Scientists in the US, Ghana, Botswana and Thailand are conducting trials on 6,600 people on the use of a drug which has been shown to offer protection against HIV infection even while engaging in unprotected sex.

Tenofovir is currently used as an antiretroviral and available in Kenya under the brand name Viread.

Tenofovir is currently used as an antiretroviral and available in Kenya under the brand name Viread.

However, although local principals are already assured of funding from two international health organisations, they are hesitant to discuss details because of the serious ethical concerns raised by similar researches elsewhere.

The studies involve putting healthy human beings, but who are at a high risk of HIV infection like prostitutes or discordant couples, on the drug and following them up to see how the intervention work. The Kenyan scientists want to undertake similar studies among high risks groups who include prostitutes.

Similar studies have been either suspended or completely cancelled in Malawi, Nigeria, Cameroon, and Cambodia following serious ethical concerns and questions over the rights of those at risk of HIV infection during the drug trial process.

In Malawi, the trials were stopped by the government for fear that it would lead to development of resistance to tenofovir, a drug they are using in HIV treatment programmes.

In Cambodia a network of prostitutes claimed that during the recruitment process potential participants were not told the truth about the side effects of tenofovir. Another concern was the lack of health insurance for trial participants if they experienced long- term adverse effects as a result of their participation.

At the core of cancellation in Cameroon last year, was the issue of treatment and care of the people involved in the trial. Of major concern was what would happen to the participants if they tested positive during the trial. It also emerged that there lacked informed consent from participants. And in Nigeria the trials were cancelled because they failed to meet “the necessary scientific standards.”

Studies in rhesus macaques — a species of the monkey family—whose genetic make-up is over 95 per cent similar to that of human beings, has shown the drugs to work in preventing HIV infection.

A number of the monkeys injected with the ARVs followed by high doses of HIV virus were able to stave-off infection.

It works on the same principal as the contraceptive morning-after pill or the application of nevirapine for preventing mother-to-child HIV transmission.

The presence of the drug in the body is expected to stop the virus from infecting the cells and replicating. Using the drug in this way is referred to as Pre-Exposure Prophylaxis (PrEP).

Similar strategy is used in the management of malaria, where one takes anti-malaria drugs before visiting malaria endemic locations.

Scientists say, tenofovir—an ARV manufactured by Gilead Science of the US— has a good safety record, low rate of developing resistance, low adverse effects, and can be taken once a day, making it the best choice as a preventive tool.

Research findings by CDC have also indicated that a combination of ARVs as is the case in HIV/ Aids treatment, may just offer better protection when taken before sex.

Currently, there are plans to test in human beings a drug called Truvada, a single pill that contains two drugs — Tenofovir and FTC. Animal studies have shown the drug to offer much better protection when used in such combination.

If all goes well, it means a person will only need to take one or two pills of ARVs before engaging in unprotected sex. The on-going studies are supposed to determine dosage levels and ‘how long’ before engaging in sex.

But those strongly opposed to using ARVs for prevention argue that the restrain the disease has inculcated in people may be undermined immediately they know they are protected.

A source at the Ministry of Health says they fear such a development may see people abandon the use of condoms that are playing a big role in reducing the incidence of HIV and other sexually transmitted diseases. “We are going to vehemently oppose such a move.”

Scientists are also worried about the potential abuse of the drug since it will be difficult to dispense as a prescription drug.

They say it would not be practical for customers to visit clinicians every time they plan to have sex to ask for a prescription.

“It will seem like you are asking for permission from the doctor to have sex,” says Dr P. Kimani, who works with a local research organisation.

“If the drug is to be used successfully as a preventive weapon, then let it be available over the counter,” says Dr Omu Anzala, one of the scientists working on an HIV preventive vaccine.

“This however,” he adds, “is the problem as some people may over use the drug and expose themselves to dangers of toxicity and resistance.”

Caroline Sucha, an Aids activist and infected with the virus herself says unscrupulous traders will take advantage of the situation and dispense the drugs in all places, especially in bars and brothels, where sex business is rampant.

“Who will control or ensure a drunken person takes the pills at the right time and dosage as well as make sure youths do not abuse it the way they are doing with morning-after pills.”

But even of serious consequence to the free sale of such drugs is the possible emergence of fake medicines and counterfeits in a country with an extremely poor policing record.

Prof Isaac Kibwage, a lecturer at the faculty of pharmacy, University of Nairobi, warns that those likely to abuse the drugs are commercial sex workers who may pop-in several of these ARVs every time they have sex.

Concurring with him, Dr Surendra Patel of MP Shah Hospital says he would prefer the drug to be sold in selected pharmacies or under prescription because not everybody should use them.

“People who have kidney problems are not supposed to use tenofovir without a doctor’s advice. But we cannot monitor this group if the drugs are sold over the counter.”

“There are also chances that some people may get infected even after taking the drugs. What do you do with such people?” asks Prof Kibwage.

For Prof Kibwage, the best way forward is to allow the drugs to be given on prescription immediately after a person suspects they have engaged in unprotect sex that is likely to result in HIV infection.

“At this point in time, we would not advocate for ARVs to be given as an over the counter drugs because of their toxicity levels.”

But doctors conducting the studies have been quoted in various forums saying they will put in place safe guards to prevent abuse.

In addition to the minimal side effects, they further argue that it will be a big win for women, who most of the times are unable to negotiate for safe sex.

Their determination to have the drug used as PrEP is buoyed by the fact that ARVs have shown to be effective when used as post-exposure prophylaxis for rape survivors and medical personnel who prick themselves when handling HIV infected persons.

How does the pill work? The virus is made of Ribonucleic Acid (RNA) which works for it the same way the Deoxyribonucleic Acid (DNA) works for human beings.

It also has three main enzymes– Protease, Reverse Transcriptase, and Integrase- that are critical for it to infect the cell and replicate.

But to infect the cell and start the process of replication, the virus has to convert its RNA into DNA so as to integrate itself into the human DNA. The enzyme that enables it to undertake this process is the Reverse Transcriptase. While the Protease enzyme allows it to replicate.

Hence, the drug to be taken before sex is expected to stop the virus from converting from RNA to DNA

Research has shown that this conversation process takes up to four hours to be completed and for infection to take place. And that is why some doctors strongly advise that those who have been exposed to the virus need to start treatment within four hours.

An AWC-Feature