations associated with decreased susceptibility to each PI was 28 (range, 19 to 32), and the median number of mutations associated with increased susceptibility to each PI was 2.5 (range, 1 to 8). Of the mutations with the greatest effect on PI susceptibility, I84AV was associated with decreased susceptibility to eight PIs; V32I, G48V, I54ALMSTV, V82F, and L90M were associated with decreased susceptibility to six to seven PIs; I47A, G48M, I50V, L76V, V82ST, and N88S were associated with decreased susceptibility to four to five PIs; and D30N, I50L, and V82AL were associated with decreased susceptibility to fewer than four PIs. This study underscores the greater impact of nonpolymorphic mutations compared with polymorphic mutations on decreased PI susceptibility and provides a comprehensive quantitative assessment of the effects of individual mutations on susceptibility to the eight clinically available PIs.

Relationship between plasma protease inhibitor concentrations and lipid elevations in HIV patients on a double-boosted protease inhibitor regimen (saquinavir/lopinavir/ritonavir).

The relationship between plasma protease inhibitor (PI) trough concentrations and hyperlipidemic effects were evaluated retrospectively using data from 2 pilot clinical trials of a double-boosted PI regimen (saquinavir/lopinavir/ritonavir) in 25 HIV patients. The patients' median age was 39 years (range, 25-60). At baseline, PI-naive patients had a median viral load of 53 500 copies/mL and median CD4 of 296 cells/mm(3), while PI-experienced patients had 37 750 copies/mL and 214 cells/mm(3). Plasma PI trough concentrations of saquinavir, lopinavir, and ritonavir at week 12 were 520, 4482, and 153 ng/mL, respectively. At week 12, median fasting lipids increased significantly from baseline: total cholesterol increased from 165 to 189 mg/dL (P = .0005) and the triglyceride increased from 113 to 159 mg/dL (P = .001). There were no associations between PI trough concentrations at week 12 and the percent total cholesterol change at week 12. No associations were found between PI trough concentrations and lipid changes in HIV patients on a double-boosted PI regimen (saquinavir/lopinavir/ritonavir). Factors other than systemic exposure to PIs (such as host or genetic factors) may modulate the hyperlipidemic effect of PIs.

HAART receipt and viral suppression among HIV-infected patients with co-occurring mental illness and illicit drug use.

Mental illness (MI) and illicit drug use (DU) frequently co-occur. We sought to determine the individual and combined effects of MI and DU on highly active antiretroviral therapy (HAART) receipt and HIV-RNA suppression among individuals engaged in HIV care. Using 2004 data from the HIV Research Network (HIVRN), we performed a cross-sectional study of HIV-infected patients followed at seven primary care sites. Outcomes of interest were HAART receipt and virological suppression, defined as an HIV-RNA <400 copies/ml. Independent variables of interest were: (1) MI/DU; (2) DU only; (3) MI only; and (4) Neither. We used chi-squared analysis for comparison of categorical variables, and logistic regression to adjust for age, race, sex, frequency of outpatient visits, years in clinical care, CD4 nadir, and study site. During 2004, 10,284 individuals in the HIVRN were either on HAART or HAART eligible defined as a CD4 cell count < or =350. Nearly half had neither MI nor DU (41%), 22% MI only, 15% DU only, and 22% both MI and DU. In multivariate analysis, co-occurring MI/DU was associated with the lowest odds of HAART receipt (Adjusted Odds Ratio: 0.63 (95% CI: (0.55-0.72]), followed by those with DU only (0.75(0.63-0.87)), compared to those with neither. Among those on HAART, concurrent MI/DU (0.66 (0.58-0.75)), DU only (0.77 (0.67-0.88)), were also associated with a decreased odds of HIV-RNA suppression compared to those with neither. MI only was not associated with a statistically significant decrease in HAART receipt (0.93(0.81-1.07)) or viral suppression (0.93 (0.82-1.05)) compared to those with neither. Post-estimation testing revealed a significant difference between those with MI/DU and DU only, and MI/DU and MI only. Co-occurring MI and DU is associated with lower HAART receipt and viral suppression compared to individuals with either MI or DU or neither. Integrating HIV, substance abuse, and mental healthcare may improve outcomes in this population.

Health-related quality of life in HIV-infected patients: the role of substance use.

HIV infection and substance use disorders are chronic diseases with complex contributions to health-related quality of life (HRQOL). We conducted a cross-sectional survey of 951 HIV-infected adults receiving care at 14 HIV Research Network sites in 2003 to estimate associations between HRQOL and specific substance use among HIV-infected patients. HRQOL was assessed by multi-item measures of physical and role functioning, general health, pain, energy, positive affect, anxiety, and depression. Mental and physical summary scales were developed by factor analysis. We used linear regression to estimate adjusted associations between HRQOL and current illicit use of marijuana, analgesics, heroin, amphetamines, cocaine, sedatives, inhalants, hazardous/binge alcohol, and drug use severity. Current illicit drug use was reported by 37% of subjects. Mental HRQOL was reduced for current users [adjusted beta coefficient -9.66, 95% confidence interval [(CI]) -13.4, -5.94] but not former users compared with never users. Amphetamines and sedatives were associated with large decreases in mental (amphetamines: beta = -22.8 [95% CI -33.5, -12.0], sedatives: beta = -18.6 [95% CI -26.2, -11.0]), and physical HRQOL (amphetamines: beta = -11.5 [95% CI -22.6, -0.43], sedatives: beta = -13.2 [95% CI -21.0, -5.36]). All illicit drugs were associated with decreased mental HRQOL: marijuana (beta = -7.72 [95% CI -12.0, -3.48]), non-prescription analgesics (beta = -13.4 [95% CI -20.8, -6.07]), cocaine (beta = -10.5 [95% CI -16.4, -4.67]), and inhalants (beta = -14.0 [95% CI -24.1, -3.83]). Facilitating sobriety for patients with attention to specific illicit drugs represents an important avenue for elevating HRQOL in patients living with HIV.

Impact of patient race on patient experiences of access and communication in HIV care.

BACKGROUND: Patient-centered care--including the domains of access and communication--is an important determinant of positive clinical outcomes. OBJECTIVE: To explore associations between race and HIV-infected patients' experiences of access and communication. DESIGN: This was a cross-sectional survey. PARTICIPANTS: Nine hundred and fifteen HIV-infected adults receiving care at 14 U.S. HIV clinics. MEASUREMENTS: Dependent variables included patients' reports of travel time to their HIV care site and waiting time to see their HIV provider (access) and ratings of their HIV providers on always listening, explaining, showing respect, and spending enough time with them (communication). We used multivariate logistic regression to estimate associations between patient race and dependent variables, and random effects models to estimate site-level contributions. RESULTS: Patients traveled a median 30 minutes (range 1-180) and waited a median 20 minutes (range 0-210) to see their provider. On average, blacks and Hispanics reported longer travel and wait times compared with whites. Adjusting for HIV care site attenuated this association. HIV care sites that provide services to a greater proportion of blacks and Hispanics may be more difficult to access for all patients. The majority of patients rated provider communication favorably. Compared to whites, blacks reported more positive experiences with provider communication. CONCLUSIONS: We observed racial disparities in patients' experience of access to care but not in patient-provider communication. Disparities were explained by poor access at minority-serving clinics. Efforts to make care more patient-centered for minority HIV-infected patients should focus more on improving access to HIV care in minority communities than on improving cross-cultural patient-provider interactions.

Substance abuse treatment in human immunodeficiency virus: the role of patient-provider discussions.

Substance abuse treatment is associated with decreases in human immunodeficiency virus (HIV) risk behavior and can improve HIV outcomes. The purpose of this study was to examine factors associated with substance abuse treatment utilization, including patient-provider discussions of substance use issues. We surveyed 951 HIV-infected adults receiving care at 14 HIV Research Network primary care sites regarding drug and alcohol use, substance abuse treatment, and provider discussions of substance use issues. Although 71% reported substance use, only 24% reported receiving substance abuse treatment and less than half reported discussing substance use issues with their HIV providers. In adjusted logistic regression models, receipt of substance abuse treatment was associated with patient-provider discussions. Patient-provider discussions of substance use issues were associated with current drug use, hazardous or binge drinking, and Black race or ethnicity, though substance use was comparable between Blacks and Whites. These data suggest potential opportunities for improving engagement in substance abuse treatment services.

Access to HAART and utilization of inpatient medical hospital services among HIV-infected patients with co-occurring serious mental illness and injection drug use.

OBJECTIVE: Among HIV-infected individuals, we examined whether having co-occurring serious mental illness (SMI) and injection drug use (IDU) impacts: (a) receipt of highly active antiretroviral therapy (HAART), and (b) utilization of inpatient HIV services, compared to those who have SMI only, IDU only or neither SMI nor IDU. METHOD: Demographic, clinical and resource utilization data were collected from medical records of 5119 patients in HIV primary care at four US HIV care sites in different geographic regions with on-site mental health services in 2001. We analyzed receipt of HAART using multivariate logistic regression and the number of medical hospital admissions using multivariate logistic and Poisson regression analyses, which controlled for demographic factors, receipt of HAART, CD4 count and HIV-1 RNA. RESULTS: Those with co-occurring SMI and IDU [adjusted odds ratio (AOR)=0.52; 95% confidence interval (95% CI)=0.41-0.81] and those with IDU alone (AOR=0.64; 95% CI=0.58-0.85) were significantly less likely to receive HAART than those with neither SMI nor IDU, controlling for demographic and clinical factors. Those with co-occurring SMI and IDU were more likely to use any inpatient medical services (AOR=2.22; 95% CI=1.64-3.01) and were significantly more likely to use them more frequently (incidence rate ratio=1.33; 95% CI=1.13-1.55) than those with neither SMI nor IDU, SMI only or IDU only. CONCLUSION: HIV-infected individuals with co-occurring SMI and IDU are significantly more likely to utilize HIV-related medical inpatient services than individuals with no comorbidity or with only one comorbidity. Individuals with both SMI and IDU did not differ from those with IDU only in receipt of HAART. Inpatient hospitalizations are expensive, and efforts should be targeted towards these populations to reduce potentially avoidable inpatient care.

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.

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.

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).

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.