WHO issues first guidance on use of antiretrovirals by HIV-negative people at high risk to prevent infection

via World Health Organization

20 JULY 2012 | GENEVA / WASHINGTON DC - WHO has issued its first guidance to countries that are considering offering HIV medications, known as antiretrovirals (ARVs), to protect people who do not have the virus but who are at high risk of HIV infection.

Pre-exposure prophylaxis (PrEP):

The guidance is based on clinical trials indicating that a daily dose of oral antiretroviral medication, known as pre-exposure prophylaxis (PrEP), taken by HIV-negative people to reduce the risk of infection, is both safe for people to use and effective in preventing HIV. The iPrEX study shows that use of PrEP can reduce HIV infection by around 40% among men who have sex with men – and up to 73% among those who took the medicine regularly. The Partners PrEP study found 75% protection among serodiscordant couples (couples in which one person is HIV positive) in Kenya and Uganda.

The range of results in these studies highlight the potential benefits of PrEP, but also the importance of combining it with consistent use of condoms, as well as frequent HIV testing, counselling, and treatment of sexually transmitted infections.

They also emphasize the importance of taking medicines every day. Many people who are at high risk for HIV may not easily be able to incorporate the diligent treatment regimen required, so the next challenge is to ascertain how best to deliver PrEP to those who would benefit from it in ‘real life’ settings in order to achieve the necessary adherence and maximum public health gains.


PrEP projects in countries:

To better understand how PrEP can best contribute to a combination HIV prevention programme, WHO is encouraging countries wishing to introduce PrEP to first establish small projects to help public health workers to better understand and realize its potential benefits. In these projects, ARVs would be given to people at high risk of HIV infection. These could include uninfected men or transgender women who have sex with men who have a high risk of being HIV-positive. The aim is to identify which groups will benefit most from PrEP, and ascertain the best ways to deliver the services to them.

WHO will evaluate the outcome of these projects, together with the evolving scientific evidence. The results will help determine the best way to integrate PrEP guidance in future consolidated WHO guidelines on the use of antiretrovirals for preventing and treating HIV infection, which are expected in the summer of 2013.


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A Qualitative Study of Provider Thoughts on Implementing Pre-Exposure Prophylaxis (PrEP) in Clinical Settings to Prevent HIV Infection

via PLoS ONE, by Emily A. Arnold, Patrick Hazelton, Tim Lane, Katerina A. Christopoulos, Gabriel R. Galindo, Wayne T. Steward, Stephen F. Morin

ABSTRAST

Background

A recent clinical trial demonstrated that a daily dose tenofovir disoproxil fumarate and emtricitabrine (TDF-FTC) can reduce HIV acquisition among men who have sex with men (MSM) and transgender (TG) women by 44%, and up to 90% if taken daily. We explored how medical and service providers understand research results and plan to develop clinical protocols to prescribe, support and monitor adherence for patients on PrEP in the United States.

Methods

Using referrals from our community collaborators and snowball sampling, we recruited 22 healthcare providers in San Francisco, Oakland, and Los Angeles for in-depth interviews from May-December 2011. The providers included primary care physicians seeing high numbers of MSM and TG women, HIV specialists, community health clinic providers, and public health officials. We analyzed interviews thematically to produce recommendations for setting policy around implementing PrEP. Interview topics included: assessing clinician impressions of PrEP and CDC guidance, considerations of cost, office capacity, dosing schedules, and following patients over time.

Results

Little or no demand for PrEP from patients was reported at the time of the interviews. Providers did not agree on the most appropriate patients for PrEP and believed that current models of care, which do not involve routine frequent office visits, were not well suited for prescribing PrEP. Providers detailed the need to build capacity and were concerned about monitoring side effects and adherence. PrEP was seen as potentially having impact on the epidemic but providers also noted that community education campaigns needed to be tailored to effectively reach specific vulnerable populations.

Conclusions

While PrEP may be a novel and clinically compelling prevention intervention for MSM and TG women, it raises a number of important implementation challenges that would need to be addressed. Nonetheless, most providers expressed optimism that they eventually could prescribe and monitor PrEP in their practice.

Read the full text here.


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HIV and the Law

via the Global Commission on HIV and the Law

The end of the global AIDS epidemic is within our reach. This will only be possible if science and action are accompanied by a tangible commitment to respecting human dignity and ending injustice.

Law prohibits or permits specific behaviours, and in so doing, it shapes politics, economics and society. The law can be a human good that makes a material diff erence in people’s lives. It is therefore not surprising that law has the power to bridge the gap between vulnerability and resilience to HIV.

We came together as a group of individuals from diverse backgrounds, experiences and continents to examine the role of the law in eff ective HIV responses. What we share is our abiding commitment to public health and social justice. We have listened with humility to hundreds of accounts describing the eff ects of law on HIV. In many instances, we have been overwhelmed by how archaic, insensitive laws are violating human rights, challenging rational public health responses and eroding social fabric. At other times, we have been moved by those who demonstrate courage and conviction to protect those most vulnerable in
our societies.

Many would say that the law can be complex and challenging and is best left alone. Our experience during this Commission has shown us a very different perspective. We have been encouraged by how frank and constructive dialogue on controversial issues can sometimes quickly lead to progressive law reform, the eff ective defence of legislation or better enforcement of existing laws. Even in environments where formal legal change is a slow and arduous process, we have witnessed countries taking action to strengthen access to justice and challenge stigma and discrimination.

Click here for the full report.


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FDA, Gilead And HIV Prevention-In-A-Pill?

via Pharmalot, by Ed Silverman


The debate over whether the FDA should approve an existing AIDS medication for preventing the spread of HIV has ratcheted up as more than a dozen advocacy groups are urging the agency to accelerate its review process and not wait for data about heterosexuals. The move comes just one month after one prominent advocacy group urged the FDA not to approve Truvada, which is sold by Gilead Sciences, for prevention, or as pre-exposure prophylaxis, for any group.

In a letter to the FDA and Gilead, the groups say that approval is needed as soon as possible in order to provide protection to gay and bisexual men and transgender women. And they cited data from a study released last November that found that men and transgender women who have sex with men and received a daily dose of Truvada, along with condoms and safe sex counseling, had an average of 42 percent fewer HIV infections than those who received only condoms and counseling (read here).

In fact, three PrEP trials have shown evidence that using Truvada or Gilead’s Viread, which is a component of Truvada, reduced the risk of infections. The other trials examined use by heterosexual men and women, and a so-called partners trial that looked at couples in which one partner is HIV-negative and the other is HIV-positive.But the advoacy groups complain that before results of the heterosexual study were released, the FDA and Gilead were believed to be ready to proceed with a review of PrEP for men who have sex with men, or MSM. And to them, delay means more infections.

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Bureaucracy in Nepal Leads to HIV Deaths

via World Policy Blog, by Kyle Knight

Bureaucratic deadlock is starting to kill people in Nepal. The country’s NGO sector working with populations deemed high-risk for contracting HIV-AIDS are in desperate need of $10 million of donor funds currently held by the cash-strapped government. While stories of stagnant bureaucracy in Nepal’s fledgling democratic government are not new, the consequences this time will put those increasingly dependent on NGO support at great risk. The failures of Nepal’s ineffective—even Kafkaesque—bureaucracy have obstructed even the most basic services, leaving NGOs to care for the country’s population.

Working with the most at-risk groups in the country such as intravenous drug users (IDUs), men who have sex with men (MSMs), and Nepal’s sizable transgender (TG) population, these organizations are unable to help treat or prevent HIV from spreading, because of the government’s embarrassing financial disorganization. NGOs working with IDUs have already reported preventable deaths linked to the funding gap, and organizations working with MSMs and TGs have not been able to hand out condoms for nearly three months. “It’s not that we don’t know how to treat people, or that we don’t have the capacity—it’s that we don’t have the money, ” explains an activist working for an IDU NGO. “Basic infections are going un-treated. Staff are looking for jobs elsewhere. These are unnecessary deaths.”

This is nothing new for donor-dependent Nepal. Sadly, the country is used to funding crises, especially in its HIV-AIDS programs. A recent impending shortage of pediatric ARV (anti-retro viral) was averted, thanks to the intervention of the United Nations.

The UN action has been a lifeline for the medical community and Nepali children living with HIV-AIDS. But it is far from enough. The HIV prevalence rate in Nepal is believed to be below 1 percent of the adult population, but infection rates vary considerably, and are substantially higher in most at-risk populations. In 2009, the government announced that the prevalence rates were decreasing across the country. The blocked $10 million will surely and unnecessarily boost the number of people infected by the virus and erase any gains made in recent years. While the impassive government receives warnings from international organizations, the risk of a new wave of infection is reaching a critical point.

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Highlights from the National Transgender Health Summit (U.S.)

"Transgender people experience significant health disparities in this country. In fact, regardless of socioeconomic status, transgender people are the most medically underserved population in the U.S."
- JoAnne Keatley, Director of the CoE for Transgender Health and the lead conference organizer (pictured)

via AIDS.gov, by Jennie Anderson and Mindy Nichamin

What do empowerment, discrimination, data, and health have in common? They are several of the many themes we heard throughout the National Transgender Health Summit that took place in San Francisco earlier this month. The Center of Excellence for Transgender Health (CoE) organized this groundbreaking two-day Summit that brought together healthcare providers, health profession students, researchers, and other health leaders. In past posts we've discussed the disproportionate impact of the HIV epidemic on the transgender community, and so this Summit was an important opportunity for us to learn from and engage with experts on this topic. As the White House National HIV/AIDS Strategy states, "Some studies have found that as many as 30 percent of transgender individuals are HIV-positive. Yet, historically, efforts targeting this specific population have been minimal."

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[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]