Kenyans involved in risky sex behaviours will soon get a 'wonder pill' that can prevent HIV infections. Experts say Truvada, which some call the 'new condom', can reduce chances of catching HIV but there are fears the drug may be misused by the youth.
Experts say the pill can cut the risk of contracting HIV by up to 75 per cent if one faithfully swallows it daily. The blue pill is a major part of treatment called pre-exposure prophylaxis (Prep).
It is already being used in Kenya as an anti-retroviral drug by people living with HIV. However, a 2010 study proved it also stops the virus when taken consistently by HIV-free people. Some have even called it "the new condom."
The National Aids and STIs Control Programme says the wonder pill has already been submitted to the Pharmacy and Poisons Board for registration.
"PPB is in the process of registering it. If that happens, we will then need a national policy and plan before it's used on large populations," Nascop's head of HIV prevention Dr Peter Cherutich said.
Dr Cherutich said it is currently illegal to prescribe Truvada as a Prep drug because it is not yet registered for that purpose. There is an ongoing demonstration project to identify key populations that will be prioritised once Truvada is registered, he said.
"Once we do that, I think we have no choice but to avail it to them," Dr Cherutich said. The demonstration projects end next year, meaning the pill would be available earliest 2015.
Prep treatment is different from post-exposure prophylaxis (pep) where people are given a cocktail of drugs immediately after exposure to the virus to try and stop infection.
Experts believe availability of Prep treatment in Kenya will help reduce part of the 100,000 new HIV infections every year.
According to Dr Michael Kiragu, a senior technical officer for HIV prevention at Liverpool VCT, Most at Risk Populations (Marps) may be prioritised in the Prep programme.
In the US, Truvada is mostly used by discordant couples because of their low condoms use. Marps in Kenya include sex workers, men who have sex with men and injecting drugs users.
They have the highest risk of transmitting and acquiring HIV and STIs because of high-risk sexual activities like unprotected anal and vaginal sex, multiple partners and drug-related HIV risk behaviours.
Most of them do not benefit from sexual health programmes because their behaviors are either illegal or highly stigmatised in Kenya. Nascop says they contribute to one third of all new HIV infections in Kenya.
"It's an expensive drug and therefore needs to be prioritised," Dr Kiragu said. "The demonstration project will try to determine who needs it, based on risk."
Truvada is a combination of two ARVs called emtricitabine and tenofovir, and is manufactured by US pharmaceutical giant Gilead Sciences.
The pill must be taken daily because it takes several days to build up to levels that can protect the body from infection. The ongoing demonstration project involves 1,000 couples at four research sites in Kenya and Uganda.
It is being conducted by Harvard University, Massachusetts General Hospital, the Kenya Medical Research Institute and Kenyatta National Hospital.
Dr Cherutich said the results, expected in 2015, will help the government draw a public policy for use of the drug to prevent HIV in Kenya. "The demonstration will also help us understand what Prep would cost the country," he said.
The drug has already become a success for Gilead. It earned the manufacturer billions of dollars last year, according to the company's financial results.
Developing countries ravaged by HIV now represent a huge potential market, where donors can be persuaded to pay for the high cost. Most developed countries including Britain have licensed Truvada as an ARV but not for Prep treatment.
Yusef Azad, the director of policy at the UK's National Aids Trust, recently said it is unlikely that it will be approved for Prep soon.
"In the real world, will people actually take the medication as they need to on a daily basis?" he told the Mirror newspaper.
There are also concerns over the high cost. Prep costs up to Sh1 million per person for a year's supply in the US, according to different market sources.
Currently, almost a million HIV-positive Kenyans who need life-prolonging ARVs still cannot get them. Is it fair to give healthy people drugs while the sick people cannot get any?
Dr Cherutich admits it will be harder to get donors to fund treatment of healthy people. Treatment of those already infected is more appealing because results are easily quantified, he said.
"But if we can identify a key population that needs it we have no choice. But we must have the resources, with our partners before we implement."
A recent study by the University of Washington, published in the British Medical Journal in August, suggests that the drug would actually be cost effective in Africa.
Researchers said they examined the incremental impact of adding Prep at pre-existing levels of male circumcision and antiretroviral therapy in 42 countries.
They assumed a drug efficacy of 68 per cent and adherence by users at 80 per cent. "After five?years, 390,000 HIV infections would be prevented," Dr Stéphane Verguet, who took part in the study, said.
The study concludes that Prep will be cost-effective only in countries that have high levels of HIV burden and low levels of male circumcision.
"Hence, Prep will likely be most effective in Southern Africa as a targeted intervention added to existing strategies to control the HIV pandemic," the study says.
Truvada works by blocking the action of a protein that HIV needs to infect the body. "So the virus dies off because it would need to multiply to survive," Dr Kiragu said. The drug however does not cure HIV or Aids if one is already infected.
"There may be some nausea but it is totally safe for use by healthy people," says Peter Michira, who works for Partners in Prevention Study in Thika.
Its approval in the US last year was given a cautious welcome, with some health experts arguing that it could lead to a false sense of security.
There were fears young people would use it as a "sex pill" and ditch condoms. Others felt it could lead to a new drug-resistant strain of HIV.
Some of these concerns are still being investigated. The American Food and Drug Administration approved Truvada after 2010 studies showed it cut infection risk in healthy gay and bisexual men by 42 per cent, when accompanied by condoms and STD counselling.
Another study found the pill may reduce HIV risk by 75 per cent among heterosexual couples in which one partner is infected with the virus.
However, the researchers could not explain why in one study involving female sex workers, those who took Truvada to prevent HIV were not protected against infection.
Reports say the authors think the participants did not take the drug in the right doses, but it is also possible that something about the vaginal environment makes the drug less effective.
Fear of misuse in Kenya is even higher following reports that carefree youths routinely ditch condoms and use emergency contraception and ARVs as sex pills.
Dr Cherutich said such fears would be addressed through a government policy.
"It is unlikely to be a freely available product like Panadol that you can buy over the counter. It will have to be delivered in form of a package. That probably includes HIV testing and other prevention methods," he said.
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