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Has the phasing out of stavudine in accordance with changes in WHO guidelines led to a decrease in single-drug substitutions in first-line antiretroviral therapy for HIV in sub-Saharan Africa?
AIDS. 2017 Jan 2; 31(1):147-157.OBJECTIVE: We assessed the relationship between phasing out stavudine in first-line antiretroviral therapy (ART) in accordance with WHO 2010 policy and single-drug substitutions (SDS) (substituting the nucleoside reverse transcriptase inhibitor in first-line ART) in sub-Saharan Africa. DESIGN: Prospective cohort analysis (International epidemiological Databases to Evaluate AIDS-Multiregional) including ART-naive, HIV-infected patients aged at least 16 years, initiating ART between January 2005 and December 2012. Before April 2010 (July 2007 in Zambia) national guidelines called for patients to initiate stavudine-based or zidovudine-based regimen, whereas thereafter tenofovir or zidovudine replaced stavudine in first-line ART. METHODS: We evaluated the frequency of stavudine use and SDS by calendar year 2004-2014. Competing risk regression was used to assess the association between nucleoside reverse transcriptase inhibitor use and SDS in the first 24 months on ART. RESULTS: In all, 33 441 (8.9%; 95% confience interval 8.7-8.9%) SDS occurred among 377 656 patients in the first 24 months on ART, close to 40% of which were amongst patients on stavudine. The decrease in SDS corresponded with the phasing out of stavudine. Competing risks regression models showed that patients on tenofovir were 20-95% less likely to require a SDS than patients on stavudine, whereas patients on zidovudine had a 75-85% decrease in the hazards of SDS when compared to stavudine. CONCLUSION: The decline in SDS in the first 24 months on treatment appears to be associated with phasing out stavudine for zidovudine or tenofovir in first-line ART in our study. Further efforts to decrease the cost of tenofovir and zidovudine for use in this setting is warranted to substitute all patients still receiving stavudine.
Expert Review of Clinical Pharmacology. 2016 Aug 22; 9(11):1493-1503.Introduction: WHO recommends tenofovir, efavirenz, and lamivudine or emtricitabine for first-line antiretroviral therapy (ART) in adults, which replaced more toxic regimens using stavudine, zidovudine or nevirapine. Areas covered: We searched Pubmed to identify observational studies and randomized controlled trials reporting toxicity of these antiretrovirals published between 2011 and 2016, and hand-searched abstracts presented at major HIV conferences in 2015 and 2016, focusing on data from sub-Saharan Africa. Tenofovir’s nephrotoxicity manifests as mild renal tubular dysfunction (common and of uncertain clinical significance), acute kidney injury (rare), and chronic declining glomerular filtration rate (common). African studies, which include high proportions of patients with renal dysfunction from opportunistic diseases, report population improvement in renal function after starting tenofovir-based ART. Tenofovir modestly decreases bone mineral density, and there is emerging data that this increases fracture risk. Efavirenz commonly causes early self-limiting neuropsychiatric toxicity and hypersensitivity rashes. Recent studies have highlighted its long-term neuropsychiatric effects, notably suicidality and neurocognitive impairment, and metabolic toxicities (dyslipidemia, dysglycemia, and lipoatrophy). We point out the challenges clinicians face in the recognition and attribution of adverse drug reactions. Expert commentary: Tenofovir and efavirenz are generally well tolerated, but both are associated with potentially serious toxicities. Pharmacovigilance systems in resource-limited settings with high HIV burden should be strengthened.
2016 Oct; New York, New York, UNICEF, 2016 Oct. 100 p.This report looks at how children, particularly the most disadvantaged, are affected by air pollution. It points out that around 300 million children live in areas where the air is toxic – exceeding international limits by at least six times – and that children are uniquely vulnerable to air pollution, breathing faster than adults on average and taking in more air relative to their body weight. The report also notes that air pollution is a major contributing factor in the deaths of around 600,000 children under age 5 every year and threatens the health, lives and futures of millions more. It concludes with a set of concrete steps to take so that children can breathe clean, safe air.
Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection: recommendations for a public health approach. 2nd ed.
Geneva, Switzerland, WHO, 2016.  p.These guidelines provide guidance on the diagnosis of human immunodeficiency virus (HIV) infection, the use of antiretroviral (ARV) drugs for treating and preventing HIV infection and the care of people living with HIV. They are structured along the continuum of HIV testing, prevention, treatment and care. This edition updates the 2013 consolidated guidelines on the use of antiretroviral drugs following an extensive review of evidence and consultations in mid-2015, shared at the end of 2015, and now published in full in 2016. It is being published in a changing global context for HIV and for health more broadly.
Human Reproduction Update. 2003 Jan-Feb; 9(1):49-59.Progestogen-only implantable contraceptives are used by increasing numbers of women worldwide. This review outlines the evidence accumulated on these methods to date. Reviews of toxicological evaluations, clinical trials, endocrinological, epidemiological and social science studies, as well as operations research and economic evaluation were undertaken in preparation for an Expert Consultation convened by the World Health Organization in 2001. At the meeting, these reviews were further evaluated and the research results summarized in this consensus paper. A large body of evidence demonstrates the high contraceptive effectiveness and safety of the 5-year levonorgestrel-releasing implants Norplant and Jadelle. Information on the 3-year etonogestrel-releasing implant Implanon is more limited, but suggests that this implant has a high contraceptive effectiveness and a satisfactory safety pro®le. Information available on levonorgestrel-releasing implants manufactured and approved in China suggests that their clinical performance is satisfactory, but was insufficient to allow their full safety assessment. For all implants, there is insufficient information on their use by women with medical conditions. Provision of contraceptive implants requires good quality family planning services and specific provider training.
Antiretroviral therapy for HIV infection in adults and adolescents: recommendations for a public health approach. 2006 revision.
Geneva, Switzerland, WHO, 2006. 127 p.This publication is intended to serve as a reference tool for countries with limited resources as they develop or revise national guidelines for the use of ART in adults and postpubertal adolescents (see Annex 9 for pubertal Tanner staging; prepubertal adolescents should follow the WHO paediatric guidelines). The material presented takes updated evidence into account, including new ART treatment options, and draws on the experience of established ART scale-up programmes. The simplified approach, with evidence-based standards, continues to be the basis of WHO recommendations for the initiation and monitoring of ART. The guidelines are primarily intended for use by national and regional HIV programme managers, managers of nongovernmental organizations delivering HIV care services, and other policy-makers who are involved in the scaling up of comprehensive HIV care and ART in resource-limited countries. The comprehensive, up-to-date technical and clinical information on the use of ART, however, also makes these guidelines useful for clinicians in resource-limited settings. The recommendations contained in these guidelines are made on the basis of different levels of evidence from randomized clinical trials, high-quality scientific studies, observational cohort data and, where insufficient evidence is available, expert opinion. The strengths of the recommendations in Table 1 are intended to indicate the degrees to which the recommendations should be considered by regional and country programmes. Cost-effectiveness is not explicitly considered as part of the recommendations, although the realities of human resources, health system infrastructures and socioeconomic issues should be taken into account when the recommendations are being adapted to regional and country programmes. (excerpt)
Treatment strategies for HIV-infected patients with tuberculosis: Ongoing and planned clinical trials.
Journal of Infectious Diseases. 2007 Aug 15; 196 Suppl 1:S46-S51.Currently, there are limited data to guide the management of highly active antiretroviral therapy (HAART) for human immunodeficiency virus type 1 (HIV-1)-infected patients with active tuberculosis (TB), the leading cause of death among individuals with acquired immunodeficiency syndrome (AIDS) in resource-limited areas. Four trials to take place in Southeast Asian, African, and South American countries will address the unresolved question of the optimal timing for initiation of HAART in patients with AIDS and TB: (1) Cambodian Early versus Late Introduction of Antiretrovirals (CAMELIA [ANRS 1295/NIH-CIPRA KH001]), (2) Adult AIDS Clinical Trials Group A5221, (3) START, and (4) a trial sponsored by the World Health Organization/Special Programme for Research and Training in Tropical Diseases. Two other clinical questions regarding patients with TB and HIV-1 coinfection are also undergoing evaluation: (1) the benefits of short-term HAART when CD4 cell counts are > 350 cells/mm3 (PART [NIH 1 R01 AI051219-01A2]) and (2) the efficacy of a once-daily HAART regimen in treatment-naive patients (BKVIR [ANRS 129]). Here, we present an overview of these ongoing or planned clinical studies, which are supported by international agencies. (author's)
Lancet. 2007 Jan; 369(9558):248.In September, 2006, WHO recommended wider use of indoor spraying with dichlorodiphenyltrichloro ethane (DDT)--once banned because of its toxic effects on the environment--and other insecticides to control malaria. Since then, a number of African countries have made their old foe DDT their new friend. Malawi is the latest, announcing last week that it would be introducing indoor residual spraying with DDT in its fight against malaria. WHO cited many reasons for making DDT a main intervention in malaria control, alongside insecticide-treated bednets. DDT has the potential to substantially reduce malaria transmission. The chemical is better than other insecticides, as it lasts longer, thereby reducing the number of times that houses need to be sprayed, is cheaper, and can repel mosquitoes from indoor environments, as well as kill those that land on sprayed surfaces. But DDT is far from problem-free. WHO, and countries that decide to adopt indoor residual spraying with the insecticide, need to monitor any negative effects of the chemical on health. They also need to ensure that DDT does not contaminate crops. (excerpt)
Toxicology. 2004 May 20; 198(1-3):39-44.The United States Public Health Service set an interim standard of 50 mg/l in 1942, but as early as 1962 the US Public Health Service had identified 10 mg/l as a goal which later became the World Health Organization Guideline for drinking water in 1992. Epidemiological studies have shown that about one in 10 people drinking water containing 500 mg/l of arsenic over many years may die from internal cancers attributable to arsenic, with lung cancer being the surprising main contributor. A prudent public health response is to reduce the permissible drinking water arsenic concentrations. However, the appropriate regulatory response in those developing countries with large populations with much higher concentrations of arsenic in drinking water, often exceeding 100 mg/l, is more complex. Malnutrition may increase risks from arsenic. There is mounting evidence that smoking and arsenic act synergistically in causing lung cancer, and smoking raises issues of public health priorities in developing countries that face massive mortality from this product. Also, setting stringent drinking water standards will impede short term solutions such as shallow dugwells. Developing countries with large populations exposed to arsenic in water might reasonably be advised to keep their arsenic drinking water standards at 50 mg/l. (author's)
International Quarterly of Community Health Education. 2006; 24(2):99-109.The power of words--and their context in the "American narrative,"--to affect international and domestic health policy, both proposal and implementation, is analyzed. The complexity of the implications for U.S. foreign policy as well as for disease outbreaks and potential bioterrorism are illustrated, with liberal references to the works of novelist James Joyce, film director Frederico Fellini, and economist/political activist Robert Reich. (author's)
Lancet. 1994 Apr 23; 343(8904):987-988.Earlier this year The Lancet received a package of material, much of it highly critical, relating to a report that we had published in July, 1993. A few weeks later virtually the same package arrived from a different source. The accompanying messages were broadly similar, essentially saying that the work in question had come in for heavy criticism and that the project itself had been abruptly halted. All this had taken place without any consultation with the researchers or proper debate. The study was by Hieu and colleagues in Vietnam and described the use of quinacrine pellet sterilisation in more than 30 000 women in that country. In this issue, Professor Hieu, Director of the Maternal and Child Health/Family Planning Department at the Ministry of Health in Hanoi, outlines his concerns, expressing dismay at the manner in which his work has come under attack. The Lancet is no stranger to controversy and its correspondence section is open to all (matters relating to efficacy and operator skill had in fact been aired in letters published in the Oct 2 issue, p 869), so why have Professor Hieu and his colleagues been treated in this underhand fashion? (excerpt)
Geneva, Switzerland, WHO, Department of Child and Adolescent Health and Development, 2001.  p. (WHO/FCH/CAH/01.02)This document reviews the efficacy and safety of cough and cold medicines in young children (under 5 years of age) with an acute respiratory infection. A systematic literature review was carried out to identify appropriate randomized controlled trials (RCTs). The results of the relatively few RCTs which have been carried out in children are especially important. Results from trials carried out on adults cannot be reliably extrapolated to include children owing to important differences in their anatomy and immune responses and in the etiology of the common cold. The pharmacokinetics and toxicity of drugs in children are often different from those in adults. Plasma drug concentrations may differ substantially because of immature liver and kidney functions and differences in gastrointestinal absorption, plasma binding, and relative volumes of fat and water. As a general rule, the differences are more pronounced in infants and young children and in malnourished children. (excerpt)
Report of the WHO Informal Consultation on the use of Praziquantel during Pregnancy / Lactation and Albendazole / Mebendazole in Children under 24 Months, Geneva, 8-9 April 2002.
Geneva, Switzerland, WHO, Programme on Communicable Diseases, Strategy Development and Monitoring for Parasitic Diseases and Vector Control, 2002. 49 p. (WHO/CDS/CPE/PVC/2002.4)There is growing evidence to suggest that soil-transmitted helminthiasis has a detrimental effect on the growth and development of children under 24 months of age. Although there is little published information about the use of anthelminthic drugs in this age group, such data as exist offer no obvious reason for excluding children of this age group from treatment. In view of the need to strengthen health care for children in this section of the community, the Expert Committee also urged WHO to assess the aspects and consequences of treating children under 24 months of age with benzimidazoles against soil-transmitted helminthiasis. Accordingly, on the basis of the published results of animal studies, veterinary usage and wide experience of using anthelminthic drugs in humans under clinical conditions, the Committee proposed that WHO should hold an Informal Consultation as a matter of urgency to assess all aspects of the use of praziquantel during pregnancy and lactation, as well as those issues related to the use of benzimidazoles in children under 24 months of age. (excerpt)
A dose escalation study of docetaxel and oxaliplatin combination in patients with metastatic breast and non-small cell lung cancer.
Anticancer Research. 2003 Jan-Feb; 23(1B):785-791.Objectives: To determine the maximum tolerated dose (MTD) and the dose-limiting toxicities (DLTs) of docetaxel in combination with oxaliplatin (L-OHP) as first-line treatment of patients with advanced breast (ABC) and non-small cell lung cancer (NSCLC). Patients and methods: Fifty-two patients (26 with NSCLC and 26 with ABC), who had not received prior chemotherapy for metastatic disease, were enrolled. The patients' median age was 64 years, and 42 (71%) had a performance status (WHO) 0-1. Docetaxel was given as a 1-hour infusion after standard premedication on day 1 and L-OHP as a 2 to 6-hour infusion on day 2 every 3 weeks. Doses were escalated at increments of 10mg/m2. Results: The DLT1 was reached at the doses of docetaxel 75mg/m2 and L-OHP 80mg/m2. The addition of rhG-CSF permitted further dose escalation (DLT2: docetaxel 90mg/m2 and L-OHP 130mg/m2). The dose-limiting events were grade 4 neutropenia, febrile neutropenia, grades 3 or 4 diarrhea and grade 3 fatigue. Out of 239 delivered cycles, grades 3 or 4 neutropenia occurred in 22 (9%) cycles with 5 (2%) neutropenic febrile episodes. There was one septic death. Grades 3 or 4 fatigue was observed in seven (13%) patients and grades 3-4 diarrhea in five (10%). Out of 42 patients evaluable for response, seven (27%) patients with ABC and five (19%) patients with NSCLC experienced a partial response. Conclusion: The combination of docetaxel and oxaliplatin is a feasible and well-tolerated regimen. The recommended doses for future phase II studies are 75mg/m2 for docetaxel on day 1 and 70mg/m2 for L-OHP on day 2 without rhG-CSF support and 85mg/m2 and 130mg/m2, respectively, with rhG-CSF support. (author's)
[Tamoxifen or tamoxifen in combination with chemotherapy in adjuvant therapy of breast carcinoma. Results of a multicenter randomized study] Tamoxifen nebo tamoxifen v kombinaci s chemoterapií v adjuvantní lécbe karcinomu prsu. Vysledky multicentrické randomizované studie.
Sbornik Lékarsky. 2001; 102(1):65-76.Between April 1994 and May 1997 103 breast cancer patients (pts), pT1c-3a, pN0-1, M0, were randomised after surgery to adjuvant tamoxifen (20 mg per day) or to tamoxifen plus CMF (C 500 mg/m2, M 40 mg/m2 and F 600 mg/m2 on days 1st and 8th q 28 day) in 6 cycles. The median age (49-72 years, median 58), tumour size, number of involved lymphnodes (0-3), estrogens receptor status, grade (I-III) and type of operation were well balanced among the 50 pts on tamoxifen and the 53 pts on tamoxifen plus CMF pts, preferably postmenopausal. Results. Grade of toxicity according to WHO criteria was not higher than two in both arms. Toxicity both haematological and non-haematological was higher in the group treated with chemotherapy (0 vs 32 resp. 20%) except weight gain +5% (52% in both group). After median follow-up of 42 mos five recurrences in tamoxifen and seven in tamoxifen plus CMF pts were observed (p=NS). The projected 3-y DFS is 92% for tamoxifen and 88% for tamoxifen plus CMF (p=NS). The 3-y OS is 88% for tamoxifen and 80% for tamoxifen plus CMF pts (p=NS). Conclusions. Both regimens are equally effective with higher toxicity in the group with combined chemo- and hormonal therapy. (author's)
Journal of the American Water Resources Association. 2000 Aug; 36(4):799-809.Drinking of arsenic-contaminated tubewell water has become a serious health threat in Bangladesh. Arsenic contaminated tubewells are believed to be responsible for poisoning nearly two-thirds of this country's population. If proper actions are not taken immediately, many people in Bangladesh will die from arsenic poisoning in just a few years. Causes and consequences of arsenic poisoning, the extent of area affected by it, and local knowledge and beliefs about the arsenic problem - including solutions and international responses to the problem - are analyzed. Although no one knows precisely how the arsenic is released into the ground water, several contradictory theories exist to account for its release. Initial symptoms of the poisoning consist of a dryness and throat constriction, difficulty in swallowing, and acute epigastric pain. Long-term exposure leads to skin, lung, or bladder cancer. Both government and nongovernmental organizations (NGOs) in Bangladesh, foreign governments, and international agencies are now involved in mitigating the effects of the arsenic poisoning, as well as developing cost-effective remedial measures that are affordable by the rural people. (author's)
Evaluation of certain veterinary drug residues in food. Fifty-fourth report of the Joint FAO / WHO Expert Committee on Food Additives.
Geneva, Switzerland, World Health Organization [WHO], 2001. vi, 96 p. (WHO Technical Report Series 900)During February 15-24, 2000, the Joint Food and Agriculture Organization (FAO)/WHO Expert Committee on Food Additives (JECFA) convened at the WHO Headquarters, Geneva, to evaluate the safety of residues of certain veterinary drugs in food and to recommend maximum levels for such residues in food. This report presents the conclusions of the Joint FAO/WHO Expert Committee's meeting. Inclusion of the report considers the interpretation of data on inhibition of cholinesterase activity and recommendations arising from an informal meeting on harmonization with the Joint FAO/WHO Meeting on Pesticide Residues. The Committee also evaluated toxicological and residue data on a variety of veterinary drugs: one anthelminthic agent (ivermectin); four antimicrobial agents (flumequine, lincomycin, oxytetracycline and tilmicosin); six insecticides (cyhalothrin, cypermethrin, alpha-cypermethrin, dicyclanil, permethrin, and metrifonate (trichlorfon)); and one production aid (melegestrol acetate). Annexed to the report are a summary of the Committee's recommendations on these drugs, including Acceptable Daily Intakes and Maximum Residue Limits and further information required.