SOWETO, South Africa – For seven years, a daily pill has been available in South Africa to protect people from HIV. But when Victoria Makhandule, a community health worker, counseled young women in her town about the drug, they told her no. don’t work for them.
These young women are among the most vulnerable in the world to HIV, the virus that causes AIDS, but they say the daily pills, known as PrEP, present challenges for the government. surname. The women may spend an unscheduled night away from home and miss a dose, or forget for a day or two. Or their mother or cousin snooping in their drawers, finding the pills and knowing their business. Or their boyfriend sees them taking the drug and suspects: Is it really prevention, or do you have HIV?
A lot of young women here are starting PrEP (short for pre-exposure prophylaxis). Few people stay on it.
So when Ms Makhandule, a The Treatment Action Campaign volunteer, heard a few years ago that a clinical trial in South Africa was testing PrEP as a shot given every two months, she thought: This is the solution we need. It will be private and invisible, and a woman will only need to remember it six times a year.
Clinical trials show injectable PrEP a great success, which virtually eliminates a woman’s risk of HIV transmission and is 88% more effective than the daily pill. But still no sign of those injections in Soweto.
“It will take a long time because money is always an issue,” said Makhandule, a South African veteran of the fight for access to HIV medicines.
The talk about PrEP — and the promise of an injectable, long-acting version — dominated the global AIDS conference, the annual meeting of researchers, policymakers and activists, held. held in Montreal last month. HIV infection rates have skyrocketed in recent years, at about 1.5 million new infections each year, and injectable PrEP is the first promising new HIV prevention technology in a long time.
“This is the best opportunity we’ve ever had, in the entire history of the AIDS pandemic, to reimagine prevention,” said Mitchell Warren, executive director of HIV advocacy organization AVAC. and do it in a fair and impactful manner. “History will judge us very harshly if in five or 10 years we go back to AIDS conferences and report on low levels of uptake, and if we don’t see new infection rates start really down.”
PrEP taken as a daily pill has reduced infection rates among men who have sex with men in high-income countries. However, prophylactic drugs are slow to reach developing countries and are less effective at stopping the virus in most groups, including young women, who account for the majority of new infections. in sub-Saharan Africa.
Dr Linda-Gail Bekker, director of the Desmond Tutu HIV Center at the University of Cape Town, said:
But the path to a more discreet, injectable PrEP where it’s needed most is proving uncertain. As Ms. Makhandule notes, cost is an important factor – as it has been through most of the global response to HIV for over 40 years.
The drug that has been successful in clinical trials is called long-acting cabotegravir, or Cab-LA, and it is manufactured by British pharmaceutical company ViiV Healthcare. ViiV is majority owned by pharmaceutical giant GSK, with Pfizer and Japanese pharmaceutical company Shionogi as shareholders.
The only country where regulators have approved Cab-LA is the United States; The Food and Drug Administration approved the injection in December. Cab-LA costs $22,200 per patient per year in the United States and will most likely be covered by private and insurance plans. Medicaid pays, covered oral PrEP.
The fight against HIV
An estimated 40 million people are living with HIV worldwide. About 10 million of them do not receive treatment.
During the excitement period after the clinical trial results are announced in 2020, Viiv said that it will apply immediately for the drug to be approved by regulatory authorities in all European countries. Africa where it is tested.
Dr Kimberly Smith, ViiV’s head of research and development, said: “With all the frustrations we’ve had to go through, including unsuccessful vaccine studies, it’s clear they I have to do something impressive, and this has the potential to be dramatic. ” She added that ViiV will aim for a “no profit, no loss” price.
The usual route to expanding access is for the company to license generic drugmakers to produce cheaper injectable versions for markets like South Africa. But in March, Viiv announced that it would not license generic drug makers for the foreseeable future, saying the company could not find a partner capable of producing the drug.
ViiV won’t tell The New York Times what rates it is offering in developing countries, but AVAC’s Warren says the company has told people working on the rollout that they expect the drug will cost 250 dollars per person per year. While that price is much lower than in the United States, it’s not nearly low enough for a country like South Africa, which requires hundreds of thousands of doses and where oral PrEP is costs about $50 per person per year.
Drug access activists reacted angrily to the idea that $250 a year was “accessible” and demanded that ViiV commit to voluntary licensing of the drug.
Two days before the AIDS conference began, ViiV announced an agreement with the Drug Patent Foundation, a United Nations-backed non-profit organization that works to make treatment and technology available. accessible healthcare. The agreement allows up to three generic drug companies to manufacture drugs for sale in 90 low- and middle-income countries. It will take at least three years for a generic drug to be available for regulatory approval. ViiV has also applied to the World Health Organization for drug prequalification, which could help expedite those approvals.
Anti-access drug activists call the evolution of limited voluntary licensing less than ideal. Leena Menghaney, Médecins Sans Frontieres’ South Asia outreach campaign leader, said the deal was “limited and disappointing”. This organization has helped pioneer the treatment of AIDS in sub-Saharan Africa.
Agreement eliminates all countries where ViiV holds patents for Cab-LA – including Brazil, where gay and transgender women volunteer to participate in trials in which the drug is tested .
Asia Russell, executive director of the Health GAP group, which organizes the drug access campaign, said: “ViiV has failed to learn its lesson over the past 40 years because their pricing strategy has been to hinder change from the very beginning. for communicating accessibility. “This is a pandemic-changing intervention, and any days lost count in preventable infections. ViiV must reduce the price”.
AIDS researchers and activists believe the company is worried about how much money they can make from Cab-LA because other HIV prevention drugs are also being tested such as injectable PrEP. Some of these drugs have longer dosing cycles – meaning they can only be given two or three times a year, which will likely appeal to more women and can be synced up with shots pregnant. The researchers also believe that ViiV may be worried about what it will earn in the United States, often the company’s most lucrative market. Cab-LA is about the same price as the brand-name oral PrEP Truvada in the United States, but a much cheaper generic oral PrEP is available.
A cost of goods study by the Clinton Health Access Initiative compared Cab-LA to similar products and concluded that Cab-LA could be profitably produced for $16 per patient per year. – one third of the cost of oral PrEP in South Africa – assuming a volume of 800,000 patients. That price is estimated for production by a generic manufacturer, most likely in India, not at ViiV’s factory in the UK. The analysis notes that the number of active pharmaceutical ingredients – a key cost in drug production – for six injections per year would be much lower than in 365 pills.
Dr Smith of Viiv said the study seriously underestimated the cost. “The complexity of the cabotegravir manufacturing process is substantial,” she said.
At the recent AIDS conference, major global health authorities announced new partnerships with charities and advocacy groups to try to expand access to injectable drugs. They will first work on getting ViiV’s products into low-income markets, most likely by negotiating with the company about guarantees for the volume of purchases that could lead the company to agree to lower prices. .
And in the longer term, the partners will provide funding to help manufacturers of generic versions speed up production. Partners include the Children’s Fund, which has pledged $33 million to the effort this month, and the Bill & Melinda Gates Foundation.
But generic drug manufacturers will monitor other drugs during the manufacturing process and may act accordingly. “If you’re a company in general and you know there might be a substitute for this product within the next three to five years, it’s a very real question of whether you’re going to spend the money to create one. this product now or not,” Warren said.
Another impediment is that injectable PrEP programs will need to fund more than the cost of the drug. The injections will need to be administered by medical staff and will require syringes and other medical supplies. Ms. Russell said that African governments considering injecting PrEP would need financial support from multilateral agencies such as the Global Fund to Fight AIDS, Tuberculosis and Malaria, in order not to draw funding from other countries. other HIV prevention and education initiatives.
Donors pledged $14.3 billion to the Global Fund at a meeting in New York last week, with many countries, including the United States, significantly raising their pledges compared to those committed that they have done in previous years. While further commitments are expected in the coming days from Italy and the UK, the fund is still likely to fall significantly short of its funding target of $18 billion.
As Ms. Makhandule, a community health worker, noticed in Soweto, across sub-Saharan Africa there is excitement about the idea of injecting PrEP. But it also needs to be proven that women will want and use it.
“We hear from many young people that this would be ideal, but the proof is in the pudding,” says Dr. Bekker. It is far from certain that healthy women will visit the clinic every two months for vaccinations, she said, and the key will be to make the drug available in community clinics and make it part of life. Live a healthy sex life rather than a drug. associated with risk.
Dr Smith said ViiV hopes to learn from the history of long-acting injectable contraceptives such as Depo-Provera, which is injected four times a year and is used by many women in the developing world. choose as their preferred method of birth control. . But there is no guarantee that bimonthly PrEP injections will be preferred because HIV has a stigma of its own.
Warren said that by the end of 2023, the new alliance hopes to have five major projects in different regions of the world. Each project will have about 50,000 participants, including sex workers and underage girls, and will test whether they want to take the drug, take it regularly, or develop drug resistance.
ViiV has committed to providing the drug only for an initial implementation study in South Africa, and no sponsor has yet committed to fund another.
“The most important thing is to get this out there, into the clinics and into the hands of people,” Dr. Bekker said.