By Annah Natukunda
But Ugandan experts warn that its time here has not yet come
On May 10, the US Food and Drug Administration (FDA) recommended that the antiretroviral drug TDF/FTC (brand name Truvada) be licensed for use as an HIV/AIDS vaccine, moving the world one step closer to a new prevention option for a still incurable disease.
Truvada is already approved for HIV-positive people as part of existing anti-retroviral therapy, and studies in 2010 showed it to reduce – by between 44% and 73% – the risk of HIV infection among healthy gay men and HIV-negative heterosexual partners of people who are HIV-positive.
While FDA approval means that members of these healthy, but high-risk groups can now take a pill a day for the rest of their lives and avoid infection, on the local scene such prevention options remain out of reach.
In fact, the Ministry of Health and Uganda AIDS Commission have warned against “undue excitement” as the drug’s high cost and strict rules of usage make it impractical in Uganda.
“This is not new,” said Dr David Tigawalana, the HIV prevention coordinator at Uganda AIDS Commission. “Drugs can be efficacious under experimental circumstances, but not effective in community settings,” he added.
Pre-exposure prophylaxis (PrEP) studies conducted in Uganda whose results were announced last year showed that Truvada – a combination of Tenofovir (sold as Viread) and Tenofovir plus Emtricitabine – dramatically reduced the risk of infection among discordant couples, with infections dropping by up to 62% to 73%.
However, Dr Tigawalana told The Independent that while “any science is useful, there is need to evaluate the appropriateness to community use”. Apart from drug resistance that is very likely to result, there are cost implications to consider, as the daily pill of Truvada is said to cost US$ 14,000 (about Shs 35 million) per person per year. For a low-income country like Uganda, this is simply unaffordable and unsustainable.
Not only that, it would draw funds away from life-saving ARVs which are needed by those already infected. Currently, only half the people living with HIV, that urgently need treatment, get drugs. Local experts consider that it is best not to start Truvada at all because once taken it is for life, or until one becomes positive, in which case they have to start a complete ARV regimen to prevent drug resistance.
None-the-less, researchers think that this is a landmark breakthrough in HIV prevention, and people should be given all the options available.
“I am not sure that the national HIV prevention team will be excited,” Dr Patrick Ndase, the African Regional Physician of Microbicides Trials Network said. “We have presented this research before, and there has always been a few yeses and a few nos.” He warns that once the public learns of the potential benefits of Truvada, individuals who deem themselves at high risk will demand the service, and it would be up to the clinician’s discretion to prescribe the pill or not.
Dr Ndase, also a research Associate with the University of Washington’s department of Global Health, says he attended the May 10 meeting in Washington that recommended Truvada, says through FDA’s mandate is only limited to the US, Uganda has followed its recommendations before. Unlike the local National Drug Authority, the FDA is subject to higher scientific rigor, not only because it can afford them, but it can also be sued in case of a wrong recommendation.
The Uganda AIDS Commission maintains that the main strategy against HIV/AIDS remains prevention, based on strengthening existing programmes that have been proven to work and are cost-effective.
“Let people get tested, utilize PMTCT [Prevention of Mother-To-Child Transmission], and let all adult HIV-negative men be circumcised,” Dr Tigawalana said.
Only 40% of Ugandans have tested for HIV and know their status, PMTCT uptake is at only 50% and 50% of people who need ARVs are getting them. Tigawalana says to use Truvada would require massive counseling and testing to be able to identify discordant couples. It would also require prohibitive laws to be lifted to enable targeting of high-risk populations like prostitutes and homosexuals, who are some of the main beneficiaries of the new drug.
“You don’t just put up a programme because science has said so!” Dr Tigawalana says.
A lot more work needs to be done to make Truvada viable in Uganda. Public health guidelines by responsible bodies need to be issued, and more studies done in real-world settings on how best to implement PrEP, and raise funds for it.
That said, the only people in Uganda that will be benefiting from this research are the Partners PrEP study participants, who have since July last year been taking the daily Truvada.
New infections have continued to rise with an estimated 135,000 new HIV infections per year. An estimated 1.5 million people are said to be living with HIV/AIDS.