Factually Deficient Screed on PrEP Harms Efforts to Prevent New Infections

A Gay San Diego editorial misrepresents the facts and, in doing so, endangers public health initiatives.

BY Todd Heywood

April 29 2014 4:00 AM ET

To say Robert Brandon Sandor gets PrEP completely wrong in his Gay San Diego editorial is an understatement. 

He blatantly misrepresents PrEP and the science of HIV prevention and transmission. 

So, let's deconstruct his claims, and get all the facts out there. 

Claim Number One:

Years of published articles and scientific reports stating that PrEP failed to gain national support are based on factual evidence; PrEP is simply not practical.

The issue of PrEP uptake, or rather the lack of uptake, has much more to do with the two things.

First, PrEP uptake is seriously hampered by public health and other medical officials who are unwilling to write PrEP scripts because the science is not strong enough, in their opinions, for its use. See my report on HIV prevention efforts in Michigan, wherein a top HIV prevention official for the state of Michigan opines, "We've had internal discussions, we've had background discussions. We're interested in the science and the outcomes," [Jane] Duframe said of the intervention that has been approved by the FDA for all high-risk groups in the US, including MSM, IVDUs and women who have HIV-positive partners. "I think it's an exciting possibility for the future."

One might also note that Gilead, to date, has done no advertising to promote Truvada for PrEP and prevention. This is a business decision by Gilead. From a New Yorker report in October of 2013: "According to Jim Rooney, Gilead’s vice-president of medical affairs, the company 'spends several million dollars' on educational initiatives related to PrEP, delivered through third-party groups, but it 'does not view PrEP as a commercial opportunity.' Truvada is already a blockbuster drug for Gilead; it earned the company more than three billion dollars in global sales in 2012."

The New Yorker report also demonstrates a clear reluctance of doctors to be "the first out of the gate" in new medical options. But that hasn't stopped Medi-Cal and the State of Washington from creating direct access to PrEP. 

Second, knowledge of the intervention is ridicuously low. How low? In a 2012 public poll from the Kaiser Family Foundation, only 17 percent of respondents responded "yes" to the question: "As far as you know, can the drugs used to treat HIV be used by people who are HIV-negative to lower their risk of getting HIV, or not?"

Is there any wonder that The National AIDS Treatment Advocacy Program reports that early uptake of PrEP (those getting prescriptions for the drug) was only 1,774 people, almost half of them high risk women? 

Claim Number Two:

The supporters of PrEP state the HIV-negative community is required to take PrEP daily for life, and wear condoms 100 percent of the time. Which begs one to ask the question: Is it the condom keeping you HIV-negative or PrEP?

That fringe group Project Inform certainly does not make that claim. In their booklet on PrEP, here's what they have to say about condom use and PrEP: "If you rarely — or never — use regular or female condoms for riskier sex, PrEP is still a great option to lower your risk for HIV. It won't protect you from most other STDs but it might strongly reduce your risk of HIV compared to not using it at all."

And Medi-Cal — California's low income health insurance program — removed requirements that recepients receive condoms and monthly HIV testing, as well as removed the pre-approval clearance from Medi-Cal before a physician could write a prescription for Truvada for HIV prevention purposes. This was reported by WEHOville.com on the very same day Sandor's piece was published by Gay San Diego
 
Here's the other thing: we know men who have sex with men simply aren't using condoms during anal sex. A recent report from the CDC concluding: "The percentage of MSM [men who have sex with men] reporting unprotected anal sex at least once in the part 12 months increased from 2005 to 2011, from 48 percent in 2005, to 54 percent in 2008, and 57 percent in 2011. This trend was statistically significant among self-reported HIV-negative or unknown status MSM…but not statistically significant for self-reported HIV-positive MSM."
 
As for his begging question, we can turn to Project Inform once again. In explaining the results of the iPrEx study which determined PrEP works to prevent HIV infection, the group writes: "Although everyone reported 'bottoming' (receptive anal sex) in the previous six months without a condom, most people reported using condoms more often during the study. Given that high-risk sexual behaviors were still quite common, and given that condom use was the same in both the Truvada and placebo groups, it is highly likely that Truvada, and not just condoms, had a lot to do with how effective the pill prevented new infections."
 
The evidence is clear. It was the drug, not the condoms, reducing new infections in the study. 
 
Claim Number Three
 
PrEP failed because it is harmful. 
 
PrEP is Truvada and according to its own website, Truvada.com, there are serious side effects: "Too much lactic acid in your blood (lactic acidosis), which is a serious medical emergency. Serious liver problems. Your liver may become large and tender, and you may develop fat in your liver. You may be more likely to get lactic acidosis or serious liver problems if you are female, very overweight (obese), or have been taking Truvada for a long time. Worsening of hepatitis B (HBV) infection. If you also have HBV and take Truvada, your hepatitus may become worse if you stop taking Truvada."
This is misleading. What Sandor fails to say is that those scary side effects are listed as the most severe, while in the common side effects section of the website, Gilead, the makers of Truvada, write, "In people taking Truvada to reduce the risk of getting HIV-1 infection, common side effects include: headache, stomach area (abdomen) pain, and decreased weight."
 
He is also being deliberately misleading about the side effects seen in PrEP users. The National Institute of Allergy and Infectious Diseases website on PrEP, explains the side effects from the 2,499 participants of the iPrEx PrEP study: "The researchers found that consistent with earlier, smaller studies that led up to the iPrEx study, the antiretroviral drug proved to be safe and well tolerated as a prophylaxis method. Side effects were mild and infrequent and included a small number of transient nauseau which dissipated after several weeks. Additionally, some participants who received the active drug experienced mild elevations of creatinine, a naturally occuring molecule filtered by the kidneys, but these elevations resolved spontaneously or with discontinuation of the pill."
 
Yep, not a single case of lactic acidosis was reported among the 2,499 study particpants. 
 
The Journal of Clinical Pharmacology published a study January of 2011 noting that acetaminophen (brand name Tylenol) can also cause lactic acidosis. However, it is linked to overdoses, which are a growing issue. But no one I can find is calling for an end of the use of acetaminophen because of the chance of lactic acidosis. 
 
Drugs have side effects. We take drugs, in fact, for their side effects. The metabolism of drugs that fight HIV cause the side effect of jamming up the viral replication process. The metabolism of acetaminophen results in a reduction of the body's inflammatory response. Those are positive side effects. But each also have negative side effects. The question we as consumers have to balance: Do the potential positive outcomes of using this drug out weight the potential negative outcomes? We rely on medical professionals to advise us on this decision, not one notice on a website required by the FDA to announce the worst possible consequences of taking a given drug. 
 
Claim Number Four: (and he makes a similar claim at the end of his piece)
 
PrEP failed because there is no need to take expensive medications with harmful side effects for something HIV-negative gay youth are doing now for free.
 
One example is the national popularity of the disease and drug free revolution. This unique, community-driven, harm-reduction, HIV prevention strategy has been accepted since it was first introduced to the public back in the mid-1990s, with the formation of the nation's first HIV-negatve safe-sex environment, called "Boy Toys — NY"; a private sex party exclusively for HIV-negative gay young men, popularly known as "HIV-UB2/Safe Sex Serosorting."
Here is the factual information on serosorting: It simply doesn't work to prevent new infections. A March 2014 study published in the Journal of Acquired Immune Deficiency Syndrome found serosorting's  "protective effect...was not statistically significant."
 
AIDSMap reported on a study in 2012 which had dramatically similar results in relation to serosorting. That study found that the risk of infection while using serosorting as an intervention was about 50-50. 
 
In fact, the CDC itself does not recommend serosorting as a strategy, thus refuting Sandor's claim it has been "accepted." It has, in fact been rejected. Soundly. 
 
This failure of serosorting as a true risk reduction option likely has much to do with low testing rates in the men who sex with men groupings. That November CDC report from 2013 found that 2011, 33 percent of HIV-positive but unaware gay and bi men had unprotected, serodiscordant anal sex. (That means one in three gay or bi men had sex in which one of them was HIV-psitive, even though they didn't realize it.)
 
A 2010 study by the CDC found that nearly one in five gay and bisexual men who go to gay bars in 20 large US cities was infected with HIV. Of those infected, 34 percent were unaware of their infection at the time of testing and presumed they were negative. And the clincher on why serosorting is a failure is that a 2008 study found that HIV-positive unaware persons were at least 3.5 times more likely to transmit the virus than men who know their status.
 
So how does that translate into a failed construction of serosorting as a prevention option? The November 2013 CDC report found: "However, one third of HIV-MSM in the [National HIV Behaviorial Surveillance System] did not know that they were infected with HIV, and a high percentage of them reported recent unprotected discordant anal sex with a partner of HIV-negative or unknown status. CDC found that MSM who were HIV-positive but unaware were more than two times more likely to engage in unprotected discordant anal sex, compared with HIV-positive aware or HIV-negative MSM."
 
New medical innovations often face controversy and difficulty upon their introduction. And they face many questions. That's OK, and that's healthy. What is unhealthy is misleading and misrepresenting the body of scientific literature on the new innovation in order to pursue some agenda. And sadly, this editorial does exactly that. 
 
 
 
 

 

 
 
 

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