15 March 2014

Kenya: Fight Against HIV - Pre - Exposure Prophylaxis

Some time back, the international media was flooded with reports of a baby in Mississippi who was cured of HIV. The miraculous procedure was performed by Dr. Gray, a pediatrician with the University of Massachusetts alongside Dr. Persaud of John Hopkins University.

The daring move to treat the child before confirmatory test results of infection was done thirty hours after the child's birth. In addition, Dr. Gray went a step further to use three drugs instead of the usual one or two. This could have posed a health risk, but against all odds the child survived and eighteen months later, was found to have no viral load despite the mother having discontinued the antiretroviral therapy. The one question on everyone's mind was: Could this be the breakthrough in finding the cure to HIV/AIDS epidemic?

We would all like to think so, but the fact still remains that there are over 34 Million people living with HIV globally and 1.7 Million fatalities annually. In Kenya, there are 1.6 Million people living with HIV and with such figures, the main focus currently is not to find a cure but to prevent transmission of HIV.

Several trials have been launched over the past few years to investigate whether certain drugs could be used to curb HIV infection before exposure. One such study funded by the Bill and Melinda Gates Foundation was started in Kenya in 2011. The Pre-Exposure Prophylaxis (PrEP) study showed reduced risk of HIV acquisition by 73%. Another trial known as VOICE (Vaginal and Oral Intervention to Control the Epidemic) whose results were released on 4th March 2013 proved that the battle was far from over.

The results indicated that none of the three pre-exposure prophylaxis and microbicide intervention provided additional protection against HIV in the study. The large scale trial among African women utilized daily oral tenofovir, daily oral Truvada (TDF/FTC) and daily 1% vaginal tenofovir gel. However, the disappointing results were not due to the inefficiency of the drugs themselves, but were more likely as a result of the large number of women who did not use the products as directed.

The results which were presented in Atlanta at the 20th Conference on Retroviruses and Opportunistic Infections (CROI) confirmed the correlation between higher levels of adherence and protection from HIV.

"The VOICE results reinforce what we already know from previous trials: these interventions work when they are used, and they don't work when they are not used," said Mitchell Warren, AVAC (AIDS Vaccine Advocacy Coalition) Executive Director. "PrEP is still a valuable option for many women, and men, who recognize their risk and can take PrEP consistently. Now we have a dual responsibility to understand who might benefit from daily PrEP and ensure that they can access it, and to accelerate the development of additional options that can meet the urgent needs of others."

In simpler terms, for the drugs to work they have to be taken as indicated. As this is a matter of life and death, we cannot afford to treat it in the same manner that most of us do a prescribed dose of antibiotics. We simply cannot take the drugs for two days and once the cough 'disappears', we forget the other pills and assume that we are 'healed'. For the VOICE and other trial medications, it is paramount that the patients take the full dose as HIV will not just 'disappear'. This raises an important question: What can be done to encourage people to take the drugs as directed or even to take the medication in the first place?

"The women of VOICE and other prevention trials have much to tell us. Now we need to listen to what they are saying and design prevention options based on a better understanding of their reproductive and sexual health needs and desires, their perceptions of personal risk for HIV infection, and their interest in and ability to use the products offered in those trials," Warren said. In Partners of PrEP study performed in Kenya, some people cited the 'pill burden' to be one of the reasons for lack of adherence.

Others were afraid of the stigma associated with HIV and therefore to avoid people thinking that they were infected yet they were not, they would not the drugs or at least not every day. This would defeat the whole purpose of the drugs which is to prevent transmission before one is exposed to the virus. Therefore there is need to package the drugs in such a way that the recipients will comfortably use it, hence promote adherence and in doing so will decrease the rate of HIV transmission.

Furthermore, AVAC called for accelerated research and development of additional HIV prevention options that rely less on adherence making it easier and more desirable for use. For example, different delivery mechanisms such as long-acting rings and injection and less stringent dosing schedules as is with FACTS 001 trial which is looking at 1% tenofovir vaginal gel used around the time of sex.

The call by AVAC is echoed the world over stemming from the WHO report showing that there are over 2.5 Million new HIV infection annually with 330, 000 being children under the age of fifteen. The high incidence rate was also reflected in the VOICE trial results. Elizabeth Bukusi, Deputy Director (Research and Training) of the Kenya Medical Research Institute (KEMRI) and an AVAC board member had this to say, "The high rates of new HIV infections among women, especially young women, are the most shocking and disturbing data from this trial. They are a sobering reminder of how desperately women need new prevention options that they can and will use to protect themselves from HIV."

Pre-Exposure Prophylaxis was the message of the year 2013, but in Kenya where over 600,000 people are on antiretrovirals in Kenya, a large coverage gap of approximately 30% still remains. We are yet to effectively broadcast the message that is anti-retroviral therapy. Which raises the question, what is our message for the year 2014?

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