Search

The live-attenuated influenza vaccine (LAIV) has generally been more efficacious than the inactivated vaccine in children. However, LAIV is not recommended for HIV-infected children because of insufficient data. We compared cellular, humoral, and mucosal immune responses to the 2013-2014 LAIV quadrivalent (LAIV4) in HIV-infected and uninfected children 2-25 years of age (yoa). We analyzed the responses to the vaccine H1N1 (H1N1-09), to the circulating H1N1 (H1N1-14), which had significant mutations compared to H1N1-09 and to B Yamagata (BY), which had the highest effectiveness in 2013-2014. Forty-six HIV-infected and 56 uninfected participants with prior influenza immunization had blood and nasal swabs collected before and after LAIV4 for IFNγ T and IgG/IgA memory B-cell responses (ELISPOT), plasma antibodies [hemagglutination inhibition (HAI) and microneutralization (MN)], and mucosal IgA (ELISA). The HIV-infected participants had median CD4+ T cells = 645 cells/µL and plasma HIV RNA = 20 copies/mL. Eighty-four percent were on combination anti-retroviral therapy. Regardless of HIV status, significant increases in T-cell responses were observed against BY, but not against H1N1-09. H1N1-09 T-cell immunity was higher than H1N1-14 both before and after vaccination. LAIV4 significantly increased memory IgG B-cell immunity against H1N1-14 and BY in uninfected, but not in HIV-infected participants. Regardless of HIV status, H1N1-09 memory IgG B-cell immunity was higher than H1N1-14 and lower than BY. There were significant HAI titer increases after vaccination in all groups and against all viruses. However, H1N1-14 MN titers were significantly lower than H1N1-09 before and after vaccination overall and in HIV-uninfected vaccinees. Regardless of HIV status, LAIV4 increased nasal IgA concentrations against all viruses. The fold-increase in H1N1-09 IgA was lower than BY. Overall, participants <9 yoa had decreased BY-specific HAI and nasal IgA responses to LAIV4. In conclusion, HIV-infected and uninfected children and youth had comparable responses to LAIV4. H1N1-09 immune responses were lower than BY and higher than H1N1-14, suggesting that both antigenic mismatches between circulating and vaccine H1N1 and lower immunogenicity of the H1N1 vaccine strain may have contributed to the decreased H1N1 effectiveness of 2013-2014 LAIV4. [ABSTRACT FROM AUTHOR]

BACKGROUND. There has been a gradual decrease in the proportion of children covered by private health insurance in Colorado and the United States with a commensurate increase in those with public insurance or having no insurance which may impact access to care and outcomes. OBJECTIVE. The purpose of this work was to determine whether children with public or no health insurance have differences in hospital admission rates, morbidity, mortality, and/or charges that might be improved if standards of primary care comparable to those of children with private insurance could be achieved. METHODS. We conducted a retrospective comparison of hospitalization-related outcomes for children RESULTS. Compared with those with private insurance, children in Colorado and the United States with public or no insurance have significantly higher rates of total hospital admission, as well as admission for chronic illness, asthma, diabetes, vaccine-preventable disease, psychiatric disease, and ruptured appendix. These children have higher mortality rates, higher severity of illness, are more likely to be admitted through the emergency department and have significantly higher hospital charges per insured child. Higher hospitalization rates occur in children who are nonwhite and/or Hispanic and those who are younger. If children with public or no health insurance in the United States in 2000 had the same hospitalization outcomes as children with private insurance, $5.3 billion in hospital charges could have been saved. CONCLUSIONS. There is an opportunity to achieve improved health outcomes and decreased hospitalization costs for children with public or no health insurance if private insurance standards of health care could be achieved for all US children. Key Words morbidity/mortality, cost-effectiveness outcomes analysis, health services, hospitalization Abbreviations SCHIP--State Children&apos;s Health Insurance Program CHA--Colorado Hospital Association APR-DRG all-patient refined diagnosis-related group MDC--major diagnostic category KID--Kids&apos; Inpatient Database UFFS-- unassigned fee-for-service CI--confidence interval ICD-9--International Classification of Diseases--Ninth Revision, THE US CENSUS reports that 34.1% of children METHODS Data Sources This was a population-based analysis of hospitalization rates for children who were >28 days and A preliminary analysis of [...]

Coadministration of didanosine (ddI) and tenofovir (TDF) results in increased ddI serum concentrations, which may lead to increased risk of ddI-associated toxicities. To evaluate the safety and tolerability of ddI/TDF, we performed a retrospective cohort analysis of patients seen in the HIV Outpatient Study, an ongoing dynamic cohort study of HIV-infected persons in clinical care. Study subjects were those who received at least 14 days of combined ddI/TDF before October 2003. Of 260 subjects who received ddI/TDF-based antiretroviral therapy, 155 (60%) received high-dose ddI (400 mg daily dose) and 105 (40%) received low-dose ddI (100--250 mg daily). Forty-two of the high-dose ddI recipients were later switched to low-dose ddI. The median time of observation for those on high-dose ddI only was 5 months, high-dose ddI switched to low-dose ddI was 16 months, and low-dose ddI only was 5 months (p < 0.05). Discontinuations because of toxicity were more frequent on high-dose ddI regimens (34/155, 22%) than on low-dose ddI regimens (9/105, 9%) (unadjusted odds ratio [[OR.sub.unadj]] 3.0, 95% confidence interval [95% CI] 1.30-7.09; p = 0.007). Among subjects without preexisting peripheral neuropathy, 12 (12%) of 101 subjects ever on high-dose ddI regimens had treatment-emergent peripheral neuropathy compared to 2 (4%) of 55 subjects on low-dose ddI regimens ([OR.sub.unadj] 3.57; 95% CI, 0.72--24.1; p = 0.14). Among patients without a history of pancreatitis, 6 (4%) of 153 subjects developed pancreatitis after starting high-dose ddI regimens, compared to none of the 103 subjects on low-dose ddI regimens ([OR.sub.adj] and 95% CIs undefined; p = 0.08). Severe laboratory abnormalities of creatinine, phosphorous, and bicarbonate were not different between the groups. A summary variable for any event--discontinuation for toxicity, treatment-emergent adverse event or abnormal laboratory values--indicated that 44 (28%) of 155 of those on high-dose ddI versus 13 (12%) of 105 on low-dose ddI developed any event ([OR.sub.unadj] 2.81; 95% CI, 1.36-5.86; p = 0.004). In conclusion, high-dose ddI/TDF-based therapy was more frequently associated with drug-related toxicity, adverse events, and treatment discontinuation than low-dose ddI/TDF regimens; low-dose ddI with TDF was generally well tolerated in these HIV-infected persons.

Background. Beginning in 1997 the Colorado Medicaid program de-emphasized managed care and shifted children from enrollment in a health maintenance organization (HMO), which required an enrollee to have an assigned primary care physician, to either the unassigned fee-for-service (UFFS) program in which the enrollee was not required to have a primary care physician (PCP) or to the primary care physician program (PCPP) in which the enrollee was required to select a participating PCP if one was available. The proportion of Medicaid enrollee-months in HMOs dropped from 75.4% in 1997 to 29% in 2003, whereas the proportion of enrollee-months in UFFS programs during this time period increased from 18.6% to 45.6%, and the proportion in the PCPP increased from 5.5% to 25.3%. This shift of children from HMO managed care to the UFFS program provided a natural experiment to assess the impact of not having an assigned PCP on pediatric primary care services. Objective. We sought to assess whether an elective shift of children from Medicaid HMO managed care plans with an assigned PCP to the UFFS program without an assigned PCP restricted access to a primary care medical home, recommended health supervision visits, and age-appropriate immunizations. Methods. Published Colorado Health Plan Employer Data and Information Set (HEDIS) data for 1999-2003 were reviewed to determine if Colorado children enrolled in Medicaid managed care programs with an assigned PCP (HMO and PCPP) compared with the UFFS program were more likely to have any type of visit with a PCP, to have recommended health supervision visits, and to be fully immunized. In the analysis, "HMO total" refers to the average of all children participating in HMO plans. Kaiser Permanente was considered a benchmark because it had the highest immunization rates of all HMOs. "Total Colorado" refers to the average of all children enrolled in Medicaid including the managed care and UFFS options. For 2-year-olds, the 4:3:2:1:1 combination immunization included 4 diphtheria-tetanus-acellular pertussis vaccines, 3 oral poliovirus vaccines or inactivated polio vaccines, 2 hepatitis B vaccines, 1 Haemophilus influenzae type b vaccine, and 1 measles-mumps-rubella vaccine. Results. In 1999 the percentages of children 12 to 24 months of age having any type of visit with a PCP were >80% for the PCPP, Kaiser Permanente, and UFFS programs. However, although the proportion with any visit remained >85% in 2001 for children enrolled in the PCPP and Kaiser Permanente program, the percentage dropped 13.9% to 66.2% for children in the UFFS program. In 2001 the percentage of children with any type of PCP visit enrolled in the UFFS program (66.2%) was significantly lower than the total Colorado (73.6%) as well as the PCPP (85.7%) and Kaiser Permanente program (97.7%). Children 12 to 24 months of age enrolled in the PCPP in 2001 were 1.3 times more likely to have any type of visit with a PCP compared with those enrolled in the UFFS program. Children in the PCPP in 2001, 2002, and 2003 were 1.4, 1.9, and 2.6 times more likely, respectively, to have all 6 of the recommended health supervision visits compared with children enrolled in the UFFS program. Children 3 to 6 years old in the PCPP in 2001, 2002, and 2003 were 1.3, 1.5, and 1.4 times more likely, respectively, to have an annual health supervision visit compared with children enrolled in the UFFS program. In 1999, 2001, 2002, and 2003 2-year-old children enrolled in the PCPP were 2.0, 1.4, 1.5, and 1.8 times more likely, respectively, to be up-to-date with 4:3:2:1:1 vaccines compared with children enrolled in the UFFS program. In 1999, 2001, 2002, and 2003 adolescents enrolled in the PCPP were 1.8, 1.6, 1.3, and 1.6 times more likely, respectively, to be up-to-date with 2 measles-mumps-rubella vaccines compared with children enrolled in the UFFS program. Conclusions. This study documents the diminishing ability of the Colorado Medicaid program to provide children access to the benefits of a medical home, including visits with PCPs, recommended health supervision visits, and immunizations as care was shifted to the UFFS program from HMO managed care. The high up-to-date immunization rates achieved by Kaiser Permanente suggest that differences in immunization rates reflect the effectiveness of the care processes rather than the characteristics of the Medicaid population. Pediatrics 2005; 116:1474-1479; managed care, primary care physician, health supervision visits, and immunizations. ABBREVIATIONS. HMO, health maintenance organization; PCP, primary care physician; PCPP, primary care physician program; UFFS, unassigned fee-for-service; HEDIS, Health Plan Employer Data and Information Set; AAP, American Academy of Pediatrics; CI, confidence interval; dTaP, diphtheria-tetanus-acellular pertussis; MMR, measles-mumps-rubella; VZV, varicella-zoster vaccine; 4:3:2:1:1, 4 diphtheria-tetanus-acellular pertussis vaccines, 3 oral poliovirus vaccines or inactivated polio vaccines, 2 hepatitis B vaccines, 1 Haemophilus influenzae type b vaccine, and 1 measles-mumps-rubella vaccine., Colorado Medicaid has 2 approaches to pediatric managed care: enrollment in a health maintenance organization (HMO), which requires that the enrollee have an assigned primary care physician (PCP), or enrollment [...]

Research has been conducted on factors associated with HIV-1-related lipoatrophy. The analysis of the lipoatrophy risk factors has been carried out focusing only on the patients with no l ipoatrophy , and the results are reported.

We evaluated treatment duration and viral suppression (VS) outcomes with integrase strand transfer inhibitor (INSTI)-based regimens versus other contemporary regimens among adults in routine HIV care. Eligible participants were seen during January 1, 2007 to June 30, 2018 at nine U.S. HIV clinics, initiated antiretroviral therapy (ART) (baseline date), and had ≥2 clinic visits thereafter. We assessed the probability of remaining on a regimen and achieving HIV RNA <200 copies/mL on initial INSTI versus non-INSTI ART by Kaplan–Meier analyses and their correlates by Cox regression. Among 1,005 patients, 335 (33.3%) were prescribed an INSTI-containing regimen and 670 (66.7%) a non-INSTI regimen, which may have included non-nucleoside reverse transcriptase inhibitors, protease inhibitors, and other agents. In both groups, most patients were male, nonwhite, and aged <50 years. Comparing the INSTI with non-INSTI group, the median baseline log10 HIV viral load (VL; copies/mL) was 4.6 versus 4.5, and the median CD4+ cell count (cells/mm3) was 352 versus 314. In Kaplan–Meier analysis, the estimated probabilities of remaining on initial regimens at 2 and 4 years were 58% and 40% for INSTI and 51% and 33% for non-INSTI group, respectively (log-rank test p = .003). In multivariable models, treatment with an INSTI (vs. non-INSTI) ART was negatively associated with a regimen switch [hazard ratio (HR) 0.67, 95% confidence interval (CI) 0.56–0.81, p < .001] and was positively associated with achieving VS (HR 1.52; CI 1.29–1.79, p < .001), both irrespective of baseline VL levels. Initial INSTI-based regimens were associated with longer treatment durations and better VS than non-INSTI regimens. Results support INSTI regimens as the initial therapy in U.S. treatment guidelines. [ABSTRACT FROM AUTHOR]

Human immunodeficiency virus (HIV) and hepatitis C virus (HCV) coinfection carries substantial risk for all-cause mortality and liver-related morbidity and mortality, yet many persons coinfected with HIV/HCV remain untreated for HCV. We explored demographic, clinical, and sociodemographic factors among participants in routine HIV care associated with prescription of direct-acting antivirals (DAAs). The HIV Outpatient Study (HOPS) is an ongoing longitudinal cohort study of persons with HIV in care at participating clinics since 1993. There are currently eight study sites in six US cities. We analyzed medical records data of HOPS participants diagnosed with HCV since June 2010. Sustained virological response (SVR) was documented with first undetectable HCV viral load (VL). We assessed factors associated with being prescribed DAAs by multi-variable logistic regression and described the cumulative rate of SVR. Among 306 eligible participants, 131 (43%) were prescribed DAA therapy. Factors associated with greater odds of being prescribed DAA were older age, private health insurance, higher CD4 cell count, being a person who injects drugs, and receiving care at publicly funded sites (p < 0.05). Of 127 (97%) participants with at least 1 follow-up HCV VL, 110 (87%) achieved SVR at 12 weeks. Of the total 131 participants, 123 (94%) eventually achieved SVR. Less than half of HIV/HCV coinfected patients in HOPS have been prescribed DAAs. Interventions are needed to address deficits in DAA prescription, including among patients with public or no health insurance, younger age, and lower CD4 cell count. [ABSTRACT FROM AUTHOR]

Background National guidelines recommend that sexually active people with human immunodeficiency virus (PWH) who are men who have sex with men (MSM) be tested for hepatitis C virus (HCV) infection at least annually. Hepatitis C virus testing rates vary by race/ethnicity in the general population, but limited data are available for PWH. Methods We analyzed medical records data from MSM in the HIV Outpatient Study at 9 human immunodeficiency virus (HIV) clinics from January 1, 2011 through December 31, 2019. We excluded observation time after documented past or current HCV infection. We evaluated HCV antibody testing in each calendar year among HCV-seronegative MSM, and we assessed testing correlates by generalized estimating equation analyses. Results Of 1829 eligible MSM who were PWH, 1174 (64.2%) were non-Hispanic/Latino white (NHW), 402 (22.0%) non-Hispanic black (NHB), 187 (10.2%) Hispanic/Latino, and 66 (3.6%) of other race/ethnicity. Most were ≥40 years old (68.9%), privately insured (64.5%), with CD4 cell count/mm3 (CD4) ≥350 (77.0%), and with HIV viral load <200 copies/mL (76.9%). During 2011–2019, 1205 (65.9%) had ≥1 HCV antibody test and average annual HCV percentage tested was 30.3% (from 33.8% for NHB to 28.5% for NHW; P <.001). Multivariable factors positively associated (P <.05) with HCV testing included more recent HIV diagnosis, public insurance, lower CD4, prior chlamydia, gonorrhea, syphilis, or hepatitis B virus diagnoses, and elevated liver enzyme levels, but not race/ethnicity. Conclusions Although we found no disparities by race/ethnicity in HCV testing, low overall HCV testing rates indicate suboptimal uptake of recommended HCV testing among MSM in HIV care. [ABSTRACT FROM AUTHOR]

Background Although chlamydia (CT) and gonorrhea (GC) infections are increasing in the United States, there are limited data on their incidence, testing rates, and associated risk factors among persons living with HIV (PLWH), including by anatomic site among men who have sex with men (MSM). Methods We analyzed 2007–2017 medical records data from Human Immunodeficiency Virus (HIV) Outpatient Study (HOPS) participants in care at 9 HIV clinics. We calculated CT (and GC) incidence and testing rates and assessed associations with sociodemographic and clinical factors using log-linear regression. Results Among 4727 PLWH, 397 had 881 CT infections and 331 had 861 GC infections, with an incidence of 2.95 and 2.88 per 100 person-years, respectively. From 2007 to 2017, incidence and testing rates increased by approximately 3.0- and 1.9-fold for CT and GC, respectively. Multivariable factors associated with incident CT (GC) included younger age, MSM, and prior diagnoses of sexually transmitted diseases (STDs). Among 1159 MSM, 583 (50.3%) had 844 CT and 843 GC tests during 2016–2017, and 26.6% of tests were 3-site (urethra, rectum, and pharynx), yielding the highest rates of CT (GC) detection. Multivariable factors associated with CT (GC) testing included younger age, non-Hispanic/Latino black race, and having prior STDs. Conclusions Recent CT and GC incidence and testing increased among PLWH; however, only half of MSM were tested for CT or GC during 2016–2017 and less than a third of tests were 3-site. To promote sexual health and STD prevention among PLWH who are MSM, research regarding the added value of CT and GC testing across 3 anatomic sites is needed. [ABSTRACT FROM AUTHOR]

Background The clinical epidemiology of treated HIV infection in the United States has dramatically changed in the past 25 years. Few sources of longitudinal data exist for people with HIV (PWH) spanning that period. Cohort data enable investigating new exposure and disease associations and monitoring progress along the HIV care continuum. Methods We synthesized key published findings and conducted primary data analyses in the HIV Outpatient Study (HOPS), an open cohort of PWH seen at public and private HIV clinics since 1993. We assessed temporal trends in health outcomes (1993–2017) and mortality (1994–2017) for 10 566 HOPS participants. Results The HOPS contributed to characterizing new conditions (eg, lipodystrophy), demonstrated reduced mortality with earlier HIV treatment, uncovered associations between select antiretroviral agents and cardiovascular disease, and documented remarkable shifts in morbidity from AIDS opportunistic infections to chronic noncommunicable diseases. The median CD4 cell count of participants increased from 244 cells/mm3 to 640 cells/mm3 from 1993 to 2017. Mortality fell from 121 to 16 per 1000 person-years from 1994 to 2017 (P  < .001). In 2010, 83.7% of HOPS participants had a most recent HIV viral load <200 copies/mL, compared with 92.2% in 2017. Conclusions Since 1993, the HOPS has been detecting emerging issues and challenges in HIV disease management. HOPS data can also be used for monitoring trends in infectious and chronic diseases, immunologic and viral suppression status, retention in care, and survival, thereby informing progress toward the Ending the HIV Epidemic initiative. [ABSTRACT FROM AUTHOR]

We assessed disparities in viral suppression (VS) and antiretroviral therapy (ART) adherence among women of the HIV Outpatient Study to inform HIV treatment strategies. We used adjusted prevalence ratios (aPR) with 95% confidence intervals (CI) to assess VS by race/ethnicity and generalized estimating equations to investigate factors associated with not achieving VS and ART non-adherence. Among 426 women (median age = 46 years), at baseline, VS was less prevalent among black women (63%) compared with Hispanic women/Latinas (73%) and white women (78%). In the multivariable analysis, factors significantly associated with not achieving VS included the following social and behavioral determinants of care: using public insurance (aPR = 1.69, CI 1.01–2.82, p = 0.044) compared to using private insurance, seeking care in a public clinic (aPR = 1.60, CI 1.03–2.50, p = 0.037) compared to seeking care in a private clinic, and ART non-adherence (aPR = 2.79, CI 1.81–4.29), p < 0.001). Although race was not a significant factor in not achieving VS, race was associated with ART non-adherence; black women were more likely to miss a dose of ART medication (aPR = 2.07, CI 1.19–3.60, p = 0.010) when compared to white women and Hispanic women/Latinas. Interventions and resources disseminated to address social barriers to care and improve VS and ART adherence among HIV-positive women, particularly black women, are warranted. [ABSTRACT FROM AUTHOR]

Background Since 2000, the incidence of syphilis has been increasing, especially among gay, bisexual, and other men who have sex with men (MSM) in the United States. We assessed temporal trends and associated risk factors for newly diagnosed syphilis infections among human immunodeficiency virus (HIV)–infected patients during a 16-year period. Methods We analyzed data from the HIV Outpatient Study (HOPS) cohort participants at 10 US HIV clinics during 1999–2015. New syphilis cases were defined based on laboratory parameters and clinical diagnoses. We performed Cox proportional hazards regression analyses of sociodemographic, clinical, and behavioral risk factors for new syphilis infections. Results We studied 6888 HIV-infected participants; 641 had 1 or more new syphilis diagnoses during a median follow-up of 5.2 years. Most participants were male (78%), aged 31–50 years, and 57% were MSM. The overall incidence was 1.8 (95% confidence interval [CI], 1.6–1.9) per 100 person-years (PY) and it increased from 0.4 (95% CI,.2–.8) to 2.2 (95% CI, 1.4–3.5) per 100 PY during 1999–2015. In multivariable analyses adjusting for calendar year, risk factors for syphilis included age 18–30 years (hazard ratio [HR], 1.3 [95% CI, 1.1–1.6]) vs 31–40 years, being MSM (HR, 3.1 [95% CI, 2.4–4.1]) vs heterosexual male, and being non-Hispanic black (HR, 1.6 [95% CI, 1.4–1.9]) vs non-Hispanic white. Conclusions The increases in the syphilis incidence rate through 2015 reflect ongoing sexual risk and highlight the need for enhanced prevention interventions among HIV-infected patients in care. [ABSTRACT FROM AUTHOR]

Maximizing the rates of virologic suppression (VS) among gay, bisexual, and other men who have sex with men (MSM) is essential to limiting HIV morbidity and sexual transmission of HIV in the United States. We analyzed data for MSM of non-Hispanic white (white), non-Hispanic black (black), or Hispanic/Latino race/ethnicity in the HIV Outpatient Study (HOPS) at nine U.S. HIV clinics. VS (HIV RNA <50 copies/ml) was measured closest to January 1, 2015. We modeled factors associated with VS among persons prescribed antiretroviral therapy (ART) for ≥6 months and assessed VS for a subset of participants with behavioral interview data. Among 1,303 MSM studied, 24% were black and 11% were Hispanic/Latino. Fewer black than white or Hispanic/Latino MSM had any documented ART use history (92% vs. 99% and 94%, respectively), and fewer had VS (72% vs. 91% and 81%), p < .001. In analyses of MSM prescribed ART, which adjusted for insurance type, duration of ART use, and CD4+ cell count, blacks had lower prevalence of VS than whites [adjusted prevalence ratio (PR) 0.87, confidence interval (95% CI) 0.81–0.93] and Hispanics/Latinos did not (PR 0.95, 95% CI 0.88–1.02). Among 331 MSM with interview data, 6% had no VS, but reported anal sex without a condom with an HIV-uninfected or unknown HIV serostatus male partner in the past 6 months. In this study of HIV-infected MSM, blacks had a significantly lower prevalence of VS than white men. Optimizing HIV care and prevention among all MSM will require addressing underlying risk factors and social determinants of health that contribute to racial/ethnic disparities in HIV outcomes. [ABSTRACT FROM AUTHOR]