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Members and supporters of the Treatment Action Campaign are addressing the Constitutional Court in Johannesburg on December 10, 2018 to thank him for what he has done for people living with HIV. (Photo: Gallo Images / Netwerk24 / Felix Dlangamandla)
The first results of a pivotal trial of an HIV prevention injection announced by researchers at the University of the Witwatersrand on Tuesday have been hailed as a “game changer” to change “the course of HIV.” This is according to Professor Helen Rees, executive director of the Wits Institute for Reproductive Health and HIV (WRHI), who announced the results via an online press conference.
The study, called HPTN084 and led by the HIV Prevention Trials Network (HPTN), tested an antiretroviral (ARV) injection given every two months against the standard prevention drug that comes in the form of a daily oral pill. The injection must be administered by a healthcare professional.
Both options fall into the category of pre-exposure prophylaxis (PrEP), which consists of using a treatment to prevent HIV infection.
The long-acting injection, containing the antiretroviral drug cabotegravir, was found to be 89% more effective in the study at preventing HIV in women compared to the daily pill containing a combination of the drugs tenofovir and emtricitabine.
“This is the first time the world has seen such important HIV prevention outcomes for women,” said Dr. Sinead Delany-Moretlwe of Wits, who led the trial.
She said that having a “well accepted” HIV prevention option for women is critical, considering that this group accounts for more than half of new infections in sub-Saharan Africa and that “women bear a disproportionate burden.”
If taken every day, on time, and as prescribed, the oral regimen has been found to be nearly 100% effective in preventing HIV. But there are countless reasons why women have been found to have a hard time complying with daily pill-taking, including stigma from their partners or family members who view their pills.
This is why these findings for an injectable option are so important.
The HPTN 084 trial enrolled 3,223 HIV-negative women in Botswana, Eswatini, Kenya, Malawi, South Africa, Uganda, and Zimbabwe. Women were assigned to the trial upon receiving the oral or injected ‘arm’ drug.
A total of 38 women contracted HIV during a period of approximately two years during follow-up. Only four of these new infections were from the arm that received the injectable, while 34 were 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 compared to 0.21% in the injectable group, with an overall average incidence of 1%, a remarkably low figure for women. young women of the region.
“I’m happy to tell you that … both options work fine, but [the injectable] it works so much better, ”Delany-Moretlwe said.
The results are so promising that the control arm, which received the preventive pill, was discontinued because it was no longer considered ethical to provide women with a treatment option that has been shown to be less effective than the injection.
In a Wits press release, he added: “We know that adherence to a daily pill remains a challenge, and an effective injectable product like long-acting cabotegravir is a very important additional HIV prevention option for them. We thank the women who volunteered for this study and the research staff; this study would not have been possible without their commitment to HIV prevention ”.
Adherence versus drug efficacy
The investigators do not have enough information to delineate what role adherence played versus the actual efficacy of the drug in achieving these results. In other words, it is not entirely clear whether there would still be a significant difference between the study groups if they all took the preventative pill every day as prescribed.
According to Delany-Moretlwe, the drug levels in the blood of both arms of the study suggested that adherence was good, not only in the group of injectables as expected, but also in the group taking daily pills. However, he said the researchers believe that an important factor in the difference between the two arms is likely due to adherence.
The World Health Organization (WHO) said in a statement These results do not contradict the evidence showing that consistent use of oral PrEP is highly effective, as has been shown in several trials.
“However, it is important to adhere to the daily dosing schedule. Even short lapses in taking oral PrEP can reduce protection against acquiring HIV, ”WHO said.
Adverse events, or the reporting of negative or unwanted side effects, was low in both study groups.
“These results are a milestone for HIV prevention among women at risk for HIV around the world and especially for women in sub-Saharan Africa. If we want to turn the tide of the HIV epidemic, we will need prevention options that work for women in sub-Saharan Africa. These findings provide great hope and motivation for further studies demonstrating safety and acceptability in adolescents, pregnant and lactating women, ”Rees said.
“After years of evaluating HIV prevention strategies for women, I am delighted to have found CAB LA [long-acting cabotegravir] it effectively reduces HIV acquisition and gives women more options on how to protect themselves, ”said Dr. Mina Hosseinipour, study protocol co-chair, in an HPTN news release.
As is the case with contraception, it has been found that the more prevention options people have access to, the more they will use them.
“We know that the real choice depends on giving women, and everyone, complete information about the risks and benefits, the pros and cons of different methods, and making sure those methods are available for people to choose. . An injectable will be a great option for some people; for others, daily oral PrEP or the dapivirine vaginal ring will be the appropriate strategy to reduce the risk of contracting HIV. A new HIV prevention option for women is cause for celebration, ”said Chilufya Kasanda Hampongo, Zambian women’s health advocate with the Treatment Promotion and Literacy Campaign (TALC) in a press release published by Advocates for HIV Prevention to End AIDS (AVAC). .
Access questions
While the HIV community has real reason to celebrate, more questions remain about access because it is not yet clear how much the injectable regimen will cost and whether low- and middle-income countries, which need it most, will be able to afford it.
Cabotegravir maker ViiV Healthcare has yet to announce its pricing, but has indicated that it will make access a priority, according to Delany-Moretlwe.
Speaking at the press conference, he said that “access is an important commitment made by ViiV Healthcare and we are looking forward to hearing more.” She estimated that it could take about two years for the injectable to reach women outside of the study. He said that the “important questions to ask ourselves in the meantime [wait for the drug to be licenced following international and domestic regulatory approvals]It must be to understand what the costs will be ”.
While cost is a concern, AVAC’s Mitchell Warren cautions the HIV community to be vigilant if access is delayed, as has historically been the case.
“The urgent work now is for policymakers, funders, program implementers and communities to design and build HIV prevention programs and health systems that can deliver the growing variety of biomedical PrEP options, including the oral ring. , vaginal and injectable, and make them feasible options for all people at risk of infection. This is essential work that can and should begin now, while we await more data, regulatory review, and possible regulatory guidance. The key to those efforts will be to ensure that we do not repeat the delays that have slowed daily oral implementation of PrEP for the past eight years, “he said in a statement.
The WHO noted that before the injection is available to people outside of the HPTN 084 study, the trial results will need to be fully reviewed and submitted to a strict regulatory authority for approval.
“CAB LA and manufacturing capacity will have to be developed. There are also other security and implementation issues that need to be considered before a broader deployment. Safety studies in adolescents and pregnant and lactating women will be needed and open label extension (OLE) studies should be considered to understand the most effective and acceptable implementation approaches, ”said WHO.
In South Africa, the injection will need to be registered with the South African Medical Device Regulatory Authority before it can be made available.
Role of universities
Professor Zeblon Vilakazi, Vice Chancellor and Principal Designee of Wits, said these results demonstrate “the important role that research-intensive institutions and universities play in transforming society and saving human lives.”
“This incredible breakthrough will undoubtedly save the lives of many women living in sub-Saharan Africa and beyond,” she said. DM / MC
