Early results from a nuclear test of an HIV prevention injection announced by researchers from the University of the Witwatersrand on Tuesday are described as a ‘game changer’ to turn ‘the tide on HIV’. This is according to Professor Helen Rees, Executive Director of the Wits Reproductive Health and HIV Institute (WRHI), who announced the results via an online information session.
The study, called HPTN084 and led by the HIV Prevention Trials Network (HPTN), tested an antiretroviral (ARV) injection given every two months and compared it to the current standard of drug prevention, which is in the form of a daily oral pill occurs. The injection must be given by a healthcare professional.
Both of these options fall into the category of pre-exposure prophylaxis (PrEP) – using treatment to prevent HIV infection.
The long-acting injection, which contains the antiretroviral drug cabotegravir, is 89% more effective in the study to prevent HIV in women compared to the daily pill, which contains a combination of the drugs tenofovir and emtricitabine.
“This is the first time the world has seen such an important impact on HIV prevention for women,” said Wits’ Dr. Sinead Delany-Moretlwe, who was at the head of the trial, said.
She said that a ‘well-accepted’ HIV prevention option for women is critical, as this group accounts for more than half of the new infections in sub-Saharan Africa and that ‘women bear a disproportionate burden’.
If taken daily in a timely and prescribed manner, oral treatment has been found to be almost 100% effective in preventing HIV. But there are myriad reasons why women are found to struggle to use pills daily, including stigma from partners or family members who see their pills.
This is why these findings are so important for an injectable option, especially for local women.
The HPTN 084 study enrolled 3,223 HIV-negative women in Botswana, Eswatini, Kenya, Malawi, South Africa, Uganda and Zimbabwe. Women were assigned to a trial arm who received the oral drug, or one who received the injection.
A total of 38 women contracted HIV during a period of approximately two years of follow-up. Only four of these new infections were from the arm that received the injection, while 34 from the arm that received the pill.
This equates to an incidence, or rate of new infections, of 1.79% in the oral treatment group versus 0.21% in the injectable group, with an overall average incidence of 1%, a particularly low figure for young women in the region.
‘I’m glad to tell you that … both options work well, but [the injectable] works so much better, ”said Delany-Moretlwe.
The results are so promising that the control arm, which receives the preventative pill, has been discontinued because it is no longer considered ethical to give women a treatment option that has been proven to be less effective than the injection.
In a press release from Wits, she added: “We know that adhering to a daily pill is still challenging, and an effective injectable product such as long-acting kabotegravir is a very important HIV prevention option. We are grateful for the women. who presented for this study and the research staff, as this study would not have been possible without their commitment to HIV prevention. ‘
Compliance with the effectiveness of medicines
The researchers did not have enough information to determine the role that compliance with the actual drug efficacy played in achieving these results. In other words, it is not entirely clear whether there would still be a significant difference between the study arms if everyone took the prescribed pill every day as prescribed – something that can be difficult for some people.
According to Delany-Moretlwe, the drug levels in the blood of both study arms indicated that compliance was good, not only in the injectable group as expected, but also in the group taking daily pills. However, she said the researchers think an important factor in the difference between the two arms probably amounts to compliance.
The World Health Organization (WHO) said in a statement that these results do not contradict the evidence that the use of oral PrEP is consistently very effective, as evidenced by several trials. “Adherence to the daily schedule is important, however. Even short delays in taking PrEP can reduce protection against HIV acquisition,” the WHO said.
Side effects, or the reporting of negative or unwanted side effects, were low in both study groups.
“These results are a milestone for HIV prevention among women at risk of HIV worldwide and especially for women in sub – Saharan Africa. If we want to stop the HIV epidemic, we will need prevention options that work for women. “Sub-Africa. -Saharan Africa. These findings offer great hope and motivation for additional studies to show safety and acceptability in adolescents, pregnant and breastfeeding women,” Rees said.
“After years of evaluating HIV prevention strategies for women, I am delighted that we have found CAB LA [long-acting cabotegravir] thus effectively reducing HIV acquisition and offering more choices for women to protect themselves, “said Dr Mina Hosseinipour, co-chair of the study, in a press release from HPTN.
As in the case of contraception, it has been found that the more prevention options people have, the more people will use them.
“We know that the right choice depends on providing women with complete information – and all men – about the risks and benefits, pros and cons of different methods, and making sure these methods are available for people to use. “an excellent choice for some people; for others, daily oral PrEP or the Dapivirine vaginal ring is the right strategy to reduce HIV risk. A new HIV prevention option for women is a cause for celebration,” said Chilufya Kasanda Hampongo, a Zambian women’s health, said. pleads with the Campaign for Treatment and Literacy (TALC) in a press release published by advocates for HIV prevention to end AIDS.
Access to questions
Although the HIV community has reason to celebrate, there are still questions about access, as it is still unclear how much the injectable treatment will cost and whether low- and middle-income countries that need it the most will be able to afford it.
The manufacturer of the Cabotegravir, ViiV Healthcare, has not yet announced its price, but has indicated that it will make access a priority, according to Delany-Moretlwe.
At the press conference, she said that “access is an important commitment by ViiV Healthcare and we look forward to hearing more”. She estimates that it may take about two years before the injection reaches women outside the study. She said that the ‘important questions we have to ask in the meantime as we move forward’ and wait until the medicine is licensed after approval of international and local regulations, must be ‘to understand what the cost is going to be’.
Although costs are a concern, Mitchell Warren, AVAC, warns the HIV community to be vigilant if access is delayed, as has historically been the case.
‘The urgent job now is for policymakers, funders, program implementers and communities to design and build HIV prevention programs and health systems that can deliver the growing range of biomedical PrEP options, including oral, vaginal rings and injectable drugs, can make choices. for all people at risk of infection. This is essential work that can and should start now, while we wait for further data, revision of the regulations and potential normative guidelines. The key to these efforts is to ensure that we do not repeat the delays that have been delayed in daily oral PrEP implementation over the past eight years, ‘he said in a statement.
The WHO pointed out that before the injection can be available to people outside the HPTN 084 study, the test results must be fully reviewed and submitted to a strict regulatory authority for approval. “CAB LA and manufacturing capacity need to be developed. There are also other safety and implementation issues that need to be considered before a broader implementation is done. Safety studies in adolescents and among pregnant and breastfeeding women will be needed and open-label extension studies (OLE) ‘must be considered to understand the most effective and acceptable implementation approaches,’ ‘the WTO said.
In South Africa, the South African Health Products Regulatory Authority must be registered before it can be made available.
Role of universities
Professor Zeblon Vilakazi, vice-chancellor and principal of Wits, said these results show ‘the important role that research entities and research-intensive universities play in transforming society and saving human lives’.
“This incredible breakthrough will definitely save the lives of many women living in sub-Saharan Africa, and beyond,” he said.