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.

Kenneth is a 2015 AVAC Advocacy Fellow, hosted by HEPS-Uganda. He works with both grassroots communities and national level stakeholders in promoting health and the rights of people living with HIV in Uganda by advocating for consumer friendly policies. He’s currently the head of HEPS-Uganda’s advocacy program, and coordinates the Uganda Coalition for Access to Essential Medicines.

The cost of providing new tools for preventing HIV infections like oral PrEP is concerning. I hear cries about the sky-high prices of these new prevention options all the time. Unfortunately, after the lament, there’s little conversation about reducing these high costs and enabling access. Access is defined by 4 A’s: Affordability, Acceptability, Accessibility and Availability. Lose any one of them and you lose access – and impact – altogether. For anything and everything you ever wanted to know about PrEP, including information about costs as it becomes available, checkout PrEPWatch.org.

Globally, we have 37 million people living with HIV, but only 50 percent of these are enrolled on treatment. That’s despite the landmark study, HPTN 052, that showed early initiation of antiretroviral treatment in people living with HIV with a CD4 count between 350 and 550, not only improved their health but also reduced HIV transmission to HIV-negative partners by 96 percent.

There is a lot of public taxpayer’s money invested in research and development of new tools for preventing, and managing HIV. No doubt, a lot of innovation and brain power goes into the development of these products and I salute that work. But let’s not forget the ultimate goal of an AIDS-free generation. This can only happen if people, irrespective of their location, gender, race, sexual and political orientation, have access to affordable commodities.

The irony is once these products are out, few can afford them.

The latest prevention option, oral PrEP, has been adopted in guidelines, or is in the process of being adopted, by several countries, both middle and low income, as a prevention option for people at substantial risk HIV infection. However, there are already concerns that the cost of PrEP may be a barrier to access, and that’s partly the reason officials are dragging their feet as they consider adding it to their package of prevention.

Pricing PrEP is still underway, but looking at cost for the delivery of antiretrovirals for treatment may give us an idea. A July 2016 analysis of three ART delivery models in Uganda, published in the Journal of the International AIDS Society, showed that it costs $257 (facility-based model), $332 (a combination of community distribution and facility-based model) and $404 (community distribution model) to deliver ART annually per person. Like ART, the expectation is that most people taking PrEP will receive it for free, and if PrEP delivery costs about the same as ART delivery, this could be a big barrier to its access, especially for low income countries and populations at risk. Someone, somewhere, will have to pay, and $257 to $404 per person per year is quite a high cost.

As we prepare to deliver PrEP, we need to mirror the solidarity and teamwork exhibited when these products were developed. A multi-disciplinary collaboration between potential PrEP users, healthcare providers, government and funders should characterize how we make PrEP accessible to everyone who needs it.

In October, I attended the 2016 HIV Research for Prevention (R4P) Conference in Chicago. Being the only conference focused solely on biomedical HIV prevention, I was really looking forward to hearing new ways to address the access issues I highlighted above. Unfortunately, even here there was too little conversation about protecting public health interests over private commercial interests, which hike prices for new HIV prevention tools. I’m excited by the potential of PrEP to drive new infections down, but I worry that if the high cost of its delivery isn’t checked, PrEP may not realize this potential, especially not in the developing countries where it’s needed most.