For seven years, a daily pill has been available in South Africa to protect people from getting H.I.V., but when Victoria Makhandule, a community health worker, counsels the young women in her township, they tell her
These young women are among the most vulnerable in the world to H.I.V., the virus that causes AIDS, but they say the daily pills, known asPrEP, brings their own challenges. The women may miss a dose or spend an unexpected night away from home. They might have their mothers or cousins look through their drawers for the pills. Do you have H.I.V., or do you take the drug for prevention?
There are a lot of young women here. Few remain on it.
A few years ago, Ms. Makhandule heard that a clinical trial in South Africa was testing a shot every couple of months to see if it worked. A woman would only need to remember it six times a year.
The clinical trial found that the injectionPrEP was more effective than the daily pill and almost eliminated the risk of contracting H.I.V. There isn't any sign of those injections in the area.
Ms. Makhandule said it would take a long time because of money.
The global AIDS conference, an annual gathering of researchers, policymakers and activists, held in Montreal last month, was dominated by talk of pre-exposure prophylactics. In the last few years, the rate of H.I.V. infections has stopped at 1.5 million a year.
Mitchell Warren is the executive director of the H.I.V. prevention advocacy organization AVAC. If we don't see the rate of new infections begin to be pulled down, history will judge us harshly.
The decline in infections among men who have sex with men in high-income countries has been caused by the use of pre-exposure prophylactics. Young women, who make up a majority of new infections in sub-Saharan Africa, have found the prophylactic less effective than before.
The stigma surrounding H.I.V. and the visibility of the drugs are deterrents.
It is not clear how to get a more discreet, injectedPrEP to where it is most needed. Much of the global response to H.I.V. over 40 years has been due to cost.
The drug that aced the clinical trial is called Cab-LA and it is made by a British pharmaceutical company. The Japanese drug company Shionogi is a shareholder in the majority owned ViiV.
The United States is the only country where Cab-LA can be used. Private insurance plans and Medicaid in the US will most likely cover Cab-LA at a price of $22,200 per patient per year.
After the clinical trial results were announced in 2020, the company said that it would apply to have the drug approved in all the African countries where it was tested.
The vaccine studies that have not been successful is one of the reasons why Dr. Smith thinks something dramatic is needed. She said that the price would not be for profit or loss.
The company could license generics makers to make a cheaper version of the drug for markets such as South Africa. In March, the company said it wouldn't be giving licenses for generics for the foreseeable future.
The New York Times was not told the price of the drug in developing countries. It's not enough for a country like South Africa, which needs to administer hundreds of thousands of doses and has a cost of about $50 per person per year.
Drug access activists demanded that ViiV commit to voluntary licensing of the drug after they were told that $250 a year was accessible pricing.
The Medicines Patent Pool is a United Nations backed nonprofit that works to make medical treatment and technologies accessible. The drug can be made for sale in 90 low- and middle-income countries. It will take at least 3 years for a generic to be approved. The World Health Organization has the power to help speed up the approval of drugs.
Drug access activists said the voluntary license progress was not ideal. The agreement was limited and disappointing according to Leena Menghaney, who leads the South Asia access campaign. AIDS treatment in Africa was pioneered by the organization.
Brazil is one of the countries where gay men and trans women volunteered for the trials in which the drug was tested.
Asia Russell is the executive director of the group Health GAP which campaigns for drug access. Any day lost is a measure of preventable infections. The price must be slashed by viiV.
The company is worried about how much it will make on Cab-LA because other H.I.V. prevention drugs are in trials as well. Some of the drugs could be injected only two or three times a year, which would appeal to more women, and could be used with contraceptives. Researchers think that the company might be concerned about what it would make in the United States. In the United States, Cab-LA costs roughly the same as the brand-name drug Truvada, but a much cheaper generic is available.
A cost-of-goods study by the Clinton Health Access Initiative concluded that Cab-LA could be produced for one-third the cost of oral contraceptives in South Africa. The price is likely to be found in India, not in Britain. The amount of active pharmaceutical ingredient for six injections per year would be less than the amount in a single pill.
The study underestimated the cost, according to Dr. Smith. She said that cabotegravir manufacturing is complex.
At the recent AIDS conference, major global health agencies announced a new collaboration with charitable agencies and advocacy groups. The first thing they will do is negotiate with the company over guarantees for purchase volumes that will entice it to agree to lower prices.
Funding will be provided to help the makers of generic versions speed up the manufacturing process. The Children's Investment Fund Foundation is one of the partners.
Generics makers could act on the other drugs that were in the process of being developed. If you know that there may be a product that supersedes this in three to five years, it's a very real question if you spend money to make this one now.
Funding for more than just the cost of the drug is one of the obstacles to overcome. Health care workers would need to give the shots and there would be other supplies needed. The Global Fund to Fight AIDS, Tuberculosis and Malaria would need financial support from other agencies in order to not take funds from other H.I.V. initiatives.
Many countries, including the United States, raised pledges to the Global Fund at a meeting in New York last week. The fund is likely to fall short of its funding target of $18 billion due to further commitments from Italy and Britain.
Ms. Makhandule, the community health worker, found that there was a lot of excitement about the idea of injections. There needs to be proof that women will use it.
The proof is in the pudding according to Dr. Bekker. It's not certain that healthy women will show up at a clinic every two months to get the shot, she said, and the key would be making it available in community clinics and framing it as part of a healthy sex life.
Many women in the developing world choose to use long-acting contraceptives such as Depo- Provera, which is delivered in a shot four times a year, as their preferred method of birth control. Because H.I.V. has a unique stigma, there is no guarantee that bimonthly shots will be popular.
The coalition hopes to have five large projects in different parts of the world by the end of the year. Sex workers and teenage girls would be tested to see if they want the medication and if they will take it regularly.
The drugs will only be supplied for an initial implementation study in South Africa.
Getting this out there, into clinics and into people's hands is the most important thing.
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