Shorter Time to Discontinuation Due to Treatment Failure in People Living with HIV Switched to Dolutegravir Plus Either Rilpivirine or Lamivudine Compared with Integrase Inhibitor-Based Triple Therapy in a Large Spanish Cohort.

INTRODUCTION: Standard therapy for HIV treatment has consisted of two nucleoside analogue reverse transcriptase inhibitors (NRTI) paired with a third agent. Use of two-drug regimens (2DR) has been considered for selected patients in part to avoid toxicities associated with the use of NRTIs. This study aimed to compare the real-world outcomes of integrase inhibitor (INSTI)-based three-drug regimens (3DR) versus 2DR of dolutegravir (DTG) + rilpivirine (RPV) or DTG + lamivudine (3TC). METHODS: All patients in the Spanish VACH cohort switching to INSTI-based 3DR or a 2DR consisting of DTG + RPV or DTG + 3TC between May 2, 2016 and May 15, 2019 were included. Kaplan-Meier curves and Cox proportional hazard models were used to assess time to/risk of discontinuation due to treatment failure (TF) (defined as virologic failure [VF], immunologic failure, or disease progression) and adverse events (AEs). Three secondary analyses were performed: (1) in restricting the analysis to patients who were virologically suppressed (HIV RNA < 50 copies/mL) at switch; (2) matched analysis (2:1, matched by age, sex, number of previous VFs, and line of regimen), and (3) using VF as the primary endpoint in all patients. RESULTS: Overall, 5047 3DR and 617 2DR patients were analyzed. Baseline characteristics differed between groups; 2DR patients were older, more treatment experienced, and more likely to be virologically suppressed at switch. Time to discontinuation due to TF was significantly shorter for 2DR (P = 0.002). The hazard ratio (HR) for discontinuation due to TF on 2DR vs 3DR was 2.33 (P = 0.003). No difference was observed for time to discontinuation (P = 0.908) or risk of discontinuation due to AEs (HR = 0.80; P = 0.488). Results were qualitatively similar in virologically suppressed patients, matched analysis, and for VF. CONCLUSION: In the real world, the risks of discontinuation due to TF and VF were more than two times higher in patients switching to DTG-based 2DR than INSTI-based 3DR, with no difference in discontinuation due to AEs.

People living with HIV (PLHIV) need lifelong treatment to prevent progression to AIDS. Standard HIV treatments use three different drugs in combination, but these can potentially cause unwanted side effects. Treatments using just two drugs have been developed. These aim to reduce side effects and treat HIV effectively. This study included 5664 participants in Spain who were split into two groups: 5047 participants switched from their old treatment to a three-drug regimen (3DR), and 617 participants switched to a two-drug regimen (2DR). The researchers measured how long it took for the participants to stop taking their treatment because it was not working, or it caused too many side effects. At the end of the study, more than 70% of participants in either group were still taking the same treatment. Of the 30% of participants who stopped treatment because it stopped working, those taking a 2DR stopped sooner than those taking a 3DR. This difference started to appear at about 18 months and got bigger until the study ended, which was 3 years after starting treatment. Participants taking a 2DR were twice as likely to stop treatment because it was not working than those taking a 3DR. There was no difference between the groups for how long it took for participants to stop their treatment because of side effects. These results show that for some PLHIV, the 2DR stopped working sooner than 3DR, without the benefit of fewer side effects.

Executive summary of the consensus document of the HIV quality of care indicators. GESIDA updated.

This article aims to review the main information taken into account for the update of the GESIDA PLWH quality indicators. Finally 54 indicators covering a major part of the clinical activity in PLWH were defined. They evaluate the detection and diagnosis of PLWH, their follow-up and prevention, initiation and adaptation of ART, women's specific aspects, comorbidities, hospitalization, and AIDS-related mortality.

Executive summary of the consensus document of the HIV quality of care indicators. GESIDA updated / Resumen ejecutivo del documento actualizado del consenso de los indicadores de Calidad de GESIDA

This article aims to review the main information taken into account for the update of the GESIDA PLWH quality indicators.Finally 54 indicators covering a major part of the clinical activity in PLWH were defined.They evaluate the detection and diagnosis of PLWH, their follow-up and prevention, initiation and adaptation of ART, women's specific aspects, comorbidities, hospitalization, and AIDS-related mortality.

Este artículo tiene como objetivo revisar la principal información que se tuvo en cuenta para la actualización de los indicadores de calidad de PVV de GESIDA.Finalmente, se definieron 54 indicadores que cubren la mayor parte de la actividad clínica en PVV. Los indicadores evalúan la detección y el diagnóstico de los PVV, su seguimiento y prevención, la iniciación y adherencia al TAR, aspectos específicos de la mujer, comorbilidades, hospitalización y mortalidad relacionada con el sida.

Real world effectiveness of standard of care triple therapy versus two-drug combinations for treatment of people living with HIV.

BACKGROUND: Since 1996, the standard of care (SOC) therapy for HIV treatment has consisted of a backbone of two nucleoside analogue reverse transcriptase inhibitors (NRTI) paired with a third agent. Use of two-drug combinations (2DC) has been considered for selected patients to avoid toxicities associated with the use of NRTIs. This study aimed to compare the real-world outcomes of integrase strand transfer inhibitor (INSTI)-containing triple therapy (TT) to dolutegravir- (DTG) and/or boosted protease inhibitor (bPI)-based 2DC in a large Spanish cohort of HIV patients. METHODS: A retrospective analysis was performed using data from the VACH cohort, a prospective multicentre Spanish cohort of adult HIV patients. All treatment experienced patients initiating a TT of an INSTI combined with two NRTIs or a 2DC-containing DTG and/or a bPI between 01/01/2012 and 01/06/2017 were included. The unit of analysis was patient-regimens. The overall sample analysis was complemented with two sub-analyses. The first sub-analysis focused on patients treated with a backbone plus DTG compared to those treated with DTG+ one other antiretroviral. The second sub-analysis focused on patients with HIV RNA<50 copies/mL at baseline, irrespective of the regimen used. The following endpoints were assessed: time to discontinuation for any reason, time to switch due to virologic failure, and time to switch due to toxicity (reasons for discontinuation according to clinician report in the database). Time-to-event analyses were conducted using Kaplan-Meier survival curves and Cox regression models. RESULTS: Overall 7,481 patients were included in the analysis, contributing to 9,243 patient-regimens. Patient characteristics at baseline differed among groups, with the 2DC group being significantly older and having a higher proportion of women, a longer time on ART and a higher number of previous virologic failures. Median (95% Confidence Interval [C.I.]) time to switch was 2.5 years (2.3, 2.7) in 2DC group versus 2.9 years (2.7, 3.0) in TT. Adjusted hazard ratios (95% C.I.) for discontinuation due to any reason, virologic failure and toxicity in the 2DC vs TT group were 1.29 (1.15; 1.44), 2.06 (1.54; 2.77) and 1.18 (0.94; 1.48), respectively. Results were consistent in the two sub-analyses. CONCLUSION: In this analysis, time to discontinuation and probability of remaining free of virologic failure were significantly higher in patients on INSTI-based TT compared to DTG- and/or bPI-containing 2DC, with no differences in toxicity.

Is there any relationship between unemployment in young graduates and psychological resources?. An empirical research from the conservation of resources theory / ¿Hay relación entre el desempleo de jóvenes graduados y los recursos psicológicos?. Investigación empírica desde la teoría de la conservación de los recursos

The recession suffered in the western world since 2007 has left thousands of people unemployed. One of the countries most affected by unemployment is Spain and specially its young population (34.7%). Considering this context, we try to find out the role of psychological resources, well-being, distress, and eustress, among young employed and unemployed graduates. We worked with a sample of 542 young graduates, of whom 48.3% were unemployed, and those employed held job positions related to their academic background. Our results suggest that: 1) it is somewhat likely for young recent graduates to find a job if they score high in optimism; 2) resilience, optimism, autonomy, self-efficacy, environmental mastery, and overall life satisfaction are deteriorated in unemployment youth, while negative affect is increased in this group; and 3) environmental mastery plays a fundamental role among young unemployed graduates, for its loss is related to distress while its gain is related to eustress. The results of this research are relevant with regards to the implementation of training programs that contribute to the improvement of the well-being and life quality of these unemployed individuals, therefore allowing them to be in a better position to find a job

La situación de crisis que ha vivido el mundo occidental desde 2007 ha generado miles de desempleados. Uno de los países más afectados por el desempleo es España, en especial los jóvenes (34.7%). A la vista de este contexto intentamos analizar el rol de los recursos psicológicos, el bienestar, el distrés y el eustrés en jóvenes graduados empleados y desempleados. Hemos utilizado una muestra de 542 jóvenes graduados, de los cuales el 48.3% estaban desempleados y los que trabajaban ocupaban puestos relacionados con su formación académica. Nuestros resultados sugieren que: 1) es algo más probable que los jóvenes recién graduados encuentren trabajo si tienen puntuaciones altas en optimismo, 2) la resiliencia, el optimismo, la autonomía, la autoeficacia, el dominio del entorno y la satisfacción general con la vida están deteriorados en los jóvenes sin trabajo, a la par que aumenta en ellos el afecto negativo y 3) el dominio del entorno juega un papel fundamental en los jóvenes graduados desempleados, dado que su pérdida guarda relación con el distrés mientras que su ganancia se relaciona con el eustrés. Los resultados de esta investigación son relevantes para implementar programas de entrenamiento que contribuyan a mejorar el bienestar y la calidad de vida de estas personas desempleadas, lo que les permitirá estar en una mejor disposición para encontrar trabajo

Monotherapy with darunavir/ritonavir is effective and safe in clinical practice.

INTRODUCTION: Monotherapy against HIV has undoubted theoretical advantages and has good scientific fundaments. However, it is still controversial and here we will analyze the efficacy and safety of MT with darunavir with ritonavir (DRV/r) on patients who have received this treatment in our hospitals. MATERIALS AND METHODS: Observational retrospective study that includes patients from 10 Andalusian hospitals that have received DRV/r in MT and that have been followed over a minimum of 12 months. We carried out a statistical descriptive analysis based on the profile of patients who had been prescribed MT and the efficacy and safety that were observed, paying special attention to treatment failure and virological evolution. RESULTS: DRV/r was prescribed to 604 patients, of which 41.1% had a CD4 nadir <200/mmc. 33.1% had chronic hepatitis caused by HCV, had received an average of five lines of previous treatment and had a history of treatment failure to analogues in 33%, to non-analogues 22 and protease inhibitors (PI) in 19.5%. 76.6% proceeded from a previous treatment with PI. The simplification was the main criteria for the instauration of MT in the 81.5% and the adverse effects in the 18.5%. We managed to maintain MT in 84% of cases, with only 4.8% of virological failure (VF) with viral load (VL) >200 c/mL and 3.6% additional losses due to VF with VL between 50 and 200 copies/mL. Thirty three genotypes were performed after failure without findings of resistance mutations to DRV/r or other IPs. Only 23.7% of patients presented some blips during the period of exposition to MT. Eighty seven percent of all determinations of VL had <50 copies/mL, and only 4.99% had >200 copies/mL. Although up to 14.9% registered at some point an AE, only 2.6% abandoned MT because of AE and 1.2% because of voluntary decision. Although the average of total and LDL cholesterol increases 10 mg/dL after 2 years of follow-up, so did HDL cholesterol in 3mg/dL and the values of triglycerides (-14 mg/dL) and GPT (-6 UI/mL) decreased. The average count of CD4 lymphocytes increased from 642 to 714/mm(3) at 24 weeks. CONCLUSIONS: In a very broad series of patients obtained from clinical practice, data from clinical trials was confirmed: MT with DRV as a de-escalation strategy is very safe, it's associated to a negligible rate of adverse effects and maintains a good suppression of HIV replication. VF (with >50 or >200 copies/mL) is always under 10% and in any case without consequences.