DHS Working Papers No. 125
The report provides a brief introduction to patents and licences and their effect on the market for antiretroviral (ARV) medicines. It gives an overview of the patent landscape with respect to a select number of ARV medicines in developing countries as of April 2014. The focus is primarily on those ...ARVs that are recommended by the World Health Organization (WHO) as well as new ARVs that have either recently obtained regulatory approval or are in phase III clinical trials.
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Document No. : FDA/SMC/SMD/GL-RAR/2013/01
WHO Regional Office for Africa
A Estratégia Conjunta Continental Africana para a COVID-19 é sustentada pela necessidade de limitar a transmissão, prevenir mortes e reduzir os danos associados. A participação das nações africanas em ensaios clínicos é um passo essencial para garantir que sejam gerados dados suficientes so...bre a segurança e eficácia dos candidatos a vacinas mais promissores entre as populações da região.
Embora a actual actividade de ensaios clínicos COVID-19 no continente seja limitada, a África tem uma experiência e capacidades substanciais para conduzir ensaios clínicos de vacinas preventivas numa série de doenças, e muitas organizações no continente estão a trabalhar incansavelmente para ajudar a preparar ensaios adicionais sobre potenciais vacinas COVID-19.
Disponível em inglês, francês e português
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La stratégie continentale commune africaine pour COVID-19 est sous-tendue par la nécessité de limiter la transmission, de prévenir les décès et de réduire les dommages associés. La participation des nations africaines aux essais cliniques est une étape essentielle pour garantir la productio...n de données suffisantes sur la sécurité et l'efficacité des candidats vaccins les plus prometteurs parmi les populations de la région.
Bien que l'activité actuelle des essais cliniques COVID-19 sur le continent soit limitée, l'Afrique possède une expérience et des capacités considérables pour mener des essais cliniques de vaccins préventifs contre toute une série de maladies, et de nombreuses organisations du continent travaillent sans relâche pour aider à préparer des essais supplémentaires sur des vaccins COVID-19 potentiels.
Disponible en anglais, français et portugais
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This website has been created to provide accurate and up-to-date information about Sputnik V.
Candid Conversations is a podcast where we talk to family planning and reproductive health champions from around the globe and take a deep dive into current topics in family planning and reproductive health, as well as the personal journeys of our champions, the challenges they’ve faced, what exci...tes them about the future and some advice for other up and coming leaders.
Our Goals:
Highlight the new generation of family planning leaders and the trailblazing work they are doing
Discuss the challenges youth face starting new programs and managing existing projects
Give a youth perspective on the needs of youth and the changing reproductive health landscape
Below are our latest episodes. Tune in by clicking below, listening to us on Apple podcasts, subscribing to our Youtube channel, or following us on Spotify.
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The Lancet olume 395, ISSUE 10232, P1259-1267, April 18, 2020. Buruli ulcer is a neglected tropical disease caused by Mycobacterium ulcerans infection that damages the skin and subcutis. It is most prevalent in western and central Africa and Australia. Standard antimicrobial treatment with oral rifa...mpicin 10 mg/kg plus intramuscular streptomycin 15 mg/kg once daily for 8 weeks (RS8) is highly effective, but streptomycin injections are painful and potentially harmful. We aimed to compare the efficacy and tolerability of fully oral rifampicin 10 mg/kg plus clarithromycin 15 mg/kg extended release once daily for 8 weeks (RC8) with that of RS8 for treatment of early Buruli ulcer lesions.
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The protozoan parasite Trypanosoma cruzi causes Chagas disease, an important public health problem throughout Latin America. Current therapeutic options are characterised by limited efficacy, long treatment regimens and frequent toxic side-effects. Advances in this area have been compromised by gaps... in our knowledge of disease pathogenesis, parasite biology and drug activity. Nevertheless, several factors have come together to create a more optimistic scenario. Drug-based research has become more systematic, with increased collaborations between the academic and commercial sectors, often within the framework of not-for-profit consortia. High-throughput screening of compound libraries is being widely applied, and new technical advances are helping to streamline the drug development pipeline. In addition, drug repurposing and optimisation of current treatment regimens, informed by laboratory research, are providing a basis for new clinical trials. Here, we will provide an overview of the current status of Chagas disease drug development, highlight those areas where progress can be expected, and describe how fundamental research is helping to underpin the process.
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After 100 years of chemotherapy with impractical and toxic drugs, an oral cure for human African trypanosomiasis (HAT) is available: Fexinidazole. In this case, we review the history of drug discovery for HAT with special emphasis on the discovery, pre-clinical development, and operational challenge...s of the clinical trials of fexinidazole. The screening of the Drugs for Neglected Diseases initiative (DNDi) HAT-library by the Swiss TPH had singled out fexinidazole, originally developed by Hoechst (now Sanofi), as the most promising of a series of over 800 nitroimidazoles and related molecules. In cell culture, fexinidazole has an IC50 of around 1 µM against Trypanosoma brucei and is more than 100-fold less toxic to mammalian cells. In the mouse model, fexinidazole cures both the first, haemolymphatic, and the second, meningoencephalitic stage of the infection, the latter at 100 mg/kg twice daily for 5 days. In patients, the clinical trials managed by DNDi and supported by Swiss TPH mainly conducted in the Democratic Republic of the Congo demonstrated that oral fexinidazole is safe and effective for use against first- and early second-stage sleeping sickness. Based on the positive opinion issued by the European Medicines Agency in 2018, the WHO has released new interim guidelines for the treatment of HAT including fexinidazole as the new therapy for first-stage and non-severe second-stage sleeping sickness caused by Trypanosoma brucei gambiense (gHAT). This greatly facilitates the diagnosis and treatment algorithm for gHAT, increasing the attainable coverage and paving the way towards the envisaged goal of zero transmission by 2030.
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In 2014, an estimated 40 million women of reproductive age were infected with Schistosoma haematobium, S. japonicum and/or S. mansoni. In both 2003 and 2006, the World Health Organization (WHO) recommended that all schistosome-infected pregnant and breastfeeding women be offered treatment, with praz...iquantel, either individually or during treatment campaigns. In 2006, WHO also stated the need for randomized controlled trials to assess the safety and efficacy of such treatment. Some countries have yet to follow the recommendation on treatment and many programme managers and pregnant women in other countries remain reluctant to follow the recommended approach.
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Diabetes mellitus (DM) is a global epidemic with significant morbidity. Diabetic
retinopathy (DR) is the specific microvascular complication of DM and affects 1 in 3 persons with DM. DR remains a leading cause of vision loss in working adult populations. Patients with severe levels of DR are report...ed to have poorer quality of life and reduced levels of physical, emotional, and social well-being, and they utilize more health care resources.
Epidemiological studies and clinical trials have shown that optimal control of blood glucose, blood pressure, and blood lipids can reduce the risk of developing retinopathy and slow its progression. Timely treatment with laser photocoagulation, and increasingly, the appropriate use of intraocular administration of vascular endothelial growth factor (VEGF) inhibitors can prevent visual loss in vision- threatening retinopathy, particularly diabetic macular edema (DME). Since visual loss may not be present in the earlier stages of retinopathy, regular screening of persons with diabetes is essential to enable early intervention.
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Chikungunya fever (CHIKF) is an emerging infectious disease caused by an alphavirus transmitted by Aedes spp. mosquitoes. Because mosquito control programs are not highly efficient for outbreak containment, vaccines are essential to reduce the burden of disease. Although no licensed vaccine against ...CHIKF is yet available, many highly promising candidates are undergoing preclinical studies, and a few of them have been tested in human trials of phase 1 or 2. Here, we review recent findings regarding the need for a CHIKF vaccine and provide an update on vaccines nearing or having entered clinical trials. We also address needs to tackle bottlenecks to vaccine development—including scientific and financial barriers—and to accelerate the development of vaccines; several actions should be taken:
(i) design efficacy trials to be conducted during the course of outbreaks;
(ii) evaluate the opportunity for adopting the “animal rule”for demonstration of efficacy for regulatory purposes;
(iii) strengthen the collective commitment of nations, international organizations, potential donors and industry;
(iv) stimulate public and/or private partnerships to invest in vaccine development and licensure; and
(v) identify potential markets for an effective and safe CHIKF vaccine.
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Chikungunya virus (CHIKV) is a re-emerging mosquito borne alphavirus responsible
for the recent outbreak in the Americas. Immunologically naïve population in the Americas favors the spread of epidemics. Chikungunya fever is characterized by an abrupt febrile illness, polyarthralgia and maculopapul...ar rash. In chikungunya fever, shock or severe hemorrhage is very rarely observed; the onset is more acute and the duration of fever is shorter than dengue disease. The pain is much more pronounced and localized to the joints and tendons in chikungunya fever, in comparison to dengue fever. There is no specific and effective antiviral therapy and vaccines are still in trails. The only effective preventive measures consist of individual protection against mosquito bites and vector control. Disease prevention is important due to the
economic burden it entails. Clinicians need to distinguish chikungunya fever between dengue fever and other diseases to give a successful treatment and prevent disease spreading.
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Human African trypanosomiasis (HAT), also called sleeping sickness, is a parasitic infection that almost invariably progresses to death, unless treatment is provided. HAT caused devastating epidemics during the 20th century. Thanks to sustained and coordinated efforts during the past 15 years the nu...mber of reported cases has fallen to a historic low. Fewer than 3,000 cases were reported in 2015, and the disease is targeted for elimination by the World Health Organization. Despite recent success, HAT still poses a heavy burden on the rural communities where this highly focal disease occurs, most notably in Central Africa. Since patients are also reported from non-endemic countries outside Africa, HAT should be considered in differential diagnosis for all travellers, tourists, migrants and expatriates who have visited or lived in endemic areas. In the absence of a vaccine, disease control relies on case detection and treatment, and vector control. Available drugs are sub-optimal, but ongoing clinical trials give hope for safer and simpler treatments.
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WHO has updated its guidelines for COVID-19 therapeutics, with revised recommendations for patients with non-severe COVID-19. This is the 13th update to these guidelines.
Updated risk rates for hospital admission in patients with non-severe COVID-19
The guidance includes updated risk rates for... hospital admission in patients with non-severe COVID-19.
The current COVID-19 virus variants tend to cause less severe disease while immunity levels are higher due to vaccination, leading to lower risks of severe illness and death for most patients.
This update includes new baseline risk estimates for hospital admission in patients with non-severe COVID-19. The new ‘moderate risk’ category now includes people previously considered to be high risk including older people and/or those with chronic conditions, disabilities, and comorbidities of chronic disease. The updated risk estimates will assist healthcare professionals to identify individuals at high, moderate or low risk of hospital admission, and to tailor treatment according to WHO guidelines:
**High: **People who are immunosuppressed remain at higher risk if they contract COVID-19, with an estimated hospitalization rate of 6%.
**Moderate: **People over 65 years old, those with conditions like obesity, diabetes and/or chronic conditions including chronic obstructive pulmonary disease, kidney or liver disease, cancer, people with disabilities and those with comorbidities of chronic disease are at moderate risk, with an estimated hospitalization rate of 3%.
Low: Those who are not in the high or moderate risk categories are at low risk of hospitalization (0.5%). Most people are low risk.
Review of COVID-19 treatments for people with non-severe COVID-19
WHO continues to strongly recommend nirmatrelvir-ritonavir (also known by its brand name ‘Paxlovid’) for people at high-risk and moderate risk of hospitalization. The recommendations state that nirmatrelvir-ritonavir is considered the best choice for most eligible patients, given its therapeutic benefits, ease of administration and fewer concerns about potential harms. Nirmatrelvir-ritonavir was first recommended by WHO in April 2022.
If nirmatrelvir-ritonavir is not available to patients at high-risk of hospitalization, WHO suggests the use of molnupiravir or remdesivir instead.
WHO suggests against the use of molnupiravir and remdesivir for patients at moderate risk, judging the potential harms to outweigh the limited benefits in patients at moderate risk of hospital admission.
For people at low risk of hospitalization, WHO does not recommend any antiviral therapy. Symptoms like fever and pain can continue to be managed with analgesics like paracetamol.
WHO also recommends against use of a new antiviral (VV116) for patients, except in clinical trials.
The update also includes a strong recommendation against the use of ivermectin for patients with non-severe COVID-19. WHO continues to advise that in patients with severe or critical COVID-19, ivermectin should only be used in clinical trials.
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