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Contraceptive method considerations for clients with HIV including those on ART: provider reference tool.
[Washington, D.C.], FHI 360, 2017 Nov. 2 p.This is an at-a-glance resource for clinical providers to determine whether clients with HIV, including those on antiretroviral therapy (ART), may initiate or continue using common contraceptive methods. This chart is based on the World Health Organization's Medical Eligibility Criteria for Contraceptive Use (2016). The tool provides foundational information for clinical providers on how the effectiveness of different types of hormonal contraceptive methods is affected by interaction with antiretroviral drugs. It also provides guidance on how to promote informed decision-making and help women with HIV who are taking antiretroviral drugs use their chosen hormonal contraceptive method successfully.
Swiss Medical Weekly. 2017 Jun 21; 147:w14432.PURPOSE: Sayana(R) was introduced as the first depot medroxyprogesterone acetate-containing contraceptive that is administered via subcutaneous injection. Within 10 months, the Regional Pharmacovigilance Centre (RPVC) Zurich received several anonymous reports of serious local reactions after Sayana(R) administration. In this retrospective study, individual case safety reports (ICSRs) on local adverse drug reactions (ADRs) related to Sayana(R) were analysed from the WHO pharmacovigilance database. METHODS: International, national and regional ICSRs during Sayana(R) administration up to 1 January 2016 were examined. Data on ADRs were retrieved from the WHO Global Database VigiBase. Demographic data, drug administration information, duration of Sayana(R) treatment, latency time of the ADR, and its course, severity and outcomes were analysed. RESULTS: Worldwide, 398 ICSRs after Sayana(R) use were registered in the database. We identified 20 reported terms that were potentially used to describe a persistent lipodystrophy. When only cases containing one or more of these 20 reported terms were selected, 323 (81.2%) international ICSRs remained for analysis. Of those, 91.6% (n = 296) were categorised as serious. The majority of the reactions (n = 193, 54.4%) did not recover. In the 67 Swiss ICSRs, 77 ADRs were reported using 10 different terms including severe or persistent local reactions like lipodystrophy, atrophy or fat necrosis. Thirty-two patients (47.7%) did not recover. All 11 regional cases reported to the RPVC Zurich were categorised as serious ADRs. For the majority of the patients (n = 7, 63.6%) the interval between the application of Sayana(R) and development of the lipodystrophy was between 2 and 4 months. Most of the reactions were irreversible (n = 9, 81.8%). One patient underwent plastic surgery for artificial infill of the dent. CONCLUSIONS: Persistent local injection site reactions such as lipodystrophy, fat tissue necrosis or atrophy occur frequently after subcutaneous Sayana(R) use. These adverse drug reactions were recently integrated in the Swiss product information. Physicians and patients should be informed and advised about these potentially irreversible effects.
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.
Research gaps identified during the 2014 update of the WHO medical eligibility criteria for contraceptive use and selected practice recommendations for contraceptive use.
Contraception. 2016 Sep; 94(3):195-201.Universal access to safe and effective contraception is an important public health goal. Family planning and prevention of unintended pregnancy are essential to securing the well-being and autonomy of individuals, while supporting the health and development of communities. The World Health Organization (WHO) recently undertook a process to update its global guidance on “who” can use contraception safely and “how” to use contraception safely and effectively to generate the fifth edition of the WHO Medical Eligibility Criteria for Contraceptive Use (MEC) and the third edition of the WHO Selected Practice Recommendations for Contraceptive Use (SPR). Overall, the MEC demonstrates that contraception is remarkably safe for most people; at least one highly effective contraceptive method is assigned a category “1” or “2” across the majority of conditions in the guidance, indicating no restrictions on use or that the advantages of using a particular method generally outweigh the theoretical or proven risks of use. Once a medically appropriate method is identified, the SPR offers critical guidance on safe and effective use, important for contraceptive management and service delivery. The major goal for producing these evidence-based recommendations is to help improve access to and strengthen the quality of family planning services worldwide. While these recommendations reflect a rigorous synthesis and interpretation of the best evidence to date and contribute significantly to medical and public health knowledge around the world, a number of recommendations in both the MEC and SPR are grounded in limited to no direct evidence. In the absence of direct evidence, indirect evidence and expert opinion inform assessments. Each revision of the MEC and SPR offers an opportunity to identify current knowledge gaps and promote research necessary to continually strengthen the guidelines. As part of the most recent revision of these guidelines, a Guideline Development Group convened in March and September 2014 to generate updated recommendations. During these meetings, we identified a number of key research questions for a variety of topics discussed during the technical consultations. The full list of research gaps is included in Table 1, not further prioritized. However, we present three important topics of global relevance to national programs and policies in greater detail: (a) intrauterine device (IUD) initiation among women at high risk for sexually transmitted infections (STIs); (b) bidirectional drug-drug interactions with use of hormonal contraception (HC) and antiretroviral therapy (ART); and (c) initiation of progestogen-containing contraception following use of ulipristal acetate (UPA) emergency contraception. Each section presents some background on the public health importance of the topic and discusses the limitations of existing data and considerations for future rigorous research. [Excerpts].
Hormonal contraceptive methods for women at high risk of HIV and living with HIV. 2014 guidance statement. Recommendations concerning the use of hormonal contraceptive methods by women at high risk of HIV and women living with HIV.
Geneva, Switzerland, WHO, Department of Reproductive Health and Research, 2014.  p. (WHO/RHR/14.24)During 9-12 March 2014, the World Health Organization (WHO) convened a meeting of the Guideline Development Group (GDG) comprising 52 individuals representing a wide range of stakeholders, for the purpose of reviewing, and where appropriate, revising its Medical eligibility criteria for contraceptive use, fourth edition (MEC) guidance. Recommendations concerning the use of hormonal contraceptive methods by women at high risk of HIV and women living with HIV, including women taking antiretroviral therapy (ART), were among the many topics reviewed at this meeting. Given the public health importance of this topic, and at the encouragement of the GDG, the World Health Organization is issuing its contraceptive eligibility guidance for women at high risk of HIV and women living with HIV in advance of the entire guideline revision. It is anticipated that the revised fifth edition of the MEC will be completed in 2015. Recommendations for hormonal contraceptive use are provided for: women at high risk of HIV infection; women living with asymptomatic or mild HIV clinical disease (WHO stage 1 or 2); women living with severe or advanced HIV clinical disease (WHO stage 3 or 4); women living with HIV using antiretroviral therapy (ART). In addition to the recommendations themselves, this publication provides a description of the background and methods used in their development. An executive summary and information on dissemination and evaluation are also included. (Excerpts)
Clinical Pharmacokinetics. 2008; 47(2):91-102.Malaria, a disease transmitted by the female Anopheles mosquito, has had devastating effects on human populations for more than 4000 years. Treatment of the disease with single drugs, such as chloroquine, sulfadoxine/pyrimethamine or mefloquine, has led to the emergence of resistant Plasmodium falciparum parasites that lead to the most severe form of the illness. Artemisinin-based combination therapies are currently recommended by WHO for the treatment of uncomplicated P. falciparum malaria. Artemisinin and semisynthetic derivatives, including artesunate, artemether and dihydroartemisinin, are short-acting antimalarial agents that kill parasites more rapidly than conventional antimalarials, and are active against both the sexual and asexual stages of the parasite cycle. Artemisinin fever clearance time is shortened to 32 hours as compared with 2-3 days with older agents. To delay or prevent emergences of resistance, artermisinins are combined with one of several longer-acting drugs - amodiaquine, mefloquine, sulfadoxine/pyrmethamine or lumefantrine - which permit elimination of the residual malarial parasites. The clinical pharmacology of artemisinin-based combination therapies is highly complex. The short-acting artemisinins and their long-acting counterparts are metabolized and/or inhibit/induce cytochrome P450 enzymes, and may thus participate in drug-drug interactions with multiple drugs on the market. Alterations in antimalarial drug plasma concentrations may lead to either suboptimal efficacy or drug toxicity and may compromise treatment. (author's)
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)
Effectiveness of an early supplementation scheme of high-dose vitamin A versus standard WHO protocol in Gambian mothers and infants: A randomised controlled trial.
Lancet. 2007 Jun 23; 369(9579):2088-2096.Most developing countries have adopted a standard WHO dosing schedule for vitamin A supplementation. However, in 2002 the International Vitamin A Consultative Group (IVACG) Annecy Accord recommended a new high-dose regimen for mothers and infants. Our aim was to test whether the new high-dose regimen of vitamin A supplementation would increase maternal and infant plasma vitamin A, reduce infant Helicobacter pylori infection and nasopharyngeal pneumococcal carriage, and improve infant gut epithelial integrity. In an area of moderate vitamin A deficiency in rural Gambia, 220 mother-infant pairs were enrolled in a randomised double-blind trial between September, 2001, and October, 2004, that compared the IVACG high dose with the WHO dose. The primary endpoints were levels of maternal and infant plasma vitamin A, H pylori infection, pneumococcal carriage, and gut epithelial integrity. The trial is registered as ISRCTN 98554309. 197 infants completed follow-up to 12 months (99 high dose and 98 WHO dose). There were no adverse events at dosing. No differences were found in the primary outcomes for high-dose versus WHO schedule: maternal vitamin A concentration at 2 months plus 0.02 macromol/L (95% CI -0.10 to 0.15); infant vitamin A at 5 months plus 0.01 macromol/L (-0.06 to 0.08); H pylori infection at 12 months -0.3% (-14.7 to 14.2); maternal pneumococcal carriage at 12 months -2.0% (-13.7 to 9.7); infant pneumococcal carriage at 12 months -4.1% (-15.8 to 7.6); infant gut mucosal damage at 12 months 5.2% (-8.7 to 19.2). There were more clinic attendances by the high-dose group in the first 6 months of life (p=0.018). Our results do not lend support to the proposal to increase the existing WHO standard dosing schedule for vitamin A in areas of moderate vitamin A deficiency. Caution is urged for future studies because trials have shown possible adverse effects of higher doses of vitamin A, and potential negative interactions with the expanded programme on immunisation (EPI) vaccines. (author's)
Antimicrobial and support therapy for bacterial meningitis in children. Report of the meeting of 18- 20 June 1997, Geneva, Switzerland.
Geneva, Switzerland, WHO, Division of Emerging and Other Communicable Diseases Surveillance and Control, 1998.  p. (WHO/CHD/98.6; WHO/EMC/BAC/98.2)WHO and UNICEF have developed an integrated approach to address the major life-threatening illnesses of children known as Integrated Management of Childhood Illness (IMCI). Lessons learned from disease-specific programmes have been applied to promote co-ordination and integration of the activities to improve the prevention and management of childhood illness. Apart from five major killer diseases of children under five years (acute respiratory infections - mostly pneumonia, diarrhoea, measles, malaria and malnutrition) bacterial meningitis is an important cause of childhood morbidity and mortality. (excerpt)
Efficacy of chloroquine, amodiaquine, sulphadoxine-pyrimethamine and combination therapy with artesunate in Mozambican children with non-complicated malaria.
Tropical Medicine and International Health. 2004 Feb; 9(2):200-208.This paper reports a two-phase study in Manhic¸a district, Mozambique: first we assessed the clinical efficacy and parasitological response of Plasmodium falciparum to chloroquine (CQ), sulphadoxine– pyrimethamine (SP) and amodiaquine (AQ), then we tested the safety and efficacy in the treatment of uncomplicated malaria, of three combinations: AQ + SP, artesunate (AR) + SP and AQ + AR. Based on the WHO (1996, WHO/MAL/96.1077) in vivo protocol, we conducted two open, randomized, clinical trials. Children aged 6–59 months with axillary body temperature =37.5 degrees C and noncomplicated malaria were randomly allocated to treatment groups and followed up for 21 days (first and second trial) and 28 days (first trial). The therapeutic efficacy of AQ (91.6%) was better than that of SP (82.7%) and CQ (47.1%). After 14 days, 69% of the strains were parasitologically resistant to CQ, 21.4% to SP and 26% to AQ. Co-administration of AQ + SP, AR + SP and AQ + AR was safe and had 100% clinical efficacy at 14-day follow-up. The combination therapies affected rapid fever clearance time and reduced the incidence of gametocytaemia during follow-up. (author's)
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)
In: Advances in international maternal and child health. Volume 7. 1987, edited by D.B. Jelliffe and E.F.P. Jelliffe. Oxford, England, Clarendon Press, 1987. 170-9.General principles of the WHO Essential Drug List (EDL) and the International Non-Proprietary Names (INN) list and their application to maternal and child health are summarized. 8 principles of good prescribing habits are introduced, such as careful dosing for infants, children, pregnant or lactating women, elderly, or those with liver or kidney disease. Most INN drug names are identical to the generic names used in the country of origin, but some are coined from common chemical or pharmacological stems. Drugs for pregnant women should be limited in number, and used with care since almost all cross the placenta and may not be tolerated by the fetus with its immature liver and kidneys. The most serious reason for restricting certain drug intake by pregnant women is the risk of teratogenicity, particularly in the 1st trimester. Potential teratogens include antiepileptics, barbiturates, cytotoxics, anticoagulants, and female sex hormones. Salicylates should not be taken near term. Opioid analgesics should not be used during labor. Drugs dangerous for the infant during breastfeeding include high dose oral contraceptives, the antithyroid drugs thiouracil and iodine, diazepam and lithium. Education and training in pharmacokinetics for personnel in maternal-child health should be included. Fixed combinations of drugs are not advisable: out of 220 drugs in the EDL, there are only 11 drug combinations.