Talking HIV PrEP and Public Health

It is estimated that 1.2 million Americans are currently living with HIV, and, despite the availability of existing prevention “tools,” such as condoms, the incidence rate has remained steady over the past two decades with approximately 50,000 new infections occurring each year.

July 2012 was a historic month in the prevention and treatment of HIV/AIDS. First there was a shift in antiretroviral treatment guidelines that now recommend inititation of these medications for HIV/AIDS once someone is diagnosed regardless of disease stage. Then new home test kits were announced. Finally based on studies to date, the U.S. Food and Drug Administration approved the combination medication tenofovir disoproxil fumarate plus emtricitabine (Truvada®) for use as prevention among sexually active adults at risk for HIV infection. When taken correctly, this once a day pill can reduce acquistion of HIV in a person with “high risk” behavior by over 90 percent.

In early August 2012, Dr. M. Keith Rawlings, Director of HIV Medical Affairs at Gilead Sciences, visted DUSPH to speak with students at the school participating in a summer research program on health disparities, as well as other students, faculty and staff, about Truvada and its implications on public health. Gilead is the company that manufactures the medication.

While noting that Truvada is "probably the biggest development since antiretrovirals [use in treatment]," Dr. Rawling acknowledged the importance of using Truvada® as part of a comprehensive prevention program that includes safer sex practices, regular HIV testing for themselves, and other proven HIV prevention methods.

There are also several public health firsts and challenges that accompany Truvada and its distribution across the public health system. Several DUSPH faculty have also been active commentators and sometimes critics of the new drug. Following is a snapshot of the reaction from the faculty at the DUSPH.

Dr. Marla Gold, Fomer Dean, DUSPH	Dr. Seth Welles, Professor, DUSPH
^{“Truvada is the first, FDA-approved medication that can be used to prevent HIV. However, the nation’s public health systems are not yet ready to effectively administer it and make it available to those who might benefit the most.} ^{We need a system of care that can identify and support high risk, HIV negative individuals in their decision-making and help decrease risky behaviors.} ^{The fact is, over 25 years into the HIV epidemic, we have known for many of those years what to do to prevent transmission of the virus. Interventions such as condoms or for injection drug users, syringe exchange, work. But social issues prevent us from fully implementing potentially life-saving interventions.”}	^{“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 suboptimal 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.”}

Marla Gold

Dr. Marla Gold, Fomer Dean, DUSPH

Seth Welles

Dr. Seth Welles, Professor, DUSPH

^{“Truvada is the first, FDA-approved medication that can be used to prevent HIV. However, the nation’s

public health systems are not yet ready to effectively administer it and make it available to those who might benefit the most.}

^{We need a system of care that can identify and support high risk, HIV negative individuals in their decision-making and help decrease risky

behaviors.}

^{The fact is, over 25 years into the HIV epidemic, we have known for many of those years what to do to prevent transmission of the virus. Interventions such as condoms or for injection

drug users, syringe exchange, work. But social issues prevent us from fully implementing potentially life-saving interventions.”}

^{“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 suboptimal 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.”}