In July, the Food and Drug Administration approved the first HIV preventive drug.
Truvada, prescribed for nearly a decade to people already infected with HIV, is now marketed as a âpre-exposure prophylaxis,â meaning it is targeted for high-risk individuals who test negative for HIV when starting the drug.
But representatives from local agencies serving people with HIV/AIDS worry people will have a false sense of security if they use the drug, and that the drug's cost may be prohibitive to those who would benefit most.
âI don't want folks to think that this is a pop-a-pill prevention,â says Lisa Terry, executive director of the AIDS Task Force of Northeast Indiana, which serves 11 counties with care coordination and case management services, prevention education, and advocacy. âIf people are hearing about Truvada and saying, 'I don't have to use condoms,' that's the big deal here.â
Truvada is actually a combination of two drugs and, as a preventive, must be taken daily, with HIV testing every three months, plus additional periodic liver enzyme testing due to possible toxicity to the liver.
The other most serious side effect, according to Truvada.com, which is a website of Truvada manufacturer Gilead Sciences, is lactic acidosis, which can be a life-threatening build-up of acid in the blood.
Patients must have close care and regular checkups by a trusted health-care provider and report symptoms that could mimic the flu but could actually be much more serious.
As a treatment, Truvada has been touted as perhaps the best drug for reducing what is called viral load, or the amount of virus in the blood, in people with HIV-1, the most common type of HIV. The viral load is considered the most important biological risk factor in whether HIV will be transmitted to another person.
Tests of Truvada as a preventive to HIV infection found it lowered the risk of HIV by 42 percent in healthy gay and bisexual men. But the demographic that saw the greatest benefit was heterosexual couples in which one person has HIV and the other is negative. For those couples, the HIV-negative partner had a 75 percent reduced risk of developing HIV.
It should be pointed out, however, that in all studies of Truvada as a preventive drug, subjects were told to practice other safe sex measures including using condoms.
The question could be raised then whether other precautions, if used 100 percent of the time, led to reduced HIV infections rather than the drug alone. People who agree to be part of scientific studies â" and who may be paid for it â" are more likely to adhere to protocols than non-study subjects who have no one looking over their shoulders.
In one study of female sex workers, Truvada did not prevent HIV infection. Whether this was because the women did not take the drug as prescribed or were less likely to use other precautions is not known, researchers said.
Still, for heterosexual couples in which past relationships â" an extramarital affair by one partner who then returns to the committed relationship, for example â" led to HIV infection, Truvada could make a world of difference.
For all whose activities place them at risk of HIV infection, âThis is not a 100 percent guarantee. There's still that percentage of gambling,â says Kathy Thornson, HIV-STD Prevention director for the Fort Wayne-Allen County Department of Health.
Kris Wise, director of client services at the AIDS Task Force, says clients in support groups are talking about the recent approval of Truvada as a preventive. A number of clients she works with, who are HIV positive, are taking Truvada, but she points out, âMany clients have noted they would worry for their partners taking Truvada as a preventative because of the possible side effects and level of adherence to the medications which they have experienced firsthand as being difficult.â
One of the main controversies surrounding Truvada involves drug resistance that could occur if people do not follow all the prescribing and testing protocols. They must be absolutely sure of their infection status before starting the drug as a preventive.
âThe virus can reproduce its DNA and RNA, so if you have HIV, the virus can mutate rapidly,â leading to drug resistance,â Thornson explains, noting the question surrounding Truvada then becomes, âIs it the beginning of the end of HIV or the beginning of the end of HIV (treatment) drugs?â
Gilead has not yet announced what it will charge for the preventive combination drug, but industry reports suggest it will be between $900 and $1,200 for a month's supply.
When the FDA gives approval for a drug, it is usually the impetus for Medicare, Medicaid and private insurers to cover it, but Terry is skeptical that Medicaid will do so in light of significant cuts in Medicaid over the last couple of years.
Though the state provides funding to county health departments for STD testing and counseling, Thornson says of coverage for Truvada, âI don't see us able to afford it here.â Some HIV/AIDS advocacy groups also fear coverage for Truvada as a preventive will dilute funding that now goes to pay for Truvada as a treatment.
Gilead is setting up a patient-assistance fund for people who want the drug as preventive but cannot afford it. However, patient-assistance programs help only the very, very low-income.
Despite the continuing debate about Truvada to prevent HIV, Thornson, Wise and Terry agree Truvada is a new option for a targeted group of people who previously had no such option.
All three are working to prevent spread of the disease. An estimated 50,000 people are newly infected a year. The CDC estimates about 1.2 million Americans today are known to be HIV positive, with one in five of them unaware they have it.
âAs a straight grandmother, it's always been my soapbox that I never wanted my kids or grandkids to get this,â Terry says. âHIV is an equal opportunity infector. It doesn't matter your socioeconomic level or what neighborhood you live in. I see the mothers come in with their children. The mother may have gotten infected by a gentleman who didn't tell or didn't know he was HIV-positive.â
Now both mother and child have the virus. That is why âprevention, education and outreach,â she says, âis the most vital part of what we do.â
This column is the personal opinion of the writer and does not necessarily reflect the views or opinion of The News-Sentinel.
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