HIV is not an easy virus to defeat. At least 1.5 million Kenyans are living with the virus and 36,000 are added to the number every year.
Thankfully, nearly all Kenyans who test positive are on treatment. But the Ministry of Health says about 20,000 people still die every year from the virus because they don’t know they have HIV and are not on treatment, or they start treatment late.
December 1 marks World Aids Day, which was created to raise awareness about HIV and the resulting Aids epidemic. This year, the theme is "End inequalities. End Aids."
Prof Elizabeth Bukusi is one of the Kenyans working to end inequalities in treatment and prevention. Over the years, she has carried out groundbreaking research and development of female-initiated methods of HIV prevention.
The subsequent technology has meant a projected 20 per cent decrease in HIV-Aids-related deaths.
She is an expert in sexually transmitted infections, women’s equity in health, reproductive health and HIV-Aids prevention and treatment.
Prof Bukusi is also chief research officer at the Kenya Medical Research Institute (Kemri) and a research professor at the University of Washington.
She spoke to Star's John Muchangi about HIV prevention in Kenya.
It is 40 years this week since HIV was first described, and we are still looking for a drug or vaccine to prevent the virus. In contrast, we got approval for the first Covid vaccine about 11 months after the genome of SARS-CoV-2 was first published. Why have we taken so long with HIV?
The response to the Covid-19 pandemic has been unprecedented, highlighting what can be achieved where there is a will and commensurate investment in resources.
From a historical perspective, response to treatment HIV was relatively swift, but arguably more could have been achieved with a similar commitment of resources as with Covid.
However, the main challenge with the development of a HIV vaccine has not been a lack of trial or funding, but biological. Unlike Covid-19, HIV establishes a chronic infection by integrating itself into the host genome. It also has a very high rate of mutation and recombination during viral replication, making it hard to develop effective HIV vaccines.
Still, HIV has not received similar resources and cooperation among countries to the scale of Covid-19, and this is a valuable lesson on what solidarity can achieve.
The pre-exposure prophylaxis (PreP) drugs are safe and effective in preventing HIV. Are they being used in Kenya?
HIV PrEP is the use of antiretrovirals to prevent HIV acquisition among HIV negative people who are at ongoing risk of getting HIV. Currently, daily oral PrEP is what has been approved for use in many countries, including Kenya, but there are ongoing studies with newer, long-acting agents.
What keeps the long-acting Prep from getting into the market so far?
Long-acting PrEP agents can take various formulations: oral, injectable, intravaginal rings/gels, among others. Currently, there are several long-acting PrEP agents in different phases of clinical trials. The most recent notable results are from the interim results of phase 3 studies (efficacy studies) with long-acting injectable cabotegravir (Cab-La). Interim results showed that CAB-LA is safe, well-tolerated and effective in MSM, transgender women and cisgender women.
PRODUCTS IN PIPELINE
The dapivirine ring, a topical HIV prevention method (monthly use), was pre-qualified for use by the WHO in 2020 and has also been included in the WHO 2021 clinical recommendations for HIV prevention.
CAB-LA is yet to get approval for use because the studies are still ongoing. However, the studies were unblinded because the interim analysis of results suggested superiority of CAB-LA. These interim results are what we have at the moment and approval (and subsequent marketing) cannot be made based solely on interim results, but after final analysis and application for a licence by the sponsor.
(UK in November approved a single injection of a combination of cabotegravir with rilpivirine drugs once every two months for people living with HIV. It has not been approved as a PreP yet.)
When will CAB-LA be available as a PreP and what will it cost?
The earliest an approval is expected is 2022. ViiV has not specified or estimated the cost of the injection per dose, an omission that makes it difficult for advocates to mobilise demand for this new strategy. A recent cost-effectiveness analysis presented at the 2021 Conference on Retroviruses and Opportunistic Infections shows that the injection must be priced in the range of generic daily F/TDF to be considered cost-effective in comparison to oral PrEP. Various advocacy groups are involved in advocating affordability by LMICs.
You’re spearheading the 'Impower 22' trial in Kenya for once-a-month Prep. Please tell us about this trial and when you can have early data to make a decision on the treatment?
Impower is a phase 3 (efficacy trial) clinical trial being conducted across different countries in Africa as well as the US. The study will evaluate the safety and efficacy of a new long-acting oral PrEP agent (developed by MSD), islatavir, administered orally once a month, in women who are at high risk for HIV-1 infection. In Kenya, the study is being conducted in Kisumu.
ONCE-A-MONTH-JAB
Approximately 4,500 participants will be enrolled across the different sites over an approximately 12-month period, with study intervention administered for approximately one year and up to three years, based on estimated accrual of primary endpoint cases (seroconversion).
We cannot tell at the moment when the early results will be available. The primary efficacy analysis will be performed upon getting a specified number of primary endpoint cases of confirmed incident HIV-1 infections, and we cannot tell beforehand how fast this number will be achieved, particularly since the comparator is an effective [daily] PrEP agent. An efficacy interim analysis is, however, usually performed midway, as in the case with CAB-LA, and we may know whether it is effective earlier.
What have you found as barriers to the daily Prep uptake in Kenya to prevent HIV?
The main barriers include stigma. There's also low risk perception among potential PrEP users, concern about potential side effects and pill burden, having to take them daily.
A number of individuals taking PrEP have also expressed a dislike for pills and the size of PrEP pills.
Other users decline PrEP due to social circumstances, such as needing to get permission to take PrEP from their partners. We have had people saying that while they are trying to protect themselves from their partner’s risky behaviour, the partners may interpret their taking PrEP as a sign of their own risky behaviour.
They fear being accused of unfaithfulness or promiscuity, therefore opting to decline PrEP.
Some individuals report that the stigma against anti-retroviral therapy in the community is transferred onto PrEP because of similar pill appearance and packaging.
FEARS AND MISCONCEPTIONS
People fear the known potential side effects of PrEP (such as renal toxicity) as well as rumoured effects such as reduced libido, infertility, or fatigue/weakening of the body. Some people feel they needed more information about the proven effectiveness of PrEP before they can take it.
Unaids has a goal to end the Aids epidemic by 2030. How possible is this?
This ambitious target by Unaids is not merely aspirational but achievable, as evidenced by the several countries that achieved or surpassed the 2020 Unaids set in 2016, 90-90-90, giving hope for the attainment of the 95-95-95 target by 2025. The incidence of HIV has been falling year after year since the universal rollout of ART but not fast enough to meet the target.
What we learnt is that countries with progressive laws and policies and strong and inclusive health systems have had the best outcomes against HIV. In those countries, people living with and affected by HIV are more likely to have access to effective HIV services, including HIV testing, pre-exposure prophylaxis (medicines to prevent HIV), harm reduction, multi-month supplies of HIV treatment and consistent, quality follow-up and care.
PUNISHING KEY POPULATIONS
On the other hand, countries with punitive laws and that do not take a rights-based approach to health, punish, ignore, stigmatise and leave key populations — which make up 62 per cent of new HIV infections worldwide — on the margins and out of reach of HIV services. This allows HIV to spread among the most vulnerable in society.
In sub-Saharan Africa, six out of seven new HIV infections among adolescents aged 15–19 years are among girls. HIV prevention services, including PrEP, have to be integrated into all healthcare service points that attend to young women, including Family Planning clinics, postabortion care services, ANC clinics, as well as being scaled out to the community through community pharmacies and peer PrEP delivery models.
You have done a lot of research into other sexually transmitted infections. Many parts of the world are reporting a re-emergence of other STIs such as syphilis, gonorrhoea and Chlamydia. How is the situation in Kenya?
It is true that we are seeing a resurgence of sexually transmitted infections, such as syphilis, chlamydia and gonorrhoea across the world, and Kenya is no different. These are of great interest as they are all curable. The prevalence and incidence of these is also highest in eastern and southern Africa.
Across our studies in which we test for STIs, up to one in five young women tests positive for chlamydia, gonorrhoea, or both.
A RE-EMERGING EPIDEMIC?
Of particular concern is that up to 90 per cent of those who test positive for STIs have no STI symptoms at the time of diagnosis, highlighting the inadequacy of the Ministry of Health STI diagnosis and treatment guidelines that rely on treatment based on symptoms.
Given the known synergistic relationship between STIs and HIV acquisition and the morbidity associated with untreated STIs, we need to strive towards making point of care testing and treatment of STIs the standard of care.
What keeps you within Kenya (or Africa), rather than venture out and work in better-resourced/equipped western research institutions?
I am privileged to be in this position. I need to make a difference and give back. We also need to build local research capacity. And today, with collaborations, one can work across different countries.
If we do not answer our research questions, who will?
Edited by T Jalio
