New Protocol For HIV Prevention Drug Reduces The Number Of Pills Required

Health officials and AIDS advocates in San Francisco hope to expand the use of an effective HIV prevention drug with a new approach that requires fewer pills than the standard once-a-day regimen.

San Francisco’s public health department and the San Francisco AIDS Foundation have long promoted what is known as preexposure prophylaxis, or PrEP, for those at high risk of contracting HIV. With regular PrEP, the daily pill is taken indefinitely. But both organizations now endorse a strategy that requires taking just four pills timed to a specific sexual encounter — two within two to 24 hours before sex and one on each of the two following days.

They believe this approach will make PrEP more palatable to people who are ambivalent about the medication because of the cost, fear of potential side effects, mistrust of pharmaceutical companies or a general dislike of taking drugs.

The new strategy, called “2-1-1” or “on-demand” PrEP, is becoming popular overseas but has gotten little traction in the United States thus far. It has been proven effective only among men who have sex with men and is currently not recommended for women.

Proponents say the approach can work well for men whose encounters are intermittent and predictable: people in long-distance relationships who know when they will be with their partners, for example, or individuals who occasionally go out to pursue sexual activity.

The approach is not suitable for those who cannot plan for sex at least two hours in advance.

“There are people who really object to taking a pill every day if they’re not having sex that frequently,” said Dr. Oliver Bacon, a deputy director and physician at the San Francisco Department of Public Health. The on-demand approach, he added, “extends PrEP to people who actually need it based on the sex they’re having but wouldn’t take a daily pill.”

Since the Food and Drug Administration approved daily PrEP use for HIV prevention in 2012, more than 200,000 people in the U.S., most of them men who have sex with men, have taken the drug. But more than a million people are at risk for HIV infection and could benefit from the treatment, according to the Centers for Disease Control and Prevention.

The list price of the PrEP drug, sold by Gilead Sciences under the brand name Truvada, is $1,758 per month when taken daily — though patients generally do not pay that much out of their own pockets.

Insurers typically cover much or most of the cost, but many have been shifting the financial burden onto patients in recent years. Help may be on the way, however.

Following a recommendation by the U.S. Preventive Services Task Force that doctors offer PrEP to at-risk patients, most health plans will be required to cover the drug starting in 2021 — though not the clinical and lab services that accompany its use.

And Gilead agreed earlier this year to donate enough Truvada to cover 200,000 patients annually for up to 11 years, though critics argue that cutting the price would be a more effective way to increase access.

Gilead declined to comment on the on-demand approach for using the drug.

Don Kirchman, a self-employed building developer in San Francisco who is on Medicare, started the on-demand regimen last year after discussing it with his doctor. He had previously taken Truvada daily, but then experienced heart trouble and a related drop in sexual interest and activity.

The new approach meets his current needs, because he prefers not to take unnecessary medication and is concerned about his out-of-pocket drug costs, he said. “There are times when I don’t feel like I’m in a sex cycle or I have a health issue that I’m concentrating on, so I’m not putting my attentions towards dating or hooking up,” Kirchman said.

In San Francisco, the health department issued an HIV update in February for local providers, suggesting they “consider” on-demand PrEP for men who were “ambivalent” about taking a pill every day. The department’s City Clinic began offering the option as a second-best choice for those reluctant to adopt the standard PrEP method.

In March, the San Francisco AIDS Foundation began formally enrolling men for on-demand PrEP at its Strut clinic in the city’s Castro district. In contrast to the health department, the foundation has presented on-demand and daily strategies as equal options. In the first two months, about a fifth of those who got PrEP at the clinic chose to take it on demand.

Since 2015, research in Europe has found on-demand PrEP to be effective at preventing HIV. Advocacy groups and health agencies in France, Netherlands, Australia and elsewhere have promoted it. The World Health Organization endorsed the approach this week during an international AIDS conference in Mexico City.

So far, neither the CDC nor the FDA has endorsed the on-demand approach. But Bacon, of the San Francisco public health department, said the city’s experience is being closely watched and he has fielded questions about the initiative from health officials in New York, Seattle and elsewhere.

A big challenge public health officials face with PrEP is that its adoption has been much slower among men of color than among whites. African Americans and Latinos are more likely to have undiagnosed or untreated HIV, so boosting awareness and use of PrEP is viewed as a key strategy for preventing infections.

Chicago physician John Schneider said the African-American gay and bisexual men he sees at a South Side clinic tend to distrust the health care establishment, including drug companies, because of a legacy of medical discrimination. “Patients don’t like taking a lot of pharmaceutical products,” he said.

Though Schneider generally recommends the standard once-a-day PrEP regimen, he said he sometimes suggests the on-demand approach for patients whose sexual behavior is compatible with it, if they struggle with taking a pill every day.

Some people who want PrEP but prefer to minimize their consumption of it have adopted a different non-daily strategy: a four-day-a-week approach known in the United Kingdom as the “T’s and S’s,” in which pills are taken on Tuesdays, Thursdays, Saturdays and Sundays.

Earlier PrEP research found that four pills a week conferred a high level of protection.

Timothy Price, an HIV prevention coordinator at the Northeast Indiana Positive Resource Connection, a Fort Wayne HIV/AIDS services organization, said he had relied on the T’s and S’s to limit his consumption of Truvada after a dispute with his insurance company involving prescription refills.

Price, a 56-year-old gay man, said he understood the science and knew he could safely reduce his intake to make his pills last longer. “I had a long period of time when they refused to fill it, so I decided after that I needed to build up some kind of cushion,” he said.

This KHN story first published on California Healthline, a service of the California Health Care Foundation.

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Most traumatic brain injuries in U.S. kids linked to consumer products

(Reuters Health) – The majority of the more than four million traumatic brain injuries in kids treated in U.S. emergency rooms involved consumer products, a new study suggests.

Brain injuries in younger children were tied to products such as beds and flooring, while injuries in older kids were tied to sports, such as football, basketball and bicycling, researchers reported in Brain Injury.

“A child’s age is important when looking at the incidence and causes of these injuries,” said the study’s lead author, Bina Ali, a research scientist at the Pacific Institute for Research and Evaluation in Beltsville, Maryland. “In this study we found that home furnishings and fixtures, primarily beds, were highest among infants and children up to 4 years old. Among children aged 5 to 19 traumatic brain injuries from sports and recreation were highest. The findings indicate priority areas for traumatic brain injury prevention.”

Using the National Electronic Injury Surveillance System—All Injury Program, the researchers identified 4,091,376 nonfatal pediatric TBIs seen in emergency rooms between 2010 and 2013. Stratified by age, there were 380,842 TBIs in infants under a year, 1,085,680 in children ages 1 to 4, 682,826 in kids ages 5 to 9, 834,565 in 10- to 14-year-olds, and 1,107,463 in those ages 15 to 19.

Most youngsters with TBIs (92%) were treated in the emergency room and then released.

Overall, 28.8% of the TBIs were related to sports and recreation, 17.2% to home furnishings and 17.1% to home structures and construction materials. Toys were linked with 2.4% of brain injuries, while personal use items, home electronics and hobbies and other product groups accounted for another 6.6% of TBIs.

Most injuries in infants (71.3%) and children ages 1 to 4 (60.6%) were related to home furnishings and fixtures, home structures and construction materials.

To protect these younger kids Ali recommends “removing tripping hazards, such as area rugs, improving lighting, avoiding hard surface playgrounds, using home safety devices, such as stair gates and stairway handrails.”

By the time children reached ages 5 to 9, sports and recreation were accounting for 31.8% of brain injuries. That percentage rose to 53.9% in children ages 10 to 14 and dropped to 38.3% among youngsters ages 15 to 19.

The biggest single source of TBIs in 10- to 19-year-olds was American football, followed by basketball.

There are a number of strategies to keep brains safe in sports-playing kids in these age groups, said Dr. Chris Giza, a professor of pediatrics and neurosurgery at the University of California, Los Angeles, and UCLA’s Mattel Children’s Hospital.

“Use protective devices,” Giza said. “Make sure helmets fit properly and are actually worn. Head injuries prevented by helmets are often skull fractures and other severe injuries. Those are the ones with the more debilitating long-term consequences.”

Giza also suggested that parents of kids playing organized sports get to know the coach and other staff. “You wouldn’t sign your child up for piano lessons without vetting the teacher,” he said. “Many parents don’t know the coach or the athletic trainer or whether there is medical supervision.”

“You also want to know whether the officials enforce the rules,” Giza said. “Does the coach have any training in injury prevention? What is the mentality of the team? Is it win at all costs or is there an emphasis on having fun and making sure there is good sportsmanship?”

Overall, Giza was pleased to see some “hard numbers” on TBIs in kids, although he suspects the numbers would be even higher if the researchers had included doctors’ visits.

Parents may be surprised to find that toys, playgrounds and monkey bars accounted for such a small percentage of injuries. But that may be because “kids don’t have as much unstructured time these days,” Giza said. “You rarely see kids playing in the park or climbing trees.”

SOURCE: Brain Injury, online July 29, 2019.

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U.S. judge blocks Medicaid work requirements in New Hampshire

(Reuters) – A federal judge on Monday overturned the Trump administration’s approval of a plan by the state of New Hampshire to impose work requirements on people seeking to obtain benefits from the Medicaid health insurance program.

The ruling by U.S. District Judge James Boasberg in Washington came after the judge earlier this year blocked the Republican-led states of Arkansas and Kentucky from moving forward with similar plans.

The three states are among nine that have received approval from the U.S. Department and Health and Human Services under Republican President Donald Trump to impose requirements that people seeking coverage under Medicaid engage in work or job training.

But Boasberg said that, as with the plans by Arkansas and Kentucky, HHS had failed to contend with the possibility that New Hampshire’s proposal might cause a substantial number of people to lose healthcare coverage.

“In short, we have all seen this movie before,” he said.

Representatives for HHS and New Hampshire Governor Chris Sununu, a Republican, did not immediately respond to a request for comment.

The ruling came in a lawsuit by four New Hampshire residents who alleged HHS had not followed proper rulemaking procedures in approving the state’s plan. The proposal required a waiver from HHS of requirements under the joint federal-state Medicaid program.

HHS approved the states’ projects as part of a push to put a conservative stamp on Medicaid, which expanded in 36 states following the 2010 passage of the Affordable Care Act, popularly known as Obamacare.

Reporting by Nate Raymond in Boston; Editing by Richard Chang

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China detects African swine fever in pigs transported to Liaoning: Xinhua

BEIJING (Reuters) – China detected African swine fever virus in live pigs being transported to the northeastern Liaoning province, the official Xinhua News Agency said on Saturday, underlining the challenge facing Beijing in its bid to control the contagious disease.

Three trucks carrying a total of 205 pigs from provinces was stopped within the jurisdiction of Liaoning, according to Xinhua, adding that 22 pigs were found dead.

African swine fever, for which there is no cure and no vaccine, kills almost all infected pigs but does not harm people. The virus is similar to the strain found in recent years in Russia, Georgia and Estonia.

Since China’s first reported case in August last year, it has spread to every province and beyond China’s borders, despite measures taken by Beijing to curb its advance.

As many as half of China’s breeding pigs have either died from African swine fever or been slaughtered because of the disease, industry insiders estimate.

Reporting by Stella Qiu and Ryan Woo; Editing by Edmund Blair

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Sanofi ends partnership with Lexicon to develop diabetes drug

FILE PHOTO: A logo of Sanofi is pictured during the company’s shareholders meeting in Paris, France, April 30, 2019. REUTERS/Benoit Tessier

(Reuters) – French drugmaker Sanofi SA said on Friday it had terminated its partnership with Lexicon Pharmaceuticals Inc to develop and manufacture a drug for use with insulin in patients with type 1 and type 2 diabetes.

Lexicon shares fell nearly 40% in extended trading.

Sanofi said the termination of the partnership comes after the results of a late stage study of the drug, sotagliflozin.

However, trials of the drug will continue without Lexicon, Sanofi said. [nGNX6l9qVW]

Reporting by Uday Sampath in Bengaluru; Editing by Anil D’Silva

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WHO says e-cigarettes, ‘smoke-free’ products do not help reduce cancer

GENEVA (Reuters) – Electronic cigarettes and heated tobacco products are not helping fight cancer, the World Health Organization (WHO) said on Friday, urging smokers and governments not to trust claims from cigarette firms about their latest products.

FILE PHOTO: The Philip Morris iQOS heat-not-burn electronic cigarette is pictured in this illustration photo April 23, 2018. To match Special Report TOBACCO-IQOS/DEVICE REUTERS/Toru Hanai/Illustration

The seventh “WHO report on the global tobacco epidemic” said blocking the industry’s interference was critical to cutting the harm from tobacco use.

“The tobacco industry has a long history of systemic, aggressive, sustained and well-resourced opposition to tobacco control measures,” the report said.

“While some strategies are public and others more covert… all have the goal of weakening tobacco control.”

The report said tobacco giant Philip Morris International was trying to position itself as a responsible public health partner via its “Unsmoke” campaign, which encourages people to “change to a better alternative”. The WHO said the campaign aimed to ensure tobacco remained socially acceptable, while confusing consumers with terms such as “smoke-free products”, which may refer to products with toxic emissions and unknown short-term and long-term health effects.

Philip Morris spokesman Ryan Sparrow said the WHO’s message made it harder to provide safer options for people who cannot quit smoking.

“There is no question that the best choice for smokers is to quit cigarettes and nicotine altogether. The reality is many people do not. We cannot turn our backs on them,” he said. “Organisations like the World Health Organization need to stop talking at smokers and start listening.”

The WHO report said the industry hoped to win respectability through manipulative messages such as claiming their products were part of a “harm reduction” strategy, even though cigarettes still account for 97% of the global tobacco market.

Vinayak Prasad, programme manager of WHO’s tobacco control unit, said development of new products was solely intended to expand the markets of tobacco firms.

“There is no difference between cigarettes and heated tobacco products except that in terms of exposure: the exposure is less and the smoke is not visible,” he said.

Electronic cigarettes, containing nicotine but not tobacco, were promoted as a way to quit smoking. But there was no evidence to justify the claim, and evidence from the United States showed they had increased the prevalence of young people smoking, he said.

“So it’s also a gateway for young people,” Prasad said.

“The answer is it needs to be regulated. WHO has clear guidelines – to get electronic cigarettes regulated. And if you are banning it, fine, but if you aren’t banning it don’t let it (go) free in the market, because the young people are taking it up.”

Reporting by Tom Miles; Editing by David Evans

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Kids with autism at increased risk of bullying by siblings and classmates

(Reuters Health) – Children with autism are more likely than kids without the disorder to be bullied by siblings and peers in early adolescence, and they may have more psychological and social problems as a result, a new study suggests.

While sibling bullying during childhood has long been linked to increased risk for a variety of mental health difficulties in adolescence, research to date hasn’t offered as clear a picture of how this plays out specifically for youth with autism, researchers note in the Journal of Autism and Developmental Disorders.

For the current study, researchers followed 231 youth with autism and 8,180 without the disorder from middle childhood through early adolescence. Sibling bullying was much more common at age 11, involving about 64% of kids with autism and 48% of children without the disorder. By age 14, bullying involvement declined, affecting 36% of kids with autism and 33% of children without it.

“There is a decrease in sibling bullying involvement from the age of 11 to 14 years for both children with and without autism,” said Umar Toseeb, lead author of the study and a researcher at the University of York in the UK.

“But children with autism are still more likely to be involved in two-way sibling bullying,” Toseeb said by email. “And being involved in sibling bullying at age 11 years is associated with more emotional and behavioral difficulties at age 14.”

Early symptoms of autism can vary but may include repetitive behaviors like hand flapping or body rocking, extreme resistance to changes in routine, and sometimes aggression or self-injury. Behavioral, educational, speech and language therapy may help reduce the severity of autism symptoms in some children – but some symptoms still can lead to difficulties with social and emotional behavior well into adolescence and adulthood.

To understand how bullying impacts the lives of children with and without autism, researchers questioned children about how often they were picked on or purposely hurt by their siblings and peers and how often they were the perpetrators of such acts.

Researchers also asked parents about children’s emotional and behavioral difficulties, such as whether the child was unhappy, downhearted or restless.

Whether or not they had autism, children involved in sibling bullying were more likely to experience emotional and behavioral difficulties, the study found.

But because sibling bullying disproportionately affects kids with autism, they may be harder hit by this exposure over the long term, the authors conclude. This is particularly true for kids with autism who are involved in sibling bullying at home as well as peer bullying at school.

Because sibling bullying disproportionately affects children with autism, the researchers are calling for more resources to help children with autism and their parents identify and deal with bullying behaviors in the home, particularly earlier in childhood.

The study wasn’t designed to prove whether or how bullying might directly impact emotional or behavioral health, or how this might play out differently for kids with autism.

Even so, the results suggest that parents need to recognize the difference between normal squabbling among siblings and bullying, which may involve persistent emotional mistreatment and not necessarily physical aggression, the study team notes.

“Persistent conflicts between siblings may be indicative of sibling bullying and this should not be viewed as a normal part of growing up,” Toseeb said.

SOURCE: Journal of Autism and Developmental Disorders, online July 22, 2019.

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Make sure you’re protected from hepatitis

Did you know there are 5 different types of viral hepatitis? These viruses cause more than one million deaths each year, and that number keeps growing.

Fortunately, Medicare can help keep you protected from Hepatitis B and Hepatitis C, the most common types of viral hepatitis in the United States.

Hepatitis is contagious. The Hepatitis B and C viruses spread through contact with blood or other body fluids of an infected person. These viruses can cause either a mild illness, lasting a few weeks (acute) or a serious long-term illness (chronic) that can lead to liver disease or liver cancer.

Part B covers Hepatitis B shots, which usually are given as a series of 3 shots over a 6-month period. You need all 3 shots for complete protection.

Medicare also covers a one-time Hepatitis C screening test if your primary care doctor or practitioner orders it and you meet one of these conditions:

  • You’re at high risk because you use or have used illicit injection drugs
  • You had a blood transfusion before 1992
  • You were born between 1945 and 1965

If you’re at high risk, Medicare covers yearly screenings.

July 28 is World Hepatitis Day. Learn more about steps you can take to protect yourself from hepatitis.

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Your Go-To Guide To Decode Medical Bills

In 2018 Kaiser Health News and NPR teamed up to create “Bill of the Month,” a crowdsourced investigative series in which we dissect and explain medical bills you send us. We have received nearly 2,000 submissions of outrageous and confusing medical bills from across the country.

Each month we select one bill to thoroughly investigate, often resulting in the bill being resolved soon after the story is published. But what about the large number of Americans who receive surprise medical bills that reporters can’t examine?

Kaiser Health News gives you this user-friendly toolkit to help patients understand some of the ins and outs of medical billing, what to do if you receive a surprise medical bill and things to keep in mind before getting medical care. Here’s your go-to guide to decode medical bills.

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Deployment of second Ebola vaccine would not be quick fix, experts warn

GOMA, Democratic Republic of Congo (Reuters) – The resignation of Congo’s health minister in the midst of the country’s worst Ebola outbreak could clear the way for a second experimental vaccine to be deployed. But the new shot would likely take months to win the trust of frightened locals and show results, health officials say.

FILE PHOTO: A Congolese health worker administers ebola vaccine to a child at the Himbi Health Centre in Goma, Democratic Republic of Congo, July 17, 2019. REUTERS/Olivia Acland/File Photo

Oly Ilunga, who opposed using the vaccine developed by U.S. pharmaceutical giant Johnson & Johnson, resigned as minister on Monday after being bumped off the Ebola response team.

The World Health Organization recommended the two-dose shot to complement a vaccine by U.S. drugmaker Merck, which has proved highly protective but is in relatively short supply.

Proponents, including medical charity Medecins Sans Frontieres (Doctors Without Borders) and the Wellcome Trust, said the new vaccine could be deployed to areas not yet affected by Ebola to create a firewall against the virus, which the WHO declared an international health emergency last week.

But Ilunga said the J&J vaccine had not been proven effective and could confuse people in eastern Democratic Republic of Congo, where wild rumours are hampering the response.

“Congolese have the right to have the gold standard, the best vaccine,” he told Reuters on Thursday, in his first public comments since resigning. “They don’t need to be the subject of experimentation.”

“You can’t have a group of promoters, producers of the vaccine (and) university researchers wanting to introduce the vaccine without contacting the health authorities,” he said, without elaborating further.

Paul Stoffels, J&J’s chief scientific officer, denied there were any efforts to secretly introduce the vaccine and said the company had been in full communication with Congolese authorities.

But scepticism about new medicines can resonate strongly on a continent where some pharmaceutical trials have faced accusations in the past of failing to obtain informed consent and providing subpar care to participants.

For example, some U.S. government-funded trials of HIV drugs in the 1990s were accused of double standards for giving placebos to women in Africa when effective therapies existed, a practice that is not generally allowed in the United States and other Western nations on ethical grounds. Researchers defended the use of placebos as scientifically necessary.

Jean-Jacques Muyembe, an epidemiologist and Ebola expert named to lead Congo’s response team, dismissed Ilunga’s concerns and said authorities would revisit whether to deploy a second vaccine. However, he downplayed the importance of the decision.

“I don’t think that a vaccine is what’s holding back the response,” he told Reuters, noting that previous Ebola outbreaks had been contained quickly without a vaccine.

“We could use or not use. It won’t change the evolution of the epidemic,” he said.


The nearly year-long outbreak has infected more than 2,500 people and killed more than 1,700, numbers topped only by a 2014-16 outbreak in West Africa that killed more than 11,300. This month, a case was detected in Goma, a city of 2 million on the border with Rwanda, heightening fears about the spread of the haemorrhagic fever.

Efforts to contain it have been undermined by mistrust of health workers and violence by armed militias. Treatment centres have been attacked.

Local campaigners say people are scared and confused about the various medicines being used. In addition to the vaccine, four experimental treatments are being given to Ebola patients.

All are still unlicensed, which means they can only be used in clinical trials overseen by Congo’s health ministry.

“We should not introduce a second vaccine when we don’t yet have scientifically-proven conclusions from the one currently being tested,” said Matina Mwanack, the administrator of an advocacy group in the eastern Congo city of Butembo called Families United Against Ebola.

“(We) have suffered a lot from the lack of needed information about the vaccines and treatments being tested.”

Omar Kavota, who heads a group of religious and political leaders in eastern Congo, said “introducing a second vaccine would amplify rumours”, including over why some patients got one while others received the second.

Muyembe said communicators had been appointed to make the process more transparent.


Proponents of a second vaccine argue it can only be tested in a live outbreak, since it would be unethical to deliberately infect trial volunteers. They propose deploying it where the disease has not yet spread, while the Merck vaccine continues to be used to protect contacts of suspected cases.

“Both vaccines should work hand in hand,” said Peter Piot, director of the London School of Hygiene and Tropical Medicine and one of the scientists who first discovered the Ebola virus.

Since the West African outbreak, J&J has tested its vaccine on more than 6,000 volunteers in a dozen trials, confirming its safety and ability to generate an immune response.

It requires two injections 56 days apart – another obstacle cited by Ilunga – in an area where fighting causes frequent displacement, but should last longer.

“The goal is to give a long-term safe profile for people who may never be exposed to Ebola,” said J&J’s Stoffels, adding that 1.5 million doses were available.

Josie Golding, head of epidemics at the Wellcome Trust, said “we could run out of Merck vaccines” if the outbreak extends into a second year. Health authorities have already begun using smaller doses to ration supplies.

FILE PHOTO: Congolese health workers collect data before administering ebola vaccines to civilians at the Himbi Health Centre in Goma, Democratic Republic of Congo, July 17, 2019. REUTERS/Olivia Acland/File Photo

Congo’s health ministry disputes there is a shortage of the Merck vaccine. The company said it expects to have about 900,000 doses available over the next six to 18 months, in addition to the 195,000 doses it has already donated.

The ministry has also considered potential vaccines developed by China’s CanSino Biologics and the Russian research institutes Rospotrebnadzor and Gamaleya, but those discussions are less advanced.

(GRAPHIC: In Africa, a virus spreads:

Mahamba reported from Goma, Kelland from London and Ross from Dakar; Additional reporting by Stanis Bujakera in Kinshasa and Manas Mishra in New York; Editing by Tim Cocks, Alexandra Zavis and Giles Elgood

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