ObjectiveTo assess the current frequency of ART-associated grade 3–4 transaminase elevations (TE) and grade 4 total bilirubin elevations (TBE) in HIV-infected patients with chronic hepatitis B and/or C, who start a new regimen of ART.Patients and MethodsA total of 192 pre-treated or treatment-naive HIV infected patients with HBV and/or HCV-coinfection who started ART in eight Southern Spanish centers from July/2011-December/2013, were followed for 12 months in this prospective study.ResultsForty-one (21.4%) subjects had been naïve to ART, median (IQR) follow-up was 11.6 (5.6–12.9) months. The most frequently initiated NRTI were tenofovir/emtricitabine [49 patients (25.5%)]. Eighty-nine (46.4%) patients started a ritonavir-boosted protease inhibitor and 77 (40.1%) individuals a NNRTI. Raltegravir and maraviroc were initiated in 24 (12.5%) and 9 (4.7%) individuals. Ten [5.21%; 95% confidence interval (CI): 2.53%-9.37%] patients presented grade 3 TE, while 8 (4.17%; 95%CI: 1.82%-8.04%) subjects showed grade 4 TBE. No episodes of grade 4 TE or ART discontinuation due to hepatotoxic events were observed. The use of ritonavir-boosted atazanavir was the only independent predictor for grade 4 TBE [adjusted odds ratio: 7.327 (95%CI: 1.417–37.89); p = 0.018] in an analysis adjusted for age, sex and baseline HIV-RNA levels, while no factor could be independently associated with grade 3–4 TE.ConclusionsCurrently, the frequency of severe ART-associated TE and TBE under real-life conditions in patients with chronic viral hepatitis is similar to what has been reported previously. However, episodes of grade 4 TE are less frequent and severe TE appears to be of lesser concern.

It is commonly accepted that human immunodeficiency (HIV) coinfection negatively impacts on the rates of sustained virological response (SVR) to therapy with pegylated interferon plus ribavirin (PR). However, this hypothesis is derived from comparing different studies. The aim of this study was to determine the impact of HIV coinfection on SVR to PR in one single population. In a multicentric, prospective study conducted between 2000 and 2013, all previously naïve hepatitis C virus (HCV)-infected patients who started PR in five Spanish hospitals were analyzed. SVR was evaluated 24 weeks after the scheduled end of therapy. Of the 1046 patients included in this study, 413 (39%) were coinfected with HIV. Three hundred and forty-one (54%) HCV-monoinfected versus 174 (42%) HIV/HCV-coinfected patients achieved SVR (p < 0.001). The corresponding figures for undetectable HCV RNA at treatment week 4 were 86/181 (47%) versus 59/197 (30%), p < 0.001. SVR was observed in 149 (69%) HCV genotype 2/3-monoinfected subjects versus 91 (68%) HIV/HCV genotype 2/3-coinfected subjects (p = 0.785). In the HCV genotype 1/4-infected population, 188 (46%) monoinfected patients versus 82 (30%) with HIV coinfection (p < 0.001) achieved SVR. In this subgroup, absence of HIV coinfection was independently associated with higher SVR [adjusted odds ratio (95% confidence interval): 2.127 (1.135-3.988); p = 0.019] in a multivariate analysis adjusted for age, sex, baseline HCV RNA load, IL28B genotype, fibrosis stage, and type of pegylated interferon. HIV coinfection impacts on the rates of SVR to PR only in HCV genotype 1/4-infected patients, while it has no effect on SVR in the HCV genotype 2/3-infected subpopulation.

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The proportion of nonresponders was significantly reduced using the IL28B genotype as a predictive tool and direct-acting antivirals further improved treatment outcome. Concomitantly, the rates of SVR showed a linear increase.

ObjectivesTo develop and validate a model for predicting the risk of hospital admission within 1 year in the HIV population under antiretroviral treatment.MethodsWe conducted a retrospective observational study. Patients receiving antiretroviral treatment for at least 1 year who were followed by the pharmacy service in a Spanish-speaking hospital between January 2008 and December 2012 were included. Demographics, and clinical and pharmacotherapy variables, were included in the model design. To find prognostic factors for hospital admission a multivariate logistic regression model was created after performing a univariate analysis. Model validity was determined by the shrinkage method and the model discrimination by Harrell's C-index.Results442 patients were included in the study. The variables ‘CD4 count <200 (cells/µL)’, ‘drug/alcohol use’, ‘detectable viral load (>50 copies/mL)’, ‘number of previous admissions’, and ‘number of drugs different from antiretroviral treatment’ were the independent predictors of risk of hospital admission. Probabilities predicted by the model showed an R2=0.98 for the development sample and an R2=0.86 for the validation sample. The Harrell's C index for the development and validation data were 0.82 (95% CI 0.77 to 0.87) and 0.80 (95% CI 0.73 to 0.88), respectively.ConclusionsThe model developed in this study may be useful in daily practice for identifying HIV patients at high risk of 1-year hospital admission.

Background Anti-HCV treatment may add significant complexity to antiretroviral treatment (ART). The complexity of the medicines regimen could be a risk factor for non-adherence or increasing incidence of blips. Purpose To determine if the addition of anti-HCV treatment to antiretroviral treatment increases the complexity of the treatment, therefore modifying medicines adherence and incidence of blips. Materials and methods We conducted a retrospective observational study. HIV/HCV co-infected patients treated with interferon alfa-2a plus ribavirin for at least 12 weeks between 01/2008–06/2012 were included. We excluded patients with HIV viral load >50 copies RNA/mL in the six months prior to the introduction of anti-HCV treatment. The following variables were collected: sex, age, weeks on anti-HCV treatment and incidence of blips. Additionally, adherence (≥95%) and complexity index were collected before and after the addition of anti-HCV treatment. Blips were defined as a detectable HIV-RNA level (>50 copies/mL but no more than 1000 copies/mL) occurring between 2 negative assays. Complexity index was calculated based on a score (Martin et al , 2007) which considers number of pills taken per day, dosing schedule, dosage form and any specific instructions related to drug use. Quantitative and dichotomous variables were compared using the t-test for related samples and McNemar’s test respectively (confidence interval (CI) 95%). Data analysis was carried out using SPSS 20.0. Results 36 patients were included (75% male, mean age 47 ± 5). The mean duration on anti-HCV treatment was 41 ± 18 weeks. The mean value of the complexity index before and after the addition of anti-HCV treatment to ART was 5.3 ± 1.9 and 11.4 ± 1.6 respectively (p < 0.001, CI:-6,68;-5,56). 4 out of 36 (11.1%) patients experienced viral blips (p > 0.005). After the introduction of the anti-HCV treatment, the number of non-adherent patients showed a non-significant increase from 11% to 22%. Conclusions The addition of anti-HCV treatment to ART correlates with a significant increase in the complexity index, leading to higher non-adherence and blips rates. No conflict of interest.

Antecedentes: La mala calidad de sueño puede tener un impacto negativo sobre la calidad de vida de la población en general, y en pacientes VIH+ puede influir negativamente sobre la adherencia del tratamiento antirretroviral. A pesar de ello, hay pocos trabajos que hayan estudiado la cantidad de personas con VIH/SIDA que padecen este trastorno del sueño. Objetivos: Determinar la prevalencia y factores asociados al insomnio y mala calidad de sueño en un grupo de pacientes con VIH+ en España. Método: Estudio observacional descriptivo trasversal. En el estudio se incluyó a pacientes mayores de 18 años diagnosticados con VIH/SIDA pertenecientes al programa de Atención Farmacéutica del servicio de farmacia del Hospital Virgen de Valme de Sevilla (España). Todos los pacientes completaron el Pittsburgh Sleep Quality Index para medir la calidad de sueño, y el Insomnia Severity Index para medir la gravedad del insomnio. Los factores asociados con la calidad de sueño fueron determinados mediante una regresión logística multivariante. Por su parte, los factores asociados a la gravedad del insomnio fueron estudiados mediante una regresión lineal multivariante. Resultados: Se incluyó 188 pacientes con una edad media de 45 años (desviación estándar DE = 8,4). El 78,7% fueron hombres. El recuento medio de CD4+ fue 609,3 (DE = 318,0), y de CD8+ fue 868,7 (DE = 446,7). La media del PSQI fue de 7,0 (DE = 4,6), y 105 (55,9%) pacientes fueron clasificados como malos dormidores (PSQI > 5). La puntuación media obtenida en el ISI fue 7,3 (DE = 9,1). En los buenos dormidores la puntuación media fue de 1,3 (DE = 2,3) y en los malos dormidores fue de 12,0 (DE = 9,7) (p < 0,001). En los malos dormidores, el 40,9% tuvieron insomnio moderado o grave. La correlación entre la puntuación del PSQI y el ISI fue 0,775 (p< 0,001). Variables como adherencia, género, edad, recuento de CD4 ó CD8 no estuvieron relacionadas con el trastorno del sueño. Conclusiones: La prevalencia de malos dormidores y de insomnes, según el PSQI y el ISI, respectivamente, es bastante mayor en pacientes con VIH/SIDA que en la población general (aproximadamente 20%), pero esto no está asociado con la adherencia del tratamiento.