Several efforts in the past have not only been partially successful, they have also been profoundly controversial. But Monday, the Food and Drugs Administration (FDA) in the United States of America (USA) approved a new drug that could be used by adults to reduce their chances of contacting the dreaded disease.
Such persons who do not already have the infection could reduce their chances of contacting the virus if they take the new drug once a day. It would be the first time the FDA would be approving a drug for the ailment.
The drug is called Truvada, an antiretroviral medication made by Gilead Sciences, Inc., which was already approved by the FDA in 2004 to help control the HIV infection. Truvada is a combination of two HIV medications – emtricitabine (Emtriva) and tenofovir (Viread) – rolled into one pill that is taken once a day. Its efficacy is said to be better enhanced when taken with other HIV drugs, when treating the HIV infection.
More significantly, the drug presents an opportunity for Africa and Asia, which have been ravaged by the ailment. The National Agency for the Control of AIDS (NACA) has been in the forefront of providing drugs, education and support to those living with the pandemic in Nigeria.
In confirming the preventive effect of the drug, the manufacturers proved that pre-exposure prophylaxis or PrEP can reduce transmission of the virus significantly – up to 96 per cent – when uninfected partners of people infected with HIV took Truvada. But the manufacturers have sounded a note of warning that the drug is no licence for reckless sexual life, neither is it a Teflon that can insulate an infection, adding that those who already have the infection must observe sexual discipline as well as combine the new drug with others to achieve greater results.
Director of the Division of Antiviral Products, Center for Drug Evaluation and Research at the FDA, Dr. Debra Birnkrant, stressed that Truvada alone should not be used to prevent the HIV infection. It should be used in combination with other safe sex practices.
“Practising safer sex and good health practices must be part of the treatment,” Birnkrant said. “We will be putting a box warning to let those using Truvada know that it is part of the therapy with combination of safer sex practices, and that doing this will reduce the risk of the development of AIDS/HIV.”
Director of the National Institute for Allergy and Infectious Diseases at the National Institute of Health, Dr. Anthony Fauci, agrees. “The approval of Truvada to prevent HIV infection in uninfected individuals who are at high risk of the sexually acquired HIV infection is a significant development, providing an important addition to our toolkit of HIV prevention interventions,” Fauci said.
“However, it is critical to stress that Truvada as ‘pre-exposure prophylaxis’ should not be considered a stand-alone method, but should be used in conjunction with other proven HIV prevention strategies such as condom use, risk-reduction counselling, and frequent HIV testing.”
Birnkrant said she hopes the right message would get out, and that Truvada is used properly. “We have the box warning that a negative HIV test must be reported before Truvada is prescribed,” she said.
According to Gilead, Truvada is the most-prescribed antiretroviral in the United States. “Today’s decision is the culmination of almost 20 years of research involving investigators, academic and medical institutions, funding agencies and nearly 20,000 trial participants around the world, and Gilead is proud to have been a partner in this effort,” said the Executive Vice-President, Research and Development and Chief Scientific Officer, Gilead Sciences, Norbert Bischofberger.
The lead investigator of the iPrEx trialat at the University of California, San Francisco, Dr. Robert Grant, who looked at Truvada as a prevention treatment among high-risk men who have sex with men (MSM), said the approval is a major milestone in the 30-year fight against AIDS. “The use of PrEP alongside routine HIV testing gives us a tremendous opportunity to reduce the rate of new HIV infections in this country and around the world,” he said.
At the University of Washington, another PrEP study proved very successful in reducing infection rates in couples where one partner is infected and the other is not (called serodiscordant). “The data clearly demonstrate that Truvada as pre-exposure prophylaxis is effective at reducing the risk of HIV infection acquired through sexual exposure,” said Professor of Global Health and Medicine at the University of Washington and lead investigator of the Partners PrEP trial, Dr. Connie Celum.
“It is exciting to consider the potential impact of this new HIV prevention tool, which could contribute to significantly reducing new HIV infections as part of a combination HIV prevention strategy. Although the implementation of PrEP will bring challenges, they can be anticipated and systems developed to address these challenges,” he said.
Yet, the new drug has its critics: “The FDA’s approval of Gilead’s Truvada as a form of HIV prevention today, without any requirement for HIV testing is completely reckless and a move that will ultimately set back years of HIV prevention efforts,” said AHF’s President, Michael Weinstein. “From the beginning, we believe there was a rush to judgment by government officials and others in favour of such approval despite decidedly mixed studies offered in support