The recent approval by the Kenya Pharmacy and Poisons Board of the drug Truvada for prevention of HIV by uninfected persons deemed at risk — Pre-exposure Prophylaxis (PrEP) — reflects commitment from the regulatory authority to fast-track the review of drugs of public health importance.
Truvada, which is already registered for use in combination regimens for HIV treatment, can now be used to prevent HIV in uninfected persons.
In other words, HIV negative persons at increased risk of HIV infection can take a daily dose of the oral Truvada tablet and significantly reduce their chances of acquiring HIV from a positive sexual partner.
Why is the approval of Truvada for prevention so significant for Kenya? The country has the world’s fourth largest HIV numbers with an estimated 1.63 million people living with HIV, 98,000 new infections occurring annually, and 1.1 million children orphaned due to Aids-related deaths.
Among the major challenges for preventing new infections is stigma, which prevents some people from disclosing their HIV-positive status to their sexual partners thereby risking infection. Oral PrEP gives the HIV-negative individual protection if they are in a sexual relationship with an HIV-positive person. PrEP must however not be seen as a stand-alone prevention method, but as an additional option to HIV testing and counselling, consistent and correct use of male and female condoms, and access to ARV treatment.
PrEP is also not a method to be used by everyone. The World Health Organisation recommends use of PrEP for persons at substantial HIV infection risk. In Kenya, populations identified as being at substantial risk include couples in serodiscordant relationships, men who have sex with men, young women and female sex workers.
From the Kenya Aids Indicator Survey of 2012, serodiscordant couples contribute 44 per cent of all new infections, while men who have sex with men and female sex workers contribute a third. HIV prevalence is highest in the population 20-29 years, and young women 20-24 years are four times more likely to be HIV positive compared with young men the same age.
To reach its goal of reducing new HIV infections by 75 per cent by 2019, Kenya must implement the highest impact targeted and appropriate combination prevention interventions for these populations and in geographic locations with a high HIV burden.
The WHO recommendation is based on high quality research studies across the world, specifically 12 clinical trials that have demonstrated its safety, efficacy and effectiveness. Whether PrEP works is no longer the question. Focus has now shifted to testing whether PrEP would have similar results in standard health care settings, where time and money are scarce resources and systems are not seamless.
There are ongoing studies looking at delivery of PrEP in real world settings in Kenya. Initial findings from these studies show high levels of willingness to take PrEP and adherence among the populations involved. These studies will provide additional evidence to inform PrEP delivery in the health system and user considerations. Such findings should efficiently be shared and translated into policy and practice.
As Kenya moves towards scaling up delivery of PrEP to specific populations, adherence will be critical if we are to experience its impact on the epidemic. The message is simple: PrEP is safe and works to prevent HIV infection, but only if taken effectively as directed by the health service provider.
The regulatory approval of Truvada as PrEP in Kenya provides further impetus for the National AIDS and STI Control Programme (NASCOP) and the National Aids Control Council (NACC) to urgently develop guidelines that ensure efficient integration of PrEP in health services.
It also calls for dialogue and collaboration across all stakeholders to develop robust and quality assured delivery methods and strategies to increase knowledge and awareness, ensure access for those eligible and high levels of adherence among users.
This must go hand in hand with strategies to effectively deal with stigma and discrimination of persons living with HIV, female sex workers and men who have sex with men so as to reap the full benefits of PrEP and see an impact on the HIV epidemic. County governments must budget for PrEP and implement cost-effectiveness prevention models identified in the Kenya Prevention Revolution Roadmap.
NASCOP and NACC must now mobilise the resources for roll out of PrEP. In the long run, it will be cheaper for the country to prevent HIV infection than to put infected persons on antiretroviral treatment for life.
With this in mind, whether health insurers will pay for PrEP will remain to be seen but it is a cover they should consider, as it is certainly cheaper than the chronic care and treatment often required by persons living with HIV.
Wanjiru Mukoma is the Executive Director of LVCT Health