Lack of benefit with omega-3 fatty acid supplementation in HIV patients: A randomized pilot study.

Objective: To assess the effect of omega-3 polyunsaturated fatty acids (n-3 PUFA) supplementation on bone metabolism in HIV-infected patients presenting with hypertriglyceridemia.Methods: Patients were randomized 1:1 to receive 2 g of n-3 PUFA or fenofibrate (FF). The primary endpoint was % change in bone mineral density (BMD) from baseline to month 24 in lumbar spine (LS) and femoral neck (FN). Secondary endpoints were changes in Z-score, calcitriol, calcitonin, parathyroid hormone, osteocalcin, and C-terminal telopeptide of type I collagen (CTX-I) at 12 and 24 months. Differences in continuous variables were evaluated using the t test or Mann-Whitney U-test for independent samples and differences in means of intra- and inter-subject continuous variables using a general linear model. Categorical variables were compared by the chi-squared or Fisher's exact test.Results: 30 patients were included in each arm; 23 in the n-3 PUFA arm and 22 in the FF arm completed follow-up. No significant differences between arms were observed after 24 months in either region (FN: -12.51% ± 7.89 in the n-3 PUFA arm and -8.18% ± 7.72 in the FF arm, p = .07; LS: 2.94% ± 6.63 in the n-3 PUFA arm, -3.07% ± 16.85 in the FF arm, p = .07), although the BMD reduction in the FN region after 24 months was noticeable in both arms (n-3 PUFA: -12.51% ± 7.89%, p =< .001; FF: -8.183% ± 7.72%, p =< .001). There was a significant difference in calcitriol changes between arms after 96 weeks. No differences in Z-score or bone turnover markers were observed between the two arms.Conclusions: Omega-3 fatty acid supplementation resulted in no beneficial changes in BMD or bone turnover markers. n-3 PUFA supplementation achieved similar reductions in triglyceride levels as FF.

Cost-effectiveness of initial antiretroviral treatment administered as single vs. multiple tablet regimens with the same or different components / Coste-efectividad del tratamiento inicial antirretroviral de comprimido único vs. tratamiento con regímenes de múltiples comprimidos con los mismos o diferentes componentes

Objective: To evaluate the efficiency of single-tablet regimens (STR) and multiple-tablet regimens (MTR) with exactly the same or different components. Methods: A study was conducted on HIV-1-infected antiretroviral-naïve patients from 6 Spanish or French centers, who were started on treatment with STR-Atripla®, or the same components separately (MTR-SC), or a different MTR (MTR-Other). Effectiveness was measured as percentage of HIV-RNA <50copies/mL at 48 weeks (ITT). Efficiency was the ratio between costs (direct cost of antiretrovirals plus outpatient visits, hospital admissions, and resistance tests) and effectiveness. Results: The study included a total of 2773 patients (759 STR-Atripla®, 483 MTR-SC, and 1531 MTR-Other). Median age was 37 years, 15% were HCV co-infected, 27% had a CD4+ count <200cells/μL, and 30% had viral load ≥100.000copies/mL. The duration of the assigned treatment was longer for STR-Atripla® (P<.0001). Response rates (adjusted for CD4+ count, viral load, and clustered on hospitals) at 48 weeks were 76%, 74%, and 62%, respectively (P<.0001). Virological failure was more common in MTR patients (P=.0025), and interruptions due to intolerance with MTR-Other (P<.0001). Cost per responder at 48 weeks (efficiency) was euros12,406 with STR-Atripla®, euros11,034 with MTR-SC (0.89 [0.82, 0.99] times lower), and euros18,353 (1.48 [1.38, 1.61] times higher) with MTR-Other. Conclusions: STR-Atripla® and MTR-SC regimens showed similar effectiveness, but virological failure rate was lower with STR-Atripla. MTR-SC, considered less convenient, had a marginally better efficiency, mainly due to lower direct costs. MTR-Other regimens had both a worse effectiveness and efficiency. Similar efficiency analyses adjusting for baseline characteristics should be recommended for new STRs (AU)

Objetivo: Evaluar la eficiencia de un régimen antirretroviral de comprimido único diario (STR) y de regímenes de múltiples comprimidos (MTR) con exactamente los mismos (MTR-SC) o distintos componentes (MTR-Other). Métodos: Se incluyeron pacientes con infección por VIH-1 no tratados de 6 centros españoles o franceses que iniciaron tratamiento con STR-Atripla®, MTR-SC, o MTR-Other. La eficacia se midió como el porcentaje de VIH-ARN <50copias/ml (48 semanas, ITT). La eficiencia fue el cociente entre los costes (costes directos de los antirretrovirales, visitas ambulatorias, ingresos y estudios de resistencia) y la eficacia. Resultados: Fueron incluidos 2.773 pacientes (759 STR-Atripla®, 483 MTR-SC, 1.531 MTR-Other) con una edad media de 37 años, el 15% coinfectados por VHC, el 27% con CD4+ <200células/μl y el 30% con carga viral ≥100.000copias/ml. La duración del tratamiento asignado fue mayor para STR-Atripla® (p<0,0001). La respuesta (ajustada para CD4+, carga viral y centro hospitalario) a 48 semanas fue del 76, 74 y 62%, respectivamente (p<0,0001). El fracaso virológico fue más frecuente con ambos MTR (p=0,0025), y las interrupciones por intolerancia lo fueron con MTR-Other (p<0,0001). El coste por respondedor a 48 semanas (eficiencia) fue 12.406euros con STR-Atripla®, 11.034euros con MTR-SC (0,89 [0,82-0,99] veces menor), y 18.353euros (1,48 [1,38-1,61] veces mayor) con MTR-Other. Conclusiones: STR-Atripla® y MTR-SC mostraron una eficacia similar, pero con menor fracaso virológico con STR-Atripla. MTR-SC, considerado menos conveniente, tuvo una eficiencia marginalmente mayor, principalmente debido a menores costes directos. MTR-Other tuvo una eficacia y eficiencia peores. Deberían recomendarse estudios similares con otros nuevos STR ajustados a las características basales de los pacientes (AU)

Lipid metabolism and cardiovascular risk in HIV infection: new perspectives and the role of nevirapine.

Effective antiretroviral regimens allow patients to successfully manage their HIV infection for decades. Both HIV infection and treatment elevate the incidence and progression of cardiovascular disease, as evidenced by higher rates of myocardial infarction. Traditional cardiovascular disease risk factors, including elevated serum lipids, lipoprotein and triglyceride levels, hypertension, and smoking, may play a role. In addition, factors directly related to HIV infection (chronic inflammation and persistent immune activation due to viral replication) further elevate risk, while some antiretrovirals adversely affect serum lipids and promote inflammation. Recent epidemiological studies report that HIV-infection rates in patients aged 50 years or greater are rising. Since HIV patients experience decades of elevated cardiovascular disease risk, and many patients are infected later in life, older patients are generally at even greater cardiovascular disease risk. Treatment guidelines recommend antiretroviral regimen initiation soon after initial diagnosis, with continuous adherence to minimize long-term consequences of HIV infection. Also, appropriate selection when initiating or switching antiretroviral regimens can play a major role in managing cardiovascular disease risk. Antiretroviral drugs with favorable lipid profiles may help. Close adherence to the NCEP guidelines for managing hyperlipidemias and other cardiovascular risk factors further reduces cardiovascular disease risk. Recent awareness of other patient factors, such as the impact of vitamin D deficiencies on cardiovascular disease risk, especially in the HIV-infected population, raises important questions with regard to the potential benefits of vitamin D repletion via supplementation. Fortunately, these and other important cardiovascular disease risk management questions designed to improve patient care are currently being addressed in large, well-controlled clinical trials.