Microbicide, Solution To Female HIV Infection?

Since the Human Immune Virus and the Acquired Immune Deficiency Syndrome (HIV/AIDS) pandemic became known in Nigeria in the mid eighties, no illness has caused more commotion and separated families and friends alike.

From being a rumour initially, it became a cruel reality which raised so much pandemonium that how it is transmitted from person to person became more horrifying and confusing almost by the day.

However, from the mid eighties to now, so much water had passed under the bridge. Form being regarded as the most dreaded diseases, which had no cure, HIV/AIDS is now manageable.

In fact, research has proved that an infected person can live a normal life like every other person. All it requires is awareness in the part of the infected person.

In spite of this encouraging development, however, research has also shown that the virus is still spreading and fastly too, for various reasons, which include the fact that people, mostly out of fear of being discriminated upon, prefer to keep their infection to themselves, or refuse to know their status.

Research has alo showed that majority of those infected are women, thus raising questions regarding why it is so.

It did not take long for researchers to reason that perharps this will not be far from the fact that women seem to be the most vulnerable when it comes to adopting preventive measures during heterosexual intercourse.

This is because the presumed efficacy  of such preventive measures as abstinence, use of condoms and being faithful to a partner could not stop more women from being infected. Hence the decision to come up with a preventive measure strictly to be controlled by women.

In the words of Dr. Orikomaba Korifama Obunge, consultant clinical microbiologist and Head of Medical Microbiology department, University of Port Harcourt Teaching Hospital (UPTH) ‘‘a lot of them (women) are still being infected, not because their partners are a little bit more adventurous, and the ability of them negotiating for the use of preventive measures such as condoms is not working much as it should.

‘‘The issue is that, can we not provide a preventive measure that is controlled by the women, that is capable of forming a barrier during heterosexual intercourse?’’

It is the search for this measure, according to Dr Obunge, that resulted in the emergence of  a concept of a microbiocide by a group of researchers and activities, which also include Dr Obunge.

According to a recent UNAIDS estimates, in 2009 more than 33 million people were living with HIV and approximately 2.5 million people were newly infected.

The estimates also showed that worldwide, nearly half of all individuals living with HIV are now women, who acquired the virus largely by heterosexual exposure.

Further more, many women, because  of limited economic options and gender inequality, cannot reliably negotiate sexual encounters, leaving them vulnerable to unwanted pregnancies and sexually transmitted infections (STIs), including HIV.

Thus, with clinical deployment of safe and effective HIV Vaccine still likely to be years away, topical microbicide formulations that are applied vaginally or rectally are receiving increasing attention as another strategy for HIV prevention.

The microbicide is a product in the form of a gel which could be infected intraveinously with the sole objective of preventing the transmission of the virus during heterosexual intercourse to the woman.

According to the researchers, a review of preclinical and clinical research on the development of microbicides formulated to prevent vaginal HIV transmission yielded 118 studies globally.

Presently, mathematical modeling has shown that if there is such a preventive measure that is workable, then millions of new infections could be prevented and it would be an encouragement for donor agencies to start working on it. Hence the emergence of research on microbicides.

In the words of Dr. Alan Stone of the Medical Research Council in the United Kingdom, ‘‘the development of an effective microbicide is a global priority of the highest order… The question is not whether the microbicide approach will prevent HIV infection but, rather, what proportion of HIV infections it will prevent.’’

Towards coming up with such a microbicide, two research organizations, FHI and Vera Halpen using collaborators in various countries embarked on research for the purpose. In Nigeria the collaborators were Dr. Orikomaba Korifama Obunge and Dr F.S.Ogusola of the university of Lagos.

The research went through the first and second phases, which are smaller studies that look at safety at does and at efficacy before this third phase which entailed randomized clinical/controlled trails on large groups of participants to look at the efficacy of the microbicide.

The products of the investigation were 6% Sodium Cellulose Sulphate (CS), which is a gel that was tested as a possible topical microbicide, but in 2007 was found to be  in effective. Researchers thought that CS could potentially block HIV infection (and possibly others STIs) by creating a barrier between the virus and the woman’s cells in the vagina which the virus targets for infection. This would make it more difficult for the virus to enter the woman’s cell.

The other products of investigation are vaginal gel, single use applicator, and 3.5ml of gel.

According to the researchers, the study design at this phase III entailed randomized placebo controlled trail, in which a total of 2160 women at high risk of HIV/STI were in Lagos while the other half were in Port Harcourt.

The placebo is not the treatment being tested, but looks exactly like the treatment. For topical microbicides trails, the control group received a gel that looked and was used the same day as the gel given to the intervention group, except that it did not contain the microbicide.

Placebos are used in blinded clinical trails so that participants for twelve months, while tests were carried out for HIV, gonnorhoea and Chlamydia at baseline and at each monthly follow up visits.

A summary of the research showed that the duration of the study was 12 months of participants recruitment, 12 months of product used for each participants and 26 total months in the fields including screening and close-down, while the primary objective of the study was to determine the effectiveness of CS gel in preventing male-female vaginal transmission of HIV infection among women of high risk.

The primary endpoint is the incidence of HIV-1 and HIV-2 infection as determined by detection of HIV antibodies from all Mucosal Transudate (OMT) specimens, while the secondary objective is to determine the effectiveness of CS gel in preventing malae-female  transmission of gonnorrhoea and chlamydial infection among women at high risk.

The secondary end point is the incidence of the genital gonorrhea or chlamydial infections as determined by DNA probe technology from self-administered vaginal swabs .

At the end of the study, it was found that the CS gel (this microbicide) did not protect against HIV and canot be used, “there were more infection in CS group compared to the placebo group from other studies outside Nigeria resulting in the stoppage of the study on CS3, and the preventive measure (HIV risk reduction messages works)”

It was thus agreed that community/scientist rapport must recognize that community involvement is an essential component in microbicide trail; that the approach to such involvement must consider the local setting (community politics and environment) that the relationship is a dynamic one.

Others are that it is clear the development of a topical microbicide to prevent the sexual transmission of HIV is scientifically, ethically and culturally complicated; and that in spite of these the benefit in lives protected may far exceed those risks seen and, as yet, unforeseen.

The implication of the foregoing is as encouraging as it is dreadful. Encouraging  because by this and other researches carried out, all in pursuit of a solution to the HIV/AIDS pandemic show that there is a relentless quest to get a solution .

However, the situation looks dreadful considering that such solution seem to have remained evasive and hence almost impossible to come by.

This, therefore, is an indicator that a lot of work still needs to be done to thoroughly put the transmission of HIV under check, particularly as it concerns the most vulnerable groups.

Such areas that require more job to be done include community sensitization/involvement, capacity building programmes for various stakeholders, including families.

The question that should thus be on every bodies mind is “which way forward in HIV prevention.”

Sogbeba Dokubo