RESUMO
There is growing evidence showing that patterns of individual sexual risk behaviors are insufficient in explaining the disproportionate HIV/AIDS burden borne by African Americans. Instead, dynamic features of social, economic, political, and geographic contexts play a more determining role. However, not enough studies have examined the impact of multi-level factors including neighborhood-level influences on HIV/AIDS sexual risk among African American emerging adults using a socio-ecologic perspective. Anchored on the socio-ecologic framework, this study examines the collective role of relevant socio-ecologic determinants of sexual risk-taking among African American emerging adults. Results from both bivariate and multivariate analyses revealed that individual and neighborhood-level variables were significantly associated with sexual risk in our study population partially confirming the hypothesis of the study. Male gender, educational attainment, and neighborhood social disorder were the strongest predictors of sexual risk. Our findings contribute to the vast literature on sexual risk behavior patterns of young adults, and increasing evidence demonstrating the role of contextual factors as stronger predictors of sexual risk and HIV infection among at-risk youth. Our findings, however, underscore the need for further research on the pathways of HIV socio-behavioral vulnerability in this demographic group.
Assuntos
Síndrome da Imunodeficiência Adquirida , Infecções por HIV , Adolescente , Adulto Jovem , Humanos , Masculino , Infecções por HIV/epidemiologia , Infecções por HIV/prevenção & controle , Negro ou Afro-Americano , Conhecimentos, Atitudes e Prática em Saúde , Assunção de RiscosRESUMO
This study tested the hypothesis that the co-occurrence of alcohol use and depressive symptoms predicts HIV suppression and antiretroviral therapy (ART) adherence among people living with HIV. Baseline cross-sectional results showed a significant interaction between depressive symptoms and alcohol use in predicting HIV suppression; individuals who drank more alcohol and had higher depressive symptoms demonstrated poorer HIV suppression relative to those who had fewer depressive symptoms. In a one-year longitudinal analysis of ART adherence, alcohol use and depressive symptoms measured in daily text-message assessments demonstrated that neither alcohol use nor depressive symptoms alone predicted ART adherence. However, the intersection of alcohol use on days when experiencing depressive symptoms did significantly predict ART non-adherence, for both moderate and heavy alcohol drinkers. Findings suggest that the co-occurrence of alcohol use and depressive symptoms is a robust predictor of poor HIV treatment outcomes.
Assuntos
Fármacos Anti-HIV , Infecções por HIV , Antirretrovirais/uso terapêutico , Estudos Transversais , Depressão/complicações , Infecções por HIV/complicações , Infecções por HIV/tratamento farmacológico , Humanos , Adesão à MedicaçãoRESUMO
Patient initiated decisions to forgo taking medications (i.e. intentional nonadherence) pose significant challenges to managing chronic health conditions. Identifying factors and their underlying mechanisms that impede medication adherence is essential to designing treatment improvement interventions. This study tested a conceptual model that posits the effects of perceived sensitivity to medicines on adherence can be explained by the experience of side-effects, leading to intentionally nonadherent behaviors. Patients receiving HIV care in the southern United States (N = 209) completed measures of perceived sensitivity to medicines, antiretroviral therapy (ART) side-effects, intentional nonadherence and overall adherence. Patients also provided consent to access their electronic medical records to collect subsequent reports of HIV viral load tests. Results indicated that more than one in four participants were intentionally nonadherent to ART. Mediation modeling showed that perceived sensitivity to medicines was associated with greater experience of ART side-effects and intentional nonadherence, which impacted overall ART adherence and HIV viral load. There were also significant indirect effects of perceived sensitivity to medicines on HIV viral load through side-effects and intentional nonadherence. Patients with increased perceived sensitivity to medicines are at risk for poor treatment outcomes and these negative outcomes are partly explained by experiencing greater side-effects and intentional nonadherence.
Assuntos
Infecções por HIV , Adesão à Medicação , Humanos , Estados Unidos , Infecções por HIV/tratamento farmacológico , Resultado do TratamentoRESUMO
BACKGROUND: Lower health literacy is associated with poorer health outcomes in people living with HIV (PLWH), but the explanatory mechanisms for these associations are not well understood. Factors such as drug use and life chaos may at least in part account for the relationship between lower health literacy and poor health outcomes. The current study tested the hypothesis that lower health literacy would predict drug use, which in turn would predict life chaos, and that all three factors would be related to poorer heath, defined by higher concentrations of HIV viremia. Methods: Patients receiving HIV care (N = 251) at an HIV clinic in the southeastern United States completed computerized interviews and permission to access their medical records. Process modeling tested direct and indirect effects of all variables in a serial mediation model. Results: The direct effects of lower health literacy and drug use were significantly related to HIV viremia. In addition, the indirect effect of health literacy on HIV viremia through drug use was significant. However, results did not demonstrate any effect, direct or indirect, of life chaos on HIV viremia. Conclusion: Findings from this study bolster previous research demonstrating lower health literacy and drug use as barriers to HIV care, and show that lower health literacy impacts HIV viremia, at least in part, through drug use. Interventions aimed to improve HIV treatment outcomes in lower health literacy populations may be enhanced by integrating evidence-based approaches to reducing drug use.
Assuntos
Infecções por HIV , Letramento em Saúde , Preparações Farmacêuticas , Infecções por HIV/tratamento farmacológico , Humanos , Sudeste dos Estados Unidos , Carga ViralRESUMO
Although anticipated HIV-related stigma-the expectation that one will experience prejudice and discrimination in the future as a result of others learning his or her HIV positive status-is theorized to be a robust predictor of antiretroviral therapy (ART) non-adherence, the association between anticipated stigma and ART non-adherence has been inconsistent. It may be, however, that anticipated stigma reliably, but indirectly, contributes to poor ART adherence through other psychosocial mechanisms. In the current study, we examine whether anticipated stigma indirectly contributes to treatment non-adherence through increased medication concerns. In a cross-sectional study, 585 people living with HIV in Atlanta and Macon, Georgia completed measures of anticipated HIV-related stigma, HIV-medication concerns, and HIV-treatment adherence. A latent variable mediation analysis revealed that anticipated stigma was positively associated with increased medication concerns, which consequently contributed to treatment non-adherence. Results reveal a psychosocial mechanism by which anticipated stigma contributes to ART non-adherence.
Assuntos
Discriminação Psicológica/fisiologia , Infecções por HIV/tratamento farmacológico , Infecções por HIV/psicologia , Adesão à Medicação/estatística & dados numéricos , Estigma Social , Cooperação e Adesão ao Tratamento/estatística & dados numéricos , Adulto , Antirretrovirais/uso terapêutico , Estudos Transversais , Feminino , Georgia/epidemiologia , Infecções por HIV/epidemiologia , Humanos , Masculino , Adesão à Medicação/psicologia , Pessoa de Meia-Idade , População Rural , População Urbana , Adulto JovemRESUMO
The phase 3 ATLAS and FLAIR studies demonstrated that maintenance with Long-Acting (LA) intramuscular cabotegravir and rilpivirine is non-inferior in efficacy to current antiretroviral (CAR) oral therapy. Both studies utilized Patient-Reported Outcome instruments to measure treatment satisfaction (HIVTSQ) and acceptance (ACCEPT general domain), health status (SF-12), injection tolerability/acceptance (PIN), and treatment preference. In pooled analyses, LA-treated patients (n = 591) demonstrated greater mean improvements from baseline than the CAR group (n = 591) in treatment satisfaction (Week 44, + 3.9 vs. +0.5 HIVTSQs-points; p < 0.001) and acceptance (Week 48, +8.8 vs. +2.0 ACCEPT-points; p < 0.001). The acceptability of injection site reactions (PIN) significantly improved from week 5 (2.10 points) to week 48 (1.62 points; p < 0.001). In both studies, ≥ 97% of LA group participants with recorded data preferred LA treatment compared with prior oral therapy. These results further support the potential of a monthly injectable option for people living with HIV seeking an alternative to daily oral treatment.
Assuntos
Fármacos Anti-HIV/uso terapêutico , Infecções por HIV , HIV-1 , Piridonas/uso terapêutico , Rilpivirina/uso terapêutico , Infecções por HIV/tratamento farmacológico , Humanos , Injeções Intramusculares , Medidas de Resultados Relatados pelo PacienteRESUMO
Erroneous beliefs that it is toxic to drink alcohol while taking antiretroviral therapies (ART) used for treating HIV infection, known as alcohol interactive toxicity beliefs, may at least in part account for ART nonadherence among alcohol drinkers. This study was conducted to test a conceptual framework to explain the effects of interactive toxicity beliefs on ART adherence. Computerized surveys were administered to 124 participants receiving HIV care in the southeastern US. Serial mediation model with perceived sensitivity to medicines predicting HIV viral load through three mediating variables: alcohol-ART interactive toxicity beliefs, alcohol-ART avoidance behaviors, and ART adherence. HIV viral load extracted from medical records. Perceived sensitivity to medicines predicted HIV viral load; greater perceptions of medication sensitivity predicted lower HIV viral loads. In addition, there was a significant indirect effect of the serial chain of interactive toxicity beliefs â avoidance behaviors â ART adherence, indicating partial mediation of the relationship between perceived sensitivity to medicines and higher HIV viral load. Perceived sensitivity to medicines provides a conceptual basis for the effects of alcohol-medication interactive toxicity beliefs on ART adherence. Interactive toxicity beliefs are modifiable and can be altered to prevent intentional ART nonadherence.
Assuntos
Consumo de Bebidas Alcoólicas/psicologia , Interações Medicamentosas , Infecções por HIV/tratamento farmacológico , Infecções por HIV/psicologia , Adesão à Medicação/psicologia , Adulto , Fármacos Anti-HIV/administração & dosagem , Feminino , Humanos , Masculino , Adesão à Medicação/estatística & dados numéricos , Pessoa de Meia-Idade , Fatores Socioeconômicos , Inquéritos e Questionários , Adulto JovemRESUMO
Antiretroviral therapies (ART) suppress HIV replication, thereby preventing HIV disease progression and potentially preventing HIV transmission. However, there remain significant health disparities among people living with HIV, particularly for women living in impoverished rural areas. A significant contributing factor to HIV-related disparities is a stigma. And yet, the relative contributions of stigma, gender, socio-economics, and geography in relation to health outcomes are understudied. We examined the associations of internalized stigma and enacted stigma with community-level income inequality and HIV viral suppression-the hallmark of successful ART-among 124 men and 74 women receiving care from a publicly funded HIV clinic serving rural areas with high-HIV prevalence in the southeastern US. Participants provided informed consent, completed computerized interviews, and provided access to their medical records. Gini index was collected at the census tract level to estimate community-level income inequality. Individual-level and multilevel models controlled for point distance that patients lived from the clinic and quality of life, and included participant gender as a moderator. We found that for women, income inequality, internalized stigma, and enacted stigma were significantly associated with HIV suppression. For men, there were no significant associations between viral suppression and model variables. The null findings for men are consistent with gender-based health disparities and suggest the need for gender-tailored prevention interventions to improve the health of people living with HIV in rural areas. Results confirm and help to explain previous research on the impact of HIV stigma and income inequality among people living with HIV in rural settings.
Assuntos
Progressão da Doença , Infecções por HIV/epidemiologia , Infecções por HIV/prevenção & controle , População Rural , Estigma Social , Fatores Socioeconômicos , Adulto , Feminino , Humanos , Masculino , Prontuários Médicos , Pessoa de Meia-Idade , Pobreza , Saúde da População Rural , Sudeste dos Estados Unidos/epidemiologia , Inquéritos e QuestionáriosRESUMO
As people living with HIV experience longer life-expectancies resulting from antiretroviral therapy, comorbid conditions are increasing, particularly metabolic disorders. There is potential for psychosocial factors such as stigma experiences, depression, and alcohol use to complicate both HIV infection and metabolic disorders, including diabetes mellitus and hyperlipidemia. While the impact of these psychosocial factors on HIV infection alone are widely studied, their role in potentially complicating HIV co-morbid metabolic conditions has received little attention. This study examined the association between HIV-related stigma and depression, and the potential role of alcohol use as a mediating factor in a clinical sample of patients with comorbid HIV infection and metabolic conditions. Results demonstrated that HIV stigma is associated with depression and this relationship is in part accounted for by alcohol use. Our results indicate that interventions aiming to improve the health of people living with HIV and co-morbid metabolic disorders should prioritize addressing alcohol use as it is related to sources of stress, such as stigma, and depression.
Assuntos
Consumo de Bebidas Alcoólicas/epidemiologia , Depressão/epidemiologia , Infecções por HIV/epidemiologia , Doenças Metabólicas/epidemiologia , Estigma Social , Comorbidade , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , População Rural/estatística & dados numéricos , Sudeste dos Estados Unidos/epidemiologiaRESUMO
AIDS stigmas delay HIV diagnosis, interfere with health care, and contribute to mental health problems among people living with HIV. While there are few studies of the geographical distribution of AIDS stigma, research suggests that AIDS stigmas are differentially experienced in rural and urban areas. We conducted computerized interviews with 696 men and women living with HIV in 113 different zip code areas that were classified as large-urban, small-urban, and rural areas in a southeast US state with high-HIV prevalence. Analyses conducted at the individual level (N = 696) accounting for clustering at the zip code level showed that internalized AIDS-related stigma (e.g., the sense of being inferior to others because of HIV) was experienced with greater magnitude in less densely populated communities. Multilevel models indicated that after adjusting for potential confounding factors, rural communities reported greater internalized AIDS-related stigma compared to large-urban areas and that small-urban areas indicated greater experiences of enacted stigma (e.g., discrimination) than large-urban areas. The associations between anticipated AIDS-related stigma (e.g., expecting discrimination) and population density at the community-level were not significant. Results suggest that people living in rural and small-urban settings experience greater AIDS-related internalized and enacted stigma than their counterparts living in large-urban centers. Research is needed to determine whether low-density population areas contribute to or are sought out by people who experienced greater AIDS-related stigma. Regardless of causal directions, interventions are needed to address AIDS-related stigma, especially among people in sparsely populated areas with limited resources.
Assuntos
Densidade Demográfica , População Rural , Estigma Social , População Urbana , Humanos , Análise Multivariada , Sudeste dos Estados UnidosRESUMO
Acute rhabdomyolysis is a rare phenomenon in the emergency setting almost exclusively associated with trauma, drugs, and recent upper respiratory and gastrointestinal infection. Rare reports in the literature have highlighted adult patients presenting with rhabdomyolysis as 1 component in a constellation of symptoms in acute HIV-1 seroconversion; however, there are few reports of rhabdomyolysis as the sole presenting symptom. This case highlights the importance of investigating HIV and other sexually transmitted diseases in pediatric cases of rhabdomyolysis in the emergency care setting.
Assuntos
Infecções por HIV/complicações , Infecções por HIV/diagnóstico , HIV-1/imunologia , Rabdomiólise/virologia , Soroconversão , Injúria Renal Aguda/etiologia , Adolescente , Homossexualidade Masculina , Humanos , Masculino , Rabdomiólise/complicaçõesRESUMO
The state of Georgia ranks first in the rate of new diagnosis of HIV/AIDS, yet studies focused on understanding the drivers of this epidemic in the most at-risk groups outside the Atlanta Metropolitan Statistical Area (MSA) remain sparse. Among the many consequences of this is the inability to effectively design tailored intervention programs that appropriately address the reduction of HIV/AIDS and other STDS in the state. Reducing disparities in HIV/AIDS remains an important goal in the National HIV/AIDS Strategy. Given the disproportionate burden of the HIV/AIDS epidemic among Blacks in the state of Georgia, there is a significant need to focus research attention on the sexual behavior of young people that predisposes them to increased risk of HIV/AIDS infection. The current study used latent class analysis (LCA) to examine the sexual behavior patterns of Black young adults living in Georgia. LCA results revealed a two-class fit with distinct sexual behavior patterns. Gender and educational attainment emerged as significant predictors of class membership. Our findings contribute to the vast literature showing that sexual behavior patterns of Black young adults are not homogenous, and underscore the significance of socio-demographic and contextual factors in shaping sexual risk behavior.
Assuntos
Síndrome da Imunodeficiência Adquirida , Infecções por HIV , Humanos , Adulto Jovem , Adolescente , Georgia/epidemiologia , Análise de Classes Latentes , Comportamento Sexual , Infecções por HIV/epidemiologiaRESUMO
PURPOSE: To determine the impact of baseline viral load (VL) and CD4+ cell count, race/ethnicity, and gender on response in a post hoc analysis of the Gemini study. METHODS: In this 48-week study, treatment-naïve, HIV-infected participants received as initial therapy twice-daily saquinavir/ritonavir (SQV/r) 1000/100 mg (n=167) or lopinavir/ritonavir (LPV/r) 400/100 mg (n=170), each with emtricitabine 200 mg/tenofovir 300 mg daily. The proportion of participants achieving HIV RNA<50 copies/mL (primary endpoint) and median change from baseline in CD4+ cell count were compared by baseline VL (>100,000 vs ≤ 100,000 copies/ mL) and CD4+ cell count (>100 vs ≤ 100 cells/µL). The impact of baseline and demographic variables on virologic response was assessed by logistic regression analysis. RESULTS: Responses were similar between arms (SQV/r vs LPV/r) with or without stratification. In a pooled analysis of SQV/r and LPV/r arms, CD4+ cell count >100 cells/µL (odds ratio [OR], 1.628;P = .0416), non-Thai/non-Black versus Black race (OR, 1.518;P = .0023), and non-Thai/non-Black versus Thai (OR, 0.467;P = .0046) were significant predictors of virologic response. CONCLUSIONS: Treatment groups had similar efficacy. Baseline CD4+ cell count and race/ethnicity were independent predictors of virologic response, whereas baseline VL and gender were not.
Assuntos
Fármacos Anti-HIV/administração & dosagem , Fármacos Anti-HIV/uso terapêutico , Infecções por HIV/tratamento farmacológico , Infecções por HIV/virologia , Adulto , Esquema de Medicação , Feminino , Infecções por HIV/imunologia , Humanos , Masculino , Razão de Chances , Grupos Raciais , Carga Viral/efeitos dos fármacosRESUMO
PURPOSE: To test the efficacy of a theory-based behavioral intervention delivered via telephone versus clinic-based counseling to improve HIV outcomes and reduce alcohol consumption for people at-risk for treatment failure in a rural setting. METHODS: Patients receiving HIV care (N = 240) were randomized using a computer-generated scheme to one of three conditions: (a) telephone behavioral health counseling, (b) clinic-based behavioral health counseling, or (c) attention control nutrition education. Behavioral counseling was delivered by either a community nurse or a paraprofessional patient navigator, with differences examined. Participants were followed for 12 months to assess medication adherence using unannounced pill counts and alcohol use measured by electronic daily text message assessments, and 18 months for HIV viral load and retention in care extracted from medical records. FINDINGS: There was evidence for telephone and office-based counseling demonstrating greater medication adherence than the control condition but only in the short term. Clinic-based behavioral counseling significantly reduced alcohol use to a greater degree than telephone counseling and the control condition. There were no other differences between conditions. There were also no discernable differences between counseling delivered by the community nurse and the patient navigator. CONCLUSIONS: Telephone and clinic-based counseling demonstrated improved medication adherence in the short term, while clinic-based counseling demonstrated reductions in alcohol use. The modest outcomes suggest that intensive intervention strategies are needed for patients that clinicians identify as at-risk for treatment discontinuation and treatment failure.
Assuntos
Aconselhamento , Infecções por HIV , Infecções por HIV/terapia , Humanos , Adesão à Medicação , População Rural , TelefoneRESUMO
BACKGROUND Neurosyphilis is a bacterial infection of the brain and the spinal cord, caused by Treponema pallidum. Its nonspecific clinical presentation includes cognitive impairment and motor and/or sensory function compromise. Neurosyphilis infections in patients with HIV have increased over the past few years and many cases of neurosyphilis manifest in patients with HIV who have low CD4 T-cell counts and high viral loads (VL). However, there is extremely limited acknowledgement in the literature about neurosyphilis presentations in patients with HIV who have normal CD4 counts. CASE REPORT We present a neurosyphilis and HIV coinfection in a patient with a normal CD4 count and an undetectable VL. A 69-year-old woman with a medical history of HIV was on a prescribed antiretroviral treatment regimen. She presented in the Emergency Room in an unresponsive state, although this had been preceded by a period of rapidly progressive cognitive decline. Her brain computed tomography scan without contrast was unremarkable. Laboratory test results were within normal limits, except for a positive result for the microhemagglutination assay for Treponema pallidum antibodies and rapid plasma regain (RPR) test, which was highly suggestive of neurosyphilis as a presumed diagnosis. She showed remarkable clinical improvement after the initiation of conventional treatment for neurosyphilis, which is a 14-day regimen of intravenous penicillin G. CONCLUSIONS Given the broad neurological manifestations of neurosyphilis and its increasing incidence in patients with HIV, it is important to consider neurosyphilis in the differential diagnosis after ruling out other causes of encephalopathy, especially in patients with an undetectable VL and a normal CD4 count.
Assuntos
Infecções por HIV , Neurossífilis , Idoso , Contagem de Linfócito CD4 , Feminino , HIV , Infecções por HIV/complicações , Humanos , Neurossífilis/complicações , Neurossífilis/diagnóstico , Neurossífilis/tratamento farmacológico , Penicilinas , Carga ViralRESUMO
With the expansion of telehealth services, there is a need for evidence-based treatment adherence interventions that can be delivered remotely to people living with HIV. Evidence-based behavioral health counseling can be delivered via telephone, as well as in-office services. However, there is limited research on counseling delivery formats and their differential outcomes. The purpose of this study was to conduct a head-to-head comparison of behavioral self-regulation counseling delivered by telephone versus behavioral self-regulation counseling delivered by in-office sessions to improve HIV treatment outcomes. Patients (N = 251) deemed at risk for discontinuing care and treatment failure living in a rural area of the southeastern USA were referred by their care provider. The trial implemented a Wennberg Randomized Preferential Design to rigorously test: (a) patient preference and (b) comparative effects on patient retention in care and treatment adherence. There was a clear patient preference for telephone-delivered counseling (69%) over in-office-delivered counseling (31%) and participants who received telephone counseling completed a greater number of sessions. There were few differences between the two intervention delivery formats on clinical appointment attendance, antiretroviral adherence, and HIV viral load. Overall improvements in health outcomes were not observed across delivery formats. Telephone-delivered counseling did show somewhat greater benefit for improving depression symptoms, whereas in-office services demonstrated greater benefits for reducing alcohol use. These results encourage offering most patients the choice of telephone and in-office behavioral health counseling and suggest that more intensive interventions may be needed to improve clinical outcomes for people living with HIV who may be at risk for discontinuing care or experiencing HIV treatment failure.
Assuntos
Aconselhamento/métodos , Infecções por HIV/terapia , Visita a Consultório Médico/estatística & dados numéricos , População Rural/estatística & dados numéricos , Telefone , Adulto , Feminino , Humanos , Masculino , Saúde da População Rural/estatística & dados numéricos , Telemedicina/métodos , Resultado do TratamentoRESUMO
We highlight 2 cases of immunocompetent pediatric patients diagnosed with osteomyelitis and cellulitis attributed to Aeromonas hydrophila. One case had a direct water source; however, the second case occurred following a wild hog bite. Both required fluoroquinolone treatment and demonstrated the need to consider A. hydrophila in patients with water exposure, animal bites and initial antibiotic failure.
Assuntos
Aeromonas hydrophila , Mordeduras e Picadas , Infecções por Bactérias Gram-Negativas , Esportes Aquáticos , Doenças Transmitidas pela Água , Animais , Antibacterianos/farmacologia , Antibacterianos/uso terapêutico , Celulite (Flegmão) , Georgia , Humanos , Osteomielite , SuínosRESUMO
BACKGROUND: Previous work established non-inferiority of switching participants who were virologically suppressed from daily oral standard of care to monthly long-acting intramuscular injections of cabotegravir plus rilpivirine over 96 weeks following a cabotegravir plus rilpivirine oral lead-in. Here, we report an evaluation of switching participants from standard of care oral regimens to long-acting cabotegravir plus rilpivirine via direct-to-injection or oral lead-in pathways. METHODS: This study reports the week 124 results of the FLAIR study, an ongoing phase 3, randomised, open-label, multicentre (11 countries) trial. Antiretroviral therapy (ART)-naive participants who were virologically suppressed (HIV-1 RNA <50 copies per mL) during the 20-week induction phase with standard of care were randomly assigned (1:1) to continue the standard of care oral regimen or switch to long-acting cabotegravir plus rilpivirine (283 per group) in the 100-week maintenance phase. Randomisation was stratified by sex at birth and baseline (pre-induction) HIV-1 RNA (<100 000 or ≥100 000 copies per mL). Participants randomly assigned to long-acting therapy at baseline received a cabotegravir (30 mg) plus rilpivirine (25 mg) once daily oral lead-in for at least 4 weeks before first injection and could choose to continue long-acting cabotegravir (400 mg) plus rilpivirine (600 mg) every 4 weeks from week 100 or withdraw. At week 100, participants in the oral comparator ART group, in discussion with the investigator, could elect to switch to long-acting therapy (extension switch population), either direct-to-injection or with a 4 week oral lead-in (oral lead-in group), or withdraw. Week 124 endpoints included plasma HIV-1 RNA 50 or more copies per mL and less than 50 copies per mL (US Food and Drug Administration [FDA] Snapshot), confirmed virological failure (two consecutive HIV-1 RNA ≥200 copies per mL), and safety and tolerability. The study is registered at ClinicalTrials.gov, NCT02938520. FINDINGS: Screening occurred between Oct 27, 2016, and March 24, 2017. At week 100, 232 (92%) of 253 participants transitioned to long-acting cabotegravir plus rilpivirine in the extension phase (111 [48%] in the direct-to-injection group and 121 [52%] in the oral lead-in group; extension switch population). 243 (86%) of the 283 who were randomly assigned to the long-acting therapy group continued the long-acting regimen into the extension phase. One (<1%) participant in each extension switch group had 50 or more HIV-1 RNA copies per mL; 110 (99%) participants in the direct-to-injection group and 113 (93%) participants in the oral lead-in group remained suppressed (HIV-1 RNA <50 copies per mL) at the week 124 Snapshot. The lower suppression rates in the oral lead-in group were driven by non-virological reasons. For participants in the randomly assigned long-acting group, 227 (80%) of 283 participants remained suppressed; at the week 124 Snapshot, 14 (5%) participants had HIV-1 RNA 50 or more copies per mL, including five additional participants since the week 96 analysis. The remaining 42 (15%) participants in the randomly assigned long-acting group had no virological data. Adverse events leading to withdrawal were infrequent, occurring in three (1%) participants in the extension switch population (one in the direct-to-injection group and two in the oral lead-in group) after 24 weeks of cabotegravir plus rilpivirine therapy, and 15 (5%) participants in the randomly assigned long-acting group up to 124 weeks of therapy. No deaths occurred in the extension phase. Overall, cabotegravir plus rilpivirine adverse event type, severity, and frequency were similar across all groups. Injection site reactions were the most common adverse event, occurring after 914 (21%) of 4442 injections in the extension switch population and 3732 (21%) of 17 392 injections in the randomly assigned long-acting group. Injection site reactions were mostly classified as mild-to-moderate in severity and decreased in incidence over time. Four (2%) of 232 participants in the extension switch population and seven (2%) of 283 in the randomly assigned long-acting group withdrew due to injection-related reasons. INTERPRETATION: After 24 weeks of follow-up, switching to long-acting treatment with or without an oral lead-in phase had similar safety, tolerability, and efficacy, supporting future evaluation of the simpler direct-to-injection approach. The week 124 results for participants randomly assigned originally to the long-acting therapy show long-acting cabotegravir plus rilpivirine remains a durable maintenance therapy with a favourable safety profile. FUNDING: ViiV Healthcare and Janssen Research & Development.
Assuntos
Fármacos Anti-HIV , Infecções por HIV , HIV-1 , Adulto , Fármacos Anti-HIV/efeitos adversos , Dicetopiperazinas , Infecções por HIV/tratamento farmacológico , HIV-1/genética , Humanos , Recém-Nascido , Injeções Intramusculares , Piridonas , Rilpivirina/efeitos adversos , Carga ViralRESUMO
The stigmatization of HIV infection impedes every step along the HIV continuum of care, particularly care engagement and retention. The differential effects of various sources of stigma on retention in HIV care have been the subject of limited research. We examined the accumulation of HIV stigma experiences over 1 year in relationship to treatment retention among 251 men and women marginally engaged in HIV care in the southeastern United States. Results showed that cumulative stigma experiences predicted poorer retention in care, with greater stigma experiences related to less consistency in attending scheduled medical appointments. HIV stigma originating from family members and acts of overt discrimination were the most frequently experienced sources of stigma and were most closely associated with disengagement from HIV care. In addition, analyses by gender indicated that retention in care for men was impacted by stigma to a greater extent than among women. These findings reaffirm the importance of HIV stigma as a barrier to HIV care and provide new directions for interventions to mitigate the negative effects of stigma on patients who are not fully engaged in HIV care. Clinical trials registration NCT104180280.