Udom Likhitwonnawut has been working as a consultant for AVAC in Thailand on community engagement on HIV research for the past 5 years. He has been a member of the first community advisory board (CAB) in Thailand from its conception more than 12 years ago. He promotes community participation in HIV research and advocates for the implementation of GPP implementation in Thailand. He is a member of the National Subcommittee on HIV Vaccine Development and the National Subcommittee on Biomedical HIV Prevention representing the Thai NGO Coalition on AIDS (TNCA), the national umbrella organization for HIV/AIDS-related organizations. He is one of the founders of Thailand national CAB (NCAB) on HIV research.

Since the introduction of combination antiretroviral (ARV) therapy almost 30 years ago, antiretroviral drugs have been a key factor in saving lives and restoring the health of millions of people living with HIV throughout the world. In addition to treatment, antiretroviral drugs have been used successfully to prevent HIV transmission from mother to child. Furthermore, over the last five years or so, scientists around the world have shown that a popular ARV drug, Truvada, is safe and effective as pre-exposure prophylaxis (PrEP) to prevent HIV infections. A number of trials, demonstration projects and implementation studies in real world settings have confirmed the findings. As a result, Truvada as PrEP has been approved for prevention of HIV infection in many countries.

Thailand is a well-known poster child in fight against the HIV epidemic. Thailand is credited for being the first country in Asia to eliminate mother to child transmission. Several HIV research institutes in Thailand have been involved in PrEP research from the beginning. Given all this, it could be assumed that PrEP uptake and scale-up in Thailand would be smooth and trouble free. No serious objection was expected, least of all from Thai HIV non-governmental organizations (NGO).

Thai HIV NGOs have been in the forefront of the fight against the HIV epidemic from the early days. They fought for accessible HIV prevention and treatment for marginalized and at-risk populations such as sex workers, injecting drug users, undocumented migrant workers, people living with HIV/AIDS, and women and young people. Thai HIV NGOs were among a core group of civil society organizations that advocated for the establishment of the country’s universal health care program. Because of their advocacy for the universal health care program, ARV treatment and other medical treatment for people living with HIV are free of charge for all Thai citizens as well as migrant workers. With this track record behind them, it is astonishing that strong, albeit subtle, resistance for PrEP scale-up in Thailand comes from a few influential leaders of HIV NGOs. Small in number, these NGOs are vocal and influential. Their opinions are esteemed by government officials and fellow NGOs.

The resistance is not stated in public. Most of the objections to PrEP I have heard from these individuals during backroom talks or various office meetings or private discussions. Concerns, doubts, or cautions against PrEP that are said in public were vague and ambivalent. The objections are couched in cautious, well-intentioned terms such as stigmatization of PrEP users, short and long-term side effects, risk compensation and the possible increase in STI infections, effectiveness in real-world situations, and lastly fairness. At one community meeting on PrEP, I watched as a participant suggested the Thai coalition of AIDS NGOs issue a statement concerning PrEP. A leading PrEP critic, who is a well-known advocate for access to HIV treatment, objected that there was no need since PrEP, in his opinion, was a personal choice. However, he also added that PrEP users should be responsible for the cost and the government should not pay for PrEP. This critic and others are not mentioned by name because they are important figures in the fight against HIV in Thailand. No one wants to jeopardize the response to HIV by alienating them.

Initially, objections centered on concerns that PrEP was a ploy to sell a drug that’s market had plateaued. Then critics shifted their concerns to questions about side effects and risk compensation. They gave voice to a myth that PrEP is a lifelong medication (actually, individuals can choose to use PrEP only during a period of time when the risk of exposure to HIV is high). This purportedly lifelong commitment was contrasted with condoms, which are effective as-needed. Later objections focused on HIV resistance. Finally, the critics talked about fairness and justice. They worried that finite resources would be siphoned off for HIV negative people. People living with HIV need ARV drugs for treatment as a matter of life and death. Wouldn’t they come up short, the thinking goes, while HIV-negative people received Truvada even though condoms would protect them just as well.

Let’s start by addressing this wishful thinking that condoms can do all the work of prevention. PrEP critics are ignoring the fact that some people have no choice; if they insist on using a condom some risk abuse from partners or customers. Some people have to engage in condomless sex in order to earn money for a meal or a place to sleep.

As for costs, the generic version of Truvada (Teno-EM), manufactured by a government agency, is widely available and much cheaper than Gilead’s Truvada. A one-month supply (30 tablets) of Teno-EM is Baht 630 (US$18). Meanwhile, people living with HIV who need ARV drugs for survival get them for free in Thailand, something PrEP critics seem to conveniently disregard. ARV treatment is not only free, it’s available to all people living with HIV at any CD4 level. When it comes to treatment access, the main problem is that a number of people don’t seek treatment due to a variety of reasons or are not aware of their status.

The latest reason cited in objecting to PrEP is that it will lead to HIV drug resistance and HBV drug resistance. Opponents claim that PrEP users will be poorly screened for HIV, will have poor adherence, or that their status will be poorly monitored. Each of these factors could contribute to the development of drug resistance. Finally, the critics assert that PrEP advocates and supporters talk only of the advantages, omitting the damaging effects of Truvada PrEP. Research results on adherence, side effects, and risk compensation, available to the public thru various venues, are snubbed by critics as unsubstantiated or cherry-picked by PrEP advocates.

Instead of Truvada PrEP, critics insist that condom use is the answer to preventing HIV infection. Condoms are cheaper, they say, and suitable to everyone on every occasion. For them, the problem is not that some people don’t or can’t use condoms, the problem is only a shortage of supply. They insist that, with enough condoms, there will be no new HIV infections. Despite their long experience with issues related to the dynamic of the HIV epidemic in the country, they persist in this oversimplified and naïve claim. It verges on chemically-induced hallucination.

They certainly cannot point to a lack of information about PrEP research to justify their apprehension. Information about PrEP research is available in many venues and formats. Though much of it is in English, a substantial amount is available in the Thai language, particularly on a variety of websites and YouTube. Furthermore, many PrEP critics are members of HIV Community Advisory Boards (CAB) and members of a few national committees related to HIV and public health. PrEP critics, if they want, could be well informed about PrEP research.

On several occasions, facts or news about PrEP were reconstructed by PrEP critics to fit their narrative against PrEP. A few examples deserve additional details here.

When the UK National Health Service (NHS) decided not to provide PrEP, the news was celebrated and circulated widely among Thai NGOs. The ensuing discussion never acknowledged that PrEP safety or effectiveness was never challenged by the NHS, only who should pay for it was at issue. Subsequent news, including UK court decisions that NHS can provide PrEP and the launch of a PrEP program that will reach a minimum of 10,000 people over three years, has been ignored by these Thai critics.

When news hit of a rare case of ARV resistant HIV appearing in a PrEP user, critics cited it repeatedly to discredit PrEP. The discussion focused only on one single issue that PrEP could lead to HIV drug resistance and other details were omitted.

A couple months ago, a leading PrEP critic, a well-known HIV activist and human rights advocate, together with a few consumer rights advocates, lodged a formal complaint with the Thai FDA about an educational video on YouTube, produced by an esteemed HIV research institute. They said it was misleading and irresponsible, comparable to false advertising because it explained the benefits of PrEP but not the risks. As a result, the video was removed from YouTube.

PrEP critics are determined to employ any means or tactics to derail PrEP uptake and scale-up. A few prominent PrEP critics who are also members of key national committees related to HIV or public health have declared they will oppose any government plan or HIV prevention budget that includes PrEP delivery.

Could it be that PrEP is guilty only by association? The leading HIV NGOs have been fighting with Gilead and other pharmaceutical companies over access to affordable ARV drugs for many years. The fight still lingers, and it extends beyond ARV drugs to direct acting antivirals for the treatment of hepatitis C infection (HCV) as well. The fight is often confrontational and acrimonious. Gilead, the patent holder and manufacturer of Truvada and several drugs used in HIV and HCV therapies, represents a boogeyman for HIV and hepatitis treatment advocates in Thailand. (It’s worth noting, these PrEP critics stand alongside other critics who had a problem with one PrEP trial in particular, the Bangkok tenofovir study (BTS). BTS was investigating the efficacy of PrEP as HIV prevention among drug users. Advocates for the drug using community had a number concerns about the commitment to harm reduction and the consent process. But the efficacy of PrEP itself was not a chief concern for those criticizing of BTS.)

Then again, maybe a conflict of interest is undermining support for PrEP. A few PrEP critics have been advocating for a national condom fund. PrEP scale-up could weaken or jeopardize their plan. Admitting that PrEP may be an important option for certain populations suggests condoms are not a perfect solution, as they obstinately insist.

Despite the criticism, a number of HIV NGOs have stepped up to support PrEP. Some are involved in demonstration projects or implementation studies. Most of them are less influential NGOs and prefer to remain silent or defer to the more experienced and better-known NGOs on most issues, including PrEP. Some of the silent PrEP supporters are key partners of community-based PrEP projects being implemented in the country now.

It is important to point out that the PrEP critics have done many good works for HIV-affected people and communities. It is unfortunate that they let their prejudice against pharmaceutical companies and their hidden agenda for a national condom fund to override the scientific evidence. Currently, these vocal PrEP critics prefer to throw up obstacles from the sidelines while others to carry the ball forward. It is up to the silent majority to work together with other stakeholders in delivering PrEP to people who need or want additional HIV preventive tools. The discussion related to PrEP should be framed to include PrEP and condoms as well as other prevention options, instead of creating a PrEP-or-condom dichotomy as it is being framed today.

In February, hundreds of people tuned in to hear researchers discuss the available data on “time to protection” required for effective oral PrEP with TDF/FTC—i.e., how many doses must be taken to build up protective levels of the drug in the blood? The answer is—it varies. Not surprisingly then, so do the guidelines for PrEP use.

As webinar participants learned, the data are varied and subject to interpretation. The World Health Organization (WHO) and the US Centers for Disease Control and Prevention (CDC) recommend different time frames to reach protection in their respective guidelines for oral PrEP use. Both of these recommendations are based on measurements of the amount of drug that accumulates in blood and/or tissue over a specific period of time. The studies of how drugs are taken into the body and how they leave the body is called “pharmacokinetics” and “pharmacodynamics” or “PK” and “PD” for short, as explained in our primer for advocates. There isn’t a single PK measurement that is associated with PrEP protection—so both WHO and CDC guidelines are based on inference.

In a follow-on webinar presentation and Q&A, representatives from both CDC and WHO reviewed their respective guidance development processes and the role, use, contexts and audience for guidance documents.

The Recording: watch on YouTube, listen to an mp3 version or download the slides. Q&A starts approximately 55 minutes in.

We’ve posted several new resources on AVAC.org that you won’t want to miss.

1) The WHO’s recently released guidance on the use of hormonal contraceptives in women at risk of HIV has prompted a great deal of interest from advocates working in HIV prevention and women’s sexual and reproductive health and rights. We have several new resources that address this complex issue.

• Check out the recording of our webinar, Hormonal contraception and HIV: Putting new developments in context, to learn about the WHO grading system for family planning methods. This discussion covers what impact a change in classification for DMPA and NET-EN has for women, programs and research, and what needs to happen next.

• Go to our blog, WHO Updates Guidance on Hormonal Contraception and HIV, for a quick overview and links to a plain-language fact sheet on the grading system, WHO FAQs and more.

2) Advocates continue to work to understand the difference between the US CDC and WHO recommendations about the number of doses that new users of daily oral PrEP need to take to achieve reliable protection. In our webinar, Time to Protection for PrEP, pharmacologists take you through their data. Check out the recording as prelude to our upcoming webinar, Time to Protection Part 2, which follows up on this issue on Tuesday, April 4, 9am US ET / 3pm CET. Tune in to hear representatives from the CDC and WHO review current PrEP guidelines.

3) And on our blog, P-Values, don’t miss Micheal Ighodaro’s post, Building Solidarity Between African American Gay Men and African Gay Men Through PrEP.

Last month, I attended my third NAESM Conference (National African American MSM Leadership Conference) in Dallas, Texas. The conference happened at a period of significant change in America. It actually took place the same week as the Presidential Inauguration! Not surprisingly, many at that conference needed an avenue to express how they were feeling. NAESM also offered the opportunity for anyone who wanted to talk to a therapist about the election.

The conference was also a space for so much more than processing feelings about and reactions to the new President. This was the largest NAESM to date, with about 600 hundred black gay men and their allies from around the country—and a few, like myself, from Africa. We talked about many things, including a growing concern about HIV among black gay men in the US. This isn’t news. In the United States, gay, bisexual, and other men who have sex with men are disproportionately affected by HIV.

Gay and bisexual men, black/African American men, especially those who are younger, are the most disproportionately affected by HIV. A lot of times this is reported in the news, but by voices who are talking about affected groups. When men talk about how HIV affects their lives and communities, it sounds different. I heard people talk about their personal lives in ways that remind me of my own experience in Africa. In one group discussion, a gay man from Houston talked about how limited access to quality health care, lower income and less education place men like him at higher risk of HIV than some other races/ethnicities. This is true for gay men in Africa, who already face a greater risk of getting infected, mainly because of who they love or their socio-economic status.

Looking at ways for gay men in the US and those in Africa to build alliances is actually one of the things that brings me to the conference. Reflecting back just before the conference, I posted on my Facebook wall about the need to have a conversation with my African American friends/brothers about the complicated relationship between Africans and African Americans! A few hours a later I was getting tens of comments and messages from friends who also felt that there was a serious need for this conversation! I believe the time has never been so urgent for us to have this very needed conversation, and what better way to do it other than using something that everyone of us can relate to? PrEP for HIV prevention!

And that is why attending NAESM this year was so crucial for me. I came there to work with members of AVAC’s PxROAR program from the US and Africa—and with our board member and External Relations Director at the HVTN, Steve Wakefield—to have a discussion about PrEP in our respective worlds.

The panel was one of the first times that I can remember that a space was created for Africans and African Americans who identify as gay to look at what our differences are and what brings us together. It was the beginning of a conversation that we need to keep going and that the PxROAR program will hopefully catalyze through online forums, calls and informal relationships to hear each other’s voices and views.

Some of the key things that we talked about in Dallas are that PrEP is a key tool no matter where you came from or the color of your skin. We looked at the data and how they show that it has been proven to be an effective tool that could help prevent new HIV infections among both communities. Then we talked about how PrEP has been delivered in the US and in Africa. We found out that in most parts of Africa, PrEP is just starting to be discussed and there is nearly no public campaign for PrEP for gay men. Whereas in the US, campaigns like PrEP4Love are already making headways in the black gay community. So, we all have a lot to share with each other! And AVAC is excited for PxROAR to engage gay men as part of its program in the US and in Africa.

Now, more than ever, is the time that black people and people of color all over the world must hold up one another up in solidarity and love. As Africans, we must not stand by and assume that what we see going on in our American communities is just an African-American problem. As Martin Luther King Jr. once said, “Injustice anywhere is a threat to justice everywhere.”

UPDATE: The audio and slides from the webinar are now available. Or watch the webinar on YouTube.

Daily oral PrEP using TDF/FTC provides high levels of protection against HIV in people who take the pill regularly. But this protection doesn’t happen overnight. Instead, a person needs to take a number of doses to build up protective levels of the drug in the blood.

Just how many doses?

Right now, the answer to this question is an educated guess—and the World Health Organization (WHO) and the US Centers for Disease Control and Prevention (CDC) have different answers about “time to protection” in their respective guidelines for oral PrEP use.

Please join us for a webinar on the data behind “time to protection for PrEP” on Thursday, February 9, 11am–12:30pm US Eastern Time (visit www.timeanddate.com for the local time in your area) to learn more. This webinar will include pharmacologists who have studied drug levels in the blood and tissue of PrEP users, as well as representatives from the WHO who were involved in developing the guidance on this topic along with advocates and implementers.

Register here.

The primary difference between US CDC and WHO guidelines on time to protection relates to women. Specifically, US CDC guidelines recommend that women complete 20 doses of daily oral TDF/FTC to achieve protective levels of the drug in the vaginal tissue. WHO recommends seven days for men (penile and rectal exposure) and women (vaginal and rectal exposure).

Both of these recommendations are based on measurements of the amount of drug that accumulates in blood and/or tissue over a specific period of time. The studies of how drugs are taken into the body and how they leave the body is called “pharmacokinetics” and “pharmacodynamics” or “PK” and “PD” for short, as explained in our primer for advocates (www.avac.org/pharmacokinetics-and-pharmacodynamics). There isn’t a single PK measurement that is associated with PrEP protection—so both WHO and CDC guidelines are based on inference.

When indirect measures are used for direct conclusions, advocates need to understand the rationale. We hope this webinar will further the conversation. Please join us.