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:
- You need to take the tablet in a regular fashion, of which the best regime is still to be worked out.
- 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
My brother suggested I might like this blog. He was once entirely right. This post actually made my day. You cann’t consider simply how much time I had spent for this information! Thanks!
Doesn’t sound to me like we’re there yet. Not worth the side-effects, the money or the risks. Everyone should be way passed any awkwardness about using condoms. What I think we as a community should be focused on is rising HIV infection rate amongst young gay men because of the benign sounding but deadly trend of barebacking, which this pill will only encourage. Even if it were a 100% effective vaccine, which it is not, how many 20 somethings have an extra $11,000 laying around to pay for the drug.
Another very important point Scott. Who in Africa can afford $11K a year? Does this mean that only white middle class men with C level jobs will be able to have this potential opportunity?
It’s not that I’m indifferent to the appalling devastation HIV/AIDS has caused in sub-Saharan Africa or to the injustices caused by the almost impossible to comprehend disparity in the distribution of wealth of which HIV/AIDS may be the most visible example. When this whole trend of “barebacking” first came to my attention I was shocked, appalled and frightened by the implications and yet like many whose Life experience should have alerted them to the need to take immediate action to try and stamp this emerging practice out, I simply couldn’t believe people in any numbers would be willing to engage in such an obviously unsafe behavior. I didn’t take into account what one AIDS activist has called a “lack of visual acuity”; there is a generation of gay men who have no personal memory of watching their friends die, of wasting syndrome and all the other horrors. Twenty years ago you couldn’t walk down the street in any Gay Neighborhood and not see these very visible signs of the epidemic, now young gay men don’t see these walking warning posters. We were scared enough to use condoms. Thank God for the medicines that have come on line; they halted that avalache of Death. The problem, as I see it, is that we forgot how hard it was in the very begining of the epidemic for people to believe it was all really happening. It wasn’t until the obvious could no longer be denied that people took effective, pro-active steps to protect themselves. The new medicines allowed young people to slip into the very human tendency to embrace denial. Denial about what a life-changing event contracting HIV continues to be and denial about what a life-ending event contracting AIDS can still be in spite of all the anti-retroviral drugs, combination therapies and cocktails. Those of us old enough and experienced enough to have known better should have recognized this trend for what it was and reacted much more quickly to its dangers. Again, it wasn’t until the numbers of rising infections could no longer be denied before any alarms were raised at all and clearly not reaching those most at risk in a way that they could really “take in” the inherent dangers of their willful blindness. Just one obvious example of how ineffective the campaign against such behavior has been is the demand for barebacking porn and the proliferation of “Vintage Gay Porn” sites that evoke a nostalgia for the heyday of Gay Sexual Liberation in the late 1970′s. What none of us should forget is that even in 1978 on Castro Street in San Francisco, AIDS was already there at The Gay Freedom Day Parade with Harvey Milk sitting in the lead car smiling and waving to the crowd and telling eveyone “come on out, just come on out”. Before the year was out Harvey would be assassinated and within three years there would be the scary article in the New York Times: “Strange Cancer Found in 24 Homosexual Men in New York and L.A.” I’m just saying that while it is right to be concerned about the cost of this and other life saving new drugs to the many living in abject poverty in Africa, I’m fearful that we have taken our eyes off the ball right here in the West and that this new therapy has the potential to make the matter worse. I’d be far more comfortable if this were a one-shot injectable vaccine rather another medicine whose efficacy depends on the users ability or willingness to keep to a daily, life-long schedule of self administered responsibility for taking the medication.
If some people take it and some people don’t get infected that’s a win in my book. Anything that’s bringing the rate of infection down has to be good. I don’t think I would take it, I’d rather just stick to safe sex.
Did anyone else think that taking a tablet which gives you diarrhea isn’t exactly a great idea for a tablet that allows you to have unprotected anal sex. BAD COMBINATION!