Soweto, South Africa — Daily pills have been available in South Africa for seven years to keep people from contracting HIV. don’t work for them.
These young women are among the most vulnerable women in the world to HIV, the virus that causes AIDS, but the daily pill known as PrEP presents its own challenges, they say. A woman may spend an unexpected night away from home, miss a dose, or forget a day or two. I know. Or their boyfriend sees them taking drugs and becomes suspicious: Is it really for prevention or do they have HIV?
Many young women are starting PrEP (short for pre-exposure prophylaxis). Few people stay on it.
So when Makhandule, a Treatment Action Campaign volunteer, heard a few years ago that PrEP was being tested in clinical trials in South Africa with injections given every two months, his thoughts were: I was. It is private and unseen, and a woman will only have to remember her six times a year.
In clinical trials, injectable PrEP was a huge success, nearly eliminating women’s risk of contracting HIV and found to be 88% more effective than the daily pill. But Soweto still has no trace of an injection.
“It will take time because money is always an issue,” said Makandur, a veteran of South Africans’ fight for access to HIV medicines.
At the Global AIDS Conference, an annual gathering of researchers, policymakers and activists in Montreal last month, talk of PrEP and promises of a long-acting injectable version dominated. With HIV infection rates plateauing in recent years, with approximately 1.5 million new infections per year, injectable PrEP is the first promising new HIV prevention technology in a long time.
“This is perhaps the best moment in the entire history of the AIDS pandemic to rethink prevention and do it with equity and impact,” said Mitchell Warren, executive director of HIV prevention advocacy group AVAC. “History will judge us very harshly if in five or ten years we don’t go back to the AIDS conferences and report low infection rates and the new infection rates really start to decline. ”
Daily use of PrEP reduced infection rates among men who had sex with men in high-income countries. But prophylactic drugs are slow to reach developing countries and have proven much less effective at blocking the virus in most groups, including young women, who account for the majority of new infections in sub-Saharan Africa. increase.
The persistent stigma surrounding HIV and the visibility of the drug is a major deterrent, says Dr. Linda Gale Becker, director of the Desmond Tutu HIV Center at the University of Cape Town.
But the path to delivering a more discreet injectable PrEP to where it’s needed most has proven uncertain.As Makhandule pointed out, cost is a key factor. For over 40 years he has experienced much of the global response to HIV.
The drug that has passed clinical trials is called long-acting cabotegravir, or Cab-LA, and is manufactured by British pharmaceutical company ViiV Healthcare. Japanese pharmaceutical company Shionogi is a shareholder.
The only country that has regulatory approval for Cab-LA is the United States. The Food and Drug Administration approved him for injectable use in December. In the United States, Cab-LA costs $22,200 per patient per year, most likely covered by private insurance plans and Medicaid, which already cover oral PrEP.
fighting HIV
It is estimated that 40 million people worldwide are living with HIV. About 10 million of them do not have access to treatment.
In a happy time following the publication of clinical trial results in 2020, Viiv said it will immediately apply for regulatory approval in all African countries tested.
said Dr. Kimberly Smith, Head of Research and Development at ViiV. She added that ViiV aims to be “non-commercial, non-loss pricing.”
The usual route to expanding access is for the company to license generic drug makers to produce cheaper versions of the injectables for markets such as South Africa. Meanwhile, the company said it would not license generic manufacturers, saying it could not find a partner capable of manufacturing the drug.
ViiV didn’t tell the New York Times what prices it’s proposing in developing countries, but AVAC’s Warren told those the company is working on the rollout. the drug costs $250 per person per year. Its price is much cheaper than in the US, but not cheap enough for countries like South Africa, where hundreds of thousands of doses are needed and oral PrEP is needed. Costs approximately $50 per person per year.
Access to drugs activists angrily responded to the idea that $250 a year was “accessible pricing” and demanded that ViiV commit to voluntary licensing of the drug.
Two days before the AIDS conference started, ViiV announced an agreement with a pharmaceutical patent pool. This is a United Nations-backed non-profit organization that works to make health care and technology more accessible. The agreement will allow up to three generic companies to market the drug in 90 low- and middle-income countries. It takes at least three years for generic drugs to receive regulatory approval. ViiV has also submitted an application for prequalification of the drug to the World Health Organization, which could help expedite these approvals.
Access to drugs activists say limited, voluntary licensing progress is less than ideal.Leena Mengany, head of Doctors Without Borders’ South Asia Access Campaign, said the deal was “limited and disappointing”. said. The organization helped pioneer AIDS treatment in sub-Saharan Africa.
The agreement excludes all countries where ViiV holds patents for Cab-LA. This includes Brazil, where gay men and transgender women have volunteered for trials of the drug.
“ViiV has not learned the lessons of the last 40 years because their pricing strategy is to block rather than immediately communicate access,” said the group Health GAP, which campaigns for access to drugs. Executive Director Asia Russell said. “This is a pandemic-altering intervention where days lost are measured in preventable infections. ViiV must cut prices.”
AIDS researchers and activists believe they are worried about how much the company will make with Cab-LA, as other HIV prevention drugs are also in trials as injectable PrEP. Some of these drugs have longer dosing cycles. That means she can only inject two or three times a year, making it appealing to more women and synchronizing it with injections for contraception. Researchers also believe ViiV may be concerned about US revenue. The United States is usually the most profitable market for companies. Cab-LA costs about the same as the US brand-name oral PrEP drug Truvada, but much cheaper generic oral PrEP is available.
A commodity cost study by the Clinton Health Access Initiative compared Cab-LA to similar products and concluded that Cab-LA can be produced for $16 per patient per year. This is one-third the cost of oral PrEP in South Africa. 800,000 patient volume. That price is probably an estimate for production by a generic manufacturer in India, not his ViiV factory in the UK. An analysis found that the amount of active pharmaceutical ingredient (a significant cost of drug production) for six injections per year would be much less than for 365 tablets.
Dr. Smith of Viiv said the study grossly underestimated costs. “Manufacturing cabotegravir is very complicated,” she said.
At the recent AIDS conference, the world’s leading health organizations announced new collaborations with charities and advocacy groups to expand access to injectable medicines. They will first work on bringing ViiV’s products to the low-income market. Perhaps by negotiating with the company for a guaranteed purchase volume, ViiV could be made to agree to a lower price.
And in the long term, partners will provide funding to help manufacturers of generic versions speed up production. Partners include the Children’s Investment Fund Foundation, which he pledged $33 million to the effort this month, and the Bill & Melinda Gates Foundation.
However, generic manufacturers are keeping an eye on other drugs in their pipelines and can act accordingly. Knowing that, it’s a very real question whether or not we’ll spend the money to make this now,” Warren said.
Another obstacle is that an injectable PrEP program would require funding that exceeds the cost of the drug. Injections must be given by a healthcare professional and will require a syringe and other medical supplies. African governments considering deploying injectable PrEP should seek financial support from multilateral agencies such as the Global Fund to Fight AIDS, Tuberculosis and Malaria to avoid depriving other HIV education and prevention initiatives. will be needed, Russell said.
Donors pledged $14.3 billion to the Global Fund at a conference in New York last week, a significant jump from pledges made by many countries over the past few years, including the United States. Further commitments from Italy and the UK are expected in the coming days, but the fund may still be well short of its $18 billion funding target.
As community health worker Makandur discovered in Soweto, there is excitement across sub-Saharan Africa about the idea of injectable PrEP. But we also need to prove that women want and use it.
“We hear from a lot of young people that this is ideal, and the proof is in the pudding,” said Dr. Bekker. According to her, it is not yet clear whether healthy women will come to the clinic to receive injections every two months. The key is to make the injection available in local clinics and frame it as part of a healthy sex life, not as a drug. associated with risk.
Dr. Smith said ViiV hopes to learn from the history of long-acting injectable contraceptives such as Depo-Provera. Depo-Provera is administered in her four injections per year and is the preferred method of birth control of choice for many women in developing countries. However, due to the unique stigma associated with HIV, there is no guarantee that her bimonthly PrEP injections will be supported.
Warren said the new coalition hopes to have five large-scale projects in different parts of the world by the end of 2023. Participants will be tested to see if they need the drug, take it regularly, or develop drug resistance.
ViiV has committed to supplying the drug only for the first implementation study in South Africa, and no other donor has yet committed to fund it.
“The most important thing is getting this into clinics and people’s hands,” Dr. Bekker said.