Pre-exposure prophylaxis program in the Community of Madrid: Two years of experience.

INTRODUCTION: Pre-exposure prophylaxis (PrEP) against the human immunodeficiency virus (HIV) is an effective and safe preventive measure. However, it has not reached all target users who could benefit from it. The study aimed to understand the sociodemographic, clinical and behavioral baseline characteristics of PrEP users. As a secondary objective, the use of concomitant medication and drug consumption were described. METHODOLOGY: Observational, retrospective and descriptive study of the sociodemographic, clinical and behavioral characteristics of the users who were included in the PrEP program of the Community of Madrid during the first two years of experience. RESULTS: Two thousand two hundred fifty-six PrEP users were included, 99.0% men, with a mean age of 36.9 years (SD 8.68). 33.1% presented a sexually transmitted infection (STI) on the first visit, highlighting chlamydiasis and rectal gonococci. 70.4% reported using drugs associated with sex, and 42.4% participated in chemsex sessions in the last 3 months. A high percentage of users with concomitant medication was observed (37.6%), highlighting drugs related to mental health and alopecia. CONCLUSIONS: A multidisciplinary approach is required to cover all the needs of PrEP users, including mental health evaluation measures and addiction treatment with the clinical approach.

Prevalence of Potential Drug-Drug Interactions in Patients of the Swiss HIV Cohort Study in the Era of HIV Integrase Inhibitors.

BACKGROUND: Prevalence of potential drug-drug interactions (PDDIs) between antiretroviral drugs (ARVs) and co-medications was high in 2008 in a Swiss HIV Cohort Study (SHCS) survey. We reassessed the prevalence of PDDIs in the era of human immunodeficiency virus (HIV) integrase inhibitors (INIs), characterized by more favorable interaction profiles. METHODS: The prevalence of PDDIs in treated HIV-positive individuals was assessed for the period 01-12/2018 by linkage of the Liverpool HIV drug interactions and SHCS databases. PDDIs were categorized as harmful (red flagged), of potential clinical relevance (amber flagged), or of weak clinical significance (yellow flagged). RESULTS: In 9298 included individuals, median age was 51 years (IQR, 43-58), and 72% were males. Individuals received unboosted INIs (40%), boosted ARVs (30%), and nonnucleoside reverse transcriptase inhibitor (NNRTIs) (32%)-based regimens. In the entire cohort, 68% received ≥1 co-medication, 14% had polypharmacy (≥5 co-medications) and 29% had ≥1 PDDI. Among individuals with co-medication, the prevalence of combined amber and yellow PDDIs was 43% (33% amber-mostly with cardiovascular drugs-and 20% yellow-flagged PDDIs) compared to 59% in 2008. Two percent had red-flagged PDDIs (mostly with corticosteroids), the same as in the 2008 survey. Compared with 2008, fewer individuals received boosted ARVs (-24%) and NNRTIs (-13%) but the use of co-medications was higher. CONCLUSIONS: Prevalence of PDDIs was lower with more widespread use of INIs in 2018 than in 2008. Continued use of boosted regimens and increasing needs for co-medications in this aging population impeded lower rates of PDDIs.

Polypharmacy and Drug-Drug Interactions in People Living With Human Immunodeficiency Virus in the Region of Madrid, Spain: A Population-Based Study.

BACKGROUND: Drug-drug interactions (DDIs) that involve antiretrovirals (ARVs) tend to cause harm if unrecognized, especially in the context of comorbidity and polypharmacy. METHODS: A linkage was established between the drug dispensing registry of Madrid and the Liverpool human immunodeficiency virus (HIV) DDI database (January 2017-June 2017). Polypharmacy was defined as the use of ≥5 non-HIV medications, and DDIs were classified by a traffic-light ranking for severity. RESULTS: A total of 22 945 people living with HIV (PLWH) and 6 613 506 individuals without HIV had received medications. ARV regimens were predominantly based on integrase inhibitors (51.96%). Polypharmacy was higher in PLWH (32.94%) than individuals without HIV (22.16%; P < .001); this difference was consistently observed across all age strata except for individuals ≥75 years. Polypharmacy was more common in women than men in both PLWH and individuals without HIV. The prevalence of contraindicated combinations involving ARVs was 3.18%. Comedications containing corticosteroids, quetiapine, or antithrombotic agents were associated with the highest risk for red-flag DDI, and the use of raltegravir- or dolutegravir-based antiretroviral therapy was associated with an adjusted odds ratio of 0.72 (95% confidence interval, .60-.88; P = .001) for red-flag DDI. CONCLUSIONS: Polypharmacy was more frequent among PLWH across all age groups except those aged ≥75 years and was more common in women. The detection of contraindicated medications in PLWH suggests a likely disconnect between hospital and community prescriptions. Switching to alternative unboosted integrase regimens should be considered for patients with risk of harm from DDIs.

Comparison of the effectiveness and renal safety of tenofovir versus entecavir in patients with chronic hepatitis B.

OBJECTIVE: To compare the effectiveness and renal safety of treatment with tenofovir versus entecavir in patients with chronic hepatitis-B. METHODS: Retrospective study in hepatitis-B patients who initiated treatment with tenofovir or entecavir since January 1998 until 2013. The primary effectiveness variable was defined as viral DNA < 20 UI/ml (HBV-DNA) and the variable for renal safety was variations in glomerular filtration rate (eGFR) after 48 weeks of treatment. RESULTS: The analysis was conducted in 64 patients (1:1), with similar characteristics except for the prevalence of naive patients (p=0.036), comorbidities (p=0.077) and nephrotoxic drugs (p=0.088) in the entecavi arm, while the tenofovir arm presented a prevalence of patients with HBV-DNA < 20 UI/ml (p=0.032) and HBeAg-positive (p=0.050). Statistical univariate analysis and adjustment for confounding variables was conducted through the Propensity Score (PS). The outcomes for the primary effectiveness variable showed tenofovir superiority after PS adjustment, with an ORadj=6.7 (95% CI:1.2-35.3; p=0.028). Three patients on tenofovir experienced seroconversion (p=0.148). The outcomes for the primary safety variable (eGFR < 60 ml/min/1.73m2) showed no difference between both arms after adjustment, achieving an ORadj=0.6 (95% CI:0.1-2.8; p=0.521). The tenofovir arm registered two cases of treatment interruption due to renal toxicity, with subsequent recovery, including one Fanconi Syndrome. CONCLUSIONS: In our study, there are significant differences between both treatments regarding effectiveness, with tenofovir demonstrating superiority. In terms of renal safety, we have not found any significant differences, but two cases of treatment interruption due to renal toxicity with tenofovir lead us to the conclusion that treatment decision in patients with renal function alteration should include an individualized assessment of each case.

Objetivo: Comparar la efectividad y seguridad renal del tratamiento con tenofovir frente al entecavir en pacientes con hepatitis B cronica. Métodos: Estudio retrospectivo en pacientes con hepatitis B que iniciaron tratamiento con tenofovir o entecavir entre enero 1998-2013. La variable principal de la efectividad fue definida como DNA viral < 20 UI/ml (HBV-DNA) y la de la seguridad renal como variaciones en el filtrado glomerular (eGFR) tras 48 semanas de tratamiento. Resultados: Se analizaron un total de 64 pacientes (1:1), con caracteristicas semejantes excepto por el predominio de pacientes sin tratamiento previo (p=0,036), comorbilidades (p=0,077) y farmacos nefrotoxicos (p=0,088) en el grupo-entecavir, y de pacientes con HBV-DNA < 20 UI/ml (p=0,032) y HBeAg-positivo (p=0,050) en el grupo-tenofovir. Se realizaron analisis estadisticos univariantes y se ajustaron las variables confusoras mediante Propensity score (PS). Los resultados para la variable principal de efectividad (HBV-DNA < 20 UI/ml) denotan una superioridad del tenofovir tras el ajuste por PS con una ORadj= 6,7 (IC95%: 1,2-35,3; p=0,028). Tres pacientes con tenofovir sufrieron seroconversion (p=0,148). Los resultados para la variable principal de seguridad (eGFR < 60ml/min/1.73m2) no mostraron diferencias entre ambas ramas tras el ajuste, obteniendo una ORadj= 0,6 (IC95%: 0,1-2,8; p=0,521). El grupo-tenofovir registro dos casos de suspension por toxicidad renal, con posterior recuperacion, entre ellos un sindrome de Fanconi. Conclusiones: En nuestro estudio existen diferencias significativas entre ambos tratamientos respecto a su efectividad, mostrandose el tenofovir superior. En cuanto a la seguridad renal, no hemos encontrado diferencias significativas, pero dos casos de suspension de tratamiento por toxicidad renal con tenofovir nos llevan a concluir que la decision de tratamiento en los pacientes con alteraciones en la funcion renal deberia incluir un analisis individualizado de cada caso.

Comparison of the effectiveness and renal safety of tenofovir versus entecavir in patients with chronic hepatitis B / Comparación entre la efectividad y la seguridad renal del tenofovir y el entecavir en pacientes con hepatitis B crónica

Objective: To compare the effectiveness and renal safety of treatment with tenofovir versus entecavir in patients with chronic hepatitis-B. Methods: Retrospective study in hepatitis-B patients who initiated treatment with tenofovir or entecavir since January 1998 until 2013. The primary effectiveness variable was defined as viral DNA < 20 UI/ml (HBV-DNA) and the variable for renal safety was variations in glomerular filtration rate (eGFR) after 48 weeks of treatment. Results: The analysis was conducted in 64 patients (1:1), with similar characteristics except for the prevalence of naive patients (p=0.036), comorbidities (p=0.077) and nephrotoxic drugs (p=0.088) in the entecavi arm, while the tenofovir arm presented a prevalence of patients with HBV-DNA < 20 UI/ml (p=0.032) and HBeAg-positive (p=0.050). Statistical univariate analysis and adjustment for confounding variables was conducted through the Propensity Score (PS). The outcomes for the primary effectiveness variable showed tenofovir superiority after PS adjustment, with an ORadj=6.7 (95% CI:1.2-35.3; p=0.028). Three patients on tenofovir experienced seroconversion (p=0.148). The outcomes for the primary safety variable (eGFR < 60 ml/min/1.73m2 ) showed no difference between both arms after adjustment, achieving an ORadj=0.6 (95% CI:0.1-2.8; p=0.521). The tenofovir arm registered two cases of treatment interruption due to renal toxicity, with subsequent recovery, including one Fanconi Syndrome. Conclusions: In our study, there are significant differences between both treatments regarding effectiveness, with tenofovir demonstrating superiority. In terms of renal safety, we have not found any significant differences, but two cases of treatment interruption due to renal toxicity with tenofovir lead us to the conclusion that treatment decision in patients with renal function alteration should include an individualized assessment of each case (AU)

Objetivo: Comparar la efectividad y seguridad renal del tratamiento con tenofovir frente al entecavir en pacientes con hepatitis B crónica. Métodos: Estudio retrospectivo en pacientes con hepatitis B que iniciaron tratamiento con tenofovir o entecavir entre enero 1998-2013. La variable principal de la efectividad fue definida como DNA viral < 20 UI/ml (HBV-DNA) y la de la seguridad renal como variaciones en el filtrado glomerular (eGFR) tras 48 semanas de tratamiento. Resultados: Se analizaron un total de 64 pacientes (1:1), con características semejantes excepto por el predominio de pacientes sin tratamiento previo (p=0,036), comorbilidades (p=0,077) y fármacos nefrotóxicos (p=0,088) en el grupo-entecavir, y de pacientes con HBV-DNA < 20 UI/ml (p=0,032) y HBeAg-positivo (p=0,050) en el grupo-tenofovir. Se realizaron análisis estadísticos univariantes y se ajustaron las variables confusoras mediante Propensity score (PS). Los resultados para la variable principal de efectividad (HBV-DNA < 20 UI/ml) denotan una superioridad del tenofovir tras el ajuste por PS con una ORadj= 6,7 (IC95%: 1,2-35,3; p=0,028). Tres pacientes con tenofovir sufrieron seroconversión (p=0,148). Los resultados para la variable principal de seguridad (eGFR < 60ml/min/1.73m2 ) no mostraron diferencias entre ambas ramas tras el ajuste, obteniendo una ORadj= 0,6 (IC95%: 0,1-2,8; p=0,521). El grupo-tenofovir registró dos casos de suspensión por toxicidad renal, con posterior recuperación, entre ellos un síndrome de Fanconi. Conclusiones: En nuestro estudio existen diferencias significativas entre ambos tratamientos respecto a su efectividad, mostrándose el tenofovir superior. En cuanto a la seguridad renal, no hemos encontrado diferencias significativas, pero dos casos de suspensión de tratamiento por toxicidad renal con tenofovir nos llevan a concluir que la decisión de tratamiento en los pacientes con alteraciones en la función renal debería incluir un análisis individualizado de cada caso (AU)

Octreotida subcutánea para el tratamiento del síndrome del Blue Rubber Bled Nevus: a propósito de un caso / Treatment of Blue Rubber Bled Nevus syndrome with subcutaneous octreotide: a case report

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