Etravirine-based highly active antiretroviral therapy in HIV-1-infected paediatric patients.

BACKGROUND: We evaluated the efficacy, safety and tolerability of etravirine in paediatric patients vertically infected with HIV-1. METHODS: A multicentre retrospective study of 23 multidrug-resistant paediatric patients (five children and 18 adolescents) enrolled in the study from 1 September 2007 to 28 February 2010 was carried out. We performed a longitudinal analysis of immunological, virological and clinical data. RESULTS: The median age of the patients was 14.2 years [interquartile range (IQR) 12.5-15.8 years]. At baseline, the median HIV-1 RNA was 29 000 (4.5 log(10) ) HIV-1 RNA copies/mL (range 4300-83 000 copies/mL), the median CD4 T-cell count was 445 cells/µL (range 221-655 cells/µL) and the median CD4 percentage was 19.6% (IQR 13.0-31.0). Remarkably, 16 of 23 patients (70%) harboured one or more etravirine-associated resistance mutations. The backbone regimen included at least two fully active drugs in 91% of patients. After etravirine-based therapy, 20 patients (87%) achieved HIV-1 RNA<400 copies/mL and 18 of 23 (78%) achieved HIV-1 RNA<50 copies/mL: three (13%) within the first month, seven (30%) within the first 4 months, and six (26%) between the 5th and 8th months. CD4 T-cell recovery was observed in 19 patients (83%). The median follow-up time was 48.4 weeks (IQR 35.7-63.4 weeks); four patients (17%) were exposed to etravirine for >120 weeks. Three mild/short-term and two moderate skin rashes were observed in the adolescents. Laboratory abnormalities included hypercholesterolaemia (11 of 23 patients), hypertriglyceridaemia (eight of 23 patients), and reduced high-density lipoprotein cholesterol (10 of 23 patients). Adherence was complete in seven patients (30%). No patients showed complete resistance to etravirine after follow-up. However, three of 21 patients (14%) who initially showed intermediate resistance interrupted etravirine treatment because of virological failure. CONCLUSIONS: We observed a sustained antiviral response and improved immunological parameters in multidrug-resistant paediatric patients, most of whom had received etravirine as part of salvage regimens with at least two fully active drugs.

Boosted protease inhibitors as a therapeutic option in the treatment of HIV-infected children.

OBJECTIVE: Paediatric HIV treatment must address various special considerations. Administration of pharmacokinetically enhanced protease inhibitors (PIs) can improve paediatric therapeutic outcomes. The objective of this study was to review the use of boosted PI regimens in children. METHODS: Systematic literature searches of published manuscripts and conference databases using generic drug names and specific keywords were performed to ensure thorough and balanced reporting of available data. RESULTS: Boosted PI regimens offer multiple options across a range of ages and are efficacious in naïve and experienced children; safety and tolerability are similar to those observed in adults. Novel boosted PI simplification approaches may foster adherence and diminish resistance. CONCLUSIONS: Boosted PIs are key components of first- and second-line treatments in children. Identifying factors associated with the response to highly active antiretroviral therapy in children may ultimately permit individualized therapies.

Recommendations from SPNS/GEAM/SENBA/SENPE/AEDN/SEDCA/ GESIDA on nutrition in the HIV-infected patient / Recomendaciones de SPNS/GEAM/SENBA/SENPE/AEDN/SEDCA/GESIDA sobre nutrición en el paciente con infección por VIH

Objective: to make recommendations on the approach to nutritional problems (malnutrition, cachexia, micronutrient deficiency, obesity, lipodystrophy) affecting HIV-infected patients. Methods: these recommendations have been agreed upon by a group of expertes in the nutrition and care of HIV-infected patients, on behalf of the different groups involved in drafting them. Therefore, the latest advances in pathophysiology, epidemiology, and clinical care presented in studies published in medical journals or at scientific meetings were evaluated. Results: there is no single method of evaluating nutrition, and diferent techniques —CT, MRI, and DXA— must be combined. The energy requirements of symptomatic patients increase by 20-30%. There is no evidence to support the increase in protein or fat intake. Micronutrient supplementation in only necessary in special circumstances (vitamin A in children and pregnant woman). Aerobic and resistance excercise is beneficial both for cardiovascular health and for improving lean mass and muscular strength. It is important to follow the rules of food safety at every stage in the chain. Therapeutic intervention in anorexia and cachexia must be tailored, by combining nutritional and pharmacological support (appetite stimulants, anabolic steroids, and, in some cases, testosterone). Artificial nutrition (oral supplementation, enteral or parenteral nutrition) is safe and efficacious, and improves nutritional status and response to therapy. In children, nutritional recommendations must be made early, and are a necessary component of therapy. Conclusion: appropriate nutritional evaluation and relevant therapeutic action are an essential part of the care of HIV-infected patients

Objetivo: realizar recomendaciones sobre el abordaje de los problemas nutricionales (malnutrición, caquexia, déficit de micronutrientes, obesidad, lipodistrofia) presentes en la infección VIH. Métodos: estas recomendaciones se han consensuado por un grupo de expertos en nutrición y en atención al enfermo VIH, en representación de las distintas sociedades firmantes. Para ello se han revisado los últimos avances fisiopatológicos, epidemiológicos y clínicos recogidos en estudios publicados en revistas médicas o presentados en congresos. Resultados: no existe un único método de valoración nutricional, debiendo combinarse cuestionarios y técnicas como TAC, RNM y DEXA. Los requerimientos energéticos en enfermos sintomáticos aumentan en un 20-30%. No existe evidencia que respalde el incremento del aporte proteico o graso. La suplementación de micronutrientes sólo es necesaria en circunstancias especiales (Vitamina A en niños y embarazadas). El ejercicio aeróbico de resistencia es beneficioso tanto para la salud cardiovascular como para mejorar la masa magra y la fuerza muscular. Es importante seguir normas de seguridad en toda la cadena alimentaria. La intervención terapéutica en la anorexia y caquexia debe ser individualizada, combinando soporte nutricional y farmacológico (estimulantes del apetito, agentes anabolizantes y testosterona en algún caso). La nutrición artificial (suplementación oral, nutrición enteral o parenteral) es segura y eficaz, mejorando el estado nutricional y la respuesta al tratamiento. En niños, las recomendaciones nutricionales deben ser muy precoces, formando necesariamente parte del tratamiento. Conclusión: La adecuada valoración nutricional y la pertinente actuación terapéutica son parte esencial de la asistencia del enfermo VIH

La terapia combinada puede ser tan efectiva como la terapia antirretroviral de alta eficacia en el control de la carga viral en niños con un sistema inmunitario conservado / Combination therapy can be as effective as highly active antiretroviral therapy in controlling viral load in children with a preserved immune system

Objetivo: Comparar la efectividad de la terapia combinada (TC) y del tratamiento antirretroviral de alta eficacia (TARGA) en el control de la replicación viral en una cohorte de niños infectados por el virus de la inmunodeficiencia humana tipo 1 (VIH-1) con un sistema inmunitario relativamente conservado. Material y métodos: Realizamos un estudio observacional en 21 niños infectados verticalmente por el VIH-1 con terapia antirretroviral(TAR), comparando la efectividad de la TC y del TARGA, en el control de la carga viral (CV) plasmática. Principales variables evaluadas: Las principales variables medidas fueron la presencia de carga viral indetectable (400 copias/ml) y el desarrollo de fracasos virológicos tras alcanzaruna CV indetectable con rebotes de CV (>400 y/o >5.000 copias/ml). Resultados: Los niños con TARGA alcanzaban CV indetectables más precozmente. La media de tiempo para alcanzar CV indetectable fue de 8,1 +/- 3,7 meses en el grupo de TC y de 2,9 +/- 0,2 meses en el grupo con TARGA (p 400 copias/mL. El tiempo mediopara el aumento de CV >400 y CV >5.000 copias/mL fue similaren ambos grupos (p >0,05). Ocho niños del grupo de la TC y6 del grupo con TARGA presentaron un rebote de CV >5.000 copias/mL. En ninguno de los dos grupos hubo reducción en el porcentaje de CD4+, que se mantuvo elevado durante todo el seguimiento. El porcentaje de niños con CV <5.000 copias/mL fue similar en ambos grupos. Conclusiones: Nuestro estudio muestra que la TC puedes ertan efectiva como el TARGA en niños infectados por el VIH con un sistema inmunitario relativamente conservado

Objective: To compare the effectiveness of combination therapy (CTI and highly active antiretroviral therapy (HAART} in the control of viral replication in a group of HIV-1-infected children with a relatively preserved immune system. Design and setting: For this purpose, we carried out an observational study in 21 vertically HIV-1-infected children on ART, comparing the effectiveness of CT and HAART regimens in the control of plasma viral load (VL). Main outcome measures: The outcome variables were undetectable VL (uVL; VL 400 copies/mL; VL >5.000 copies/mL). Results: The children on HAART achieved u VL at earlier timepoints. The median time required to achieve uVL was 8.1 +/- 3.7 months in the CT group and 2.9 +/- 0.2 months in the HAART group (p 400 copies/mL. The median time to a rebound of VL >400 and VL>5.000 copies/mL were similar in the two groups of children(p >0.05). Eight children in the CT group and 6 children in the HAART group presented a rebound of VL over 5.000 copies/mL. In the CT group and HAART group, there was no reduction of the mean %CD4+, which remained high throughout the follow uperiod. The percentage of HIV children with VL <5.000copies/mL was similar in the two groups. Conclusions: The present study suggests that CT may be justs a effective as HAART in children with a relatively preservedimmune system