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Adherence and virologic outcomes among treatment-naive veteran patients with human immunodeficiency virus type 1 infection.

ABSTRACT: Many studies have estimated the association between the adherence to antiretroviral therapies and human immunodeficiency virus (HIV) patients' virologic/immunologic outcomes. However, evidence is lacking on the causal effect of adherence on the outcomes. The goal of this study is to understand whether near perfect adherence is necessary to achieve optimal virologic outcome and also to investigate the effect of initial adherence to antiretroviral therapies on initial viral suppression by different regimens. A cohort study was conducted on HIV veterans initiating antiretroviral therapies in 1999 to 2015. The primary outcome was the first viral suppression occurred within 30 to 60 days since the index date. Multiple imputation was used to impute the missing value of virologic outcomes. The inverse probability of treatment weighting (IPTW) method was applied to estimate the viral suppression rate at each specific adherence category for each regimen category. Marginal structural models with IPTW were used to estimate the risk of viral suppression in lower-adherence categories in comparison to near-perfect adherence level ?95%. Data showed that lower adherence caused lower viral suppression rate, with the association differentiated by the regimen. Patients on integrase strand transfer had the highest viral suppression rate, with patients on protease inhibitors having the lowest rate. Regardless of regimens, the viral suppression rate among patients at initial adherence of 75 to <95% was not statistically different from patients at adherence of ?95%; however, the differences might be clinically significant.

SUBMITTER: Cheng Y

PROVIDER: S-EPMC5943894 | biostudies-other | 2018 Jan

REPOSITORIES: biostudies-other

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Adherence and virologic outcomes among treatment-naïve veteran patients with human immunodeficiency virus type 1 infection.

Cheng Yan Y Sauer Brian B Zhang Yue Y Nickman Nancy A NA Jamjian Christine C Stevens Vanessa V LaFleur Joanne J

Medicine 20180101 2

Many studies have estimated the association between the adherence to antiretroviral therapies and human immunodeficiency virus (HIV) patients' virologic/immunologic outcomes. However, evidence is lacking on the causal effect of adherence on the outcomes. The goal of this study is to understand whether near perfect adherence is necessary to achieve optimal virologic outcome and also to investigate the effect of initial adherence to antiretroviral therapies on initial viral suppression by differen ...[more]

PMID: 29480831

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Project description:IMPORTANCE:Individuals with human immunodeficiency virus (HIV) infection receiving combined antiretroviral therapy (ART) have an increased risk of myocardial infarction. Effects of ART on arterial inflammation among treatment-naive individuals with HIV are unknown. OBJECTIVE:To determine the effects of newly initiated ART on arterial inflammation and other immune/inflammatory indices in ART-naive patients with HIV infection. DESIGN, SETTING, PARTICIPANTS:Twelve treatment-naive HIV-infected individuals underwent fludeoxyglucose F 18 ([18F]-FDG) positron emission tomographic scanning for assessment of arterial inflammation, coronary computed tomographic angiography for assessment of subclinical atherosclerosis, and systemic immune and metabolic phenotyping before and 6 months after the initiation of therapy with elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate (combined ART). Systemic immune and metabolic factors were also assessed in 12 prospectively recruited individuals without HIV serving as controls. The study began July 24, 2012, and was completed May 7, 2015. INTERVENTIONS:Combined ART in the HIV-infected cohort. MAIN OUTCOMES AND MEASURES:The primary outcome was change in aortic target-background ratio (TBR) on [18F]-FDG-PET with combined ART in the HIV-infected group. RESULTS:For the 12 participants with HIV infection (mean (SD) age, 35 [11] years), combined ART suppressed viral load (mean [SD] log viral load, from 4.3 [0.6] to 1.3 [0] copies/mL; P?<?.001), increased the CD4+ T-cell count (median [IQR], from 461 [332-663] to 687 [533-882] cells/mm3; P?<?.001), and markedly reduced percentages of circulating activated CD4+ T cells (human leukocyte antigen-D related [HLA-DR]+CD38+CD4+) (from 3.7 [1.8-5.0] to 1.3 [0.3-2.0]; P?=?.008) and CD8+ T cells (HLA-DR+CD38+CD8+) (from 18.3 [8.1-27.0] to 4.0 [1.5-7.8]; P?=?.008), increased the percentage of circulating classical CD14+CD16- monocytes (from 85.8 [83.7-90.8] to 91.8 [87.5-93.2]; P?=?.04), and reduced levels of CXCL10 (mean [SD] log CXCL10, from 2.4 [0.4] to 2.2 [0.4] pg/mL; P?=?.03). With combined ART, uptake of [18F]-FDG in the axillary lymph nodes, as measured by TBR, decreased from a median (IQR) of 3.7 (1.3-7.0) at baseline to 1.4 (0.9-1.9; P?=?.01) at study end. In contrast, no significant decrease was seen in aortic TBR in response to combined ART (mean [SD], 1.9 [0.2]; median [IQR], 2.0 [1.8-2.1] at baseline to 2.2?[0.4]; 2.1 [1.9-2.6], respectively, at study end; P?=?.04 by 2-way test, P?=?.98 for test of decrease by 1-way test). Changes in aortic TBR during combined ART were significantly associated with changes in lipoprotein-associated phospholipase A2 (n?=?10; r?=?0.67; P?=?.03). Coronary plaque increased among 3 participants with HIV infection with baseline plaque and developed de novo in 1 participant during combined ART. CONCLUSIONS AND RELEVANCE:Newly initiated combined ART in treatment-naive individuals with HIV infection had discordant effects to restore immune function without reducing arterial inflammation. Complementary strategies to reduce arterial inflammation among ART-treated HIV-infected individuals may be needed.

Project description:Adherence to therapy with pegylated interferon and ribavirin for hepatitis C virus (HCV) infection has been incompletely examined.To evaluate the relationship between adherence to HCV therapy and early and sustained virologic response, assess changes in adherence over time, and examine risk factors for nonadherence.Retrospective cohort study.National Veterans Affairs Hepatitis C Clinical Case Registry.5706 HCV-infected patients (genotypes 1, 2, 3, or 4) with at least 1 prescription for both pegylated interferon and ribavirin between 2003 and 2006 and HCV RNA results before and after treatment initiation.Adherence was calculated over 12-week intervals by using pharmacy refill data. End points included early virologic response (decrease of ?2 log(10) HCV RNA at 12 weeks) and sustained virologic response (undetectable HCV RNA 24 weeks after the end of treatment).Early virologic response increased with higher levels of adherence to ribavirin therapy over the initial 12 weeks (patients with HCV genotype 1 or 4, 25 of 68 [37%] with ?40% adherence vs. 1367 of 2187 [63%] with 91% to 100% adherence [P < 0.001]; patients with HCV genotype 2 or 3, 12 of 18 [67%] with ?40% adherence vs. 651 of 713 [91%] with 91% to 100% adherence [P < 0.001]). Among patients with HCV genotype 1 or 4, sustained response increased with higher adherence to ribavirin therapy over the second, third, and fourth 12-week intervals. Results were similar for adherence to interferon therapy. Mean adherence to therapy with interferon and ribavirin decreased by 3.4 and 6.6 percentage points per 12-week interval, respectively (P for trend < 0.001 for each drug). Patients who received growth factors or thyroid medications during treatment had higher mean adherence to antiviral therapy.This was an observational study without standardized timing for outcome measurements.Early and sustained virologic responses increased with higher levels of adherence to interferon and ribavirin therapy. Adherence to therapy with both antivirals decreased over time, but more so for ribavirin.

Project description:To investigate the mechanism and functional significance of infection of CD8+ lymphocytes by human immunodeficiency virus type 1 (HIV-1) in vivo, we determined frequencies of infection, proviral conformation, and genetic relationships between HIV-1 variants infecting naive (CD45RA+) and memory (CD45RO+) peripheral blood CD4+ and CD8+ lymphocytes. Infection of CD3+ CD8+ CD45RA+ cells was detected in 9 of 16 study subjects at frequencies ranging from 30 to 1,400 proviral copies/10(6) cells, more frequently than CD3+ CD8+ lymphocytes expressing the RO isoform of CD45 (n = 2, 70 and 260 copies /10(6) cells). In agreement with previous studies, there was no evidence for a similar preferential infection of CD4+ naive lymphocytes. Proviral sequences in both CD4+ and CD8+ lymphocyte subsets were complete, as assessed by quantitation using primers from the long terminal repeat region spanning the tRNA primer binding site. In six of the seven study subjects investigated, variants infecting CD8+ lymphocytes were partially or completely genetically distinct in the V3 region from those recovered from CD4+ lymphocytes and showed a greater degree of compartmentalization than observed between naive and memory subsets of CD4+ lymphocytes. In two study subjects, arginine substitutions at position 306, associated with use of the chemokine coreceptor CXCR4, were preferentially found in CD4 lymphocytes. These population differences may have originated through different times of infection rather than necessarily indicating a difference in their biological properties. The preferential distribution of HIV-1 in naive CD8+ lymphocytes indeed suggests that infection occurred early in T-lymphocyte ontogeny, such as during maturation in the thymus. Destruction of cells destined to become CD8+ lymphocytes may be a major factor in the decline in CD8+ lymphocyte frequencies and function on disease progression and may contribute directly to the observed immunodeficiency in AIDS.

Project description:BACKGROUND:Persons with human immunodeficiency virus (HIV) who get and keep a suppressed viral load are unlikely to transmit HIV. Simple, practical interventions to help achieve HIV viral suppression that are easy and inexpensive to administer in clinical settings are needed. We evaluated whether a brief video containing HIV-related health messages targeted to all patients in the waiting room improved treatment initiation, medication adherence, and retention in care. METHODS AND FINDINGS:In a quasi-experimental trial all patients (N = 2,023) attending two HIV clinics from June 2016 to March 2017 were exposed to a theory-based, 29-minute video depicting persons overcoming barriers to starting treatment, taking medication as prescribed, and keeping medical appointments. New prescriptions at index visit, HIV viral load test results, and dates of return visits were collected through review of medical records for all patients during the 10 months that the video was shown. Those data were compared with the same variables collected for all patients (N = 1,979) visiting the clinics during the prior 10 months (August 2015 to May 2016). Among patients exposed to the video, there was an overall 10.4 percentage point increase in patients prescribed treatment (60.3% to 70.7%, p< 0.01). Additionally, there was an overall 6.0 percentage point improvement in viral suppression (56.7% to 62.7%, p< 0.01), however mixed results between sites was observed. There was not a significant change in rates of return visits (77.5% to 78.8%). A study limitation is that, due to the lack of randomization, the findings may be subject to bias and secular trends. CONCLUSIONS:Showing a brief treatment-focused video in HIV clinic waiting rooms can be effective at improving treatment initiation and may help patients achieve viral suppression. This feasible, low resource-reliant video intervention may be appropriate for adoption by other clinics treating persons with HIV. TRIAL REGISTRATION:http://www.ClinicalTrials.gov (NCT03508310).

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Adherence and virologic outcomes among treatment-naive veteran patients with human immunodeficiency virus type 1 infection.

Publications

Adherence and virologic outcomes among treatment-naïve veteran patients with human immunodeficiency virus type 1 infection.

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