RESUMEN
BACKGROUND: In 2023, Tennessee replaced $6.2â M in US Centers for Disease Control and Prevention (CDC) human immunodeficiency virus (HIV) prevention funding with state funds to redirect support away from men who have sex with men (MSM), transgender women (TGW), and heterosexual Black women (HSBW) and to prioritize instead first responders (FR), pregnant people (PP), and survivors of sex trafficking (SST). METHODS: We used a simulation model of HIV disease to compare the clinical impact of Current, the present allocation of condoms, preexposure prophylaxis (PrEP), and HIV testing to CDC priority risk groups (MSM/TGW/HSBW); with Reallocation, funding instead increased HIV testing and linkage of Tennessee-determined priority populations (FR/PP/SST). Key model inputs included baseline condom use (45%-49%), PrEP provision (0.1%-8%), HIV testing frequency (every 2.5-4.8 years), and 30-day HIV care linkage (57%-65%). We assumed Reallocation would reduce condom use (-4%), PrEP provision (-26%), and HIV testing (-47%) in MSM/TGW/HSBW, whereas it would increase HIV testing among FR (+47%) and HIV care linkage (to 100%/90%) among PP/SST. RESULTS: Reallocation would lead to 166 additional HIV transmissions, 190 additional deaths, and 843 life-years lost over 10 years. HIV testing reductions were most influential in sensitivity analysis; even a 24% reduction would result in 287 more deaths compared to Current. With pessimistic assumptions, we projected 1359 additional HIV transmissions, 712 additional deaths, and 2778 life-years lost over 10 years. CONCLUSIONS: Redirecting HIV prevention funding in Tennessee would greatly harm CDC priority populations while conferring minimal benefits to new priority populations.
RESUMEN
While multi-level theories and frameworks have become a cornerstone in broader efforts to address HIV inequities, little is known regarding their application in adolescent and young adult (AYA) HIV research. To address this gap, we conducted a scoping review to assess the use and application of multi-level theories and frameworks in AYA HIV prevention and care and treatment empirical research. We systematically searched five databases for articles published between 2010 and May 2020, screened abstracts, and reviewed eligible full-text articles for inclusion. Of the 5890 citations identified, 1706 underwent full-text review and 88 met the inclusion criteria: 70 focused on HIV prevention, with only 14 on care and treatment, 2 on both HIV prevention and care and treatment, and 2 on HIV-affected AYA. Most authors described the theory-based multi-level framework as informing their data analysis, with only 12 describing it as informing/guiding an intervention. More than seventy different multi-level theories were described, with 38% utilizing socio-ecological models or the eco-developmental theory. Findings were used to inform the adaptation of an AYA World Health Organization multi-level framework specifically to guide AYA HIV research.
Asunto(s)
Infecciones por VIH , Adolescente , Femenino , Humanos , Masculino , Adulto Joven , Infecciones por VIH/prevención & controlRESUMEN
New diagnoses of HIV infection have decreased among women in the USA overall, but marked racial and geographical disparities persist. The federal government has announced an initiative that aims to decrease the number of new infections in the nation by 90% within the next 10 years. With this in mind, we highlight important recent developments concerning HIV epidemiology, comorbidities, treatment, and prevention among women in the USA. We conclude that, to end the US HIV epidemic, substantially greater inclusion of US women in clinical research will be required, as will better prevention and treatment efforts, with universal access to health care and other supportive services that enable women to exercise agency in their own HIV prevention and care. Ending the epidemic will also require eliminating the race, class, and gender inequities, as well as the discrimination and structural violence, that have promoted and maintained the distribution of HIV in the USA, and that will, if unchecked, continue to fuel the epidemic in the future.
Asunto(s)
Síndrome de Inmunodeficiencia Adquirida/prevención & control , Epidemias/prevención & control , Infecciones por VIH/prevención & control , Disparidades en Atención de Salud/etnología , Adolescente , Adulto , Protocolos Clínicos , Comorbilidad , Femenino , Infecciones por VIH/diagnóstico , Infecciones por VIH/epidemiología , Accesibilidad a los Servicios de Salud/normas , Disparidades en el Estado de Salud , Disparidades en Atención de Salud/tendencias , Humanos , Prevalencia , Sexismo , Personas Transgénero/estadística & datos numéricos , Estados Unidos/epidemiología , Adulto JovenRESUMEN
BACKGROUND: Adherence to antiretroviral treatment (ART) remains the cornerstone of optimal HIV outcomes, including viral suppression (VS), immune recovery, and decreased transmission risk. For many people with HIV (PWH), particularly those with early-acquired HIV, structural, behavioral, and cognitive barriers to adherence and competing priorities related to life events may be difficult to overcome, resulting in nonadherence. Long-acting injectable antiretroviral therapies (LAI-ART) may be a useful strategy to overcome some of these barriers. However, to date, the approved LAI-ART strategies (e.g., cabotegravir and rilpivirine (CAB/RPV)) have targeted those who have already attained viral suppression, precluding their use in the 40% of adolescents and young adults (AYA) that VS has eluded. CASE PRESENTATION: Ms. X is a 30-year-old woman with perinatally-acquired HIV and barriers to adherence. Despite many interventions, she remained persistently viremic, with resultant immune suppression and multiple comorbid opportunistic conditions, and viral load (VL) > 10,000,000 copies/ml. Given her longstanding history of poor adherence to an oral regimen, a switch to monthly intramuscular (IM) injections and biweekly infusions of ibalizumab were initiated leading to decreased viral load to 8,110 copies/ml within two weeks. Ms. H is a 33-year-old woman with cognitive limitations due to childhood lead poisoning. Her viral load trajectory took a downward turn, precipitated by various life events, remaining elevated despite intensive case management. Initiation of LAI-ART (CAB/RPV) in this patient led to an undetectable VL (< 20 copies/ml) within two months of treatment initiation. Miss Y. is a 37-year-old woman with perinatally-acquired HIV and chronic challenges with nonadherence and longstanding immunosuppression with CD4 < 200 cells/mm3 for > 5 years. She received a 1-month oral lead-in (OLI) of cabotegravir/rilpivirine, followed by the injectable loading dose. She has since adhered to all her monthly dosing appointments, sustained VS, and transitioned to a bi-monthly injection schedule. CONCLUSION: These three individuals with HIV (perinatally and non-perinatally acquired) with longstanding nonadherence and persistent viremia were successfully initiated on LAI-ART through the process of care coordination and the collective efforts of the care team, highlighting the barriers, challenges, and the multidisciplinary coordination needed to assure successful implementation of this strategy for the most vulnerable of patients.
Asunto(s)
Infecciones por VIH , Adolescente , Adulto Joven , Femenino , Humanos , Niño , Adulto , Infecciones por VIH/tratamiento farmacológico , Antirretrovirales/uso terapéutico , Carga Viral , Viremia/tratamiento farmacológico , Rilpivirina/uso terapéuticoRESUMEN
Advances in antiretroviral therapy (ART) have made it possible for persons with human immunodeficiency virus (HIV) to live a near expected life span, without progressing to AIDS or transmitting HIV to sexual partners or infants. There is, therefore, increasing emphasis on maintaining health throughout the life span. To receive optimal medical care and achieve desired outcomes, persons with HIV must be consistently engaged in care and able to access uninterrupted treatment, including ART. Comprehensive evidence-based HIV primary care guidance is, therefore, more important than ever. Creating a patient-centered, stigma-free care environment is essential for care engagement. Barriers to care must be decreased at the societal, health system, clinic, and individual levels. As the population ages and noncommunicable diseases arise, providing comprehensive healthcare for persons with HIV becomes increasingly complex, including management of multiple comorbidities and the associated challenges of polypharmacy, while not neglecting HIV-related health concerns. Clinicians must address issues specific to persons of childbearing potential, including care during preconception and pregnancy, and to children, adolescents, and transgender and gender-diverse individuals. This guidance from an expert panel of the HIV Medicine Association of the Infectious Diseases Society of America updates previous 2013 primary care guidelines.
Asunto(s)
Infecciones por VIH , Adolescente , Niño , Comorbilidad , Femenino , VIH , Infecciones por VIH/complicaciones , Humanos , Lactante , Embarazo , Atención Primaria de SaludRESUMEN
The goal of the Ending the HIV Epidemic Initiative is to reduce new infections in the United States by 90% by 2030. Success will require fundamentally changing human immunodeficiency virus (HIV) prevention and care delivery to engage more persons with HIV and at risk of HIV in treatment. While the coronavirus disease 2019 (COVID-19) pandemic reduced in-person visits to care facilities and led to concern about interruptions in care, it also accelerated growth of alternative options, bolstered by additional funding support. These included the use of telehealth, medication delivery to the home, and increased flexibility facilitating access to Ryan White HIV/AIDS Program services. While the outcomes of these programs must be studied, many have improved accessibility during the pandemic. As the pandemic wanes, long-term policy changes are needed to preserve these options for those who benefit from them. These new care paradigms may provide a roadmap for progress for those with other chronic health issues as well.
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COVID-19 , Enfermedades Transmisibles , Infecciones por VIH , VIH , Infecciones por VIH/epidemiología , Humanos , Pandemias , Políticas , SARS-CoV-2 , Estados UnidosRESUMEN
The Adolescent Medicine Trials Network for HIV/AIDS Interventions is evaluating treatment adherence interventions (AI) to improve virologic suppression (VS) among youth with HIV (YWH). Using a microsimulation model, we compared two strategies: standard-of-care (SOC) and a hypothetical 12-month AI that increased cohort-level VS in YWH in care by an absolute ten percentage points and cost $100/month/person. Projected outcomes included primary HIV transmissions, deaths and life-expectancy, lifetime HIV-related costs, and incremental cost-effectiveness ratios (ICERs, $/quality-adjusted life-year [QALY]). Compared to SOC, AI would reduce HIV transmissions by 15% and deaths by 12% at 12 months. AI would improve discounted life expectancy/person by 8 months at an added lifetime cost/person of $5,300, resulting in an ICER of $7,900/QALY. AI would be cost-effective at $2,000/month/person or with efficacies as low as a 1 percentage point increase in VS. YWH-targeted adherence interventions with even modest efficacy could improve life expectancy, prevent onward HIV transmissions, and be cost-effective.
RESUMEN: La Red de Ensayos Médicos sobre Adolescentes para Realizar Intervenciones sobre el VIH/SIDA está evaluando intervenciones de adherencia (IAs) al tratamiento para mejorar la supresión virológica (SV) entre los jóvenes con VIH (JCV). Usando un modelo de microsimulación, comparamos dos estrategias: cuidado convencional (CC) y una intervención de adherencia hipotética durando 12 meses que aumentaría la SV a nivel de cohorte entre JCV en tratamiento por 10 puntos de porcentuales y que costaría US$ 100/mes/persona. Resultados proyectados incluyeron transmisiones de VIH primarias, muertes y esperanza de vida, costos de por vida asociados con el VIH, y razones incrementales de costo-efectividad (RICEs, $/año de vida ajustado por la calidad [AVAC]). Comparado al CC, la IA reduciría transmisiones de VIH por 15% y muertes por 12% a los 12 meses. La IA mejoraría esperanza de vida descontada/persona por 8 meses a un costo de por vida adicional/persona de US$ 5.300, resultando en una RICE de US$ 7.900/AVAC. La IA sería costo-efectiva a un costo de US$ 2.000/mes/persona o si mejorara SV por al menos un punto porcentual. Intervenciones de adherencia dirigidas a jóvenes con una eficacia incluso modesta podrían mejorar esperanza de vida, prevenir transmisiones de VIH, y ser costo-efectivas.
Asunto(s)
Infecciones por VIH , Adolescente , Análisis Costo-Beneficio , Infecciones por VIH/tratamiento farmacológico , Infecciones por VIH/prevención & control , Humanos , Años de Vida Ajustados por Calidad de Vida , Estados Unidos/epidemiologíaRESUMEN
With the increasing proportion of youth living with human immunodeficiency virus (YLHIV) and the aging of the perinatally infected population, there is a need for clinical services that are "youth friendly" to address the multiple challenges YLHIV face in terms of engagement in care and maintenance of combination antiretroviral therapy (cART). Little is known about how and where YLHIV receive their care. Further, the impact of the care structure on engagement and retention outcomes for YLHIV is ill defined. In order to better classify how YLHIV receive care in the United States, we performed a review of published literature characterizing the structure and outcomes of care for YLHIV. Several key concepts emerged: 1. The majority of YLHIV (13-24 years old) are cared for at adult sites, 2. Clinics providing care to YLHIV are varied in terms of the services offered and the types of services offered can impact outcomes, 3. YLHIV cared for in adult clinical sites have poor retention and antiretroviral treatment initiation, and 4. YLHIV cared for at adult sites had poorer retention and cART outcomes compared to YLHIV cared for at pediatric sites. There were no studies identified that specifically examined "youth friendly" care for YLHIV within the context of adult clinical sites. The results of this review highlight disparities for YLHIV and the need for interventions to improve outcomes for YLHIV in the context of adult care.
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Continuidad de la Atención al Paciente/organización & administración , Atención a la Salud/organización & administración , Infecciones por VIH/tratamiento farmacológico , Adolescente , Femenino , Infecciones por VIH/psicología , Accesibilidad a los Servicios de Salud , Humanos , Masculino , Transición a la Atención de Adultos , Estados Unidos , Adulto JovenRESUMEN
INTRODUCTION: Equipoise is usually discussed as an ethical issue in clinical trials. However, it also has practical implications. BACKGROUND: Clinical equipoise is usually construed to mean uncertainty or disagreement among the expert clinician community. However, an individual physician's sense of equipoise may vary by location, based on the local standard of care or availability of specific treatment options, and these differences can affect providers' willingness to enroll participants into clinical trials. There are also logistical barriers to enrollment in international trials due to prolonged timelines for approvals by government agencies and ethical review boards. CASE STUDY: A multinational clinical trial of bridging strategies for treatment of non-adherent HIV-infected youth, experienced differing perceptions of equipoise due to disparities in availability of treatment options by country. Unfortunately, the countries with most demand for the trial were those where the approval process was most delayed, and the study was closed early due to slow accrual. DISCUSSION: When planning multicenter clinical trials, it is important to take into account heterogeneity among research sites and try to anticipate differences in equipoise and logistical factors between sites, in order to plan to address these issues at the design stage.
Asunto(s)
Investigación Biomédica/métodos , Ensayos Clínicos como Asunto , Infecciones por VIH/terapia , Selección de Paciente , Proyectos de Investigación , Equipoise Terapéutico , Salud Global , Disparidades en Atención de Salud , Humanos , Estudios Multicéntricos como Asunto , Cumplimiento y Adherencia al Tratamiento , IncertidumbreRESUMEN
BACKGROUND: Before implementation of the Patient Protection and Affordable Care Act (ACA) in 2014, 100 000 persons living with human immunodeficiency virus (HIV) (PLWH) lacked healthcare coverage and relied on a safety net of Ryan White HIV/AIDS Program support, local charities, or uncompensated care (RWHAP/Uncomp) to cover visits to HIV providers. We compared HIV provider coverage before (2011-2013) versus after (first half of 2014) ACA implementation among a total of 28 374 PLWH followed up in 4 sites in Medicaid expansion states (California, Oregon, and Maryland), 4 in a state (New York) that expanded Medicaid in 2001, and 2 in nonexpansion states (Texas and Florida). METHODS: Multivariate multinomial logistic models were used to assess changes in RWHAP/Uncomp, Medicaid, and private insurance coverage, using Medicare as a referent. RESULTS: In expansion state sites, RWHAP/Uncomp coverage decreased (unadjusted, 28% before and 13% after ACA; adjusted relative risk ratio [ARRR], 0.44; 95% confidence interval [CI], .40-.48). Medicaid coverage increased (23% and 38%; ARRR, 1.82; 95% CI, 1.70-1.94), and private coverage was unchanged (21% and 19%; 0.96; .89-1.03). In New York sites, both RWHAP/Uncomp (20% and 19%) and Medicaid (50% and 50%) coverage were unchanged, while private coverage decreased (13% and 12%; ARRR, 0.86; 95% CI, .80-.92). In nonexpansion state sites, RWHAP/Uncomp (57% and 52%) and Medicaid (18% and 18%) coverage were unchanged, while private coverage increased (4% and 7%; ARRR, 1.79; 95% CI, 1.62-1.99). CONCLUSIONS: In expansion state sites, half of PLWH relying on RWHAP/Uncomp coverage shifted to Medicaid, while in New York and nonexpansion state sites, reliance on RWHAP/Uncomp remained constant. In the first half of 2014, the ACA did not eliminate the need for RWHAP safety net provider visit coverage.
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Infecciones por VIH/terapia , Cobertura del Seguro , Medicaid , Patient Protection and Affordable Care Act , Adolescente , Adulto , Anciano , California/epidemiología , Femenino , Infecciones por VIH/epidemiología , Humanos , Masculino , Maryland/epidemiología , Persona de Mediana Edad , New York/epidemiología , Oregon/epidemiología , Minorías Sexuales y de Género , Estados Unidos/epidemiología , Adulto JovenRESUMEN
BACKGROUND: During the COVID-19 pandemic, many US youth with HIV (YHIV) used telehealth services; others experienced disruptions in clinic and antiretroviral therapy (ART) access. METHODS: Using the Cost-effectiveness of Preventing AIDS Complications (CEPAC)-Adolescent HIV microsimulation model, we evaluated 3 scenarios: 1) Clinic: in-person care; 2) Telehealth: virtual visits, without CD4 or viral load monitoring for 12 months, followed by return to usual care; and 3) Interruption: complete care interruption with no ART access or laboratory monitoring for 6 months (maximum clinic closure time), followed by return to usual care for 80%. We assigned higher 1-year retention (87% vs 80%) and lower cost/visit ($49 vs $56) for Telehealth vs Clinic. We modeled 2 YHIV cohorts with non-perinatal (YNPHIV) and perinatal (YPHIV) HIV, which differed by mean age (22 vs 16 years), sex at birth (85% vs 47% male), starting CD4 count (527/µL vs 635/µL), ART, mortality, and HIV-related costs. We projected life months (LMs) and costs/100 YHIV over 10 years. RESULTS: Over 10 years, LMs in Clinic and Telehealth would be similar (YNPHIV: 11â 350 vs 11â 360 LMs; YPHIV: 11â 680 LMs for both strategies); costs would be $0.3M (YNPHIV) and $0.4M (YPHIV) more for Telehealth than Clinic. Interruption would be less effective (YNPHIV: 11â 230 LMs; YPHIV: 11â 620 LMs) and less costly (YNPHIV: $1.3M less; YPHIV: $0.2M less) than Clinic. Higher retention in Telehealth led to increased ART use and thus higher costs. CONCLUSIONS: Telehealth could be as effective as in-person care for some YHIV, at slightly increased cost. Short interruptions to ART and laboratory monitoring may have negative long-term clinical implications.
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Fármacos Anti-VIH , COVID-19 , Infecciones por VIH , Telemedicina , Embarazo , Femenino , Recién Nacido , Humanos , Masculino , Adolescente , Adulto Joven , Estados Unidos/epidemiología , Fármacos Anti-VIH/uso terapéutico , Pandemias , Infecciones por VIH/tratamiento farmacológico , Infecciones por VIH/epidemiologíaRESUMEN
Five long-acting (LA) antiretrovirals (ARVs) are currently available in a limited number of countries worldwide for HIV-1 prevention or treatment - cabotegravir, rilpivirine, lenacapavir, ibalizumab, and dapivirine. Implementing use of LA ARVs in routine clinical practice requires significant changes to the current framework of HIV-1 prevention, treatment, and service provision. Given the novelty, complexity, and interdisciplinary requirements of safe and optimal use of LA ARVs, consensus recommendations on the use of LA ARVs will assist clinicians in optimizing use of these agents. The purpose of these recommendations is to provide guidance for the clinical use of LA ARVs for HIV-1 treatment and prevention. In addition, future areas of research are identified and discussed.
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Fármacos Anti-VIH , Infecciones por VIH , VIH-1 , Humanos , Infecciones por VIH/tratamiento farmacológico , Infecciones por VIH/prevención & control , VIH-1/efectos de los fármacos , Fármacos Anti-VIH/uso terapéutico , Fármacos Anti-VIH/administración & dosificación , Preparaciones de Acción Retardada , Consenso , Antirretrovirales/uso terapéutico , Antirretrovirales/administración & dosificaciónRESUMEN
Five long-acting (LA) antiretrovirals (ARVs) are currently available in a limited number of countries worldwide for HIV-1 prevention or treatment-cabotegravir, rilpivirine, lenacapavir, ibalizumab, and dapivirine. Implementing use of LA ARVs into routine clinical practice requires significant changes to the current framework of HIV-1 prevention, treatment, and service provision. Given the novelty, complexity, and interdisciplinary requirements needed to safely and optimally utilize LA ARVs, consensus recommendations on the use of LA ARVs will assist clinicians in optimizing use of these agents. The purpose of these recommendations is to provide guidance for the clinical use of LA ARVs for HIV-1 treatment and prevention. In addition, future areas of research are also identified and discussed.
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Fármacos Anti-VIH , Infecciones por VIH , VIH-1 , Humanos , Infecciones por VIH/tratamiento farmacológico , Infecciones por VIH/prevención & control , VIH-1/efectos de los fármacos , Fármacos Anti-VIH/uso terapéutico , Fármacos Anti-VIH/administración & dosificación , Preparaciones de Acción Retardada , Consenso , Antirretrovirales/uso terapéutico , Antirretrovirales/administración & dosificaciónRESUMEN
BACKGROUND: Long-acting injectable cabotegravir and rilpivirine have demonstrated safety, acceptability, and efficacy in adults living with HIV-1. The IMPAACT 2017 study (MOCHA study) was the first to use these injectable formulations in adolescents (aged 12-17 years) living with HIV-1. Herein, we report acceptability and tolerability outcomes in cohort 1 of the study. METHODS: In this a secondary analysis of a phase 1/2, multicentre, open-label, non-comparative dose-finding study, with continuation of pre-study oral combination antiretroviral treatment (ART), 55 adolescents living with HIV-1 were enrolled to receive sequential doses of either long-acting cabotegravir or rilpivirine and 52 received at least two injections. Participants had a body weight greater than 35 kg and BMI less than 31·5 kg/m2 and had been on stable ART for at least 90 consecutive days with an HIV-1 viral load of less than 50 copies per mL at a participating IMPAACT study site. Participants had to be willing to continue their pre-study ART during cohort 1. The primary objectives of the study were to confirm doses for oral and injectable cabotegravir and for injectable rilpivirine in adolescents living with HIV. This analysis of participant-reported outcomes included a face scale assessment of pain at each injection and a Pediatric Quality of Life Inventory (PedsQL) at baseline and week 16 for participants in the USA, South Africa, Botswana, and Thailand. A subset of 11 adolescents and 11 parents or caregivers in the USA underwent in-depth interviews after receipt of one or two injections. This trial is registered at ClinicalTrials.gov, NCT03497676. FINDINGS: Between March 19, 2019, and Nov 25, 2021, 55 participants were enrolled into cohort 1. Using the six-point face scale, 43 (83%) of participants at week 4 and 38 (73%) at week 8 reported that the injection caused "no hurt" or "hurts little bit", while only a single (2%) participant for each week rated the pain as one of the two highest pain levels. Quality of life was not diminished by the addition of one injectable antiretroviral. In-depth interviews revealed that parents and caregivers in the USA frequently had more hesitancy than adolescents about use of long-acting formulations, but parental acceptance was higher after their children received injections. INTERPRETATION: High acceptability and tolerability of long-acting cabotegravir or rilpivirine injections suggests that these are likely to be favoured treatment options for some adolescents living with HIV. FUNDING: National Institutes of Health and ViiV Healthcare.
Asunto(s)
Fármacos Anti-VIH , Dicetopiperazinas , Infecciones por VIH , Seropositividad para VIH , VIH-1 , Piridonas , Adulto , Niño , Humanos , Adolescente , Rilpivirina/uso terapéutico , Fármacos Anti-VIH/uso terapéutico , Infecciones por VIH/tratamiento farmacológico , Calidad de Vida , Antirretrovirales/uso terapéutico , Seropositividad para VIH/tratamiento farmacológico , Dolor/tratamiento farmacológicoRESUMEN
BACKGROUND: Combined intramuscular long-acting cabotegravir and long-acting rilpivirine constitute the first long-acting combination antiretroviral therapy (ART) regimen approved for adults with HIV. The goal of the IMPAACT 2017 study (MOCHA [More Options for Children and Adolescents]) was to assess the safety and pharmacokinetics of these drugs in adolescents. METHODS: In this phase 1/2, multicentre, open-label, non-comparative, dose-finding study, virologically suppressed adolescents (aged 12-17 years; weight ≥35 kg; BMI ≤31·5 kg/m2) with HIV-1 on daily oral ART were enrolled at 15 centres in four countries (Botswana, South Africa, Thailand, and the USA). After 4-6 weeks of oral cabotegravir (cohort 1C) or rilpivirine (cohort 1R), participants received intramuscular long-acting cabotegravir or long-acting rilpivirine every 4 weeks or 8 weeks per the adult dosing regimens, while continuing pre-study ART. The primary outcomes were assessments of safety measures, including all adverse events, until week 4 for oral cabotegravir and until week 16 for long-acting cabotegravir and long-acting rilpivirine, and pharmacokinetic measures, including the area under the plasma concentration versus time curve during the dosing interval (AUC0-tau) and drug concentrations, at week 2 for oral dosing of cabotegravir and at week 16 for intramuscular dosing of cabotegravir and rilpivirine. Enrolment into cohort 1C or cohort 1R was based on the participant's pre-study ART, meaning that masking was not done. For pharmacokinetic analyses, blood samples were drawn at weeks 2-4 after oral dosing and weeks 4-16 after intramuscular dosing. Safety outcome measures were summarised using frequencies, percentages, and exact 95% CIs; pharmacokinetic parameters were summarised using descriptive statistics. This trial is registered at ClinicalTrials.gov, NCT03497676, and is closed to enrolment. FINDINGS: Between March 19, 2019, and Nov 25, 2021, 55 participants were enrolled: 30 in cohort 1C and 25 in cohort 1R. At week 16, 28 (97%, 95% CI 82-100) of the 29 dose-evaluable participants in cohort 1C and 21 (91%; 72-99) of the 23 dose-evaluable participants in cohort 1R had reported at least one adverse event, with the most common being injection-site pain (nine [31%] in cohort 1C; nine [39%] in cohort 1R; none were severe). One (4%, 95% CI 0-22) participant in cohort 1R had an adverse event of grade 3 or higher, leading to treatment discontinuation, which was defined as acute rilpivirine-related allergic reaction (self-limiting generalised urticaria) after the first oral dose. No deaths or life-threatening events occurred. In cohort 1C, the week 2 median cabotegravir AUC0-tau was 148·5 (range 37·2-433·1) µg·h/mL. The week 16 median concentrations for the every-4-weeks and every-8-weeks dosing was 3·11 µg/mL (range 1·22-6·19) and 1·15 µg/mL (<0·025-5·29) for cabotegravir and 52·9 ng/mL (31·9-148·0) and 39·1 ng/mL (27·2-81·3) for rilpivirine, respectively. These concentrations were similar to those in adults. INTERPRETATION: Study data support using long-acting cabotegravir or long-acting rilpivirine, given every 4 weeks or 8 weeks, per the adult dosing regimens, in virologically suppressed adolescents aged 12 years and older and weighing at least 35 kg. FUNDING: The National Institutes of Health and ViiV Healthcare.
Asunto(s)
Fármacos Anti-VIH , Dicetopiperazinas , Infecciones por VIH , Adolescente , Niño , Humanos , Infecciones por VIH/tratamiento farmacológico , Piridonas , Rilpivirina/efectos adversos , Rilpivirina/uso terapéuticoRESUMEN
BACKGROUND AND PURPOSE: Although HIV infection is decreasing in infants and children, there is a steady cohort of perinatally HIV-infected (PHIV) children that are growing older. Increased risk of acute stroke has been reported in PHIV children. Our goal was to evaluate evolution/progression of neuroimaging findings in PHIV youth initially presenting with acute stroke. MATERIALS AND METHODS: The medical records of PHIV pediatric patients (n = 179) from 1996 to 2010 were reviewed and patients with clinical documentation of acute stroke referred to the neuroradiology service were eligible for the study. Neuroimaging (brain CT, MRI, and MRA) and charts were evaluated; clinical and neuroimaging findings at the initial acute stroke and at the last presentation to the neuroradiology service were documented and analyzed. RESULTS: Eight PHIV patients with clinical findings of acute stroke referred to the neuroimaging were identified. CT and MRI findings of infarction were found in all (8/8) patients in their first and/or last neuroimaging study; including basal ganglia-thalami (BGT) infarction (7/8), focal cortical infarction (4/8), and internal capsule infarction (4/8). Imaging depicted cortical atrophy (5/8), BGT calcification (3/8), and posterior reversible encephalopathy syndrome, wallerian degeneration, and periventricular white matter hyperintense T2 signal each in one patient. No tumors or infectious masses, cysts or abscesses were identified. Subsequent available neuroimaging revealed progression of the cerebrovascular disease in seven patients, 5/7 in the absence of new clinical signs or symptoms. Segmental occlusion, narrowing or narrowing/dilatation in the circle of Willis was found in 6/6 patients who underwent MR angiography and fusiform aneurysms were detected in three of them, a saccular aneurysm in one patient. CONCLUSION: Asymptomatic progression of cerebrovascular disease was found in PHIV adolescents with prior stroke. These findings may have implications for long-term risk and outcomes for this patient population. There should be a low threshold to evaluate for CNS pathology even with minor symptoms in this population. More studies are necessary to determine if there is a benefit from screening of asymptomatic patients.
Asunto(s)
Isquemia Encefálica/diagnóstico , Infecciones por VIH/patología , Neuroimagen/métodos , Accidente Cerebrovascular/diagnóstico , Adolescente , Isquemia Encefálica/complicaciones , Isquemia Encefálica/patología , Niño , Progresión de la Enfermedad , Femenino , Infecciones por VIH/complicaciones , Humanos , Masculino , Estudios Retrospectivos , Accidente Cerebrovascular/complicaciones , Accidente Cerebrovascular/patología , Adulto JovenRESUMEN
Shared decision making for infant feeding in the context of HIV in high-resourced settings is necessary to acknowledge patient autonomy, meet increasing patient requests and address the changing reality of perinatal HIV care. In low-to middle-income countries (LMIC), where the majority of individuals living with HIV reside, persons with HIV are recommended to breastfeed their infants. In the setting of maternal anti-retroviral therapy (ART) use throughout pregnancy, viral suppression and appropriate neonatal post-exposure prophylaxis (PEP) use, updated information indicates that the risk of HIV transmission through breastmilk may be between 0.3 and 1%. While not endorsing or recommending breastfeeding, the United States' DHHS perinatal guidelines are similarly pivoting, stating that individuals should "receive patient-centred, evidence-based counselling on infant feeding options." Similar statements appear in the British, Canadian, Swiss, European, and Australasian perinatal guidelines. We assembled a multi-disciplinary group at our institution to develop a structured shared decision-making process and protocol for successful implementation of breastfeeding. We recommend early and frequent counselling about infant feeding options, which should include well known benefits of breastfeeding even in the context of HIV and the individual's medical and psychosocial circumstances, with respect and support for patient's autonomy in choosing their infant feeding option.
RESUMEN
OBJECTIVE: Prior research has documented sociodemographic disparities in the use of antiretroviral therapy (ART). Recent therapeutic developments and changing epidemiological profiles may have altered such disparities. We examine the extent to which sociodemographic differences in prescribed ART have changed between 2002 and 2008. METHODS: We analyzed data abstracted from medical records at 13 US sites participating in the Human Immunodeficiency Virus Research Network. Prescription of ART was assessed for each year in care for each patient. A total of 14,092 patients were followed up for 39,251 person-years. We examined ART use as a function of sex, race/ethnicity, human immunodeficiency virus risk group, age, and CD4 history (no test <500 cells/mm, one or more tests between 500 and 350 cells/mm, 1 test ≤350 cells/mm, and 2 or more tests ≤350 cells/mm). Using multiple logistic regression, we ascertained interactions between each of these variables and calendar year. RESULTS: The overall percentage prescribed ART increased from 60% to 80% between 2002 and 2008. Among those with 2 or more CD4 tests ≤350 cells/mm, the percentage increased from 82% to 92%. ART rates were higher for those with lower CD4 counts but increased over time for all CD4 groups and for all demographic groups. Nevertheless, sex and racial/ethnic disparities persisted. Significant interactions were obtained for CD4 history by year, age by year, and age by CD4 history. CONCLUSIONS: Although prescription of ART became more widespread from 2002 to 2008, patients who were female, black, or younger still had lower ART rates than male, white, or older patients.
Asunto(s)
Antirretrovirales/administración & dosificación , Infecciones por VIH/tratamiento farmacológico , Disparidades en Atención de Salud/estadística & datos numéricos , Adolescente , Adulto , Factores de Edad , Antirretrovirales/uso terapéutico , Recuento de Linfocito CD4 , Femenino , Infecciones por VIH/epidemiología , Humanos , Cobertura del Seguro/estadística & datos numéricos , Masculino , Persona de Mediana Edad , Factores de Riesgo , Factores Sexuales , Factores Socioeconómicos , Estados Unidos , Adulto JovenRESUMEN
We assessed breastfeeding outcomes for a cohort of infants born to women living with HIV (WLHIV) at an urban health care center in the United States. Ten infants were exclusively breastfed for a mean duration of 4.4 (1.0-8.6) months. All had negative HIV RNA PCRs at a median age of 16 months.