Truvada is a prescription drug that was first approved by the FDA for use in combination with other drugs in the so called cocktail therapy to manage and control established HIV infections in 2004. In 2012 the FDA approved it as safe and effective as a prophylactic treatment to prevent new HIV infections. It is not the long hoped for AIDS vaccine, but it is the first approved preventive drug. There are various controversies fueling debate over how it should be used and whether it should replace other established preventive campaigns such as condom use.
Truvada has been called the 'miracle' HIV pill – so why is uptake so slow?
Across San Francisco’s hilly streets, rainbow flags are always present, shining through the city’s persistent fog, displayed outside the city’s trademark brightly colored Victorian homes – and their modern apartments packed with Silicon Valley millionaires. And now this longtime home to gay pride and technological innovation may soon become the country’s leader in the fight to eradicate Aids.
This week, city supervisor David Campos unveiled a radical plan with a single goal: to wipe out HIV in the city. The plans could rest on what some have described as an HIV miracle drug and others have described as a public health disaster in the making: Truvada.
The drug, if taken every day, has a remarkable record in preventing HIV infection, and some believe it’s as effective as condoms. Campos has introduced a proposal that would make it available to any San Franciscan – male, female or transgender – who could benefit from it. This effort is backed by fellow supervisor Scott Wiener, who on Wednesday announced that he takes Truvada.
But take-up has not been wide. “It’s a boutique intervention at this point,” said Johns Hopkins’ Dr Chris Beyrer, who co-chaired the WHO guidelines for Prep, which were released in July. He hopes that these guidelines along with an even stronger endorsement by the CDC in July will help make the drug available in more places.
“If this is going to have efficacy as a public health intervention that can really reduce rates of new infection at population levels, we have to have a different model,” he said. Beyrer, as well as other researchers and politicians, are trying to figure out how to get Prep prescribed to more people, especially in places where people aren’t linked closely to healthcare services. New York governor Andrew Cuomo has proposed an initiative similar to Campos’s for his state.
A key part of these attempts is education, but Truvada has been plagued by salacious criticism since it was introduced, and even prominent Aids activist Larry Kramer described those who take the drug as “cowardly”. The Los Angeles-based Aids Healthcare Foundation has been vehemently anti-Truvada for years and launched its latest anti-Prep campaign last month.
“Now is not the time to be throwing away the condoms,” said AHF president Michael Weinstein, the most frequently quoted voice by media members looking to provide balance in articles touting the drug’s potential.
The writer of this Guardian article appears to have pretty much bought the claims of it being a panacea for prevention and is inclined to label people with reservations as obstructionists. However, the various clinical studies seem to suggest that there is a gap between an effective means of prevention and a perfect means of control.
Is Truvada, the Pill to Prevent H.I.V., 99 Percent Effective? Don’t Be So Sure
Truvada, the once-a-day pill to help keep people from contracting H.I.V., is on the cover of this week’s New York magazine, and Tim Murphy’s cover story focuses on how the pill is changing sex by drastically reducing gay men’s fear of infection.
It’s not hard to see why: Mr. Murphy writes, “When taken every day, it’s been shown in a major study to be up to 99 percent effective.” This is a claim I hear thrown around a lot among gay men in New York. And it’s wrong. The 99 percent figure isn’t a study finding; it’s a statistical estimate, based on a number of assumptions that are reasonable, but debatable.
Here’s how the estimate was reached: A major study of men who have sex with men, called iPrEx, found that H.I.V.-negative men who were prescribed daily Truvada were 44 percent less likely to contract the virus than those who were given a placebo. But a great many of the subjects did not take their prescribed medication regularly, or at all. Of 48 iPrEx subjects who were assigned to take Truvada and contracted H.I.V. anyway, just four had any detectable level of the drug in their system when they were diagnosed, indicating a 92 percent reduction in risk for people who were actually taking the medicine.
But wait, there’s more: Those four subjects who took Truvada and became infected had its active ingredients in their blood only at levels consistent with taking the drug twice a week. That is, in the study, there were zero apparent cases of subjects taking their pills daily and contracting H.I.V.
Other studies involving groups at risk other than gay men have shown various rates of success. Condoms are very effective when they are used, but the problem is that they aren't always used. The groups of gay men who have shown rising infection rates have low rates of condom use. These are young and otherwise marginalized groups. It seems likely that expectations that they would reliably take daily doses of a drug to which they might not have easy access aren't particularly high.
Private purchase of the drug can cost between $8000 -$14000 a year. Insurance plans are beginning to cover it. There are proposals in New York and San Francisco for government funding of it. Outreach and education to the communities that are the most at risk for new infections would also require government funding.
It does sound like this is an important new addition to the means of HIV prevention. Anyone who is in any way at risk for HIV infection would be well advised to investigate it carefully. However, the people who are saying that it is probably too soon to throw away the condoms might also have a point worth listening to.