Newly approved drug to prevent HIV is expensive, must be taken properly and is no substitute for condoms, so keep the champagne on ice

The FDA this week approved Truvada, the new drug touted as a proactive preventive for HIV transmission. The acronym PrEP (PreExposure Prophylaxis) is what this kind of treatment is commonly called now. It is the first drug approved as treatment for people not infected with HIV but who are at high risk of getting the disease. But that doesn’t mean Truvada hasn’t already been on the market.

In fact, Truvada is already the most widely prescribed treatment in combination with other drugs for HIV-positive patients, but the new use is something entirely different.

Needless to say, the promise of a preventive medication for contracting HIV seems really great. I used to keep a bottle of champagne in my fridge for the day when a cure or at least a vaccine was announced. But as usual, the devil is in the details, and there are a lot of details.

First, there’s the drug itself.

In one study, Truvada had a 44 percent success rate preventing new transmissions when combined with counseling and regular use. (A study of 2,500 gay men and “men who have sex with men” showed this reduction over a placebo. To be fair, though, many of those who tested positive had no signs of the drug in their system. In other words, they didn’t stick with the regimen.)

Considering that regular condom use has an 85 percent effectiveness rate, this seems pretty puny, which brings me to the point of this column.

For some people — for example, a couple in which one partner is HIV positive and the other is HIV negative — a drug like Truvada taken as a preventive may make a lot of sense.

However — and it’s a big however — you must take the drug according to the manufacturer’s recommendations and not miss a dose.

Sporadic use can decrease the effectiveness and worse, could have implications for drug-resistant strains of HIV.

Possible side effects include nausea, muscle pain and diarrhea, but on the serious end Truvada can cause liver and kidney problems.

The second big problem I have is the cost.  For someone infected with HIV, Truvada as part of a regimen of treatment is covered by some insurance plans.

However, the prophylactic use of it may not be, and at $14,000 a year, it will be beyond the reach of most people.

A few forward-thinking insurers have decided to add Truvada to their approved drugs, and so it might eventually be within everyone’s reach.  Oddly, or perhaps not so oddly, the cost of the drug in Thailand is a princely $480. Same manufacturer, same drug — though I suspect heavily subsidized.

But the biggest problem I have is this: The uninformed, which is most of us, myself included, might hear of this wonder pill and figure that all bets are off when it comes to safer sex. That was my first impression until I dug a bit deeper.

The problem is, considering how people in the study skipped their medication or perhaps didn’t take it at all, and knowing how our society is always in search of a quick fix, Truvada could become a talisman rather than a treatment.

Sexually active guys might end up discarding condoms and opting for a once-in-a-while dose of Truvada. The results of that would not be pretty.

I know this is a sensitive topic, and having lived through so many years of the epidemic, I would be the first to cheer a vaccine, preventive pill or, more importantly, a cure. But HIV is not the only nasty disease out there.

Recently, new drug-resistant strains of chlamydia and gonorrhea have started showing up at clinics around the country.  Although condoms are not a cure-all, they still are safer than nothing at all.

Many voices have chimed in on this topic. AIDS Health Care Foundation Director Michael Weinstein called the FDA approval “negligent.” He went on to say,

“The FDA’s approval of Gilead’s Truvada as a form of HIV prevention today without any requirement for HIV testing is completely reckless and a move that will ultimately set back years of HIV prevention efforts.”

The San Francisco AIDS Foundation took an opposite stand saying, “Truvada … won’t end AIDS by itself, but we certainly can’t end the HIV epidemic without it.”

Rather than a cure, I think Truvada will prove to be another weapon in the arsenal against HIV/AIDS.  Since it is already a highly effective drug in treating people who are HIV positive, it’s not going away.

As a condition to approving the drug, the FDA has told the manufacturer, Gilead Sciences Inc., it must test people who become HIV positive while taking the drug and “collect viral isolates from individuals who acquire HIV while taking Truvada and evaluate these isolates for the presence of resistance.”

A Truvada-resistant strain of HIV would be disastrous for the treatment of the disease, and that is a really big risk.
Personally, I don’t think a condom during sex is that big a sacrifice when you can still have a sexually active life and minimize the risk of contracting the virus. I feel pretty sure there will be a lot of people who will disagree, but for now, I will keep the champagne on ice and wait and see.  Meanwhile, the medical community will be monitoring the success of Truvada as a preventive measure and only time will tell.

I am hoping and praying for success.

Hardy Haberman is a longtime local LGBT activist and board member for the Woodhull Freedom Alliance. His blog is at   

This article appeared in the Dallas Voice print edition July 20, 2012.