Editorial in September Issue of “The Lancet Infectious Diseases” Raises Questions about Widespread Use of HIV Treatment Drug Truvada as an HIV Prevention Pill (Pre-exposure Prophylaxis or PrEP)
Among the Concerns: Encouragement of High-Risk Sexual Behavior, No Sustainability as a Long-Term Approach to Fighting the Epidemic and Increased Resistance
LOS ANGELES--(BUSINESS WIRE)-- Today AIDS Healthcare Foundation (AHF) commented on an editorial published in the September 2011 issue of The Lancet Infectious Diseases that raises concerns about the use of the HIV treatment drug Truvada, manufactured by Gilead Sciences Inc., as an HIV prevention pill or pre-exposure prophylaxis (PrEP), agreeing with the publication’s public health concerns.
The Lancet article, Treatment as prevention for HIV (Volume 11, Issue 9), reflects on the state of global AIDS research after the Sixth International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention held in Rome in mid-July. In particular, the publication address the fact that HIV “treatment as prevention” has become common wisdom in the field. Major studies have shown that an HIV-infected individual who is on treatment is up to 96% less infectious and, therefore, significantly less likely to pass the virus on to others. Also, the results of the iPrEx study, a study of 2,499 HIV-negative high-risk men who have sex with men (MSM), showed that taking the once-daily HIV treatment pill Truvada could decrease the likelihood of HIV infection.
The Lancet urges restraint regarding increasing the use of antiretroviral drugs—medications used to treat HIV and AIDS—saying, “Enthusiasm generated by these results must be tempered with caution.”
The article continues: “Expanding the use of antiretrovirals to include pre-exposure prophylaxis will increase the risk of resistance, which is already a serious problem. HIV is a rapidly evolving virus and development of resistance creates the need for ever changing regimens of drugs in various classes. The current dire situation with antibiotics should serve as a lesson to initiatives seeking to increase the ways in which we use antiretroviral drugs.”
Concerns over the potential decrease in safer sex is also addressed: “Furthermore, although some of the trial results have been very impressive, the protection with pre-exposure prophylaxis is unlikely to be 100%, and making drugs available as prophylaxis could encourage high-risk sexual behaviour among those who believe themselves to be protected.”
“As a healthcare provider, AHF shares The Lancet’s concerns over the use of Gilead’s Truvada as PrEP and its potential negative affects on the medical community’s ability to fight AIDS and on the public health,” said Michael Weinstein, President of AIDS Healthcare Foundation. “Going forward with FDA approval of PrEP without more information would be a mistake. AHF’s first priority is ‘to do no harm.’ The issues that The Lancet addresses—such as the potential for increases in high-risk sexual behavior and increased viral resistance—are potentially very harmful to individuals and the health of the public at large. It would be unwise to ignore the need for caution expressed in this article.”
The Lancet editorial also looks at the issue of sustainability presented by the possible expansion of antiretroviral use beyond treatment and concludes: “Integration of antiretroviral prophylaxis into HIV prevention strategies must not be at the expense of tried and tested behavioural interventions, and care must be taken to safeguard the usefulness of these drugs for treatment in the future and to encourage a healthy drug-development pipeline. The fight against HIV/AIDS is a long-game, and current enthusiasm for positive results must lead to approaches that are sustainable in the long-term.”
The Lancet is joined by the American Journal of Public Health (a publication of the American Public Health Association) which published an article this past April that raised similar concerns regarding PrEP. Authored by Arleen A. Leibowitz, PhD, Karen Byrnes Parker, MPP, and Mary Jane Rotheram-Borus, PhD (two of whom are professors at UCLA’s School of Public Health in Los Angeles), a U.S. Policy Perspective on Oral Preexposure Prophylaxis for HIV discusses the possibly harmful public health consequences of widespread use of Truvada by HIV-negative individuals.
Gilead’s campaign for approval by the U.S. Food & Drug Administration (FDA) of Truvada as an HIV prevention pill has ramped up since the iPrEx study. Recently, 618 doctors and advocates sent or signed letters to the FDA and to Gilead detailing a number of concerns raised by the iPrex study. Ultimately, the doctors are concerned that widespread use of PrEP, based on the available data, will unwittingly lead to more risky behavior, and more HIV infections.
AHF has been spearheading a campaign against the premature FDA-approval of Truvada as PrEP under the name “There is no magic pill.” More information can be found at: www.nomagicpills.org.
Background on Gilead’s Truvada
Truvada, a drug compound that consists of Gilead’s drugs Viread (tenofovir DF) and Emtriva (emtricitabine), is currently FDA-approved for use as part of antiretroviral therapy combinations for individuals already living with HIV or AIDS. In 2010, Truvada was Gilead’s second-best selling product generating over $2.6 billion in revenue. One analyst told Bloomberg that FDA-approval to prescribe the drug for pre-exposure prophylaxis may add $1 billion to Gilead’s sales of Truvada.
AIDS Healthcare Foundation (AHF), the largest global AIDS organization, currently provides medical care and services to more than 181,000 individuals in 26 countries worldwide in the US, Africa, Latin America/Caribbean, the Asia/Pacific region and Eastern Europe. www.aidshealth.org
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