Measles deaths are on the rise for the second year in a row, killing more than 140,000 people worldwide in 2018 according to estimates released Thursday by the World Health Organization and the United States Centers for Disease Control and Prevention (CDC). Also on Thursday, a massive measles vaccination campaign was announced in North Kivu, the Democratic Republic of the Congo – the country where a full one-third of the world’s reported measles cases have so far occurred in 2019.

“Our finding is that in 2018, there has been an increase in both the cases and the deaths that have occurred from measles. In other words, we’re backsliding,” said WHO’s Director of Immunization, Vaccines and Biologicals Kate O’Brien.

Total deaths in 2018 were 26,000 more than in 2017, where an estimated 124,000 people died, and 55 percent more than the 89,780 deaths reported in 2016. The number of measles cases also increased by more than 2 million between 2017 to 2018, with 9,769,400 estimated cases in 2018 as compared with 7,585,900 estimated cases in 2017, according to the WHO and CDC estimates. As in previous years, most deaths were among children under the age of 5, and the most highly impacted region was Sub-Saharan Africa.

A health worker vaccinates a child against measles in the DRC.

One of the worst afflicted countries, the DRC, has been concurrently battling a massive measles outbreak and deadly Ebola outbreak for over a year. It’s estimated that over 5000 people, mostly children have died in the current measles outbreak, more than double the number killed by Ebola over the past year.

The DRC appears to account for about one-third of this year’s measles case load, WHO said, although the national data upon which that estimate has been made has yet to be validated.  DRC, together with Liberia, Madagascar, Somalia, and Ukraine, accounted for almost half of all measles cases worldwide in 2018. Children in these countries persistently miss out on measles vaccination.

“The fact that any child dies from a vaccine-preventable disease like measles is frankly an outrage and a collective failure to protect the world’s most vulnerable children,” said Dr Tedros Adhanom Ghebreysus, Director-General of the World Health Organization in a press release. “To save lives, we must ensure everyone can benefit from vaccines – which means investing in immunization and quality health care as a right for all.”

While low-income countries bear the brunt of the global burden of measles, it has also resurged in some wealthy countries, including some that had previously eliminated the disease.

This year, the United States reported its highest number of cases in 25 years, while four countries in Europe – Albania, Czechia, Greece and the United Kingdom – lost their measles elimination status in 2018 following protracted outbreaks of the disease.

Measles is a highly contagious virus, and outbreaks can occur when coverage of the vaccine is too low, leaving a proportion of the community unprotected. Some 95% of the population receive at least two doses of the measles vaccine in order to prevent outbreaks from occurring, according to WHO recommendations. In countries that have lost measles-elimination status, misinformation spread about the safety and efficacy of vaccines has contributed greatly to vaccine hesitancy, leading parents to forgo vaccinating their children.

Global measles vaccination rates have stagnated for almost a decade. WHO and UNICEF estimate that 86% of children globally received the first dose of measles vaccine through their country’s routine vaccination services in 2018, and fewer than 70% received the second recommended dose. In 2019, as of mid-November, there have already been over 413,000 cases reported to the WHO globally, with an additional 250,000 cases in DRC reported through the national surveillance system. Together, this marks a three-fold increase compared with this same time period in 2018.

2.2 Million Children To Be Vaccinated Against Measles In North Kivu

While the Ebola outbreak has captured international attention, the DRC is also currently experiencing the world’s largest and most severe measles epidemic, with an estimated 250,000 suspected cases and over 5000 deaths so far. Low rates of vaccination and high rates of malnutrition have contributed to the measles epidemic, and the high rate of mortality in the outbreak.

“While the Ebola outbreak in the DRC has won the world’s attention and progress is being made in saving lives, we must not forget the other urgent health needs the country faces,” said WHO Regional Director for Africa Matshidiso Moeti in a press release by WHO’s African Regional Office.

Launch of the vaccination campaign in North Kivu

As part of a second phase of a country-wide preventative vaccination campaign, this specific surge aims to vaccinate an additional 2.2 million children in North Kivu province, a particularly challenging context, as it is the center of the Ebola outbreak and has been plagued with insecurity. Just last week, four Ebola responders were killed in a directed attack in Biakato Mines and Mangina.

“In the context of North Kivu, where the population is highly mobile, it is imperative that we reach out to travelers and ensure that their children are also covered,” said Deo Nshimirimana, WHO acting representative in the DRC.

The five-day campaign is being implemented by the Ministry of Health with the support of WHO and partners and is fully funded by Gavi, the Vaccine Alliance. North Kivu is the last province in the second phase of the country-wide preventative vaccination campaign, and will be followed by a third and final phase planned in 10 remaining provinces: Bas Uélé, Equateur, Haut Katanga, Haut Lomami, Haut Uélé, Kasai Oriental, Lualaba, Maniema, Mongala and Tshuapa.

The campaign ultimately plans to reach 18.9 million children, with a particular focus on children who may have been missed by routine immunization.

“Sadly, measles has claimed more Congolese lives this year than Ebola. We must do better at protecting the most vulnerable, who are often also the hardest to reach. This campaign is an important step in that direction,” said Thabani Maphosa, managing director of Country Programmes for Gavi. “For maximum impact, campaigns must be combined with the strengthening of routine immunization and health systems.”

To date, US$ 27.5 million have been mobilized for the measles response; however, another estimated US$ 4.8 million are needed to complete the vaccination campaign and to strengthen other elements of response such as disease surveillance, case-management and communication.

 

 

Image Credits: WHO/Kisimir Jonh Shim, WHO AFRO.

For the first time ever, leading cancer organizations across Latin America have signed onto a joint declaration pledging to intensify action against millions of avoidable cancer deaths on the continent.

The Bogota Statement on Leading BOLD Cancer Prevention into the Future was signed by leaders of cancer organizations and foundations from 8 Latin American countries, Argentina, Brazil, Chile, Colombia, Ecuador, El Salvador, Mexico, and Peru at a meeting in Bogota, Colombia, which ended Wednesday. The December 3-4 meeting was hosted by Liga Colombiana Contra el Cáncer and the US-based American Cancer Society, which pledged to support the Latin America initiative.

“Meeting in Bogotá provided us with a great opportunity to discuss common challenges in addressing cancer risk factors and inequities that mean marginalized people suffer most,” said Sally Cowal, senior vice president of Global Cancer Control, American Cancer Society.

“We agreed we have a significant opportunity to share our knowledge and experiences, and provide a strong voice for the growing evidence base in Latin America…We acknowledge we are stronger together and this meeting has provided new impetus for progressing work to prevent future cancer deaths.”

Cancer is already the second-leading cause of death in Latin America. But if current trends continue, there could be a 91 percent increase in cancer incidence across the region between 2012 and 2035, to 1.8 million new cancer cases every year, and cancer deaths will double to around 1 million deaths annually, according to a 2018 study published in the International Journal of Cancer. 

Colombia’s Minister of Health and Social Protection, Dr. Juan Pablo Uribe Restrepo, and Vice Minister of Health and Social Protection, Dr. Iván Darío González, both expressed their support for the initiative at the meeting of some 20 leaders of cancer foundations, advocacy groups, and research centers from around the continent.

Colombia’s Minister of Health and Social Protection, Dr. Juan Pablo Uribe Restrepo, speaking at the meeting.

“We are working to improve the health of the population…We are strongly committed to reducing smoking and are working to reduce the number of tobacco users, especially among youth and students…Together with institutions like the Liga Colombiana Contra el Cáncer, we continue to fight against human papillomavirus,” said Minister Restrepo, noting that only 32% of eligible Colombians have so far received the vaccine that helps prevent cervical cancer. “Our goal is to reach 100 percent coverage,” he said.

Cancer experts present at the conference called the projections for cancer’s rising disease and death toll a predicted “tsunami” that constitutes a “public health emergency which is exacerbating social, economic and health inequities.”

To combat the growing threat of cancer, Cowal said that the Bogota Statement focuses on adopting a set of “best buys for cancer prevention.”

Dr. Carlos Castro, medical and scientific director at the Liga Colombiana Contra el Cáncer, further clarified, “We must join forces to increase tobacco taxes as the most effective way to reduce tobacco consumption, regulate e-cigarettes, and increase vaccination against human papillomavirus, which causes cervical cancer. Those are our principal commitments against cancer included in the Bogotá Declaration.”

It’s estimated that more than 30 percent of all cancer deaths are preventable. Tobacco is associated with more than 14 different cancers and causes more than 20 percent of cancer deaths, globally. Obesity and unhealthy diet is associated with 14 different cancers and alcohol with seven different cancers. Other risk factors associated with the most prevalent cancers across the region include inconsistency of vaccination programs and treatment of cervical, stomach and liver cancer infections.

In signing the declaration, the cancer leaders, agreed to intensify their activities across a number of key, shared priorities, including the following:

  1. Support measures to increase tobacco taxes as the main tool to reduce tobacco consumption and prevent initiation in young people.
  2. Urge countries that have not yet signed or ratified the World Health Organization Framework Convention on Tobacco Control to be a party to this global treaty, the first international public health treaty which provides the guidelines for tobacco control worldwide
  3. Monitor and report corporate interference (especially from the tobacco, alcohol and ultra-processed foods industries) in public policy decision-making.
  4. Advocate for the regulation of electronic nicotine delivery systems (SEAN) and new devices.
  5. Actively participate in the elimination of cervical cancer through national human papillomavirus vaccination programs and strengthened early detection programs that use DNA-HPV testing.
  6. Support research and the eradication of Helicobacter Pylori infection to prevent gastric cancer.
  7. Promote the development of cancer prevention and early detection activities related to the main cancers in the region.
  8. Contribute to the dissemination of academic research that helps build cancer prevention policies.
  9. Act in conjunction with existing networks in the region to document and share successful experiences, lessons learned and communication strategies to achieve strong and sustainable progress.

Underlying all the commitments made in the Bogota Declaration was the theme of shared learning. Gloria Inés Forero, president of the Liga Colombiana Contra el Cáncer, said that collaboration between the organizations, based on “experiences and lessons learned,” is the key to “countering the imminent advance of cancer in the region.”

Signatories to the Bogota Statement.
(Left-right back) Sebastian Jimenez, CEPREME, Ecuador; Luiz Augusto Maltoni Jr., presidente, Fundação do Câncer, Brasil; Dr. Jorge Jiménez de la Jara, presidente, Fundación Foro Nacional de Cáncer, Chile; Dr. Bill Cance, chief medical & scientific officer, American Cancer Society, USA; Diego Paonesa, chief executive officer, Liga Argentina de Lucha Contra el Cáncer, Argentina; Adolfo Dammert Ludowieg, presidente, La Liga contra el Cancer, Peru; Dr. Carlos José Castro, medical and scientific director, Liga Colombiana Contra el Cáncer
(left-right front) Blanca Llorente, directora, Fundación Anáas, Colombia; Dr. Lisseth Ruíz de Campos, presidente, ASAPRECAN, El Salvador; Sally Cowal, senior vice president, Global Cancer Control, American Cancer Society, USA; Gloría Inés Forero de Ruíz, presidenta, Liga Colombiana Contra el Cáncer, Colombia; Diana Rivera, directora, Fundación Ellen Riegner de Casas, Colombia; Dr. Guadalupe Ponciano, Asociación Mexicana de Lucha contra el Cáncer, Mexico

Global progress against malaria continued to plateau in 2018 for the third year in a row, and the disease hit young children and pregnant women in Sub-Saharan Africa the hardest, according to the World Malaria Report 2019 released by the World Health Organization on Wednesday. Despite stalled progress at the global level, however, four new countries have successfully eliminated the disease in 2018 and 2019.

“We’re seeing encouraging signs, but the burden of suffering and death caused by malaria is unacceptable, because it is largely preventable. The lack of improvement in the number of cases and deaths from malaria is deeply troubling,” said WHO Director-General Dr Tedros Adhanom Ghebreyesus in a press release. “Pregnant women and children are the most vulnerable to malaria, and we cannot make progress without focusing on these two groups.”

A village malaria worker is testing a young child for malaria in Battambang Province, Cambodia.

In 2018, WHO estimates that there were 228 million cases of malaria globally, causing 405 000 deaths, as compared to 231 million cases and 435 000 deaths in 2017. A dramatic reduction in malaria incidence and mortality was seen through 2010 to 2015, but global progress against the disease has stalled since then.

The report underlines that malaria continues to strike particularly hard at pregnant women and children in Sub-Saharan Africa,, with an estimated 11 million pregnant women infected in 38 countries with moderate-to-high malaria transmission in that region alone in 2018. Malaria infection in pregnancy can cause a variety of complications, including malaria-related anemia, low birth weight, and even maternal death.

An estimated 24 million children in the region were infected last year with the deadliest strain of malaria – P. falciparum –  with at least half experiencing moderate anemia and 1.8 million experiencing severe anemia. Malaria-related severe anemia is still a major contributor to child mortality in Sub-Saharan Africa.

Funding for malaria control and elimination 2010-2018, by source of funds (constant 2018 US$)

The plateau in progress may in part be caused by the shortfall in malaria funding – the report estimates that funding towards malaria control and prevention fell to US$2.7 billion last year with governments of malaria-endemic countries contributing an estimated 30% of the pool, falling far short of the US$5 billion needed to fully fund WHO’s Global technical strategy for malaria 2016 – 2030.

On the flip side, a handful of low-burden countries have seen progress. In 2018, WHO certified that endemic malaria was successfully eliminated Paraguay and Uzbekistan. Algeria and Argentina were recognized for eliminating endemic malaria in early 2019, and China, El Salvador, Iran, Malaysia, and Timor-Leste reported zero indigenous cases. Progress to achieve a global milestone to certify at least 10 countries for the elimination of malaria by 2020 is also on track.

Large reductions in malaria were also seen in WHO’s Southeast Asian region, said Dr Abdisalan Noor, lead author of the report and team leader of the Surveillance Unit in WHO’s Global Malaria Programme, in a press conference. Significant reductions in India, which had 2.6 million fewer malaria cases than the previous year, accounted for a large share of the success. Progress has also been made in the Greater Mekong sub-region – an important strategic area as resistance to antimalarial medications has historically been traced back to the region.

Protecting Pregnant Women and Young Children

Coverage of pregnant women and children by malaria treatment and prevention interventions has increased in Africa, but these two groups continue to be the hardest hit by malaria.

“We have brought back the focus to the key populations at risk that suffer and carry the brunt of malaria; pregnant women and young children in Africa. And by highlighting this space, we also signal that they must become our number one priority in the fight against malaria,” said Dr Pedro Alonso, director of WHO’s Global Malaria Programme.

The WHO report estimates that in 2018, 67% of all malaria-related deaths occurred in children under 5, and malaria continues to be a leading cause of infection-related maternal mortality in Sub-Saharan Africa.

“Now, [another] one of the consequences of malaria in pregnancy is children that are born with low birth weight, less than 2500 grams at birth,” Dr Noor clarified. Low birth weight is not only an immediate problem for the growth of the child, but is also “a significant predictor of early infant death,” he added. The WHO report estimates that of the 11 million cases of malaria in pregnancy in Sub-Saharan Africa in 2018,  872,000 children were born with low birth weight.

This is despite the fact that the number of pregnant women and children sleeping under insecticide-treated bed nets and receiving preventative medicine for malaria has increased in recent years. An estimated 61% of pregnant women and children in sub-Saharan Africa slept under an insecticide-treated net in 2018 compared to 26% in 2010.  Among pregnant women in the region, coverage of the recommended 3 or more doses of intermittent preventative malaria treatment, delivered during antenatal care visits, increased from an estimated 22% in 2017 to 31% in 2018. Some 72% of eligible children received seasonal malaria prevention medication in 2018.

A new WHO-recommended strategy to prevent malaria in infants – intermittent preventative treatment for infants (IPTi) – recommends delivering anti-malarials to very young children through the immunization programme, and is being piloted in Sierra Leone.

“IPTi offers a tremendous opportunity to keep small children alive and healthy,” said Dr Alonso. “WHO welcomes Unitaid’s new drive, announced today, to accelerate the adoption and scale-up of IPTi in other malaria-endemic countries in sub-Saharan Africa.”

Some “Elimination by 2020” Targets May Be in Sight

 Despite little progress being made on the global scale, certain regions and countries are inching closer to eliminating malaria, defined as completely stopping endemic transmission within national or territorial borders. Globally, a total of 38 countries and territories have been certified malaria-free by WHO, with Paraguay, Uzbekistan, Algeria, and Argentina just added to that list between 2018 to 2019. WHO grants the malaria-free certification when a country proves, beyond a reasonable doubt, that the chain of indigenous transmission of malaria has been interrupted for at least 3 consecutive years. At least 10 countries that are part of WHO’s “E-2020 initiative” are on track to reach the 2020 elimination milestone of the global strategy.

P. Falciparum cases in the Greater Mekong Subregion, 2010- 2018

The six countries of the Greater Mekong sub-region – Cambodia, China, Laos, Myanmar, Thailand, and Vietnam – have made significant progress. Across the subregion, there was an impressive 76% reduction in malaria cases and a 95% drop in deaths between 2010 and 2018. This includes a steep decline in cases of P. falciparum malaria, a primary target in view of the ongoing threat of antimalarial drug resistance.

Some 11 African countries and India account for approximately 70% of the world’s malaria burden – Burkina Faso, Cameroon, Democratic Republic of the Congo, Ghana, India, Mali, Mozambique, Niger, Nigeria, Uganda and the United Republic of Tanzania. The WHO and Roll Back Malaria Partnership launched a “high burden high impact” (HBHI) approach in these countries in 2018. By November 2019, the HBHI approach had been initiated in nine high burden countries in Africa.

Image Credits: WHO/ V. Sokhin, WHO/World Malaria Report 2019.

For the second year running, some 37 organizations have launched a week-long mini campaign to raise awareness and promote action against falsified and substandard medicines.  This year’s annual Fight the Fakes week aims to mobilize the public and international global health community to speak up more assertively about the growing threat of fake or substandard medicines under the theme “Be Aware, Speak Up, Fight the Fakes.”

“Poor-quality care is now as big a barrier to reducing mortality than insufficient access to healthcare. This is why ensuring high-quality medicines reach patients should be a key component of Universal Health Coverage initiatives,” said Grey Perry, assistant director-general of the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), a founding member of the campaign.

Drugs that deliberately misrepresent their identity and medicines that do not meet regulatory or quality specifications are particularly prevalent in low- and middle-income countries, where an estimated 1 in 10 medical products is falsified or substandard, according to a 2017 report by the World Health Organization.

But the problem can affect higher income regions too. A medical product alert issued earlier this year by the WHO found that a falsified version of the leukemia medication ICLUSIG containing none of the active cancer-fighting agent Ponatinib hydrochloride had been circulating in the WHO Region of the Americas as well as in WHO’s European Region.

There is also evidence that take and substandard products can fuel illicit trade, as well as organized crime, which has broader social and economic implications, according to a report released by the UN Office on Drugs and Crime in June. The report estimates that consumers in Southeast Asia alone spend between US$20 million and US$2.6 billion a year on falsified medicines.

Legitimate pharmaceutical producers in countries such as China and India often outsource parts of their drug production process to manufacturers in countries with weaker regulatory requirements, and that can lead to substandard medications, says the UN Office on Drugs and Crime report. The rapid proliferation of online pharmacies has also facilitated the trade of substandard and falsified medications, the report finds.

The Fight the Fakes campaign has received support from industry, product development partnerships, and civil society actors alike, who say that addressing the issue of falsified and substandard drugs is paramount to ensuring that patients have access to safe and quality essential medicines.

“The risk [of falsified and substandard medicines] concerns everyone in every corner of the world,” said the World Heart Federation’s Director of Partnerships and Programmes, Andrea Vassalotti.

Individual and Societal Risks of Substandard and Falsified Pharmaceutical Products

Antibiotics and antimalarials are among the most frequently reported falsified medical products – accounting for almost 65% of all products reported to WHO.

This also contributes to the growing resistance of many bacteria and parasites to commonly used drugs – known as antimicrobial resistance. Many falsified or substandard antibiotics or antimalarials do not contain the proper dose of the active ingredient. When ingested by patients, exposure to lower doses of the active ingredient allows pathogens to develop resistance to the drug. Although the extent of the effect is unclear, WHO has listed drug resistance driven by subpar medications as a global concern in its 2017 review, A study on the public health and socioeconomic impact of substandard and falsified medical products.

While antibiotics and antimalarials represent the lion’s share of reported falsified and substandard medical products, fake and substandard medicines for other life-threatening illnesses such as rabies, diabetes, cancer, cardiovascular disease, and HIV are also present on the market. This year so far WHO issued 11 alerts for falsified medical products that have been circulating in certain countries and globally.

Confirmed falsified hydrochlorothiazide 50mg

These medications at best fail to have any impact on the disease they purport to treat, and at worst contain other compounds that can have devastating consequences on individuals’ health.

In March, a falsified medication claiming to contain hydrochlorothiazide, a medicine used to control hypertension, caused blood sugar levels to crash in a number of patients who were prescribed the medication in Cameroon. According to the WHO alert on the product, the medication instead contained glibenclamide, an antidiabetic medication, and was the cause of the hypoglycaemia experienced by patients.

“Currently, cases come to light when high numbers of people are affected by very severe or unusual suspected side effects,” said Oksana Pyzik, senior teaching fellow at the University College London and founder of UCL’s Fight the Fakes chapter.

The combined effects of exposure to substandard and falsified medicines can also erode public trust in health authorities and health systems, mistrust that is already fueled by a growing anti-vaccination movement, said Pyzik.

“We have entered an interesting time in history where trust of science, fact and authority has never been so fragile, fleeting and called into question… As such leading health authorities cannot afford any further dents in credibility that damage trust in health systems,” she added.

“Awareness of the issue remains low amongst health care professionals (HCPs) and the general public globally. Education and training of HCPs, alongside wider campaign efforts such as Fight the Fakes, are of paramount importance to improve reporting rates of substandard and falsified medical products by pharmacists and patients,” said Pyzik.

As part of this year’s Fight the Fakes campaign, partners of the movement have organized events around the world, including a series of events at UCL, a photo competition hosted by the International Pharmaceutical Students Federation, and a panel that will be co-hosted by IFPMA and the Graduate Institute in Geneva on Friday.

Image Credits: WHO, WHO, Sanofi.

[Drugs for Neglected Diseases Initiative]

Geneva, Switzerland (29 November 2019) – The Indian pharmaceutical company Cipla has announced their commitment to price the ground-breaking new product Quadrimune, a “4‑in‑1” treatment for young children with HIV, at below a dollar a day. Quadrimune is currently under review by the US Food and Drug Administration (FDA) for use in children between 3 and 25 kg bodyweight.

This pleasant tasting, heat-stable fixed-dose combination of four antiretrovirals (ARVs) for infants and young children with HIV was developed in partnership by Cipla and the not-for-profit Drugs for Neglected Diseases initiative (DNDi) with financial support from Unitaid and other donors. If it receives FDA tentative approval in 2020, the 4-in-1 will represent a major improvement in the treatment of HIV in very young children and will replace older, bitter-tasting medicines, medicines requiring refrigeration, or regimens that are no longer recommended by the World Health Organization (WHO).

Demonstration of how to administer Quadrimune, a “4-in-1” treatment for young children with HIV

‘Cipla is happy that over the past 20 years it has contributed to making adult antiretroviral drugs available at affordable prices for patients throughout the developing world, in particular Africa, and has pioneered the development of paediatric fixed-dose combinations of ARVs for children,’ said Dr Yusuf K Hamied, Chairman of Cipla. ‘Over the years, the treatment of children with HIV has been neglected. In order to ensure faster access, particularly in sub-Saharan Africa, our product Quadrimune, once approved, will be offered for less than one dollar a day for children.’

‘Children living with HIV have been neglected for too long, with the recommended treatment for years consisting of a bitter-tasting syrup with 40% alcohol content,’ said Dr Bernard Pécoul, Executive Director of DNDi. ‘Mothers were often forced to bury the syrup in the sand to keep it cool, because it required refrigeration. The new Quadrimune is pleasant-tasting, heat-stable, and easy-to-use. We will finally have a treatment designed specifically for infants and young children, who are at the highest risk of dying if they do not receive treatment.’

It is estimated that 1.8 million children are living with HIV, almost 90% of whom live in sub-Saharan Africa. Only an estimated 54% of these children have access to HIV treatment and over 300 children still die from the disease every day. Inappropriate, suboptimal treatment options have contributed to low treatment coverage.

Cipla will provide Quadrimune at an ex-factory price of US$ 15 per pack of 120 capsules, giving a price of $1 per day ($360 per year) for children in the medium weight bracket of 10 to 13.9 kg, with prices lower, at 50 US cents per day, for younger children and infants. Quadrimune contains the WHO-recommended ARVs abacavir, lamivudine, lopinavir, and ritonavir in the form of granule-filled capsules. If approved, parents and caretakers will be able to administer the drugs to children by sprinkling the granules on soft food, water, or milk. The 4-in-1 does not require refrigeration and is easy to administer to infants and children of different weights and ages.

‘This optimal child-adapted all-in-one ARV regimen, that meets WHO recommendations, will be a game-changer for millions of infants and young children,’ Unitaid Executive Director Lelio Marmora said. ‘Unitaid is proud to have supported from day one the development of this new 4-in-1 treatment that is safe and effective, adapted and palatable, easy-to-use and with no requirement for refrigeration. Once adopted, this innovative formulation will enable great advances in the treatment of the youngest kids.’

Since 2013, WHO has recommended regimens that include a class of ARVs called protease inhibitors, which includes lopinavir/ritonavir (LPV/r), for infants and young children. Cipla and DNDi worked closely to develop Quadrimune, testing over 30 formulations of abacavir, lamivudine, and LPV/r, ensuring good taste-masking, and selecting one which met the standards required to enable regulatory submission.

The 4-in-1 could be the first of several new treatment options now on the horizon for young children with HIV.

 

Image Credits: Emmanuel Museruka/DNDi.

African leaders, scientists, and activists are mobilizing to address the scientific, political, and social challenges inherent to ending the HIV epidemic. That was the key message as the 20th International Conference on AIDS and STIs in Africa (ICASA) kicked off on Monday in Kigali, Rwanda under the theme, “AIDS-free Africa: Innovation, Community and Political Leadership.”

“HIV, Hepatitis B and syphilis are all endemic in Africa. All three can be maternally transmitted; are devastating; take a heavy toll on health systems, with catastrophic expenditures for families leading to poverty in our communities. And all three can be prevented,” said World Health Organization Director-General Dr. Tedros Adhanom Ghebreyesus at the conference opening ceremony.

(back row, left-right) Rwandan President Paul Kagame, Rwandan First Lady Jeannette Kagame WHO Director General Dr Tedros, and UNAIDS Executive Director Winnie Byanyima along with other First Ladies of African States (first row) at the ICASA 2019 Opening Ceremony.

Rwandan President Paul Kagame added that AIDS is an “epidemic without borders.” In a brief opening statement, the president of the host country highlighted a number of key challenges that the HIV/AIDS response faces – themes around which the conference has organized.

When it comes to sexually-transmitted infections, Kagame said, stigma and silence “are the real killers, just as much as the underlying virus.”  Stigma discourages people with STIs, including people with HIV, from seeking life-saving care, he explained.

On the care provision side, sustained investment in strengthening health systems is needed to “win the fight” against HIV/AIDS, and “build the resilience required to handle other challenges down the line,” he said.

He stressed the importance of “good politics and good governance,” highlighting that governments in Africa must prioritize domestic financing for healthcare, investing in infrastructure, technology, and a highly-skilled medical and administrative workforce. Additionally, investment in community health workers can help build trust in the health system so that citizens will to “act on health guidelines from public institutions and change their behavior accordingly.”

The conference is organized along three thematic tracks that address the major opportunity areas for improving HIV/AIDS response. A scientific track features sessions that focus on tools for HIV prevention and treatments regimens, including topics such as “operationalizing the implementation of innovative biomedical prevention such as PrEP, microbicides, and long-acting antiretrovirals.”

A second track focuses on leadership and issues around the political mobilization required in the fight against HIV/AIDs, including sessions such as “Stronger positioning of women leadership in Africa in the HIV response.” A third stream focuses on community-based work in the HIV response, with sessions such as “accessing services for people living with disabilities.”

The six-day conference is co-sponsored by the Society for AIDS in Africa (SAA) and the Government of Rwanda, and runs from December 2-7. Co-organized by WHO, UNAIDS, and the UN Population Fund (UNFPA), as well as the pharmaceutical companies Gilead and Mylan, it brings together thousands of delegates to share lessons learned and chart the way forward for reaching the 90-90-90 UNAIDS targets for HIV/AIDS and sexually transmitted infections (STIs) on the African continent. Those targets aim to ensure that by 2020, 90% of all people living with HIV will know their HIV status; 90% of all people with diagnosed HIV infection will receive sustained antiretroviral therapy; and 90% of all people receiving antiretroviral therapy will be have the virus supressed.

 

Image Credits: Twitter: @DrTedros.

The World Health Organization has issued new HIV testing recommendations to help countries expand treatment coverage and reach the estimated 8.1 million people living with HIV who have not yet been diagnosed. The WHO guidelines were released on Wednesday ahead of World AIDS Day on December 1 and the International Conference on AIDS and Sexually Transmitted Infections in Africa (ICASA2019), which will take place in Kigali, Rwanda on December 2-7.

“The face of the HIV epidemic has changed dramatically over the past decade,” said WHO Director-General Dr Tedros Adhanom Ghebreyesus in a press release. “More people are receiving treatment than ever before, but too many are still not getting the help they need because they have not been diagnosed.”

A woman prepares for an HIV test in Uganda.

The launch of the WHO guidelines comes right on the heels of a UNAIDS report published Wednesday that highlighted mixed success in tackling the HIV/AIDS epidemic. Access to HIV treatment has expanded and new HIV infections have declined by 28% from 2010 to 2018 in eastern and southern Africa, the region most affected by HIV, but women and girls are still disproportionately affected. Four out of five new HIV infections among adolescents in the Sub-Saharan Africa region occur in girls. Additionally, new HIV infections are increasing in eastern Europe, central Asia, northern Africa, and parts of Latin America.

WHO estimates that at the end of 2018, there were 36.7 million people with HIV worldwide. Of these, 21% have not yet been diagnosed. Expanding testing for HIV helps ensure that people are diagnosed early and can start treatment. Testing also helps identify people who are HIV-negative but may be at high risk for contracting the infection and link them to appropriate and effect prevention services.

Both publications highlight that key populations such as injecting drug users, sex workers, transgender people and prison populations are at higher risk of testing positive for HIV, but may be less engaged in HIV decision-making and have less access to healthcare services. Additionally, in countries where high proportions of people have already been tested and treated, it can be difficult to reach the remaining proportion of people living with HIV who have not yet been tested, according to WHO.

The new “WHO consolidated guidelines on HIV testing services” recommends strategies for expanding a package of HIV-related services to those hardest to reach including:

  • Adoption of a standard HIV testing strategy which uses three consecutive reactive tests to provide an HIV positive diagnosis. Previously, most high burden countries were using two consecutive tests. The new approach can help countries achieve maximum accuracy, particularly in high-prevalence settings.
  • Use of HIV self-testing as a gateway to diagnosis based on new evidence that finds people who are at higher HIV risk and not tested in clinical settings are more likely to be tested if they can access HIV self-tests.
  • Implement social network-based HIV testing to reach key populations who are at high risk but have less access to services, and use peer-led, innovative digital communications such as short messages and videos to build demand and increase uptake of HIV testing.
  • Focus on community-based delivery of rapid testing through lay providers for relevant countries in the European, South-East Asian, Western Pacific and Eastern Mediterranean regions. Rapid testing methods cost less and can provide results up to 2-3 weeks earlier than traditional laboratory-based diagnostic tests.
  • Use HIV/syphilis dual rapid tests in antenatal care as the first HIV test to help eliminate mother-to-child transmission of both infections.
Power to Choose, Power to Know, Power to Thrive, Power to Demand

The UNAIDS report, Power to the People, found that significant progress has been made in expanding access to treatment, with an estimated 24.5 million people with HIV accessing anti-retroviral drugs and other therapies. However, progress to slow HIV transmission has stalled, and an estimated 1.7 million people were newly infected with the virus in 2018.

In Eastern and Southern Africa, the hot spots of the global HIV/AIDS epidemic, new infections declined by 28% between 2010 and 2018. However, outside of eastern and southern Africa, new HIV infections have declined by only 4% since 2010. Of concern is the rise of new HIV infections in certain regions. The annual number of new HIV infections rose by 29% in eastern Europe and central Asia, by 10% in the Middle East and North Africa and by 7% in Latin America. the report notes.

“In many parts of the world, significant progress has been made in reducing new HIV infections, reducing AIDS-related deaths and reducing discrimination, especially in eastern and southern Africa, but gender inequality and denial of human rights are leaving many people behind,” said Winnie Byanyima, executive director of UNAIDS in a press release.

The report aims to highlight the importance of including people and communities affected by HIV in HIV service delivery and policy-making. Specifically, stigma and discrimination can still prevent people from seeking knowledge on how to prevent HIV transmission, or accessing diagnosis and treatment.  But when people living with HIV are empowered, these barriers are more frequently overcome. Specifically, the report notes four areas of empowerment for programmes to target:

  • Power to Choose – The report finds almost 40% of adult women and 60% of adolescent girls (aged 15–19 years) in sub-Saharan Africa have unmet needs for modern contraception. Family planning services are closely tied to HIV treatment and prevention services. In sub-Saharan Africa, young women’s uptake of medicine to prevent HIV—pre-exposure prophylaxis (PrEP)—is high in projects that integrate PrEP into youth-friendly health services and family planning clinics and when provision of PrEP is separated from treatment services.
  • Power to Know – Knowledge of HIV among young people is alarmingly low in many regions. In countries with recently available survey data, just 23% of young women (aged 15–24 years) and 29% of young men (aged 15–24 years) have comprehensive and correct knowledge of HIV. This can lead to people finding out their HIV status too late, sometimes years after they became infected, facilitating transmission and leading to a delay in starting treatment.
  • Power to Thrive – Certain populations are being left behind. In 2018, 160 000 children (aged 0–14 years) became newly infected with HIV, and 100 000 children died from an AIDS-related illness. In Eswatini, a recent study showed that adolescent girls and young women who experienced gender-based violence were 1.6 times more likely to acquire HIV than those who did not. The same study also showed that economic empowerment of girls and women helped reduce new HIV infections among women by more than 25% and increased the probability of young women and girls going back to school and finishing their education.
  • Power to Demand – There have been reports of crackdowns, restrictions and even attacks on groups and campaigns supporting key populations most affected by HIV. Some governments refuse to recognize, support or engage community organizations in their national responses to HIV and are subsequently missing out on their enormous potential to reach the people most affected by HIV.

Image Credits: 2011, Sokomoto Photography for International AIDS Vaccine Initiative (IAVI).

The lower house of the French parliament has approved a milestone requirement that pharmaceutical companies must disclose the amount of public funding that was used in the research and development of new medicines entering the national market, as well as allowing those contributions to be factored into negotiations over final drug pricing.

After being initially rejected by the government, the new provision was adopted as an amendment to the French Social Security Budget Bill for 2020 in a nearly unanimous vote by the National Assembly, with 40 Members of Parliament voting in favor and only one opposed. The bill must still pass the French Senate in order to become law, but observers said the upper house was unlikely to drop the amendment after being approved in the National Assembly.

“Of course the adopted amendment is not perfect, but it’s still a historical first step toward the implementation of transparency at the French Parliament, and another proof that mobilization works,” said Pauline Londiex, co-founder of  l’Observatoire Transparence Médicaments (OTM), a French civil society watchdog that had lobbied heavily to see the provision passed by parliament.

The new requirement, enshrined in amendments n°474, n°505 and n°520 of the budget bill, stipulates that pharma companies must disclose the amount of public funding that was received for R&D of a new drug when applying for approval to market the product in France. Moreover, the government body in charge of negotiating drug prices, CEPS, will be able to take into account such public investments when negotiating the final drug price to be paid.

A series of other proposed requirements to disclosing the manufacturing costs of drugs, including costs of active ingredients, as well as profits such as the margins of intermediaries, were dropped from the final approved version of the amendment. A last minute sub-amendment was added to National Assembly approved-bill to further clarify that CEPS’ consideration of public R&D funding in drug price negotiations was optional.

Véran presenting the transparency amendment at the National Assembly on November 25.

Still, the parliamentary move is an important win for civil society groups advocating greater price transparency for health products after months of mobilization, following the approval in May of a landmark World Health Assembly (WHA) resolution on transparency in medicines markets.

The French National Assembly amendments appear to take the WHA resolution a step further – unlike the watered down WHA-approved language to only recommend voluntary disclosure by industry of public contributions to R&D costs, the National Assembly amendments appear to require companies report public funding.

The parliamentary proposal to require disclosure of public funds used for R&D costs had initially been shot down by French Minister of Health Agnéz Buzyn and the general rapporteur Olivier Véran at the first reading of the Social Security Budget Bill on October 24.

A month of political tensions followed, including the French Senate’s rejection of the original budget bill on November 14 in the wake of Prime Minister Emmanuel Macron’s announcement of an Emergency Funding Plan for Hospitals. Civil society groups continued to pressure the government to adopt the transparency amendment, publishing an open letter signed by over 80 notable French personalities that urged the government to support the amendment.

In a turn-around show of support, Véran presented the R&D cost amendment alongside presentations by La France Insoumise, and MP Caroline Janvier at a second meeting of the National Assembly on Monday where it was finally approved.

The final Social Security Budget Bill for 2020 must still be sent to the Senate for a first reading of the bill on Saturday, where the transparency amendment could then still be dropped  – or further expanded. But observers predict that the amendment may remain unchanged due to the wide consensus reached by the National Assembly, although there might be more attempts to weaken rather than strengthen the amendments in the Senate.

Image Credits: http://www.assemblee-nationale.fr.

Unitaid will expand its work in malaria to include chemoprevention for infants in the first year of life and pilot a new “agility” mechanism to support global health innovation in 2020, following approval granted by Unitaid’s Executive Board on November 20 to 21.

(left-right) ED Lelio Marmora, Board Vice-Chair Maria Luisa Escoral de Moraes, Board Chair Marisol Touraine, Deputy ED Philippe Duneton

The Board’s approval will allow Unitaid to launch a call for proposals for projects on malaria chemoprevention for infants.

“Chemoprevention is a key piece of the puzzle in the fight against malaria,” said Unitaid Executive Director Lelio Marmora in a press release.

“Adding infant malaria chemoprevention to Unitaid’s expanding malaria portfolio will not only protect millions of babies from this deadly disease but also help reignite the stalled progress in the global malaria response.” 

Infants and children are highly vulnerable to malaria because they have not yet developed protective immunity, according to Unitaid. Of the 435,000 malaria deaths in 2017, more than 60 percent occurred in children under 5.

Currently, malaria chemoprevention, or the strategy of providing medication to prevent malaria, is used by Global Fund financed programmes protect children 3 to 59 months old during the four-month rainy season in 12 countries in the Sahel, based on evidence from a Unitaid/Malaria Consortium project (ACCESS-SMC). Unitaid also invests in projects to expand and monitor malaria chemoprevention in pregnant women.

In a separate decision, the Board approved up to US$20 million in 2020 to fund a new framework to respond quickly to global health innovation, delegating the authority to enter into legal agreements under the pilot to the Executive Director. Current ED Lelio Marmora also announced to the Board that he will be stepping down by March 2020, and Deputy Executive Director Philippe Duneton has been identified as acting ED in the interim.

Image Credits: Unitaid.

A global campaign focusing on the issue of rape as a form of violence against women is being launched Monday on International Day for the Elimination of Violence against Women. The annual sixteen-day campaign, which is set to end on 10 December, Human Rights Day, will bring together activism against gender-based violence under this year’s theme “Orange the World: Generation Equality Stands against Rape.”

“We must show greater solidarity with survivors, advocates and women’s rights defenders. And we must promote women’s rights and equal opportunities,” said UN Secretary-General Antonio Guterres in a video message. “Together, we can – and must — end rape and sexual assault of all kinds.”

WHO has called violence against women a “public-health problem,” estimating that one in three women globally have experienced some form of sexual or physical violence in their lifetime. Most violence is perpetrated by intimate partners or other people the women know; almost one third of women who have been in a relationship report that they have experienced some form of physical or sexual violence, including rape, by an intimate partner in their lifetime according to the WHO.

The statistics around the prevalence of rape can be unclear, but UN Women’s Executive Director Phumzile Mlambo-Ngcuka notes in an official statement that “almost universally, most perpetrators of rape go unreported or unpunished.”

Mlambo-Ngcuka further adds that women require a great deal of “resilience to re-live the attack, a certain amount of knowledge of where to go, and a degree of confidence in the responsiveness of the services sought – if indeed there are services available to go to” in order to decide to report sexual violence. For those who do report, especially adolescent girls, less than 10% go to the police, Ngcuka says.

Health-care providers are often the first point of professional contact for a woman experiencing violence, according to the WHO. Women who are abused are more likely to seek health services even if they do not explicitly seek care for violence, making providers important first responders for survivors of sexual violence.

WHO launched global guidelines for healthcare providers to respond to sexual violence in 2013 and began working with partners to implement trainings for healthcare workers in India, Namibia, Pakistan, Uganda and Zambia. A pilot of the trainings was completed in two tertiary hospitals in the State of Maharashtra India, and a recent assessment of the impact of the trainings done by the Center for Enquiry into Health and Allied Theme (CEHAT) will be used to inform a potential national-roll out of the trainings.

See here for more information about the WHO Guidelines for Healthcare Providers and WHO and CEHAT’s work in Maharashtra.

See here for more information about the “16 Days of Activism Against Gender-based Violence.”

 

Image Credits: UNICEF/Nesbitt.