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Can A Daily Truvada Tablet Replace Condoms?

Hey there Guys,

In USA news the medication Truvada, a combination of HIV drugs tenofovir and efavirenz, has been deemed safe for use as a HIV prevention drug by the food and drug administration (FDA). In a press release from Gilead Sciences, Truvada’s manufacturer they have noted:

Truvada was safe and effective when used to protect uninfected people from getting HIV..

Truvada was “well tolerated” and its ability to reduce the risk of infection was backed by two studies, the Food and Drug Administration staff said in a report Tuesday. Gilead, based in Foster City, is seeking to sell the drug as the first pill to keep people from becoming infected.

Decisions to prescribe Truvada “should carefully weigh the individual risks for acquiring HIV, their understanding of the importance of adherence to medication, and their potential for development of renal toxicity,” the FDA staff said Tuesday in a report on the agency’s website. Education and counseling will be “critically important.”

As with starting any medication there is potential risks with drug interactions and side effects with some of the most common noted to be diarrhea, nausea, fatigue, headache, dizziness, depression, insomnia, abnormal dreams and rash.

Truvada has also been associated with changes in fat distribution in the body and also in the blood, potential kidney and liver dysfunction and in some people, weakening of the bones. Don’t get me wrong, this medicine is revolutionary and has absolutely changed lives for many people living with HIV. My question is more that if safe sex is effective why add a medication with so many potential side effects?

Barry Zingman, medical director at the AIDS Center at Montefiore hospital hopes the drug is approved and plans to offer it to some patients. He states:

“If condoms were 100 percent effective and useful we wouldn’t have HIV at all,” Zingman said in an interview. “The reality is many people don’t like to use condoms or won’t, and taking a pill can be a lot more acceptable to them.”

But is taking a pill as effective as safe sex?

Truvada was studied as a prevention treatment in 2011 with the following results:

Once-daily oral FTC–TDF [Truvada] provided 44% additional protection from HIV among men or transgender women who have sex with men who also received a comprehensive package of prevention services. The protective effect of FTC–TDF was significant but not as high as originally hypothesized during the design of the study.

It’s important to note that the reasoning behind the poorer than expected results has been partially attributed to poor adherence to the daily tablet regime. Of the 34 people prescribed Truvada who became infected with HIV, only three had detectable Truvada in their blood. The drug levels were tested using an assay that was able note the drug up to 14 days after the last tablet was taken. Essentially 31 of those who became infected were not taking the tablet daily. Also important to note is that of the 43 people on Truvada who did not become infected with HIV, just 51% also had evidence of having taken the medicine.

The question is why? The research team suggested that side effects, in particular when first starting Truvada may have contributed to people choosing to not take the medicine.

The three people who became infected with HIV with Truvada detectable in the blood had concentrations of Truvada lower than the average for those who had taken it daily. This may indicate that erratic use may decrease its affect.

From this study it is thought that in people who took the medicine on a daily basis, the risk of HIV infection was reduced by 95%. Two of the 3 people who became infected while on Truvada were infected with a strain of HIV that was resistant to one of the medications in its formulation. Nobody was infected with a HIV strains that was resistant to both agents in Truvada.

This data indicates that daily Truvada reduces the risk of infection with HIV with two caveats:

  1. You need to take the tablet in a regular fashion, of which the best regime is still to be worked out.
  2. It would appear that if you are exposed to HIV virus that is resistant to one or both of the drugs in Truvada it is less likely to prevent HIV infection.

So the question is one of weighing up risks and benefits.

With taking any medicine there are risks of drug interactions and side effects. Truvada may not be a magic bullet as some strains of the HIV virus are resistant to the medicines in Truvada.

Side effects and efficacy aside it’s important to note that this treatment is not cheap. A year of medication can cost over $11,000 in the USA.  Insurance companies are unlikely to pay while condoms are available and much cheaper.

As a sole strategy to reduce HIV infection I personally would not choose to go the tablet alone. I am comfortable with condom use and feel that the additional benefit of the medicines vs the side effects are not worth it.

This of course is going to be different for other people. People in relationships with one person who is positive and the other negative or people who are not able to use condoms may consider a daily treatment a potential option. These situations would require careful counselling with a HIV specialist.

What are your thoughts guys?

Yours in good health.

Dr George

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