A pill a day to prevent HIV? Could it be “that” easy?

I’ve written previously about pre-exposure prophylaxis (PrEP) for preventing HIV (here and here, as well).

For those unaware, PrEP makes use of an antiretroviral pill called Truvada® (a combination of tenofovir and emtricitabine), along with safer-sex practices (e.g., condom use), to vasty decrease the risk of contracting HIV. PrEP is something that HIV negative people use.

Several studies were done using PrEP in different populations (men who have sex with men (MSM), women, sex workers, partners in zero-discordant couples (one member of the couple HIV positive the other HIV negative)) in several countries on different continents. The results were published in a number of papers, several of which are listed in the previous articles I did on PrEP linked above. In brief, most of the studies showed a dramatic decrease, by 92%, in the transmission of HIV when this drug combination was used along with safer-sex practices.

AIDS-HIV activist dispenses awareness information near Yoyogi Park, popular with teens and young adults on Sept. 18, 2009 in Tokyo. 20-30 year-olds have the highest rate of HIV in Japan. cdrin / Shutterstock.com

AIDS-HIV activist dispenses awareness information near Yoyogi Park, popular with teens and young adults on Sept. 18, 2009 in Tokyo. 20-30 year-olds have the highest rate of HIV in Japan. cdrin / Shutterstock.com

The Food and Drug Administration approved this drug for PrEP in 2012 in the United States. Earlier this year, the US Public Health Service (USPHS), in conjunction with the Centers for Disease Control, (CDC) released guidelines for the use of PrEP. The guidelines were formulated by members of the USPHS, CDC, doctors who treat HIV patients, researchers, HIV patients and others. The guidelines provide criteria for determining when PrEP should be used.

• Provide clear criteria for determining a person’s HIV risk and indications for PrEP use.
• Require that patients receive HIV testing to confirm negative status before starting PrEP.
• Underscore importance of counseling about adherence and HIV risk reduction, including encouraging condom use for additional protection.
• Recommend regular monitoring of HIV infection status, side effects, adherence, and sexual or injection risk behaviors.
• Include a providers’ supplement with additional materials and tools for use when prescribing PrEP.
[. . . ]
For sexual transmission, this includes anyone who is in an ongoing relationship with an HIV-positive partner. It also includes anyone who 1) is not in a mutually monogamous* relationship with a partner who recently tested HIV-negative, and 2) is a
• gay or bisexual man who has had anal sex without a condom or been diagnosed with an STD  in the past 6 months; or
• heterosexual man or woman who does not regularly use condoms during sex with partners of  unknown HIV status who are at substantial risk of HIV infection (e.g., people who inject drugs or have bisexual male partners).

The USPHS, CDC, et al. said that, “[t]he new federal guidelines recommend that PrEP be considered for people who are HIV-negative and at substantial risk for HIV.”

The recommendation is that PrEP should be considered for use in people who are at a substantial risk for HIV.

On July, 11th the World Health Organization (WHO) came out with its opinion on using PrEP. Its report looked at several different groups: MSMs, serodiscordant couples, prison populations, transgender women and others. Here’s what the WHO said about MSMs and PrEP:

Among men who have sex with men, PrEP is recommended as an additional HIV prevention choice within a comprehensive HIV prevention package (strong
recommendation, high quality of evidence).

The parenthetical phrase “high quality of evidence” refers to the validity, and sometimes amount, of research on the topic.

The WHO is essentially saying that it recommends that all MSMs take tenofovir-emtricitabine, and use safer-sex practices, to help prevent them from getting HIV. The USPHS/CDC said that PrEP with Truvada® should be “considered” while the WHO the “considered” to an outright recommendation.

You can access a copy of the full guidelines (free) here: (184 pages), and an overview (8 pages) here.

One concern that some have raised is whether people on PrEP may stop using condoms (thinking they’re fine simply taking the drug). Some people and organizations came out against using PrEP for just that reason, characterizing it as a “party drug.” There was also some Internet-shaming going on against men who were using PrEP.

Of course, if people did stop using condoms, that would increase their risk for other sexually transmitted infections (STIs), and their risk to contract HIV. Two studies (one cited in the longer WHO report, linked above) show that this doesn’t seem to be true. One study showed that all men enrolled in one PrEP trial increased their use of condoms over what had been their baselines before enrolling in the study.

Another point raised was that there are side effects that can occur when someone takes a medication. The same holds true for PrEP. The WHO study concludes from studies that side effects from taking tenofovir-emtricitabine were low, rarely serious, often remitted over time or after a hiatus from the drug.

The medication involved needs to be taken daily. Some fear that people won’t adhere to a once-daily dosing schedule. That may happen and could increase the risk that HIV may become resistant to this antiretroviral drug combination. However, many of the participants adhered well to their daily dosing. Some others did not. Some of the data showed that even with less than ideal adherence to the medication, protection against HIV transmission was still relatively good.

The cost of the medication is high. Yet almost all health insurances are willing to cover the cost. Their feeling seems to be that, as expensive as it is, it’s less expensive than paying for triple antiretrovirals, hospital admissions, physician specialist consults and other medications necessary to treat complications of someone with HIV or AIDS. Additionally, the manufacturer of the drug has a patient-assistance program available for those who are uninsured and may not be able to pay for the drug.

The recommendations from the WHO and the USPHS/CDC require that those people who get started on PrEP be followed regularly. They are not just given an infinite supply of the drug. They have to see their doctors regularly, be tested for HIV, have other tests done to be monitored for side effects from the drug, have counseling, etc.

PrEP is not just the drug; it’s a program to reduce the spread of HIV.

If you’re not taking PrEP and are sexually active, you at least owe it to yourself to discuss the topic with your doctor. Even if you’re in a monogamous relationship, there may be the possibility that your husband, or you, may have an extramarital affair at some time.

If you want more information on HIV or PrEP you can contact the CDC 1-800-CDC-INFO or call your state HIV/AIDS hotline.

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Mark Thoma, MD, is a physician who did his residency in internal medicine. Mark has a long history of social activism, and was an early technogeek, and science junkie, after evolving through his nerd phase. Favorite quote: “The most exciting phrase to hear in science... is not 'Eureka!' (I found it!) but 'That's funny.'” - Isaac Asimov

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