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A new drug could save the lives of 25,000 women living with HIV but could it be at the cost of their baby's life?
It was Friday afternoon and Rebecca Zash thing between her and the weekend. She boarded a commuter train from downtown Boston and searched for her computer.
For nearly four years, Zash, associate director of global health programs at the Beth Israel Deaconess Medical Center in the United States of America, had been investigating how mothers and babies in Botswana were shooting at antiretrovirals (ARVs).
On Zash's computer, were the latest data from eight sites in the country.
In 2016, the country became the first in sub-Saharan Africa to start a new ARV, dolutegravir. It would replace an older drug, efavirenz – associated with more side effects – as part of the standard three-drug HIV treatment course.
Data on dolutegravir appeared excellent, and months later, Brazil announced its intention to deploy the drug. The countries of the world would soon start to see how they could also use the new drug.
But something was missing. Because pregnant women pose ethical challenges to researchers, they are generally not included in clinical trials, as are children. Almost no drug (97%) approved for use in the United States between 2000 and 2010 was not tested to see if they posed a risk for fetal development, research published in 2011 in the American Journal of Medical Genetics.
(WHO) thought that Botswana offered a chance to fill the gaps, so they asked Zash and his team to compare the mothers' results on the new drug with those of efavirenz.
"We said [to the WHO] [women] we do not think that will tell you much," Zash recalls.
"They said, you know what, we really need everything we have."
New dawn, new ARVs: Countries around the world were planning to drop old HIV treatment courses for the next big thing, dolutegravir. (Thomas Mukoya, Reuters)
In March 2016, doctors, nurses and researchers sat in a dimly lit room on the fifth floor of the Sandton Convention Center in Johannesburg. Their eyes were glued to a projection screen. Jan van Lunzen, medical director of pharmaceutical company ViiV Healthcare, stood on one side bathed in a bluish glow of his PowerPoint slides projected on the screen. He was talking about a new drug that would soon be on the market in South Africa
It was dolutegravir
When doctors replaced efavirenz with dolutegravir as part of ### 39, a combination of three drugs, he said, about 10% more patients were bringing down the amount of HIV virus in their blood to levels so low that they were undetectable by laboratory standards. Van Lunzen cited a study presented at the 2012 Interscience Conference on Antimicrobial Agents and Chemotherapy.
Patients who tolerate this low level of HIV in the blood, also known as viral suppression, can not sexually transmit the virus. In addition, Van Lunzen told clinicians that the drug could be taken without food and that it was more tolerant than other ARVs when it involved missed doses, which made it less likely to lead to drug resistance. Journal of Antimicrobial Chemotherapy.
Dolutegravir also had fewer side effects than efavirenz. In clinical trials, up to half of people treated with efavirenz reported side effects such as hallucinations, nightmares, and depression during the first few months after starting treatment. The new miracle drug allowed patients to measure the number of CD4s – a measure of their immune system strength – to bounce back faster after the start of treatment, according to presentations made this week at the 22nd International AIDS Conference in Amsterdam. Workers quickly began to demand access to the drug that Van Lunzen said was on the market in a few months in the private sector.
The World Health Organization (WHO) had already included the drug in the standard recommended by HIV. treatment regimen in the 2016 guidelines after reviewing 71 clinical trials conducted with approximately 34,000 patients. According to a WHO study presented at the conference, people taking dolutegravir were less likely to stop treatment than patients taking efavirenz.
The United Nations also found that the new wonder drug was allowing patients' CD4 count – a measure of the strength of their immune system – to bounce back faster once they started the treatment, according to the presentations of the conference.
But of course, very few of them included pregnant women. we, without us: the protesters demand access to dolutegravir and the right to resist the ultimatums that oppose them the right to a better treatment against their right to choose what kind of contraception suits them best. (Marten van Dijl)
On a commuter train from Boston, on the east coast of the United States, Rebecca Zash sat in her seat and opened her laptop. The deadline for her latest analysis for the WHO comparing how pregnant women fought over the new drug compared with efavirenz was in two weeks and she had delayed start-up. She thought that she could go through a preliminary analysis before going home.
"I thought, okay, I'll finish this," she recalls
"Then I watched the analysis. "
Four of the 426 women in Botswana who had conceived while taking dolutegravir had given birth to babies with severe malformations, known as neural tube defects, that affected the spine and skull, and three of the babies had died.
But women who had started pregnancy while they were already pregnant did not show such signs – something had to happen in the first 28 days of pregnancy. "And the analysis was -exactly?
As the city passed the windows, Zash crunched the numbers over and over again until she got off the train.
"I panicked," remembers she "I was just saying [to myself] that someone else needs to tell me that I did well, that I was not mistaken.
" J & # 39; I sent an email to everyone. "
Zash spent Saturdays and Sundays with his children, checking his email every three minutes.
On Monday, Lewis Holmes, a geneticist and researcher at the Massachusetts General Hospital, had called:" That looks like something you need to point out. "
Shortly after, on May 18, 2018, the WHO issued a warning: Pregnant women under dolutegravir should continue to take the drug, but pregnant women would ensure that "consistent contraception" should return to the old regime. Drug regulators from the United States and Europe followed with similar precautions.
Since May, Zash and his team have followed 173 more mothers who conceived during dolutegravir, no more congenital malformations.It is still too early to say it, explains Zash: "This is preliminary: we do not know exactly how to explain it and if it is not possible. is a real [side effect of the drug] or not. "
South Africa already has a task force that is looking at what a call for tenders could look for the new drug – and the cost, which is not a small factor for a nation that expects to pay -billion for the treatment of HIV by 2033, according to the 2015 estimates contained in the Department of Health's investment report.
A new modeling presented at the Amsterdam conference suggests replacing old efavirenz with dolutegravir would double the percentage of new infections averted between 2019 and 2038. dolutegravir would also be more effective in reducing the number of AIDS-related deaths and save money Almost immediate costs, said Gesine Meyer-Rath of the Research Bureau of Economics and Epidemiology of Health at the University of Witwatersrand found Meyer-Rath is based at the office of research in eco health and epidemiology of the university.
A separate modeling study conducted by the US Medical Practice Evaluation Center predicted that the change would prevent more than 25,000 deaths of women between the ages of 15 and 49 years. countries with stubbornly high maternal deaths. This would also prevent 5,000 more infections from mother to child.
But the researchers warned that if a link between dolutegravir was true, it could also lead to more deaths in children. At the same time, he could only save three times more women
But framing it as a decision on life to save is risky, warn experts and activists.
"Do not complain about our children," Martha Akello of the International Community of Women Living with HIV says, "Some HIV-positive women absolutely want to have babies, it's a motivation for us to live another day, to live for tomorrow and to see their children graduate. Life, "she explains
" Women living with HIV are not homogeneous, I could have finished having children … I could be of childbearing age and not want to to have children. . "
But the real choice is to be able to offer women on dolutegravity access to contraception – if they want it. A fact more and more complicated by the gag rule of the US government, which has closed hundreds of clinics in Southern Africa alone, the organization of Reproductive Health Population Services International told Bhekisisa in February.Also known as the Mexico City Policy , the rule of gag cuts American funding to any organization that promotes abortion as part of sexual and reproductive health services, even if it is by referring women to other organizations for the There is a link between dolutegravir taken very early in pregnancy and congenital malformations, so more women may need abortions or information to avoid having to give fetuses. stillbirths or severely deformed – conditions that make them candidates for abortion.
"That's precisely what the world's gag rule is mine.
For Linda-Gail Bekker, Deputy Director of the South African HIV Center Desmond Tutu, the issues surrounding the safety of dolutegravir luck for the world to take action on birth control.
"We can find, as other cases of pregnancy arrive, it is nothing [and there is no link between dolutegrevir and birth defects]. There is really something out there, in which case we will have to understand what we are doing with women who have fertility intentions, "says Bekker.
"In any case, we should treat women better than in our clinics. For too long, we have considered HIV irrespective of sexual reproductive health and that makes absolutely no sense. South Africa, meanwhile, is approaching the eighth month of a national birth control shortage.
Zash's unexpected discoveries triggered a chain reaction and global conversation about the choice: How countries will choose to weigh the pros and cons of the new drug and how much choice they will give women access .
Seventy-one nations have already included dolutegravir in standard HIV treatment, according to the data presented. In the aftermath of Zash's discovery, almost one in five of these countries has now completely banned dolutegravir to women of reproductive age or made access to long-acting contraception conditional.
Less than a handful are even willing to discuss options with women as per their guidelines, leading many to wonder if women living with HIV are offered a real choice about A in a recent survey WHO has asked HIV-positive women how they would respond if they received an ultimatum: No contraception, no dolutegravir.
Nearly 60% of women said that they wanted Doherty said, "The WHO is softening the previous messages on dolutegravir in the new HIV guidelines released this week. The document still carries a warning about the ARV and says that women should be counseled about its risks but the body has not banned women from taking it. But at the launch of the guidelines, more than a dozen activists, including women living with HIV, marched through the halls of the RAI convention center's air-conditioned room in the south from Amsterdam
on the cellphone, using the common abbreviation for dolutegravir "DTG".
Executive Director of the International Health Gap Organization Asia Russell says that the WHO is actually not enough to say to countries like Malawi, Uganda, and Tanzania Doldegravir for women of childbearing age goes against the recommendations of the WHO
"Many high-burden countries have already decided that women under 50 should not receive dolutegravir. Russel explains, "Countries are partly," she says, weighing the benefits of giving the drug to information – pregnant women, including a cheaper and milder treatment, with possible risks for fetuses.
There are two ways to do this: General prohibitions – or empowering health workers to talk to women
Russell says, "Maybe the doctor is very worried – and doctors often worry about fetus. Then a woman says, I will not get pregnant, so thank you very much for your concern, I always need to dolutegravir. "
But she says that fear is not the only motivation:" It's a lack of confidence. In the end, the decision will be in the hands of a woman – she will come out of the clinic and take the drugs and it must be believed that she calculates the risks that make sense to her. You might not understand it.
"There are so many other things involved in [women’s choices] that just the pregnancy part in deciding on HIV treatment," says Zash. Zash has just finished her second panel of the day: the queue of people waiting to talk to her at five points deep … Half an hour later, she finally frees herself and goes down the alley of the 39, auditorium with 300 seats. 19659011] A colleague bends over and jokes, "Becca, it's all your fault."
"We also presented data on pregnancy at the last AIDS conference – at the time it seemed like nobody cared." 19659069] Since the day in the train, she says that his thinking went from initial shock and panic to focusing on one thread: Choice
"At first I thought of that as someone who was pregnant on the train. gone so far: How I would have felt knowing this and the decisions that I would have probably made and how I do you "So, I started thinking a lot more about what it would be like not to be me. There are so many other things involved in [women’s choices] that just the part of pregnancy in deciding on HIV treatment. "
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