[Primary isoniazid preventive therapy : A strategy still relevant in the era of test and treat ; literature review]. / Chimioprophylaxie antituberculeuse primaire à l'isoniazide : une stratégie d'actualité à l'ère du tester et traiter ; revue de la littérature.

BACKGROUND: Tuberculosis remains a public health threat responsible as recently as 2018 for more than one million deaths. Chemoprophylaxis with isoniazid is one of the strategies implemented to control the disease. Although it is not yet widely prescribed, its utilization raises additional questions in the "test and treat" era of for anti-retroviral therapy. The objective of this study is to review the different randomized controlled trials of antitubercular Isoniazid Preventive Therapy (IPT). We have distinguished (a) "efficacy trials" (ET) comparing IPT to a placebo or the absence of chemoprophylaxis and (b) "IPT regimen trials" (RT) comparing IPT to one or several other regimens. METHODS: Literature search (keywords from published articles found in the Medline and Scopus data bases: "tuberculosis", "prophylaxis", "HIV", "randomized controlled trial") and standardized reading of selected articles reporting results from randomized trials of IPT in HIV-infected people. RESULTS: Eighteen selected trials (11 ET and 7 RT), including 19,725 participants. The regimens studied were 3H, 6H, 9H, 12H, 12H, 36H/2RZ, 3RH, 3RZ, 3RHZ, and 3HP [H: Isoniazid, R: Rifampicin, Z: Pyrazinamide, P: Rifapentine]. LOCATIONS: Ten in Africa, three in Haiti, one in India, one in the USA, one in the Americas and two multi-continental trials. In ET with or without antiretrovirals (ART), IPT significantly reduces the risk of tuberculosis, by 32 to 71%. In ET prior to ART, IPT does not appear to reduce mortality. In ET in patients receiving ART, on the other hand, IPT reduces mortality. As regards RT, there seems to be no reason to prefer other regimens to IPT. Tolerance is good. Importantly, IPT may reduce (rather than worsen) the risk of multidrug-resistant bacilli selection by decreasing the number of TB episodes and, consequently, the number of curative tuberculosis treatments. CONCLUSION: Far from becoming obsolete due to ARV treatment, IPT has remained a timely and relevant intervention.

[Access to the management of HIV infected children: Overview of the healthcare supply in Cameroon in 2014]. / Accès à la prise en charge de l'infection VIH pédiatrique ­ État des lieux de l'offre des soins au Cameroun en 2014.

BACKGROUND: In Cameroon in 2012, the proportion (15%) of children eligible for antiretroviral treatment (ART) was one of the lowest among the 21 Global Fund priority countries. The objective of this study was to carry out a situational analysis of the existing care offer for pediatric HIV in Cameroon. METHODS: A descriptive cross-sectional study was conducted over a 4-month period (April to August 2014) in 12 healthcare facilities in 7 regions of Cameroon selected by systematic sampling. The data were collected in a self-administered questionnaire filled out by the caregiving and administrative personnel included in the study. RESULTS: All in all, 142 persons in charge of pediatric HIV treatment were included in the study, of whom 115 were working at the operational level: 59 (51.2%) health personnel, 44 (38.3%) community agents and 12 (10.4%) department heads; the other 27 exercised responsibilities at the regional (19) and the local (8) levels. An overwhelming majority of the caregivers involved in pediatric VIH treatment were nurses, a factor necessitating the delegation of medical tasks institutionalized in Cameroon. Few standardized nationwide documents take into account these treatment modalities. Inadequate dissemination of the documents at all levels of the healthcare pyramid may justify the non-compliance with the care protocols that has been observed in the training programs dedicated to the subject. CONCLUSION: The updating and large-scale dissemination of standardized nationwide documents taking into account the specificities of HIV-infected children are required to improve implementation at the operational level of the Cameroonian healthcare system of the existing guidelines for pediatric HIV treatment.

Timing of combination antiretroviral therapy (cART) initiation is not associated with stillbirth among HIV-infected pregnant women in Malawi.

OBJECTIVE: To assess the association between timing of maternal combination ART (cART) initiation and stillbirth among HIV-infected pregnant women in Malawi's Option B+ programme. METHODS: Cohort study of HIV-infected pregnant women delivering singleton live or stillborn babies at ≥28 weeks of gestation using routine data from maternity registers between 1 January 2012 and 30 June 2015. We defined stillbirth as death of a foetus at ≥28 weeks of gestation. We report proportions of stillbirth according to timing of maternal cART initiation (before pregnancy, 1st or 2nd trimester, or 3rd trimester or labour). We used logistic regression, with robust standard errors to account for clustering of women within health facilities, to investigate the association between timing of cART initiation and stillbirth. RESULTS: Of 10 558 mother-infant pairs abstracted from registers, 8380 (79.4%) met inclusion criteria. The overall rate of stillbirth was 25 per 1000 deliveries (95% confidence interval 22-29). We found no significant association between timing of maternal cART initiation and stillbirth. In multivariable models, older maternal age, male sex of the infant, breech vaginal delivery, delivery at < 34 weeks of gestation and experience of any maternal obstetric complication were associated with higher odds of stillbirth. Deliveries managed by a mission hospital or health centre were associated with lower odds of stillbirth. CONCLUSION: Pregnant women's exposure to cART, regardless of time of its initiation, was not associated with increased odds of stillbirth.

OBJECTIF: Evaluer l'association entre le moment d'initiation de l'ART de combinaison (cART) maternel et la mortinaissance chez les femmes enceintes infectées par le VIH dans le programme Option B+ du Malawi. MÉTHODES: Etude de cohorte de femmes enceintes infectées par le VIH qui ont accouché de bébés singletons vivants ou mort-nés à 28 mois ou plus de grossesse, en utilisant les données de routine des registres de maternité entre le 1er janvier 2012 et le 30 juin 2015. Nous avons défini la mortinatalité comme le décès d'un fœtus à 28 semaines ou plus de gestation. Nous rapportons sur les proportions de mortinatalité selon le moment de l'initiation du cART maternel (avant la grossesse, au 1er , 2è ou 3è trimestre ou durant le travail). Nous avons utilisé une régression logistique, avec des erreurs standards robustes, pour prendre en compte le regroupement des femmes par établissements de santé, afin d'investiguer le lien entre le moment d'initiation du cART et la mortinaissance. RÉSULTATS: Sur 10.558 paires mère-enfant extraites des registres, 8.380 (79,4%) répondaient aux critères d'inclusion. Le taux global de mortinatalité était de 25 pour 1.000 accouchements (intervalle de confiance à 95%: 22-29). Nous n'avons trouvé aucune association significative entre le moment de l'initiation du cART maternel et la mortinatalité. Dans les modèles multivariés, l'âge plus élevé de la mère, le sexe masculin du nourrisson, l'accouchement par voie basse, l'accouchement à moins de 34 semaines de gestation et l'expérience de toute complication obstétricale maternelle étaient associés à des probabilités de mortinatalité plus élevées. Les accouchements gérés par un hôpital de la mission ou un centre de santé étaient associés à une probabilité plus faible de mortinatalité. CONCLUSION: L'exposition des femmes enceintes au cART quel que soit le moment de son initiation, n'a pas été associée à une probabilité accrue de mortinatalité.

[Non-antiretroviral drugs uses among HIV-infected persons receiving antiretroviral therapy in Senegal: Costs and factors associated with prescription]. / Médicaments non antirétroviraux chez les personnes vivant avec le VIH sous traitement antirétroviral au Sénégal : coûts et facteurs associés à la prescription.

BACKGROUND: In addition to antiretroviral therapy, non-antiretroviral drugs are necessary for the appropriate care of people living with HIV. The costs of such drugs are totally or partially supported by the people living with HIV. We aimed to evaluate the overall costs, the costs supported by the people living with HIV and factors associated with the prescription of non-antiretroviral drugs in people living with HIV on antiretroviral therapy in Senegal. METHODS: We conducted a retrospective cohort study on 331 people living with HIV who initiated antiretroviral therapy between 2009 and 2011 and followed until March 2012. The costs of non-antiretroviral drugs were those of the national pharmacy for essential drugs; otherwise they were the lowest costs in the private pharmacies. Associated factors were identified through a logistic regression model. RESULTS: The study population was 61 % female. At baseline, 39 % of patients were classified at WHO clinical stage 3 and 40 % at WHO clinical stage 4. Median age, body mass index and CD4 cells count were 41 years, 18kg/m2 and 93 cells/µL, respectively. After a mean duration of 11.4 months of antiretroviral therapy, 85 % of patients received at least one prescription for a non-antiretroviral drug. Over the entire study period, the most frequently prescribed non-antiretroviral drugs were cotrimoxazole (78.9 % of patients), iron (33.2 %), vitamins (21.1 %) and antibiotics (19.6 %). The mean cost per patient was 34 Euros and the mean cost supported per patient was 14 Euros. The most expensive drugs per treated patient were antihypertensives (168 Euros), anti-ulcer agents (12 Euros), vitamins (8.5 Euros) and antihistamines (7 Euros). The prescription for a non-antiretroviral drug was associated with advanced clinical stage (WHO clinical stage 3/4 versus stage 1/2): OR=2.25; 95 % CI=1.11-4.57 and viral type (HIV-2 versus HIV-1/HIV-1+HIV-2): OR=0.36; 95 % CI=0.14-0.89. CONCLUSION: Non-antiretroviral drugs are frequently prescribed to people living with HIV in developing countries; mainly those infected with HIV-1 and those at an advanced clinical stage. Their costs can be a barrier to appropriate care and necessary efforts must made to make them available. However, early initiation of antiretroviral therapy and the registration of some non-antiretroviral drugs on the list of essential drugs, as well as social protection systems, should reduce their use and costs.

Continuum in HIV care from entry to ART initiation in rural KwaZulu-Natal, South Africa.

OBJECTIVE: To quantify time from entry in HIV care until Antiretroviral therapy (ART) initiation and identify factors associated with ART initiation in rural KwaZulu-Natal, South Africa. METHODS: Adults ≥16 years entering the decentralised Hlabisa ART programme between 2007 and 2011 were followed until June 2013. Median survival times to ART initiation from date of programme entry and from date of ART eligibility were estimated with Kaplan-Meier methods. Associated factors were evaluated in Cox regressions, censoring for deaths. RESULTS: Of 37 749 adults (71.6% female), 17 638 (46.7%) initiated ART. Nearly half (46.9%) met the CD4 criteria for treatment eligibility at programme entry. Among the 20 039 individuals not yet ART-eligible at entry, only 62.5% were retained in care with at least one further CD4 measurement, of whom 6688 subsequently became ART-eligible. Overall, 65.5% of the 24 398 ART-eligible individuals initiated ART over the study period. ART initiation was more likely in women (P < 0.001), in individuals ≥ 25 years old (P < 0.001) and in patients with low CD4 count (P < 0.001). Patients who became eligible during follow up were significantly more likely to initiate ART than those eligible at programme entry (72.6% vs. 62.9%, Adjusted Hazard Ratio = 1.46; 95% Confidence Interval [1.41-1.51]), adjusting for sex, age, year and CD4 count at eligibility. CONCLUSIONS: In this rural programme, continuation of care remains challenging, especially in men and younger adults. ART initiation is more likely in those engaged prior eligibility than in those entering HIV care only late in their HIV disease.

High rates of antiretroviral coverage and virological suppression in HIV-1-infected children and adolescents.

OBJECTIVES: To assess the outcome of HIV-infected individuals attending one of the largest French pediatric HIV centers in 2016-2017 and to compare the rates of antiretroviral coverage and virological suppression with the UNAIDS targets. PATIENTS AND METHODS: The clinical and immuno-virological status of 163 HIV-1-infected children and adolescents attending Necker Hospital in Paris, France, were investigated. Virological suppression was defined as an HIV-1 viral load<50 copies/mL for at least six months. All genotypic resistance tests performed since birth were analyzed. RESULTS: Most patients were born in Sub-Saharan African countries (41.7%) or in France (38.0%). Their median age was 14 years [IQR 7.3-17.0]. Although 33.7% of individuals had a history of AIDS-defining clinical event(s), 86.5% of children/adolescents were free from HIV-related symptoms at their most recent evaluation. Antiretroviral coverage was high (98.2%; mainly including one integrase inhibitor [42.3%] or one protease inhibitor [23.9%]). At the last visit, most patients (82.8%) had normal CD4T lymphocytes counts (≥25%). Although 61.7% of antiretroviral-experienced children had resistance to≥1 drug class and 9.2% had triple-class resistance, 80.3% of patients receiving antiretrovirals for≥6 months (126/157) were virologically suppressed. International adoptees were more frequently virologically suppressed than other patients (96.0% versus 74.6%, P=0.02). CONCLUSIONS: Antiretroviral coverage exceeded the second UNAIDS 90 target aimed at ending the AIDS epidemic. The rate of virological suppression, one of the highest reported in children in high-income countries, is approaching the third UNAIDS 90 target and the rate observed in French HIV-infected adults on antiretrovirals.

[Low Body Mass Index and impact of antiretroviral therapy on nephrotoxicity, chronic renal disease among HIV-infected patients in Brazzaville, Congo]. / Faible indice de masse corporelle et impact des antirétroviraux sur la néphrotoxicité, la maladie rénale chronique chez les patients infectés par le VIH à Brazzaville, Congo.

OBJECTIVE: To describe the incidence and risks factors of ART induced nephrotoxicity and chronic kidney disease in HIV-1-infected adults with low body mass index (<18.5kg/m2). METHODS: A retrospective cohort study at the Ambulatory Treatment Center in Brazzaville, Congo. Patients with estimated glomerular filtration rate decrease by 25% compared to baseline or a 0.5mg/dL increase in serum creatinine above baseline were classified as having nephrotoxicity, and chronic kidney disease was defined as a value less than 60mL/min/1.73m2. We used Cox proportional hazards regression models to determine factors associated with nephrotoxicity and chronic kidney disease. RESULTS: Of 325 patients, 73.23% were women. Median values were an age 37.55 years (IQR: 33.51-44.96), weight 45kg (IQR: 41-49), CD4 count 137.5 cells/µL (42-245). In the first 24-months, follow-up on ART incidence rate of nephrotoxicity and chronic kidney disease was 27.95 and 7.44 per 100 persons-year respectively. Multivariate analysis identified as a risk factor of nephrotoxicity, baseline haemoglobin below or equal 8g/dL (aHR=2.25; 95%CI 1.28-3.98; P=0.005) and the use of tenofovir (aHR=1.51; 95%CI 1.01-2.27; P=0.04). DFG between 60-80 mL/min/1.73 m2 (aHR=0.35; 95%CI 0.21-0.59; P<0.001) and 45-59mL/min/1.73 m2 (aHR=0.10; 95%CI 0.01-0.72; P=0.02) was not a contraindication for initiating antiretroviral therapy. Each 10-year older age was associated with an increased risk of developing chronic kidney disease (aHR=1.95; 95%CI 1.2-3.17; P=0.007). CONCLUSION: Incidence of nephrotoxicity and chronic kidney disease were high. African HIV-positive patient with low body mass index at baseline need close monitoring of their renal function when treated with tenofovir.

[Analyze of the performance of procurement and distribution system of antiretroviral, antituberculosis and antimalarials drugs in Benin in 2016]. / Analyse de la Performance du Système D'Approvisionnement et de Distribution des Antirétroviraux, Antituberculeux et Antipaludiques au Bénin en 2016.

OBJECTIVE: We aimed to analyze the performance of procurement and distribution system of antiretroviral, antituberculosis and antimalarial drugs in Benin. METHODS: We carried out a cross-sectional study in 2016. Data on the procurement, storage and distribution of drugs were collected by either individual interview or observation of storage sites at the central procurement center for essential medicines (CAME) in Benin. Compliance with the norms of the procurement and distribution of the products was appreciated. At the operational level, order satisfaction, drug expiry and stock status of the targeted health programs were measured based on the participants statements. RESULTS: Three workers of the CAME and 76 of health programs were surveyed. According to the norms, malfunctioning impaired the system of the procurement, storage and the distribution of the products. At the operational level, our study participants reported that antiretroviral drug orders were satisfied in 83%, drugs were distributed within three months of their expiration date in 26- 33%, and the CAME often ran out of antiretroviral drugs (stock-outs)in 69%. CONCLUSION: Malfunctioning impaired the system of the procurement, storage and the distribution of antiretroviral, antimalarial and antituberculosis drugs. These dysfunctions negatively affect the performance of the system.

OBJECTIF: Analyser la performance du système d'approvisionnement et de distribution des antirétroviraux, des antituberculeux et des antipaludiques au Bénin. MÉTHODES: L'étude transversale descriptive a été menée en 2016. Les informations sur l'approvisionnement, le stockage et la distribution des médicaments ont été collectées par entretien et observation des lieux de stockage à la centrale d'achat des médicaments essentiels (CAME). La conformité aux normes des composantes du système d'approvisionnement, de stockage et de distribution des produits a été appréciée. La satisfaction des commandes, la péremption des médicaments et l'état des stocks ont été évalués. RÉSULTATS: Trois responsables de la CAME et 76 acteurs des programmes de santé ont participé à l'étude. Des dysfonctionnements par rapport aux normes ont été notés dans les composantes du système d'approvisionnement, de stockage et de distribution des produits. Au niveau opérationnel, les commandes d'antirétroviraux étaient satisfaites selon 83% des enquêtés, les médicaments distribués étaient à moins de trois mois de la date de péremption selon 26 à 33% des participants et les ruptures de stocks d'antirétroviraux étaient signalées par 69%. CONCLUSION: Le système d'approvisionnement et de distribution des antirétroviraux, antipaludiques et antituberculeux comporte des dysfonctionnements qui impactent négativement sa performance.

[Lung cancer in HIV-infected patients]. / Le cancer bronchopulmonaire chez les patients infectés par le VIH.

Until 1996, AIDS was the leading cause of deaths from HIV infection. In 2010, because of introduction of powerful antiretroviral therapies, AIDS represented less than 25% of deaths. Cancer has become the leading cause of death in this population, and, because of smoking and immunosuppression, lung cancer risk is more important than in general population. Furthermore, treatment is more difficult, due to potential interactions between antiretroviral and anticancer therapies, to comorbidities and to tumor aggressiveness. Research will focus on molecular biology, immunotherapies and lung cancer screening in order to improve survival of HIV patients with lung cancer. For all these reasons, HIV patients must be included in clinical trials.

[Not Available]. / Analyse des effets indésirables des médicaments du VIH.

Analysis of Antiretroviral Drugs-Induced Adverse Elfects. In 1999, The Regional Center of Pharmacogilance and the Department of Infectious Disease of the Toulouse University Hospital set up a system to improve the data collection about antiretroviral-induced adverse reactionss (ADRs). From November 1999 to April 2003, a resident of pharmacovigilance collected ADRs reported with antiretroviral drugs during 2 weekly medical consultations. A total of 613 ADRs corresponding to 428 patients were reported, classified as "non serious" in 88.6% of cases and required the withdrawal of suspected drugs in 57% of cases. Our data show an improvement of antiretroviral drug-induced ADRs reporting.

Generic antiretroviral drugs and HIV care: An economic review.

The cost of HIV care in European countries is high. Direct medical costs, in France, have been estimated at 500,000 Euros per patient's lifetime (20,000 Euros/year/patient). Overall, 73% of these costs are related to antiretroviral treatments. In the current financial crisis context, some European countries are beginning to make economic decisions on the drugs to be used. These approaches are likely to become more frequent. It is obviously essential to prescribe the most effective, appropriate, best tolerated, and easy-to-use antiretroviral treatments to patients. However, while taking the above into consideration, and if various treatment options or combinations are available, cost should also be considered in the treatment choice. One may thus reflect on the use of generic antiretroviral agents as they have just been launched in France. We aimed to review the cost and cost-effectiveness of generic antiretroviral drugs and to review treatment strategies other than generic drugs that could help reduce HIV-related costs. HIV clinicians should consider treatment costs to avoid any future coercive measures.

[Choice of initial regimen for antiretroviral-naïve HIV patients: Analysis of motivation]. / Analyse des motivations du choix des antirétroviraux (ARV) prescrits chez des patients infectés par le VIH (PVVIH) naïfs.

OBJECTIVE: Several therapeutic combination antiretroviral therapy regimen are available for initial treatment in naïve HIV infected patients. The choice of a particular regimen remains often subjective. The aim of this study was to determine factors associated with the choice of molecules in initial ARV prescriptions. METHODS: From 01/01 to 30/10/2014, every initial cART prescription was analyzed regarding patients and physicians characteristics. Then, prescriptions were evaluated by an independent committee of ART prescribers. RESULTS: One hundred and thirty two consecutive initial prescriptions by 34 physicians of 11 medical centers were included: 71 M, migrants: 57 %, MSM: 21 %, CD4<200/mm3: 26 %, HIV RNA>100 000 cp/mL (33 %). cART regimen were: NRTI/PI (43 %), NRTI/NNRTI (29.5 %), NRTI/integrase inhibitor (23 %). 75 % of initial cART regimen were consistent with expert guidelines recommendations. The choice of initial cART was not influenced by the type of HIV contamination risk group, patient's geographic origin, CD4 levels. In contrast, working or not (P=0.007), pregnancy wish (P=0.07), pregnancy (P=0.001), HIV RNA levels (P=0.02) and HIV primary infection (P=0.049) influenced the initial choice. Neither physician's age, nor physician's experience influenced this choice. The prescription's non accordance to 2013 French guidelines was mainly related to integrase inhibitor utilisation (P= 0.0001). CONCLUSION: Overall, cART initial choice is mostly consistent with guidelines. Primary HIV infection, procreation features and high viral load are the main factors influencing this choice. New regimen with better tolerability is prescribed even if it is not yet included in the guidelines.

Epidemiology of coronary heart disease in HIV-infected versus uninfected individuals in developed countries.

The widespread use of combination antiretroviral therapy (cART) among people living with HIV in developed countries has lead to significantly improved life expectancy. However, extensive use of the effective cART coincides with increasing reports of coronary heart disease (CHD) among people living with HIV, and CHD has become a major cause of death. CHD results from a complex and multifactorial atherosclerotic process involving the over-representation of traditional cardiovascular risk factors, particularly smoking, uncontrolled viral replication, chronic inflammation, immune activation, and exposure to antiretroviral drugs. Consequently careful selection of antiretroviral drugs, cardiovascular risk reduction, and lifestyle modifications are needed. In individuals living with HIV, cardiovascular risk assessment is becoming an important element of care.

Hospital and ambulatory management, and compliance to treatment in HIV infection: regional health insurance agency analysis.

OBJECTIVE: We had for objective to study HIV management (hospital, ambulatory, and mixed) and assess compliance with health insurance database. METHOD: We conducted a retrospective study using the French Social Security (CPAM) database. The inclusion criteria were: age>18years of age, at least 2 prescriptions of antiretroviral therapy. RESULTS: Five hundred and seventy-five patients were included: extra-hospital (12), hospital (162), mixed (401). The prescriptions were exclusively hospital issued for 76.2% of the patients. Among the mixed group patients, 91% of treatments were delivered at least once in the community, and 45.6% of biological tests were performed in private laboratories at least once. The sex ratio (2.1 vs. 1.3), the number of patients having switched antiretroviral therapy (36.7% vs. 27.8%), and the frequency of biological tests (3.1 vs. 2.6) were significantly higher in the mixed group compared to the hospital group. The mean compliance was 90% in the hospital group and 91.8% in the mixed group. The compliance was<80% for 104 patients (21.8%). Patients with≥80% compliance were older (46.1years of age vs. 42.7years of age), with more frequent biological tests (3 per year vs. 2.5 per year), and more frequent switches in treatment (35.4% vs. 26.0%). CONCLUSION: Prescriptions of ARV were almost exclusively hospital issued. Their dispensation and biological tests were split between hospital and extra-hospital settings. Most patients demonstrated an optimal compliance. The CPAM database allows describing HIV management and assessing compliance.

From antiretroviral originator to generic drugs: bioequivalence and pharmacovigilance.

UNLABELLED: Antiretroviral drugs have been available in generic form in developing countries, which has expanded access to treatment; they have also become available in developed countries more recently. OBJECTIVES: The validation of generic drugs (GD) compared to originator drugs (OD) is mandatory to ensure that using generics will lead to a decreased cost of treatment. RESULTS: The results were obtained by analyzing published data as well as European Medicines Agency recommendations. METHOD: The GD should have the same qualitative and quantitative active principle formula, the same pharmaceutical forms, and the same criteria in terms of quality, effectiveness, and safety. This equivalence is based on bioequivalence rules: comparison of the concentration/time curves (AUC); Cmax and Tmax (90%), for which the confidence intervals in the range of 80-125% should be included. Naturally, that does not mean that the concentrations can vary from 80 to 125%: this would indicate unacceptable deviations. Conforming to these criteria allows substituting an OD by a GD. Adverse effects should not be different from those observed for the OD. Adverse effects observed when the GD is used must be notified, as is the case for the OD. Accountability is established according to 4 essential pieces of information: a prescriber, a patient, a drug, and an adverse effect. It is sometimes difficult to identify the provider of the GD that has been delivered. CONCLUSION: The level of safety concerning effectiveness and tolerance required is identical for OD and GD, in Europe. Analyzing confirmed adverse effects and therapeutic failures is the only way to identify differences that could question a GD's effectiveness.

[HIV and pregnancy: 2013 guidelines from the French expert working group]. / Infection par le VIH et grossesse: nouvelles recommandations 2013 du groupe d'experts français.

With effective antiretroviral therapy, the risk of mother to child transmission (MTCT) is now under 1%. The 2013 French guidelines emphasize early antiretroviral lifelong antiretroviral therapy. Thus, the current trend for women living with HIV is to take antiretroviral therapy before, during and after their pregnancies. A major issue today is the choice of antiretroviral drugs, to maximize the benefits and minimize the risks of fetal exposure. This requires interdisciplinary care. The use of effective therapies permits gradual but profound changes in obstetric practice. When maternal plasma viral load is controlled (<50 copies/ml), obstetrical care can be more similar to standards in HIV-negative women. Prophylactic cesarean section is recommended when the viral load in late pregnancy is above 400 copies/mL. Intravenous zidovudine during labor is recommended only if the last maternal viral load is>400 copies/mL or in case of complications such as preterm delivery, bleeding or chorio-amnionitis during labor. In case of premature rupture of membranes before 34 weeks, a multidisciplinary decision should be made, based on gestational age and control of maternal viral load; if the woman is under antiretroviral therapy and especially if her viral load is undetectable, steroids and antibiotics should be offered and pregnancy can be continued except in case of signs or symptoms of chorio-amnionitis. Breastfeeding is not recommended in women living with HIV in France, as in industrialized countries. Prophylaxis in the newborn is usually zidovudine for 1 month. In case of significant exposure to HIV perinatally, in particular when, maternal viral load is>1000 copies/mL, prophylactic combination therapy is recommended. Monitoring of the child is necessary to determine whether or not it is free of HIV infection and to monitor possible adverse effects of perinatal exposure to antiretroviral drugs.

'Dented' and 'resuscitated' masculinities: the impact of HIV diagnosis and/or enrolment on antiretroviral treatment on masculine identities in rural eastern Uganda.

There is limited research on the impact of HIV or its treatment on men's identity construction and gender roles in sub-Saharan Africa. Based on in-depth research with 26 men in rural Uganda, this article discusses men's vulnerabilities and shifting gender relations and sense of masculinity resulting from HIV infection or enrolment on treatment in eastern Uganda. The findings suggest two broad categories of masculinity: respectable and reputational. HIV infection and illness dented masculinity as men lost authority within the domestic sphere. A weakened provider role and over-reliance on wives and children undermined masculinity as family head, and social sanctioning of their sexual activity, undermined conventional masculine identities predicted on reputation. However, treatment led to a more reflexive approach to demonstrating masculinity, increased attentiveness to health and restored hope to father children free of HIV, resuscitating respectable masculinities. The balance between eroded and restored masculinity varied between men by their treatment history, age, family composition and state of health. HIV support agencies need to pay attention to the way HIV and antiretroviral treatment (ART) influence men's perception of their masculinity and support them to overcome the anxieties about dented or eroded masculinity, while building on the positive ways in which treatment restores masculinity to support men's adherence to HIV treatment. In particular, there is a need to support men's engagement in productive activities that bring income so that men can regain their provider roles following ART and restore their respectability in both the public and the domestic sphere.

[Lung cancer and HIV infection]. / Cancer du poumon et infection par le Virus de l'Immunodéficience Humaine.

AIDS was the cause of the majority of deaths from HIV infection before 1996 but since the introduction of antiretroviral therapies the causes of mortality have changed considerably. In 2010, 75 % of deaths were due to diseases other than AIDS, the majority being cancers. Lung cancer is the most common in terms of both incidence and mortality. It shows specific features when compared to the general population: there is an excess risk due to heavy smoking but also probably due to immunosuppression. The age of onset is younger and the prognosis worse than in the general population. Management is difficult, partly due to the aggressive nature of the tumor and partly to co-morbidities and potential interactions between anticancer and antiretroviral therapies. A phase II therapeutic trial (IFCT-CHIVA 1001) is under way nationally.

Reacciones adversas evitables graves por antivirales. Sistema Cubano de Farmacovigilancia, 2008-2017 / Serious adverse reactions avoidable by antivirals. Cuban Pharmacovigilance System, 2008-2017 / Reações adversas severas prevenidas por antivirais. Sistema cubano de farmacovigilancia, 2008-2017 / Réactions indésirables graves évitable par les antiviraux. Systeme cubain de pharmacovigilance, 2008-2017

Resumen Objetivo: Caracterizar las reacciones adversas graves evitables por antivirales presentes en el Sistema Cubano de Farmacovigilancia durante los años 2008 al 2017. Material y métodos: Investigación cuantitativa, observacional y descriptiva; enmarcada dentro de los estudios de farmacovigilancia, con un diseño de serie de casos. El universo conformado por las notificaciones de reacciones adversas graves evitables provocadas estos fármacos. Se utilizaron variables como: reacción adversa identificada, grupo de edad, sexo, fármaco antiviral, frecuencia y causas de evitabilidad. Resultados: Las reacciones adversas evitables graves a los antivirales se comportaron a ritmo irregular que muestra tendencia al incremento. Predominaron en hombres (77.8%) y en adultos (94.4%). Zidovudina (44.4%) y nevirapina (38.9%) muestraron la mayor cantidad de reportes, relacionados con la aparición de anemia y síndrome de Stevens Johnson. Los médicos reportaron el 72.2% de los casos. Las reacciones encontradas se describen como frecuentes. Las interacciones medicamentosas (61.1%) fue la principal causa de evitabilidad. Conclusiones: La caracterización de las reacciones adversas graves evitables a los antivirales permitió identificar que las mismas fueron frecuentes, producidas por antirretrovirales y presentadas hombres adultos; siendo la anemia y síndrome de Stevens Johnson las más frecuentes. Las causas de evitabilidad identificadas con mayor frecuencia responden a errores de la prescripción.

Abstract Object: To characterize the serious adverse reactions avoidable by antivirals present in the Cuban Pharmacovigilance System during the years 2008 to 2017. Materials and methods: Quantitative, observational and descriptive research; framed within the pharmacovigilance studies, with a case series design. The sample conformed by the reports of avoidable serious adverse reactions caused by these drugs. Variables were: identified adverse reaction, age group, sex, antiviral drug, frequency and causes of preventability. Results: Severe avoidable adverse reactions to antivirals were presented at an irregular level that shows a tendency to increase. They predominated in men (77.8%) and in adults (94.4%). Zidovudine (44.4%) and nevirapine (38.9%) showed the highest number of reports, related to the appearance of anemia and Stevens-Johnson syndrome. The doctors reported 72.2% of the cases. The reactions found are described as frequent. Drug interactions (61.1%) was the main cause of preventability. Conclusions: The characterization of the serious adverse reactions avoidable to the antivirals allowed to identify that they were in their majority produced by antiretroviral and occurred mainly in adult men; anemia and Stevens-Johnson syndrome were the most frequent. The causes of preventability identified with greater frequency correspond to errors of the prescription.

Resumo Objetivo: Saracterizar as reações adversas graves evitáveis por antivirais presentes no Sistema Cubano de Farmacovigiláncia durante os anos de 2008 a 2017. Materiais e métodos: Pesquisa quantitativa, observacional e descritiva; enquadrada no ámbito de estudos de farmacovigiláncia, com um desenho de estudos de casos. O universo foi constituido pelos relatórios das notificações de reações adversas graves causadas por esses medicamentos. Foram utilizadas variáveis, tais como: reacjao adversa identificada, grupo etário, sexo, fármaco antiviral, frequência e causas de prevenjao. Resultados: Reações adversas severas preveníveis por antivirais surgem a um ritmo irregular mostrando um aumento crescente. Predominaram em homens (77,8%) e em adultos (94,4%). Zidovudina (44,4%) e nevirapina (38,9%) apresentaram o maior número de relatos, relacionados ao aparecimento de anemia e síndrome de Stevens Johnson. Os médicos relataram 72,2% dos casos. As reações encontradas são descritas como frequentes. As interajoes medicamentosas (61,1%) foram a principal causa da prevenção. Conclusões: A caracterização de reações adversas graves, preveniveis por antivirais permitiram identificar que eram frequentes, produzidos por anti-retrovirais e apresentados em homens adultos; sendo a anemia e a síndrome de Stevens Johnson as mais frequentes. As causas mais frequentemente identificadas de prevenção demonstram erros de prescrição.

Résumé Objectif: Caractériser les effets indésirables graves évitables par les antiviraux présents dans le systéme cubain de pharmacovigilance pendant les années 2008 á 2017. Matériaux et méthodes: Recherche quantitative, observationnelle et descriptive; encadré dans les études de pharmacovigilance, avec une conception de série de cas. L'échantillon était conforme aux rapports d'effets indésirables graves évitables provoqués par ces médicaments. Les variables utilisées étaient réaction indésirable identifiée, groupe d'áge, sexe, médicament antiviral, fréquence et causes de prévention. Résultats: Les réactions indésirables évitables tombes aux antiviraux se sont comportées á un rythme irrégulier qui a tendance á augmenter. Ils prédominaient chez les hommes (77,8%) et chez les adultes (94,4%). La zidovudine (44,4%) et la névirapine (38,9%) présentaient le plus grand nombre de signalements, liés á l'apparition de l'anémie et au syndrome de Stevens-Johnson. Les médecins rapportent 72.2% des cas. Les réactions trouvées sont souvent déclinées. Les interactions médicamenteuses (61,1%) étaient la principale cause évitable. Conclusion: La caractérisation des effets indésirables graves évitables antiviraux a permis d'identifier qu'ils étaient produits principalement par les antirétroviraux et se produisaient principalement chez les hommes adultes; l'anémie et le syndrome de Stevens-Johnson étaient les plus fréquents. Les causes évitables identifiées généralement correspondent á des erreurs de prescription.