Are we PrEPared for PrEP?

This article was written by Volunteer Blog Writer Tyler Faulds. Tyler is a student of Mount Royal University who is obtaining his Honours Degree in Psychology. This is Tyler's first article for The AWord. If you are interested in being a writer for The A Word, please visit: http://www.aidscalgary.org/getinvolved/volunteer/volunteeroverview.cfm

Since the introduction of treatment for HIV, the lines have been drawn between medical based approaches and those rooted in social change. The two schools of treatment differ in how they combat HIV and how they foresee an end to the spread of the virus. While medical oriented treatments put heavy emphasis on drug regimens and regular testing, treatments rooted in society and culture believe that change comes through people (Kippax & Stephenson). They often focus on behavioural change and dissect the socio-cultural context of HIV on our planet. Medical approaches can be conceptualized as treatment, and societal ones as prevention. Combined approaches have become more popular, and campaigns that focus on condom use along-side regular testing have been gaining momentum. Still, we see more than 2.6 million new HIV infections a year (Geneva, 2009), and the problem is evidently not under control – yet.

Enter PrEP, or Pre-Exposure Prophylaxis. Considered a medical based approach, this type of treatment involves prescribing HIV negative individuals with HAART as a way to prevent HIV acquisition. It stands as a possible breakthrough in the prevention of new HIV infections, but is also marred with controversy and critics. Approved by the United States’ FDA, Truvada is a combination pill of Tenofovir and Emtricitabine. With perfect adherence in clinical trials, it has shown to reduce the risk of transmission by approximately 40-70% (Okwendu, 2012). These trials evaluated the effectiveness of Truvada within six “high risk” categories including HIV negative men who have sex with men, males and females in relationships where one partner is HIV positive and one is negative, and people that use intravenous drugs. Due to its incredibly high costs (~12 000 USD a year) as well as numerous other factors, PrEP is a highly contentious issue.

The cost alone is a major barrier. While proponents of PrEP suggest that it is applicable to people in higher risk categories, it is evident that cost would be a huge hurdle to cross for some of these groups. In Sub-Saharan Africa, where incomes are low and HIV transmission is high, a $12 000 USD price tag is inconceivable when food is a daily concern. Reactions to this criticism, especially from the drug’s manufacturer Gilead, cite that cost is a concern for any new medical intervention, but through regulation and development the costs would come down.

Salim Karim of the Centre for the AIDS Programme of Research in South Africa, argues that PrEP empowers women. Many must rely on their sexual partners to get tested, get treatment, and wear condoms and that is often a difficult task to accomplish. PrEP would allow women to take their health into their own hands, protecting themselves from HIV with no help needed from others. Opponents argue that relying on PrEP will direct attention away from the heavily needed condom supply and prevention which so many communities still require.

PrEP has been branded a short cut in some arenas. Does it make sense to offer a solution where a person just takes a pill and forgets about it? – they could worry less about safer sex practices, condom use, and needle awareness. Is it that simple? Is it really that black and white? People living with HIV on HAART are all too aware of the possible side effects. Although they differ on a person by person basis, many of them are unpleasant, disruptive and a mountain to overcome. An HIV negative person taking PrEP would not be just taking a pill. They could endure the nausea, diarrhea, and fatigue that accompany the treatment, as well as the kidney damage and bone loss that are hallmarks of Truvada. This is another reason why proponents stress that PrEP is not for everyone. The second part of the shortcut argument is that a widespread use of PrEP (which has been shown to reduce HIV transmission by about 40+%) would change attitudes towards the risks of certain activities and cause people to lax on their diligence and safety. Note - condoms reduce HIV transmission ~90%). Countless studies have asked, “If Truvada or something similar was available to you, and you knew that it would cut your risk of transmission would you still use condoms?” The results have been inconclusive. A study by Golub et al. (2010) showed that 35% of the men they surveyed thought they would decline condom use if on PrEP. Other studies like the one performed by Holt et al. (2012) showed that only 8% of the men they surveyed thought they would reduce condom use. It’s worth knowing that those 8% were also correlated with older age and monogamous relationships.

These answers are likely swayed by the need to answer in a desirable fashion. That is, people will always answer in a way which they think they should rather than how they actually feel. There is no way to tell if people will really stop wearing condoms or using clean needles until actually given the chance. This illustrates why a combined social and medical model is the strongest, because all sides need to be addressed.

One of the largest arguments against PrEP is the issue of adherence. For Truvada to be effective it must be taken every day with no missed doses, and consistently this is not the case. Myers (2012) argues that just like a half-finished bottle of antibiotics following strep throat, an inconsistent adherence schedule would eventually develop resistance to the treatment. This in turn could create strains of HIV resistant to Truvada, a main component of treatment for people already living with HIV. In the pilot study of Truvada, participants were paid for their involvement and also received daily counselling on their medicine adherence. Even still, only 18% of participants adhered to treatment perfectly. If people who are paid and counseled to take a drug cannot do it consistently, how will HIV negative, unpaid and uncounseled individuals fare?

Finally, let’s revisit the side effects. The first antiviral for HIV is not 30 years old, and HAART hasn’t turned 20 yet. There is no denying the ground breaking leaps and bounds that these drugs have provided for those living with HIV. People are living longer and healthier, and the tides may be slowly turning. We know that if treated efficiently and if treatment adherence is high, a person today has a much better outlook than someone 20 years ago did. It might be what we don’t know however, that’s more important.

We still don’t know what will happen after 40 or 50 years on the drugs. What will happen to the virus, to the body or to resistance? There is no data on these risks. We know the drugs are toxic, and is there sense in giving these drugs to anyone other than the people that need them? Should we be putting more effort on social change, or is PrEP really the next step in the battle against HIV and AIDS?

There will always be those that rush ahead, and those that hang back and wait to see what happens. What should happen now? Would you take PrEP if it were an option?

References

Karim S. (2012). Antiretroviral prophylaxis for HIV prevention reaches a key milestone.

Kippax S. & Stephenson N. (2012). Between biomedical and social dimensions of HIV. American Journal of Public Health. 102 (5).

Myers , T. (2012, August 03). Hiv prevention pill will do more harm than good . Retrieved from http://www.usnews.com

Okwundu , Uthman , Okoromah (2012) Antiretroviral pre-exposure prophylaxis (PrEP) for preventing HIV in high-risk individuals". Cochrane Database Syst Rev 7 (7)

AIDS Epidemic Update (Geneva, Switzerland: Joint United Nations Programme on HIV/AIDS, 2009).
Golub, Sarit, Kowalczyk, Weinberger and Parsons (2010). Pre-exposure prophylaxis and predicted condom use among high-risk men who have sex with men. Journal of Acquired Immune Deficiency Syndromes. 54(5).
Holt, Murphy, Callander, Ellard, Rosengarten Kippax and de Wit. (2012). Willingness to use HIV pre-exposure prophylaxis and the likelihood of decreased condom use are both associated with unprotected intercourse and the perceived likelihood of becoming HIV positive among Australian gay and bisexual men. Sexually Transmitted Infections. 88(4).

Day 0 - Fear

ACAA had the opportunity to share a fantastic video from one of our volunteers. The video detailed his own personal story of being a young gay man living with HIV and the stigma he faces regarding online disclosure. http://aidscalgary.blogspot.ca/2012/01/lets-talk-about-online-disclosure.html We are very proud of this individual for sharing his story. He is back with a new video regarding his new treatment regimen.

The views and opinions expressed in this video are soley those of the original authors and other contributors. These views and opinions do not necessarily represent those of AIDS Calgary Awareness Association, the staff, and/or any/all contributors to this site. For more info on our GIPA program, please visit: http://www.aidscalgary.org/getinvolved/gipa.cfm

Mothers and HIV

With Mother’s Day coming up this weekend, I thought I would share some knowledge surrounding mother-to-child-transmission (MTCT), which is so often a topic surrounded by myth and false information.

Primarily MTCT can occur during the pregnancy, the birthing process and through breastfeeding. In Alberta, pregnant women are offered HIV testing although there is an option to ‘opt-out’ of the testing. You can read more on this topic from our November 5/10 blog titled “Opt-out HIV Testing.” By knowing her HIV status ahead of time, a mother can significantly reduce the risk of transmission to her child. It has been shown that by taking the proper medications, a mother’s risk of transmission during delivery can be reduced to under 2%. Without the proper treatment and medications the risk of transmission rises to 20-45% during delivery (Avert, 2011).

Mothers who are HIV positive will be given antiretroviral drugs (ARTs), to help to prevent the transmission to the child and once the child is born, they too will be started on a medication regiment known as Azidothymidine (AZT) for the first six weeks of their life. When a child is born they have their mother’s antibodies, which can be deceiving as the child could test ‘positive’ for HIV without actually being HIV positive. It can take sometime before a child develops their own antibodies and this is why a child is tested for up to 12-18 months after they are born (Alberta Medical Association, 2005). As the standard HIV test measures against antibodies in the system, a child would be tested specifically for the virus itself to determine if they are living with HIV.

As mentioned earlier, HIV can be transmitted through breast milk, which can pose questions of affordability and availability of formula for new mothers. The statistics state that the risk of transmitting the virus from mother to child through breast milk can vary from 20-45% (CATIE, 2009). Unfortunately not every mother has access to clean drinking water to mix with the infant’s formula. This may leave a mother with no choice in her mind but to breast feed, rather than give her child unsafe formula. Studies have shown that if a mother does not have access to ARTs, she is better off to breast feed the entire time rather than go back and forth between formula and breast milk. The mixing of breast milk and formula can break down the lining of the infant’s stomach, therefore potentially increasing the risk of transmission.

In Alberta, an HIV positive mother can access free formula through the Northern and Southern Alberta HIV Clinics. Here at the Calgary Cares Centre, we offer a Positive Women’s Network which is held every second Thursday of the month and is client directed. If you are interested in meeting with fellow positive women and share stories and ideas, or discuss topics like mother to child transmission, we encourage you to come by and be a part of the community!

References:
1.Avert: Averting HIV and AIDS. HIV/AIDS and Pregnancy. Retrieved March 30, 2011.
2.CATIE. You can have a healthy pregnancy if you are HIV positive. Retrieved March 30, 2011.
3.Alberta Medical Association. Information for Health Professionals on HIV and Pregnancy. Retrieved March 30, 2011.

This article was written by one of AIDS Calgary Awareness Association's Case Managers.

Recent medical breakthroughs in the fight against HIV/AIDS

Scientists have cracked a puzzle about the HIV virus and how it works in the human body. This discovery could lead to better HIV treatments. The key is an enzyme called integrase.

What is integrase?
Integrase is an enzyme that assists HIV during the integration phase of the HIV replication cycle. Essentially, integrase helps HIV DNA copy itself into the host cell DNA.

HIV weakens the immune system by entering and taking control of healthy CD4 cells. Ultimately HIV destroys the immune system’s CD4 cells. Before these cells are destroyed, however, HIV uses the cell to produce and distribute more copies of the HIV virus.

Integrase plays a key role in the creation of new virus cells. Hijacked CD4 cells are only able to produce new copies of the HIV virus after integrase has done its job.

Who is doing the research?
Scientists at Imperial College London and Harvard University: Stephen Hare, Saumya Shree Gupta, Eugene Valkov, Alan Engelman & Peter Cherepanov.

When was it discovered?
January 2010

Why is this groundbreaking?
Researchers are now able to see the structure of the integrase enzyme, a previously impossible feat. It took over 40,000 trials to develop a crystal that gives a high quality three-dimensional view of the enzyme. Years of projects working to obtain a high-quality crystal had failed.

There is currently one drug in clinical use in Canada that blocks HIV replication by acting as an integrase inhibitor. It is now possible to see exactly how the drug works and potentially how to make improvements to the drugs efficacy. Understanding the structure of integrase will also open the door to development of new drugs that work to block HIV at this point in the replication cycle.

How long until treatment is available?
The researchers make no predictions as to how long it will be until new HIV treatments may be available based on the results of this research.

For more on this study:
Nature - Full Research Findings
cbc.ca - Enzyme structure cracks HIV puzzle

Recent Canadian led medical breakthroughs in the fight against HIV/AIDS

Although 2009 is just half over, already a number of important medical breakthroughs have occurred in the fight against HIV/AIDS, with some of the most groundbreaking studies coming out of Canada.

The first Canadian medical breakthrough of the year came this spring. The research focused on finding where HIV is hiding in the body and how to attack HIV’s hiding places using chemotherapy and current Highly Active Retroviral (HAART) treatments.

What is it?
A new way of attacking HIV

When was it discovered?
Spring 2009

Why is this groundbreaking?
One of the largest issues with combating HIV, is that it establishes a hideout within specific cells (known as an HIV reservoirs), making the virus almost impossible for current antiretroviral drugs to target and kill.

In the study, the researchers were able to identify HIV reservoir cells and the stealthy mechanisms that protect them. In short they found HIV’s hideout in the body.

The researchers further learned that when the HIV virus hides within reservoir cells, it can no longer survive without the cell. As a result, if the problematic cell dies, so does the virus resident within it.

Because scientists know where the virus is they believe they can now target and attack the infected cells using antiretroviral drugs and chemotherapy while giving the body a chance to produce new healthy immune cells.

Who is doing the research?
Dr. Rafick-Pierre Sékaly, of the Université de Montréal. Dr. Jean-Pierre Routy of the Research Institute of the McGill University Health Centre (RI-MUHC) and scientists from the National Institutes of Health (NIH) and the University of Minnesota in the United States

How long until this treatment is available?
A study will begin in September to test the validity of these results. If targeted chemotherapy successfully eliminates HIV, researchers say the feasibility of the treatment will be determined over the next two to three years, with medication becoming available a few years after that.

Possible issues:
Some HIV-positive patients do not respond to antiretroviral therapy. For those patients, zapping the cell will not likely yield any significant results.


For more on this study:

Science Daily - New Weapon In The War Against HIV-AIDS: Combined Antiviral And Targeted Chemotherapy
Health News - No More Hiding for Virus Causing AIDS-HIV
Ottawa Citizen - Treatment of HIV 'sanctuary' cells creates path for possible cure: researchers
Study Abstract

Treatment as Prevention – A Three Part Series

Part Two – Controversy Rocks Foundations of Prevention Messaging
Community Response to the Controversial Swiss Study

The mantra of AIDS Service Organizations for the last twenty years has been that the best way to prevent the transmission of HIV is to use a condom, properly, every time you engage in sexual activity. But the recent statement made by the Swiss Federal Commission for HIV/AIDS in their Bulletin of Swiss Medicine is posing a challenge to this fundamental message (see Part 1 – HIV Treatment Debate Rages).

The statement suggests that people living with HIV who are on antiretroviral treatment and have undetectable viral loads do not pose a risk of sexual transmission to their partners. The community has responded with a resounding cry for proof, assailing the Commission’s statement and admonishing them for publishing a document based on “opinion” and “belief” rather than fact. Interestingly, even the Commission is reluctant to make any firm guarantees in relation to their statement.

As they explain, “medical and biologic data available today do not permit proof that HIV-infection during effective antiretroviral therapy is impossible, because the non-occurrence of an improbable event cannot be proven. If no transmission events were observed among 100 couples followed for two years, for instance, there might still be some such events if 10,000 couples are followed for ten years. The situation is analogous to 1986, when the statement ‘HIV cannot be transmitted by kissing’ was publicised. This statement has not been proven, but after 20 years’ experience its accuracy appears highly plausible.” 1

In many ways, this parallel pinpoints the grey areas within which public health officials and AIDS Service Organizations have operated for the past 30 years. In truth, when it comes to HIV transmission, it is almost impossible to prove anything beyond a level of uncertainty. Ethically speaking, scientists cannot run controlled studies on human subjects while knowingly placing them at risk of HIV transmission. In the absence of hard scientific evidence, the community is forced to operate within a realm of estimations, based on the best scientific data available, but often without totally definitive scientific proof. In other words, recommendations get made, and everyone crosses their fingers and hopes that they are right.

In the case of the Commission’s statement, there seems to be a general consensus that the risks are too high to just cross our fingers and hope for the best, and the evidence is not strong enough to inspire confidence.

Significantly, a recent study by UNSW's National Centre in HIV Epidemiology and Clinical Research (NCHECR) found that if the Swiss Commission’s statement were adopted at the community level, over a ten year period HIV transmission among serodiscordant couples would be four times higher in couples who abandon condom use than if condoms had been used. The study used mathematical modeling to extrapolate HIV transmission in a population of 10,000 serodiscordant couples and showed that there would be 215 female-to-male transmissions, 425 male-to-female transmissions and 3,524 male-to-male transmissions. As Dr. Wilson, one of the study authors states, "While it is true that the individual risk of HIV transmission per act is fairly small for people on antiretrovirals, the risk of transmission over large numbers of acts could be substantial.” 2

It is within this context that we must view the statements put forward by the Swiss Commission. The best way to reduce HIV transmission remains to use a condom properly every time you engage in sexual activity. For people living with HIV/AIDS, being adherent to your HIV treatment, maintaining an undetectable viral load, testing for and treatment of all STIs are all additional ways to reduce the risk of passing HIV to your partner. Practicing these steps, in conjunction with regular and consistent condom use, provides a new strategy for reducing risks even further. In many ways, this is great news for serodiscordant couples as it provides new tools and peace of mind for preventing the onward transmission of the virus, and poses a great incentive to stay adherent to one’s treatment and improve one’s overall health.

Part Three of Treatment as Prevention

1 Bernard, Edwin J. (2008). Swiss experts say individuals with undetectable viral load and no STI cannot transmit HIV during sex. http://www.aidsmap.com/en/news/4E9D555B-18FB-4D56-B912-2C28AFCCD36B.asp Retrieved November 2008

2 Study Says Swiss Commission Advice may See HIV Infection Quadrupling http://www.medindia.net/news/Study-Says-Swiss-Commission-Advice-may-See-HIV-Infection-Quadrupling-40023-1.htm Retrieved November 2008.

Treatment as Prevention – A Three Part Series

Part One – HIV Treatment Debate Rages

An Introduction to the Controversial Swiss Study

Following a review of recent medical research, the Swiss Federal Commission for HIV/AIDS issued a highly controversial statement in their Bulletin of Swiss Medicine. The Swiss study stated that “an HIV-infected person on antiretroviral therapy with completely suppressed viraemia (“effective ART”) is not sexually infectious, i.e. cannot transmit HIV through sexual contact.”1

According to the Commission, this is true so long as the following requirements are met:2

• the person adheres to antiretroviral therapy (and the effects of this are monitored regularly by the treating physician)
• the viral load has been suppressed to an “undetectable level” (less than 40 copies/ml) for at least six months
  
• the person does not have any sexually transmitted infections
• the person is in a “stable relationship”
  

The findings of the Commission are significant and hotly debated, as they imply that HIV positive people can have unprotected sex with HIV negative partners without risk of transmitting HIV.

Since the Commission issued this statement, their conclusions have come under considerable scrutiny by UNAIDS, WHO, Public Health Agency of Canada and AIDS Service Organizations such as AIDS Calgary. Criticisms have centred both on the scientific accuracy of their argument and the real world applicability of their statement. Some key areas of concern are:3

• People are not always adherent to their medication regime, particularly in the face of severe side effects or other life challenges, and this can cause their viral loads to increase suddenly and significantly. Even those who do adhere to treatment can develop resistance to their drug regime or simply have “blips” in their viral load. In addition, the frequency with which people actually visit the doctor for viral load testing combined with the waiting period to receive test results makes it extremely difficult for someone to accurately know their viral load levels.

• Although the Commission argues that antiretroviral therapy eliminates HIV from genital secretions, this statement has been challenged. Critics point out that with only 2% of the body’s immune cells carried in the blood, blood may not accurately reflect viral load levels in other parts of the body (98% of immune cells are found in the lymph nodes and lymph tissues that line the gastrointestinal tract).

• It is common for people to have sexually transmitted infections without experiencing any symptoms; therefore it is difficult for people to know whether they have an STI at any given time.

• While some people maintain long term monogamous relationships, others do not, and people may be unaware of whether their relationships are monogamous due to the undisclosed affairs of their partners. The Commission’s statement is also based solely on data from studies of heterosexual couples, so the applicability of their statement to relationships between men is unclear.

While it may be true that adherence to treatment reduces viral load and that undetectable viral load correlates with a reduced likelihood of HIV transmission, when placed in real world conditions, the feasibility of the Commission’s statement comes under significant fire.

Next Week: Part 2 of Treatment as Prevention explores the community response to the Swiss study.

1 Bernard, Edwin J. (2008). Swiss experts say individuals with undetectable viral load and no STI cannot transmit HIV during sex. http://www.aidsmap.com/en/news/4E9D555B-18FB-4D56-B912-2C28AFCCD36B.asp%20%20Retrieved%20November%202008

2 Bernard, Edwin J. (2008). Swiss experts say individuals with undetectable viral load and no STI cannot transmit HIV during sex. http://www.aidsmap.com/en/news/4E9D555B-18FB-4D56-B912-2C28AFCCD36B.asp Retrieved November 2008; Canadian AIDS Treatment Information Exchange (2008). Swiss guidelines take a troubling turn. http://www.catie.ca/catienews.nsf/news/A2EFD4077BD44FB285257405005EE5EF?OpenDocument%20%20Retrieved%20November%202008.

3 Canadian AIDS Treatment Information Exchange (2008). Swiss guidelines take a troubling turn. http://www.catie.ca/catienews.nsf/news/A2EFD4077BD44FB285257405005EE5EF?OpenDocument%20%20Retrieved%20November%202008