Dynamic Regulatory Assessment: Unpacking the Process Reveals Readiness to Pilot for Europe-An EFPIA View.

The medicines regulatory network of the European Economic Area comprises 30 countries, their National Competent Authorities (NCA), and the European Medicines Agency (EMA). The NCAs and EMA are involved at different stages of the medicine life cycle; not all are engaged in a particular medicine's development discussions. As a result, knowledge management (ie, acquisition and transfer between medicine developer and the NCAs) is fragmented and inefficient. Dynamic regulatory assessment (DRA), a regulatory science concept developed by the European Federation of Pharmaceutical Industries and Associations (EFPIA), could drive increased connectedness supporting more continuous knowledge building. DRA works via iterative release and assessment of discrete data packets (DDPs) at mutually agreed milestones during development, culminating in more efficient development and faster authorization. This commentary seeks to build on an earlier article by unpacking the DRA concept, with a particular focus on DDPs. Its aim is to show how DDPs can support efficient and predictable release of data to encourage development and assessment of promising medicines, and it makes the case for piloting the DRA concept with European regulators now.

Recommendations for defining preventable HIV-related mortality for public health monitoring in the era of Getting to Zero: an expert consensus.

Getting to Zero is a commonly cited strategic aim to reduce mortality due to both HIV and avoidable deaths among people with HIV. However, no clear definitions are attached to these aims with regard to what constitutes HIV-related or preventable mortality, and their ambition is limited. This Position Paper presents consensus recommendations to define preventable HIV-related mortality for a pragmatic approach to public health monitoring by use of national HIV surveillance data. These recommendations were informed by a comprehensive literature review and agreed by 42 international experts, including clinicians, public health professionals, researchers, commissioners, and community representatives. By applying the recommendations to 2019 national HIV surveillance data from the UK, we show that 30% of deaths among people with HIV were HIV-related or possibly HIV-related, and at least 63% of these deaths were preventable or potentially preventable. The application of these recommendations by health authorities will ensure consistent monitoring of HIV elimination targets and allow for the identification of inequalities and areas for intervention.

Dynamic Regulatory Assessment: evolving the European Regulatory Framework for the Benefit of Patients and Public Health-an EFPIA View.

The European Union regulatory framework supports development, review, authorization, and maintenance of medicines to benefit public health; however, many elements are 2 decades old and undergoing review. Scrutiny was triggered by the coronavirus disease 2019 pandemic, the need to support future innovative medicines, the digital transformation of data exchange, and the need to address efficiency and capacity limitations. There are also ongoing evolutions in regulatory science for medicines (eg, cell and gene therapies), medical device combinations, and software, as well as the need to fully leverage contemporary information technology (IT). Important initiatives to address these challenges include the European Medicines Agency (EMA) Regulatory Science Strategy,1 the EU Regulatory Network Strategy,2 and the Big Data Steering Group,3 alongside European Commission-led initiatives such as the Pharmaceutical Strategy.4 Dynamic regulatory assessment (DRA) is a concept that seeks to integrate these various elements to re-imagine regulatory review interactions across the product life cycle. DRA calls for iterative regulatory dialogue, data submission, and evidence assessment, enabled by contemporary IT. DRA will facilitate iterative interaction and data assessment as it accumulates over a product's life cycle, bringing significant efficiencies for all product types. The DRA concept primarily evolved through dialogue within working groups of the European Federation of Pharmaceutical Industries and Associations. This article describes the long-term vision of the European Federation of Pharmaceutical Industries and Associations and outlines important strategic elements of progress, including: aligning on a multi-stakeholder vision for DRA in the European Union and across regions; leveraging learnings from ongoing initiatives; and advancing IT, governance, and standards considerations. Ultimately, DRA should consider outcomes that deliver optimal benefits for patients in the European Union and worldwide.

Assessment of Obesity and Cardiometabolic Status by Integrase Inhibitor Use in REPRIEVE: A Propensity-Weighted Analysis of a Multinational Primary Cardiovascular Prevention Cohort of People With Human Immunodeficiency Virus.

BACKGROUND: Emerging data demonstrate that the use of integrase inhibitor (INSTI)-based antiretroviral treatment (ART) is associated with increased weight, but the cardiometabolic health consequences of increased weight remains poorly understood. METHODS: This analysis examined INSTI use (>6 months) at entry among REPRIEVE participants enrolled in High Income and Latin America/Caribbean Global Burden of Disease regions. Primary analyses used linear and logistic regression; secondary analyses used quantile regression to examine differences across the full data distribution. Characteristics of those with and without INSTI use were balanced using inverse probability of treatment weighting. RESULTS: Among 4500 REPRIEVE participants, 1848 were on an INSTI-based regimen at entry for an average of 2.1 ±â€…1.8 years. Integrase inhibitor use (vs no INSTI use) was associated with higher odds of obesity (odds ratio [OR], 1.63; 95% confidence interval [CI], 1.4-1.9) and higher mean body mass index ([BMI] +1.5kg/m2; 95% CI, 1.0-1.9) and waist circumference (+3.6cm; 95% CI, 2.6-4.6). Differences in weight related to INSTI use were greater in the upper tails of the distribution (+3.1kg/m2 [95% CI, 1.9-4.4] at the 90th centile vs +0.7kg/m2 [95% CI, 0.2-1.2] at the 50th centile) and among women and nonwhite participants, with sex and race having an additive effect on BMI. Conversely, INSTI use was not associated with differences in glucose, low-density lipoprotein cholesterol, or higher odds of metabolic syndrome or hypertension. CONCLUSIONS: Differences in weight and waist circumference associated with INSTI use are (1) not uniform across people with human immunodeficiency virus, (2) greatest among women and nonwhites, and (3) concentrated at the upper tails of weight distribution. These data identify at-risk subgroups for whom long-term cardiovascular disease outcomes should be carefully assessed.

Effective Pharmacovigilance System Development: EFPIA-IPVG Consensus Recommendations.

Pharmaceutical legislation provides a legal framework to ensure the safe and effective use of medicines. This framework requires national regulatory authorities (NRAs) to establish and maintain a pharmacovigilance system (PV system) stating and enforcing the regulatory commitments that key stakeholders, including marketing authorisation holders (MAHs), are required to fulfil. In recent years, national legislative bodies and NRAs across the world have issued a significant amount of legislation and guidance enforcing the obligation to perform pharmacovigilance activities. In countries where the NRA is a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), safety management requirements are generally consistent with ICH guidelines. In a number of countries beyond this scope, requirements may deviate from internationally agreed standards, adding a substantial complexity and increasing burden on the stakeholders involved, whilst the benefit for patients' safety may not be evident. Committed to fulfilling safety-regulatory obligations in any country where a product licence is held, global pharmaceutical companies have accumulated a broad and deep experience acquired whilst meeting the expectations of a large array of diverse PV systems across the world. These range from sub-optimal frameworks, according to the World Health Organization (WHO) Global Benchmarking Tool, to highly effective resource-optimised PV systems. In order to support countries creating or further developing their PV systems, especially where infrastructure and resources are limited, the European Federation of Pharmaceutical Industries and Associations (EFPIA) International Pharmacovigilance Group (IPVG) has developed consensus recommendations consistent with harmonised standards for the development and step-wise implementation of key PV system components. These recommendations endorsed by the EFPIA membership constitute the focus of this review article.

Non-pharmaceutical interventions for containment, mitigation and suppression of COVID-19 infection.

BACKGROUND: The best scientific evidence is required to design effective Non-pharmaceutical interventions to help policymakers to contain COVID-19. AIM: To describe which Non-pharmaceutical interventions used different countries and a when they use them. It also explores how Non-pharmaceutical interventions impact the number of cases, the mortality, and the capacity of health systems. METHODS: We consulted eight web pages of transnational organizations, 17 of international media, 99 of government institutions in the 19 countries included, and besides, we included nine studies (out of 34 identified) that met inclusion criteria. RESULT: Some countries are focused on establishing travel restrictions, isolation of identified cases, and high-risk people. Others have a combination of mandatory quarantine and other drastic social distancing measures. The timing to implement the interventions varied from the first fifteen days after detecting the first case to more than 30 days. The effectiveness of isolated non-pharmaceutical interventions may be limited, but combined interventions have shown to be effective in reducing the transmissibility of the disease, the collapse of health care services, and mortality. When the number of new cases has been controlled, it is necessary to maintain social distancing measures, self-isolation, and contact tracing for several months. The policy decision-making in this time should be aimed to optimize the opportunities of saving lives, reducing the collapse of health services, and minimizing the economic and social impact over the general population, but principally over the most vulnerable. The timing of implementing and lifting interventions could have a substantial effect on those objectives.

Antecedentes: Se requiere la mejor evidencia científica para diseñar intervenciones no farmacológicas efectivas para ayudar a los formuladores de políticas a contener COVID-19. OBJETIVO: Describir qué intervenciones no farmacológicas utilizaron diferentes países y cuándo las implementaron. También explora cómo las intervenciones no farmacológicas afectan el número de casos, la mortalidad y la capacidad de los sistemas de salud. MÉTODOS: Consultamos ocho páginas web de organizaciones transnacionales, 17 de medios internacionales, 99 de instituciones gubernamentales en los 19 países incluidos, y además, incluimos nueve estudios (de 34 identificados) que cumplían con los criterios de inclusión. RESULTADOS: Algunos países implementaron restricciones de viaje, aislamiento de casos identificados y personas de alto riesgo. Otros combinaron varias medidas más drásticas de distanciamiento social. El tiempo para implementar las intervenciones varió desde los primeros quince días después de detectar el primer caso hasta más de 30 días. La efectividad de las intervenciones no farmacológicas combinadas ha demostrado ser efectivas para reducir la transmisibilidad de la enfermedad, el colapso de los servicios de salud y la mortalidad. Cuando se controle el número de casos nuevos, es necesario mantener medidas de distanciamiento social, autoaislamiento y rastreo de contactos durante varios meses. La toma de decisiones políticas en este momento debe tener como objetivo optimizar las oportunidades de salvar vidas, reducir el colapso de los servicios de salud y minimizar el impacto económico y social sobre la población en general, pero principalmente sobre los más vulnerables.

Non-pharmaceutical interventions for containment, mitigation and suppression of COVID-19 infection / Intervenciones no farmacéuticas para la contención, mitigación y supresión del COVID-19

Abstract Background: The best scientific evidence is required to design effective Non-pharmaceutical interventions to help policymakers to contain COVID-19. Aim: To describe which Non-pharmaceutical interventions used different countries and a when they use them. It also explores how Non-pharmaceutical interventions impact the number of cases, the mortality, and the capacity of health systems. Methods: We consulted eight web pages of transnational organizations, 17 of international media, 99 of government institutions in the 19 countries included, and besides, we included nine studies (out of 34 identified) that met inclusion criteria. Result: Some countries are focused on establishing travel restrictions, isolation of identified cases, and high-risk people. Others have a combination of mandatory quarantine and other drastic social distancing measures. The timing to implement the interventions varied from the first fifteen days after detecting the first case to more than 30 days. The effectiveness of isolated non-pharmaceutical interventions may be limited, but combined interventions have shown to be effective in reducing the transmissibility of the disease, the collapse of health care services, and mortality. When the number of new cases has been controlled, it is necessary to maintain social distancing measures, self-isolation, and contact tracing for several months. The policy decision-making in this time should be aimed to optimize the opportunities of saving lives, reducing the collapse of health services, and minimizing the economic and social impact over the general population, but principally over the most vulnerable. The timing of implementing and lifting interventions could have a substantial effect on those objectives.

Resumen Antecedentes: Se requiere la mejor evidencia científica para diseñar intervenciones no farmacológicas efectivas para ayudar a los formuladores de políticas a contener COVID-19. Objetivo: Describir qué intervenciones no farmacológicas utilizaron diferentes países y cuándo las implementaron. También explora cómo las intervenciones no farmacológicas afectan el número de casos, la mortalidad y la capacidad de los sistemas de salud. Métodos: Consultamos ocho páginas web de organizaciones transnacionales, 17 de medios internacionales, 99 de instituciones gubernamentales en los 19 países incluidos, y además, incluimos nueve estudios (de 34 identificados) que cumplían con los criterios de inclusión. Resultados: Algunos países implementaron restricciones de viaje, aislamiento de casos identificados y personas de alto riesgo. Otros combinaron varias medidas más drásticas de distanciamiento social. El tiempo para implementar las intervenciones varió desde los primeros quince días después de detectar el primer caso hasta más de 30 días. La efectividad de las intervenciones no farmacológicas combinadas ha demostrado ser efectivas para reducir la transmisibilidad de la enfermedad, el colapso de los servicios de salud y la mortalidad. Cuando se controle el número de casos nuevos, es necesario mantener medidas de distanciamiento social, autoaislamiento y rastreo de contactos durante varios meses. La toma de decisiones políticas en este momento debe tener como objetivo optimizar las oportunidades de salvar vidas, reducir el colapso de los servicios de salud y minimizar el impacto económico y social sobre la población en general, pero principalmente sobre los más vulnerables.

Analysis of the costs and cost-effectiveness of the guidelines recommended by the 2018 GESIDA/Spanish National AIDS Plan for initial antiretroviral therapy in HIV-infected adults.

BACKGROUND: The GESIDA/National AIDS Plan expert panel recommended preferred regimens (PR), alternative regimens (AR) and other regimens (OR) for antiretroviral treatment (ART) as initial therapy in HIV-infected patients for 2018. The objective of this study was to evaluate the costs and the efficiency of initiating treatment with PR and AR. METHODS: Economic assessment of costs and efficiency (cost-effectiveness) based on decision tree analyses. Effectiveness was defined as the probability of reporting a viral load <50copies/mL at week 48, in an intention-to-treat analysis. Cost of initiating treatment with an ART regimen was defined as the costs of ART and its consequences (adverse effects, changes of ART regimen, and drug-resistance studies) over the first 48 weeks. The payer perspective (National Health System) was applied considering only differential direct costs: ART (official prices), management of adverse effects, studies of resistance, and HLA B*5701 testing. The setting was Spain and the costs correspond to those of 2018. A deterministic sensitivity analysis was conducted, building three scenarios for each regimen: base case, most favourable and least favourable. RESULTS: In the base-case scenario, the cost of initiating treatment ranges from 6788 euros for TAF/FTC/RPV (AR) to 10,649 euros for TAF/FTC+RAL (PR). The effectiveness varies from 0.82 for TAF/FTC+DRV/r (AR) to 0.91 for TAF/FTC+DTG (PR). The efficiency, in terms of cost-effectiveness, ranges from 7814 to 12,412 euros per responder at 48 weeks, for ABC/3TC/DTG (PR) and TAF/FTC+RAL (PR), respectively. CONCLUSION: Considering ART official prices, the most efficient regimen was ABC/3TC/DTG (PR), followed by TAF/FTC/RPV (AR) and TAF/FTC/EVG/COBI (AR).

Costs and cost-efficacy analysis of the 2017 GESIDA/Spanish National AIDS Plan recommended guidelines for initial antiretroviral therapy in HIV-infected adults.

INTRODUCTION: GESIDA and the Spanish National AIDS Plan panel of experts have recommended preferred (PR), alternative (AR) and other regimens (OR) for antiretroviral therapy (ART) as initial therapy in HIV-infected patients for 2017. The objective of this study was to evaluate the costs and the efficiency of initiating treatment with PR and AR. METHODS: Economic assessment of costs and efficiency (cost-efficacy) based on decision tree analyses. Efficacy was defined as the probability of reporting a viral load <50copies/mL at week 48, in an intention-to-treat analysis. Cost of initiating treatment with an ART regimen was defined as the costs of ART and its consequences (adverse effects, changes of ART regimen and drug resistance studies) during the first 48 weeks. The payer perspective (National Health System) was applied considering only differential direct costs: ART (official prices), management of adverse effects, resistance studies and HLA B*5701 screening. The setting was Spain and the costs correspond to those of 2017. A deterministic sensitivity analysis was conducted, building three scenarios for each regimen: base case, most favourable and least favourable. RESULTS: In the base case scenario, the cost of initiating treatment ranged from 6882 euro for TFV/FTC/RPV (AR) to 10,904 euros for TFV/FTC+RAL (PR). The efficacy varied from 0.82 for TFV/FTC+DRV/p (AR) to 0.92 for TAF/FTC/EVG/COBI (PR). The efficiency, in terms of cost-efficacy, ranged from 7923 to 12,765 euros per responder at 48 weeks, for ABC/3TC/DTG (PR) and TFV/FTC+RAL (PR), respectively. CONCLUSION: Considering ART official prices, the most efficient regimen was ABC/3TC/DTG (PR), followed by TFV/FTC/RPV (AR) and TAF/FTC/EVG/COBI (PR).

Aging metabolism: intervention strategies.

Human beings are subjected to aging and age-associated diseases. Life expectancy has improved impressively in the last century due to social and economic development, but despite increasing improvement is still more limited than average in those ones with chronic diseases such as treated HIV infection. There has been a substantial research on the underlying factors responsible for aging both in the general and the HIV-infected populations. Several specific targets for potential intervention have been identified but studies so far have been limited to small experiments in cultured cells or living beings other than humans such as mice or flies. Time has come for designing and developing human studies with those candidate therapies showing most promising benefits and least potential toxicities to treat age-related diseases.

Improving the implementation of a condom availability program in urban high schools.

PURPOSE: We conducted an intervention to improve the implementation of a high school condom availability program, and evaluated its effect on students' awareness of the program and acquisition of condoms. METHODS: Twelve public high schools in the Los Angeles, CA area participated, half each in the intervention and control conditions. Project staff facilitated intervention schools' self-assessment of compliance with the school district's condom availability policy, creating an action plan by determining which mandatory program elements were lacking and identifying steps to improve compliance. Staff provided technical assistance and follow-up to assist schools in improving program implementation. From 2005 to 2009 (T1-T5), 29,823 students were randomly selected by classroom and they completed surveys. We tested for changes in students' awareness and acquisition of condoms over time between conditions using mixed model logistic regression analyses. Records of condom orders by schools also were reviewed. RESULTS: Awareness increased significantly among intervention versus control participants from T1 to T3 (adjusted odds ratio [AOR]: 1.28; 95% confidence interval [CI]: 1.01, 1.62), T4 (AOR: 2.17; 95% CI: 1.70, 2.76), and T5 (AOR: 2.78; 95% CI: 2.18, 3.56). Acquisition of condoms increased significantly among intervention versus control participants from T1 to T4 (AOR: 1.69; 95% CI: 1.23, 2.32) and T5 (AOR: 1.81; 95% CI: 1.32, 2.49). Results were similar across gender and different levels of sexual experience. Orders of condoms increased markedly in intervention schools by T5. CONCLUSIONS: Feasible minor enhancements to condom availability program implementation improved program delivery, resulting in increased student awareness of the program and acquisition of condoms.

Mitochondrial assessment in asymptomatic HIV-infected paediatric patients on HAART.

BACKGROUND: HAART can cause mitochondrial DNA (mtDNA) depletion, which may lead to mitochondrial dysfunction. We aimed to determine whether mtDNA and mitochondrial function abnormalities are present in peripheral blood mononuclear cells from asymptomatic HIV-infected children. METHODS: A cross-sectional study in peripheral blood mononuclear cells was performed in 47 asymptomatic (free from any HIV- or AIDS-related active condition or HAART-related toxicity), HIV-infected, HAART-treated children and adolescents and 27 uninfected healthy paediatric patients. We measured mtDNA and mitochondrial RNA (mtRNA) content by quantitative real-time PCR. Mitochondrial respiratory chain enzymatic activity of complex-IV (CIV) and mitochondrial mass (estimated by citrate synthase) were measured spectrophotometrically, and CIV protein subunit content was measured with western blot analysis. RESULTS: A reduction in mtDNA levels was observed in HIV-infected children compared with controls (mean ± sem 4.47 ± 0.31 and 5.82 ± 0.48, respectively; 23% depletion; P=0.018), whereas similar levels of mtRNA, CIV protein subunit content and enzymatic activity were found in the two groups. These findings remained unaltered after considering mitochondrial abundance. Among HIV-infected children, mtDNA levels did not correlate with viral load, CD4(+) T-cell counts or lactataemia at the time of assessment. No differences were observed when current or past use of individual antiretroviral drugs or HAART regimens were taken into account. CONCLUSIONS: Depletion in mtDNA from asymptomatic HIV-infected children did not lead to differences in mtRNA levels or mitochondrially-encoded CIV proteins, nor to CIV dysfunction. This may be explained by homeostatic-compensatory mechanisms at the transcription level or by the mild depletion we observed.

School-based health center access, reproductive health care, and contraceptive use among sexually experienced high school students.

PURPOSE: The current analyses compared receipt of reproductive health care, contraceptive use, and screening for sexually transmitted diseases (STD) among adolescents who are sexually experienced, with or without access to a school clinic. METHODS: A total of 12 urban California high schools, selected from areas with high teen pregnancy and STD rates, half with school-based health centers (SBHCs), participated in an intervention study designed to improve sexual health among adolescents. Of the participating students, 44% indicated that they had ever had intercourse and were included in these analyses. RESULTS: Access to an SBHC did not influence receipt of reproductive health care for either males or females and did not influence contraceptive use, either hormonal or condoms, for males. For females, however, those with access to an SBHC had increased odds of having received pregnancy or disease prevention care (adjusted odds ratio [AOR] = 1.45, 95% confidence interval [CI] = 1.16-1.80), having used hormonal contraceptives at last sex (AOR = 1.68, 95% CI = 1.24-2.28), and were more likely to have ever been screened for an STD (AOR = 1.85, 95% CI = 1.43-2.40). Also among female students, those with access to an SBHC were more likely to have used emergency contraception at last sex (AOR = 2.1, 95% CI = 1.08-4.22). CONCLUSION: Although access to an on-site clinic does not seem to lead to increases in all types of reproductive care in the population as a whole, sexually active females are more likely to have received more specific care and to have used hormonal contraceptives if their school has an SBHC.

Epidemiology, assessment, and management of excess abdominal fat in persons with HIV infection.

Metabolic and morphologic abnormalities in persons with HIV remain common contributors to stigma and morbidity. Increased abdominal circumference and visceral adiposity were first recognized in the late 1990s, soon after the advent of effective combination antiretroviral therapy. Visceral adiposity is commonly associated with metabolic abnormalities including low HDL-cholesterol, raised triglycerides, insulin resistance, and hypertension, a constellation of risk factors for cardiovascular disease and diabetes mellitus known as "the metabolic syndrome". Medline and conference abstracts were searched to identify clinical research on factors associated with visceral adiposity and randomized studies of management approaches. Data were critically reviewed by physicians familiar with the field. A range of host and lifestyle factors as well as antiretroviral drug choice were associated with increased visceral adiposity. Management approaches included treatment switching and metformin, both of which have shown benefit for insulin-resistant individuals with isolated fat accumulation. Testosterone supplements may also have benefits in a subset of individuals. Supra-physiological doses of recombinant human growth hormone and the growth hormone releasing hormone analog tesamorelin both significantly and selectively reduce visceral fat over 12-24 weeks; however, the benefits are only maintained if doping is continued. In summary, the prevention and management of visceral adiposity remains a substantial challenge in clinical practice.

Genetic and functional mitochondrial assessment of HIV-infected patients developing HAART-related hyperlactatemia.

BACKGROUND: Mitochondrial damage of HIV and antiretrovirals, especially nucleoside-analogue interference on mitochondrial DNA (mtDNA) replication, is reported to underlay highly active antiretroviral therapy (HAART)-related hyperlactatemia, but scarce approaches have been performed to correlate clinical manifestations and mitochondrial abnormalities. METHODS: We obtained lymphocytes and monocytes of 26 HIV-infected and treated patients who developed hyperlactatemia and after recovery, 28 nonhyperlactatemic HIV subjects on HAART, 31 naive individuals, and 20 uninfected controls. Mitochondrial replication and transcription analysis were performed by quantitative real-time PCR, mitochondrial translation quantification by western blot and mitochondrial enzymatic activities by spectrophotometry. RESULTS: Mitochondrial parameters decreased during hyperlactatemia and improved at recovery. Mitochondrial replication and transcription species were reduced (P = 0.16 and P = 0.71), but the most significant decay was observed on mitochondrial protein content (P < 0.05) and mitochondrial complexes III and IV activities (P < 0.01 and P < 0.001). During hyperlactatemia lactate level correlated complexes III and IV function (P < 0.05). After recovery mitochondrial parameters achieved values of nonhyperlactatemic HIV individuals, which were lower than ranges of naive subjects and uninfected controls. CONCLUSIONS: HIV and HAART-related hyperlactatemia is associated with a general mitochondrial impairment which reverts after recovery. Mitochondrial biochemistry show a better correlation with lactate levels than mitochondrial genetics suggesting that mitochondrial function could be a better marker of hyperlactatemia development than mtDNA content.

[Assessment of suicide risk: clinical and legal aspects]. / Evaluación del riesgo suicida: aspectos clínicos y médico - legales de la peligrosidad para sí.

Suicide is a multicausal phenomena, that can be studied from different points of view. This article reviews suicide risk factors and legal issues and tries to give physicians a guide of procedures taking into account the current legal framework in Argentina.

Assessment of the efficacy of a cognitive-behavioural group psychotherapy programme for HIV-infected patients referred to a consultation-liaison psychiatry department.

BACKGROUND: Most HIV-infected patients attending a consultation-liaison psychiatry service show symptoms of anxiety and depression. The present study sought to evaluate the immediate and long-term efficacy of a structured cognitive-behavioural group therapy reducing anxiety and depression in HIV-infected patients referred to a consultation-liaison psychiatry department, and to identify baseline variables predictive of greater improvement. METHODS: Repeated-measures ANOVA was used to analyse changes in the Beck Depression Inventory (BDI) and the state subscale of the State/Trait Anxiety Inventory (STAI) administered to 39 participants at 4 time points: T1 (1 month before beginning the therapy), T2 (during the first session), T3 (during the last session) and T4 (3 months after the last session). The therapy consisted of 16 weekly 2-hour sessions following a structured time-limited cognitive-behavioural group psychotherapy programme. RESULTS: During the intervention time (between T2 and T3) an improvement was observed in depression and anxiety, which persisted after the 3-month follow-up period (between T3 and T4). No changes were observed during baseline (between T1 and T2). Patients with higher levels of anxiety at baseline showed greater improvement in STAI state subscale scores. Transmission of HIV infection through intravenous drug use was associated with less improvement on the BDI. CONCLUSIONS: This is the first report of an ongoing study which suggests long-lasting efficacy of a structured cognitive-behavioural group psychotherapy programme in a heterogeneous sample of HIV-1-infected patients referred to a consultation-liaison psychiatry unit.