On Monday, July 16, the FDA approved Truvada, the first drug intended to prevent HIV infection in uninfected individuals who are at high risk of HIV infection and who may engage in sexual activity with HIV-infected partners. Truvada, taken daily, was shown to be effective in reducing the risk of HIV infection by 42 percent compared with a placebo.
Dr. Lisa Bowleg, an associate professor at the Drexel University School of Public Health and an expert in HIV/AIDS, LGBT issues and health in African American communities, provided her opinion and reaction to the news:
“Truvada is unquestionably one of the largest and most exciting developments in HIV prevention in decades.
Alas, there is the harsh reality of cost and access. Estimates put the cost of Truvada at roughly $13,000 a year, and there is doubt whether health insurance (for those who have health insurance) will cover it.
Thus, African Americans, the focus of my research, and the U.S. population with the most disproportionately elevated rates of poverty, lack of health insurance, and HIV/AIDS, simply will not have ready access to this innovative prevention breakthrough.
So while I celebrate the arrival of Truvada and welcome the benefits it will have for many Americans, it remains the case that many Americans who are poor and lack access to health insurance and care, will not reap the same benefits as those who can afford Truvada.
As such, HIV prevention work pre-Truvada remains the order of the day: advocacy for social structural-level (e.g., addressing poverty, incarceration, etc. communities) and individual-level (e.g., increasing condom use, limiting sexual partners) interventions to reduce HIV in low-income ethnic minority communities hardest hit by HIV/AIDS.”
Dr. Seth Welles, a professor at the Drexel University School of Public Health and a leading researcher in HIV disease progression and transmission, also offered his expert opinion. He was cautiously optimistic about the news:
“I believe that the FDA approval of Truvada to prevent HIV infection in high-risk individuals is a move in the right direction—that this is a good thing overall. I am cautiously optimistic, since there are at least two or three negative aspects of ongoing treatment.
Truvada has many possible side effects, including lactic acidosis, hepatotoxicity, changes in kidney function, osteopenia (thinning of bones), lipodystrophy, as well as less serious but common side effects including diarrhea, dizziness, and depression.
Use of Truvada could increase the amount of unsafe sex in persons taking this drug, since persons taking prophylactic treatment could believe that they are fully protected from acquiring infection. Since degree of protection is related to treatment adherence, some individuals with sub-optimal adherence would remain at risk for infection. Therefore, individuals with sub-optimal adherence would be at increased risk for becoming infected as a result of increased frequency of condomless intercourse.
HIV treatment optimism has been studied even before this FDA approval: In those studies, persons who had high treatment optimism (that HIV infection was not as serious or life-threatening since the use of HAART) also were more likely to have unsafe sex.
Widespread use of Truvada in high-risk populations could lead to an increased prevalence of HIV strains that are resistant to one or both components in this treatment. If other drugs are approved to prevent infection, one could expect to observe increasing levels of resistant strains to these drugs as well. Over time, this would limit the use of these drugs to prevent infection.
Patients who elect to receive Truvada need to be carefully counseled to maintain optimal adherence, and to maintain use of condoms for intercourse (ideally). Otherwise, infection is a real possibility.”
Dr. Bowleg, an associate professor within the School of Public Health's Department of Community Health and Prevention, conducts NIH-funded HIV prevention research that focuses on the sexual HIV risk and protective behaviors of Black heterosexual men in Philadelphia. Her research, publications, and presentation focus on: (1) intersectionality, stress and resilience in the lives of Black, lesbian, gay bisexual and transgendered people; and (2) the effects of structural factors (e.g., racism, poverty, incarceration, unemployment), gender roles, and sexual scripts on HIV risk among Black heterosexual women and men. She has received numerous awards and recognition for her research, and has many published articles. Dr. Bowleg received a PhD in Applied Social Psychology and a Masters degree in Public Policy from The George Washington University.
Dr. Welles, a professor within the School of Public Health’s Department of Epidemiology and Biostatistics has worked for more than 14 years to understand the impact of HIV phenotypic and genotypic antiretroviral drug resistance on HIV disease progression and transmission. Dr. Welles also studies psychosocial risk for HIV infection and STDs among sexual minority adults and adolescents. He is committed to community-based participatory research and has a demonstrated interest in working with marginalized populations. His research has been funded by both the NIH and the CDC. Dr. Welles has experience teaching epidemiology at all levels. He has led a number of different graduate epidemiology courses (at Boston University and University of Minnesota) and has advised and mentored many MPH and several doctoral students.