[Op-ed]: New PrEP injection testament to HIV research and community partnership
With the development of a new delivery form of PrEP, HIV advocacy and research communities bolster itself after the HVTN 702 clinical trial’s premature ending, writes Ntando Yola.
An injectable form of pre-exposure prophylaxis (PrEP) is welcomed and exciting development in the midst of Covid-19. It has been almost a month since the news came out and it still brings a lot of pleasure for the field. The search for expanding HIV prevention options to choose from has yielded yet another success through research. This is another form of PrEP and is different from the daily PrEP pill we’ve come to know. A research study known as HPTN 083 compared a long-acting injection given every two months, known as cabotegravir (CAB LA) with Truvada (TDF/FTC) that is taken orally each day as PrEP.
The study wanted to see if it is safe and does protect from HIV – and a review by an international independent body found that it does. Convincingly, CAB LA showed that it is highly effective in preventing HIV infection. The announcement of the results was based on a scheduled review by the independent data and safety monitoring board (DSMB) that found that CAB-LA provided significant protection. This finding comes before the scheduled end of the trial and it means everyone in the study can find out which of the two versions of PrEP they were receiving.
Once more, South Africa contributed to this success with a community of, and participants of men-having-sex-with-men (MSM) having taken part in the study. They joined other MSM and transgender women from the U.S., Argentina, Brazil, Peru, Thailand and Vietnam. According to the South African National Strategic Plan (NSP) 2017 – 2019, MSM form part of the key population for HIV prevention and need more options to use for protection against HIV.
According to the government’s plan, in South Africa an estimated 28% of MSM are living with HIV, making them amongst one of the groups most at risk of acquiring HIV. Having another potential HIV–prevention option that may be easier than a daily tablet for other men and transgender women, can help us reach even more and bring down the numbers of new infections.
Options for HIV-prevention expanded
At the same time, we know that women, especially adolescent girls, remain unforgivingly affected by HIV. This is because of a range of social and health inequalities and other factors that they face being part of disadvantaged communities in South Africa. Another similar study had followed HPTN 083 about a year after it started and enrolled Sub-Saharan African women in the study. It is known as HPTN 084, and later in the year, the same independent review body will analyse the data collected in the study to see if there is an indication of efficacy at that point. If the trial continues to its completion, we expect the results in 2022. Whilst we cannot know based on the results of HPTN 083 if this product will also work for women, there is a lot of hope that this might be yet another needed addition of choice to those women who are not able to take the daily PrEP pill for HIV–prevention.
As with contraceptives, some prefer pills, others gravitate towards injections and other forms of delivery, like implants. Some women may prefer to use a monthly dapivirine vaginal ring for HIV–prevention. The dapivirine ring was found to provide modest protection when worn vaginally by two trials here in South Africa and other African countries. There is hope that regulators later this year would give the ring green light to being an option available as HIV–prevention for women.
All of these show a lot of work by researchers to search and provide even more options for HIV prevention, with additional products being studied. South Africa has a lot to offer when communities, researchers and other role players work together towards a common goal of finding solutions for this epidemic. A number of South African communities have – for the longest time – participated in HIV prevention trials collaborating with hundreds of South African researchers to find new solutions. These are all with a goal to gain control of the new HIV infections that negatively affected most of us, especially youth in the region.
Ups and downs
The news about HPTN 083 is, therefore, such an exciting development given that on 6 February 2020, a colleague and I wrote about a different trial that was stopped early. The HIV vaccine trial HVTN 702 was stopped early because its independent review board found the vaccine was not effective. It was a disappointing result because there remains an urgent need to find as many HIV prevention tools for all who need them. We wrote then that we were still optimistic about HIV–prevention research. And we’re even more optimistic now, even as the world has now shifted its attention to respond to the coronavirus pandemic.
As we were mourning the end of that vaccine trial and recommitting ourselves to the work to find new HIV–prevention options, the country and the world were already seeing signs of another public health crisis. Covid-19 was fast emerging and has now effectively held the world at standstill, and is promising to alter how we live for the foreseeable future.
South Africa, like the rest of the world, is currently hard at work dealing with the complexities brought about by Covid-19. Through research, a lot more questions are being asked and answers are emerging, largely based on experiences the country has collected from HIV and TB work. The expertise we have as a country is helping to generate knowledge about this new virus that causes Covid-19. Hence, there are calls from advocates, researchers and public health workers that the Covid-19 response should not be at the expense of other diseases, like HIV and TB.
HIV and TB burden increases
The focus on Covid-19 doesn’t mean the burden of HIV and TB that South Africa carries has become any less. In fact, researchers are pointing at evidence that the burden is exacerbated by the full focus that is given to the Covid-19 response. Media reports are coming through stating that HIV patients are missing their antiretroviral (ARV) medication. We know that people with HIV who take their medication religiously not only get to live a quality life, but contribute by not transmitting the virus to their sexual partners. This is known as U=U, which means if because ARV medications are taken and work well, the virus in the body become ‘undetectable-equaling-untransmittable‘ or U=U. If the ARV programme suffers, any gains achieved by U=U will be lost.
Research and researchers continue to be key in generating knowledge on how the country should respond to public health crises. These efforts contribute to coming up with needed solutions that help in achieving healthy nations.
In South Africa we have seen the role of research being instrumental in leading the country’s response to the HIV and TB epidemics. The medical interventions that we have today which provided and continue to promise better treatment for South Africans, and the world, are the same that helped identify new HIV–prevention options like daily oral PrEP, the dapivirine ring and now CAB-LA.
The same research framework should inform us as we work to generate a comprehensive response to Covid-19 that does not disadvantage other health gains and ensures we keep our eyes on, and sustain the response to HIV and TB and other health challenges. Our world class researchers are already working on the Solidarity trial aimed at finding effective treatments for Covid-19, and expectations are they will continue to help lead the way in finding solutions for South Africa and the world.
The successful trial results of the HPTN 083 study affirm the strength and resilience that South Africa has. It shows the capacity and infrastructure of not only research, but what can be achieved when everyone pulls together towards a common goal of humanity. It is a message that South Africans can and should celebrate these gains whilst continuing to face times of hardships, be it diseases or other social ills.
The work we have been involved in as community mobilisers with many clinical trials over, a number of years, has displayed how researchers cannot do it alone. In fact, research for communities without the backing of communities is a futile exercise. A number of community respecting approaches are implemented to reach out to communities, mobilize them, hear from them, understand their strengths and other assets they posses. These processes of community engagement are based on principles and ethics that when adequately done will yield rigorous research results that are trusted by and useful to communities.
Even as we find ourselves on an emergency footing responding to Covid-19, researchers must find ways to continue to engage communities around HIV research and begin to engage communities around Covid-19 research and the Covid-19 response. It is a display of the relationships that exist between communities and researchers, that participants and their families in ongoing HIV and other studies can work effectively with researchers to find ways to safely continue clinic visits and trial participation.
The good news from the HPTN 083 study is a testament to the strong pledge between communities and researchers. It is these kinds of bonds that will see us through to a solution to not only Covid-19 but all-embracing strategies to address our historical burdens of diseases like HIV and AIDS.
Ntando Yola is an HIV prevention advocate, a co-founder of Advocacy for Prevention of HIV in Africa (APHA) and a Community Working Group Co-Chair of the HIV Prevention Trials Network.