Switching course, Gilead markets HIV drug for prevention ..........

Gilead Sciences Inc has begun marketing its HIV treatment Truvada in a way thousands of consumers already use it – to prevent infection with the virus that causes AIDS.

The company introduced Truvada to the U.S. market in 2004 for HIV treatment. In 2012, Gilead won approval to market it for prevention after two large, peer-reviewed studies showed it also was effective at preventing infections in healthy people.

But the company decided against promoting the drug as a preventative treatment, deferring to patient advocates who feared it could encourage promiscuity and unsafe practices, such as having sex without condoms.

Even without Gilead's help, many consumers learned Truvada was more than 90 percent effective in tests at preventing HIV infection. In 2014, the U.S. Centers for Disease Control and Prevention recommended it as an option for people at high risk for HIV infection.

As many as 90,000 people in the United States used the drug for prevention, or pre-exposure prophylaxis (PrEP), last quarter. That's up from 60,000 to 70,000 earlier this year, the company said. Usage also is growing in France, where about 2,000 people have been prescribed Truvada for prevention since January.

In July, the drugmaker began marketing Truvada for PrEP to doctors through professional publications, digital advertising and other channels, including the website PreventHIV.com.

And this fall, the drugmaker began marketing directly to consumers with print advertisements in publications geared toward the lesbian, gay, bisexual and transgender community, including OUT, Advocate and SWERV. It plans soon to expand to social media and digital.

Gilead said it wants to reach people whose doctors are either unaware or reluctant to prescribe Truvada for prevention.

The marketing "is primarily driven by demand by patients," said David Piontkowsky, Gilead's vice president of HIV Medical Affairs, in an interview.

Attitudes toward Truvada started to change a couple years ago as doctors, AIDS activists and potential users saw its effectiveness, he said. The "criticism now is we're not saying enough."

Truvada is helping bolster Gilead's profits as sales of its biggest moneymakers – treatments for hepatitis C – decline.

U.S. net product sales of Truvada for the first nine months of 2016 were $1.8 billion compared with $1.5 billion for the same period in 2015. The company said in its earnings report that the gain was driven by price increases as well as "increased usage of Truvada for PrEP."

"We expect PrEP to continue to be a significant part of Gilead's growth in HIV going forward, particularly in the U.S.," Gilead Chief Operating Officer Kevin Young recently told investors.

The new Truvada campaign has been well received, even by those who once opposed promoting the drug for prevention. They include David Duran, a writer and HIV advocate, who helped popularize the term "Truvada Whore" in a 2012 article describing his fear that it would encourage people to have sex without condoms.

Duran began rethinking that concern about a year later in light of newer research showing that PrEP helped prevent more cases of HIV, without a rise in other sexually transmitted disease, which suggested people were using condoms.

"I'm thrilled they are starting to pump some money into marketing and awareness," Duran said. "There is a solid base of folks who know about PrEP, but it's still not a topic the country as a whole knows about."

GROWTH POTENTIAL

As a preventive measure, the blue Truvada pill is taken once daily. Some people experience nausea, vomiting or headaches during the first few weeks on the drug.

Users must be tested every three months to ensure they don't have HIV or other sexually transmitted diseases and to monitor kidney function and bone density.

Some Medicaid programs and most private insurance cover the treatment, which lists for $1,500 a month before any negotiated discounts. With greater awareness and favorable coverage for preventative treatments, the number of Americans using Truvada could rise, said the company and healthcare providers.

An estimated 50,000 new U.S. HIV infections are diagnosed each year.

The CDC estimated in 2015 that about 1.2 million Americans were at substantial risk of HIV infection and could benefit from PrEP.

That includes men who have sex with men, transgender women who have sex with men, partners of people who are HIV-positive and intravenous drug users who share needles.

The number of high risk groups "is much broader than one might think," said Dr. Jennifer Childs-Roshak, president and CEO of Planned Parenthood League of Massachusetts. "It is not just men with multiple partners. There are a whole host of folks who could benefit."

At least 15 patients have gone on Truvada for prevention since Planned Parenthood's six Massachusetts clinics began offering it this fall. Planned Parenthood of New York City plans to offer the treatment to all of its 50,000 patients, said Julia Sullivan, associate director of quality management.

Wider use also could buffer Gilead when Truvada, the only drug currently approved in the United States for PrEP, loses patent protection in 2021. Gilead has a successor treatment in the works. The once-daily F/TAF (emtricitabine/tenofovir alafenamide) has been approved for HIV treatment and is under study as a preventative.

"PrEP is indeed a significant part of Truvada," said Leerink Partners analyst Geoffrey Porges. "It can certainly keep Truvada relatively flat but the key question is, when will they show that TAF works for PrEP?"

In the meantime, the concept of taking an HIV drug to prevent infection is making inroads in popular U.S. culture. It came up in an episode of "Transparent," the Emmy award-winning Amazon series about a family with a transgender parent, when a character was contemplating sex with an HIV-positive partner.

"We were trying to make the conversation reflect what happens in real life," said a writer on the show who works under the name Our Lady J. "PrEP is a big part of that conversation. As an HIV positive person, I'm struck with the level of ignorance around PrEP."

(Reporting By Jilian Mincer; Editing by Michele Gershberg and Lisa Girion)

African Women Using Anti-HIV Vaginal Ring Say Sex Felt the Same

African women in a study of a vaginal ring used as pre-exposure prophylaxis (PrEP) for the most part said wearing the ring did not affect the physical act of sex. However, for some the worry that their partner would discover they were using the ring reduced the enjoyment of sex. Also, the few women who were burdened by intimate partner violence were much less likely to use the ring.

At the HIV Research for Prevention (HIVR4P) meeting in Chicago, researchers presented new findings from the MTN-020 study, also known as ASPIRE, of a dapivirine-containing vaginal ring studied as PrEP among 2,629 women 18 to 45 years old in Malawi, South Africa, Uganda and Zimbabwe.

Study results presented at the 21st International AIDS Conference in Durban, South Africa (AIDS 2016), in July showed that on the whole, giving the ring to women reduced their risk of HIV by 27 percent. Women who used the ring with greater frequency had a 56 percent reduced risk, and those who used it consistently had a 75 percent reduced risk of HIV.

To reach the new findings, the researchers interviewed 214 participants who used the ring about their qualitative experiences with it. Most said the ring did not affect the physical act of sex negatively.

However, some women said they fixated on how their male partners would react if they found out about the ring. Consequently, some of them removed the ring before sex, which is not recommended. Others curtailed certain sexual practices they thought would raise the risk of the man finding the ring, including particular sexual positions and receptive oral or digital sex.

Some women reported having greater sexual satisfaction because they believed the ring was protecting them against HIV. But others had the opposite experience because of their worries over their male partners discovering the ring.

Less than 5 percent of the women said they experienced intimate partner-related violence or other related social harms. Those who did were nearly two and a half times more likely to adhere poorly to the ring’s protocol for use (the women received instructions to leave each ring in for a month).

Sixty-four percent of the women told their male partners they were using the ring at the beginning of the study. Thirteen percent never disclosed their use of the ring to their partners.

To read a press release about the study, click here or HERE: Women Report Vaginal Ring for Preventing HIV Had Little Effect on Sexual Intercourse

ASPIRE evaluated whether the ring, which continuously releases the anti-HIV drug dapivirine, could safely reduce HIV infection among 2,629 women aged 18-45 years living in Malawi, South Africa, Uganda and Zimbabwe. Among participants randomized to receive the dapivirine ring, risk of HIV infection fell by 27 percent. A further analysis found that the ring reduced the risk of HIV infection by at least 56 percent among women who used it with greater frequency, and up to 75 percent or higher among those who used it consistently. Further exploration of the ring’s clinical potential began in July 2016 through the large-scale HOPE (HIV Open-Label Prevention Extension) study, also known as MTN-025 (link is external). ASPIRE, HOPE and their ancillary studies were primarily funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). The nonprofit International Partnership for Microbicides developed the dapivirine ring and supplied it for the studies.

“Women need an HIV prevention modality that offers safe, effective protection and is practical for use in their daily lives,” said NIAID Director Anthony S. Fauci, M.D. “Women enrolled in the MTN-020/ASPIRE study reported that the experimental vaginal ring generally did not interfere with sexual intercourse, which is an encouraging sign that this product could appeal to a larger group of women at risk for HIV infection.”

The ASPIRE study staff interviewed 214 participants who used the ring to obtain qualitative data about their sexual experiences during the trial. A team led by Nicole Laborde, Ph.D., M.P.H., of RTI International in Research Triangle Park in North Carolina, analyzed the participant responses. While most of these women found that the ring did not negatively affect the physical act of sex, some women said they were continually preoccupied with how their partners would react if they felt or discovered the ring. To address this issue, some women removed the ring before sex, a practice not recommended by study investigators. Other women limited sexual activities that they believed might heighten their partners’ awareness of the ring, such as certain sexual positions and receptive oral or digital sex.

Some women reported greater sexual satisfaction partially due to perceived protection provided by the ring. Other women reported diminished sexual pleasure associated with the worry that their male partners would notice the ring during sex.

Additional analyses of the ASPIRE data revealed other patterns of experience among study participants. Because women who face intimate partner violence and other social harms more often find it difficult to adhere to the clinically proven once-daily antiretroviral drug Truvada as pre-exposure prophylaxis, or PrEP, researchers investigated the connection between consistent use of the ring and these issues. While fewer than 5 percent of all ASPIRE study participants reported incidents of intimate partner-related violence or other social harms, women who did report violence or social harm within a month of the interview were nearly 2.5 times more likely to have low adherence to the ring. Younger age at enrollment, having a new primary partner and not disclosing study participation or ring use to the primary partner were significantly associated with reporting social harms. These findings, reported by a team led by Thesla Palanee-Phillips, M.Med.Sci, Ph.D., M.Sc., at the Wits Reproductive Health and HIV Institute in Johannesburg, South Africa, indicate that more research is needed to determine strategies to mitigate low adherence in the context of intimate partner violence and other social harms in future studies of female-controlled prevention methods.

News From the 2016 International AIDS Conference

The 21st International AIDS Conference in Durban, South Africa (AIDS 2016), held July 18 to 22, featured numerous pivotal presentations on HIV science. Conference goers absorbed cutting-edge information about antiretrovirals (ARVs), including treatment for the virus, treatment as prevention (TasP) and pre-exposure prophylaxis (PrEP), as well as the effort to test and treat the global HIV population, HIV among women, and the search for a vaccine and a cure.

Below is a recap of the major scientific findings presented at the conference. To read more about any of these studies, click the hyperlinks. To see a newsfeed of all AIDS 2016 reporting from POZ, click here or on the #AIDS2016 hashtag at the bottom of any article, including this one.

Vaccine:

Following a pilot study’s promising findings of an HIV vaccine’s ability to spur the immune system, researchers intend to begin enrolling participants into the Phase IIb/III HVTN 702 vaccine trial in southern Africa this fall. This will be the seventh major HIV vaccine efficacy trial. The vaccine under investigation is a retooled version of the one that in 2009 showed some success in preventing HIV among Thai participants.

Long-Acting HIV Treatment:

A long-acting injectable version of the ARVs cabotegravir and Edurant (rilpivirine), dosed every four weeks, will enter Phase III trials during the latter half of 2016, with initial results coming two years later. The Phase IIb LATTE-2 trial tested injections of the treatment given every four and eight weeks and found that the more frequent dosing schedule suppressed HIV more effectively.

Treatment as Prevention (TasP):

Three major studies underlined the considerable power of HIV treatment to prevent the spread of the virus, adding greater scientific heft to the notion that it may in fact be impossible to transmit HIV with a fully suppressed viral load.

In 2011, interim results from the HPTN 052 trial found that starting HIV treatment early rather than delaying was associated with a 96 percent reduced risk of transmission among mixed-HIV-status heterosexual couples. Now, final results from the study have showed that there were no transmissions within couples when the HIV-positive member was on ARVs and had a fully suppressed virus.

Interim results from the PARTNER study, which included both heterosexual and male-male mixed-HIV-status couples, also found no transmissions between partners when the virus was fully suppressed.

Also, the Partners PrEP study examined the effect of providing mixed-HIV-status heterosexual couples Truvada (tenofovir/emtricitabine) as pre-exposure prophylaxis (PrEP) for the HIV-negative partner as a “bridge” to the HIV-positive partner being on ARVs for at least six months. This protocol slashed HIV risk by 95 percent.

PrEP:

Gilead Sciences, manufacturer of Truvada, conducted an analysis of data from 80 percent of U.S. retail pharmacies and found that nearly 80,000 people had filled at least one prescription for the drug’s use as PrEP between January 2012 and December 2015. (If all sources of PrEP prescriptions could be accounted for, this number would likely be quite a bit greater.) Between the fourth quarters of 2012 and 2015, quarterly new PrEP prescriptions rose 738 percent, from 1,671 to 14,000, largely among men. This upward trend shows no signs of abating.

The IPERGAY study of an intercourse-based PrEP dosing protocol among men who have sex with men (MSM) in France and Canada found that the participants used condoms less frequently after they shifted from the trial’s placebo-controlled phase to its open-label portion in which everyone knew they were receiving Truvada. Despite such a shift in sexual risk taking, the men’s HIV rate was low during the open-label phase. The study’s researchers believe they now have enough evidence to support the notion that the dosing protocol itself was indeed responsible for reducing the risk of HIV among the men, rather than the mere fact that men were on average taking Truvada about four times a week. (Previous research has shown that taking Truvada that often offers maximum protection.)

Researchers found that teenagers given PrEP may need monthly monitoring to adhere well to a daily Truvada regimen. (PrEP is not currently approved for minors in the United States, and current guidelines stipulate monitoring every three months.) A separate studyfound that Truvada-related bone loss is reversible after young men stop PrEP and that the drug was not associated with fractures during the study’s follow-up period.

Another study found that among black MSM receiving PrEP, men were more likely to adhere to the regimen if they were older than 25, had more than a two-year advanced degree, did not use multiple medications that they were not prescribed and had a primary partner.

Women:

A follow-up of the previously reported MTN-020/ASPIRE study of an ARV-containing vaginal ring found that HIV-negative women who used the monthly ring well had a 56 percent reduced risk of contracting the virus compared with women receiving a placebo ring. Those who used the ring at the highest level cut their HIV risk by 75 percent or greater.

Two studies provided excellent news regarding the prevention of mother-to-child transmission of HIV. A nationally representative study found that just 4 percent of children born to HIV-positive women in South Africa contracted the virus by 18 months of age. Another trial found that HIV treatment could practically halt the transmission of HIV through breast feeding.

A collection of three studies provided new insight into why HIV rates among young women in South Africa are so high. In one study, researchers found that HIV transmission among adolescent girls and young women is driven by their sexual relations with men who are an average of eight years older. Two other studies suggest that particular bacteria in women’s vaginas may facilitate transmission.

Cure:

Researchers have developed a consortium to help develop and study stem-cell transplant cures for HIV that would replicate the success of the pair of such transplants that cured the famed Berlin Patient while also treating his leukemia. They already have a few transplant recipients who, while still taking HIV treatment, show very small amounts of the virus in their viral reservoirs. These individuals would need to stop taking ARVs for researchers to determine whether they may have been cured of the virus.

A study found that treating HIV within 15 days of infection prevented the development of antibodies to the virus among a group of South African women. Such early treatment also preserved their immune function. The study’s ethics committee believes the women should remain on treatment for two to three years before researchers may discuss with the participants the possibility of taking them off treatment to see whether the virus rebounds.

On the subject of viral rebound after a treatment interruption, an experimental treatment with the HDAC inhibitor (a kind of cancer drug) vorinostat, the immunosuppressant hydroxychloroquine and the ARV Selzentry (maraviroc) had no effect on viral rebound after an HIV treatment interruption.

90-90-90:

The Joint United Nations Programme on HIV/AIDS (UNAIDS) has called for, by 2020, getting 90 percent of the world’s HIV population diagnosed, 90 percent of that group on treatment for the virus, and 90 percent of that group virally suppressed. Achieving the 90-90-90 targets would mean that, of all people living with the virus, 90 percent would know their status, 81 percent would be treated and 73 percent would be virally suppressed.

Research suggests that nations are advancing toward these targets, with 17 million people on treatment in 2015. One intervention in particular has surpassed the targets in certain rural Ugandan and Kenyan communities. But UNAIDS executive director Michel Sidibé raised serious concerns at AIDS 2016 that a retreat of major donor commitments from paying for HIV care and treatment worldwide could stymie such progress.

An analysis of spending by the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) found that foreign aid dollars go disproportionately to epidemics more generalized across a national population than to those concentrated among MSM or injection drug users (IDUs).

In another wrinkle, the first major study of the public-health effects of programs to aggressively test and treat HIV found that, in South African communities receiving such an intervention, providing immediate treatment rather than following national guidelines was not associated with any difference in the rate of new HIV cases.

Gay Men and Trans Women Adhere Well to Rectal Gel As PrEP in Early US Study

A rectal gel containing 1 percent tenofovir showed promise as pre-exposure prophylaxis (PrEP) against HIV in a group of transgender women and men who have sex with men (MSM), who adhered well to the protocol for the gel’s use. The Phase II MTN-017 trial included 187 MSM and trans women in sites in the United States, (including Puerto Rico), Peru, Thailand and South Africa. Results were presented at the 2016 Conference on Retroviruses and Opportunistic Infections (CROI) in Boston.

Tenofovir-infused topical gel has protected non-human primates and successfully combats HIV in laboratory tests. Previous research has found that a vaginal formulation of 1 percent tenofovir was neither safe nor acceptable in the rectum. So the gel in this study was one that had been reformulated into a reduced glycerin formation of 1 percent tenofovir gel.

The participants for this study, all of whom reported receptive anal intercourse, were randomized so that each went through three phases of the trial, but in different orders. These phases included eight weeks each of the following (with a one-week “wash-out” period between each phase): the rectal 1 percent tenofovir gel with instructions to insert it into the rectum daily; the gel with instructions to use it rectally before and after anal intercourse, or at least twice weekly in the event of no receptive anal intercourse; or Truvada (tenofovir/emtricitabine) with instructions to take the tablet orally once daily. The study lasted for 27 weeks.

The participants, 12 percent of whom identified as women or transgender, made study visits every four weeks. The researchers measured the participants’ adherence to the various forms of PrEP through daily SMS texts as well as through returns of the product at each study visit (to see how much unused PrEP remained). They also tested study members’ plasma tenofovir levels at each study visit and gave them the results of that test at the subsequent visit. High adherence was defined as taking greater than 80 percent of expected doses.

There were no differences between the three versions of PrEP in terms of grade 2 adverse health problems. The researchers concluded that the rectal gel was safe in either of the dosing protocols.

Overall, the participants preferred the oral regimen to the two rectal application protocols, in particular the daily regimen. Ninety percent of individuals said they like liked the oral regimen, 80 percent liked the dosing protocol associated with sexual activity, and 70 percent liked the daily rectal gel protocol.

Adherence was generally high, and participants adhered similarly to administering the gel at least twice weekly and taking Truvada daily.

The researchers concluded that the trial supported further study of rectal microbicides in MSM and trans women, and that research should focus on convenient dosing regimens.

To read the conference abstract, click here.

Non-Daily PrEP Study Raises Doubts of Its Real-World Applicability

Researchers have published in the New England Journal of Medicine their findings from the IPERGAY trial of an intermittent dosing schedule of Truvada (tenofovir/emtricitabine) as pre-exposure prophylaxis (PrEP) among men who have sex with men (MSM). Preliminary results from the study, which found that the non-daily dosing protocol reduced the risk of HIV infection by 86 percent in the double-blind, placebo-controlled trial, were presented at the February 2015 Conference on Retroviruses and Opportunistic Infections (CROI) in Seattle and the 20th International AIDS Conference in Melbourne, Australia, in July 2014.

In the published study, the study investigators cautioned that PrEP’s effectiveness in this trial may have been exaggerated by the fact that the placebo arm was discontinued early. The relative brevity of the time participants spent in the placebo phase—a median nine months, compared, for example, with 1.2 years in the global iPrEx study of daily PrEP—may have inflated the results, as the participants may have become less adherent if more time had passed.

The researchers also cautioned that the IPERGAY findings may not apply to individuals who follow the study’s PrEP dosing protocol and take fewer than 15 pills per month, which was the median number of pills the men in the study took. Previous research has estimated that taking four daily doses of Truvada per week confers maximum protection against HIV. The protection the men in IPERGAY’s Truvada arm experienced may be more related to their taking the drug at about that frequency, rather than the particulars of the actual dosing schedule.

Participants were recruited at six sites in France and one in Canada between February 2012 and October 2014. Four hundred MSM were randomized into two groups; 201 received a placebo and 199 received Truvada. At enrollment, the participants all reported condomless anal intercourse with at least two partners during the previous six months.

The participants were instructed to take two doses between two and 24 hours before intercourse, or one pill if the most recent dose was taken between one and six days before. If intercourse did occur, they were to take one dose every 24 hours after that first dose, until they had taken two pills since the last time they had anal sex. The participants all received enough tablets to take one per day throughout the study.

Participants made clinic visits four and eight weeks after they were enrolled in the trial and then every eight weeks after that. At each visit they received a comprehensive package of HIV and sexually transmitted infection (STI) prevention services, including counseling, free condoms and lubricant, STI and HIV testing, and any necessary STI treatment.

The researchers measured use of Truvada or the placebo by having participants bring their pill bottles to each study visit so that unused tablets could be counted. The first 113 people to be enrolled also had their blood tested for levels of the two components of Truvada. The test could detect if at least one pill had been taken within nine days. Adherence was also measured through computerized interviews.

On October 23, 2014, the trial’s independent data safety monitoring board, after determining that those in the Truvada arm were experiencing a considerable reduction in HIV risk, recommended the discontinuation of the placebo arm. The current analysis reflects data collected during the double-blind phase of the trial, through January 2015. The study has since continued under an open-label protocol in which all participants know they are receiving Truvada.

Forty-nine participants (12 percent) dropped out of the study. All told, participants contributed 431 person-years of follow-up (person-years reflect the cumulative years participants spend in a study), with a median of 9.3 months per person. (The 25th percentile was 4.9 months and the 75th percentile 20.6 months.)

The participants in both arms of the study took a median 15 tablets per month, with a 25th to 75th percentile range of 11 to 21 tablets in the Truvada group and 9 to 21 tablets in the placebo group. There was considerable variability in the individual and overall patterns of pill taking during the study.

Eighty-six percent of the participants in the Truvada arm had detectable tenofovir at the study visits, and 82 percent had detectable emtricitabine at the visits. Eight people in the placebo group (4 percent) had detectable Truvada, including three that were receiving post-exposure prophylaxis (PEP).

According to the computer interviews, 28 percent of the participants did not take Truvada or the placebo at all, 29 percent took the assigned drug at a suboptimal level, and 43 percent took it correctly.

The computerized interview findings contrast the drug-testing figures, for one, because only the first 113 of the 400 participants who enrolled had their drug levels tested. According to the study’s lead author, Jean-Michel Molina, MD, chief of the department of infectious diseases at Paris’s Hôpital Saint-Louis, these particular participants may have been more likely to adhere because they enrolled earlier. Also, since the drug tests only indicate that someone took at least one pill during the previous nine days, a test showing detectable drug may be indicative of an individual who fell into the suboptimal category or the ideal adherence category.

The participants did not report changing their sexual practices during the study.

Forty-one percent of those in the Truvada group and 33 percent of the placebo group were diagnosed with an STI during the study. Thirty-nine percent of the STIs were rectal infections. Eighty-one participants (20 percent) were diagnosed with chlamydia, 88 (22 percent) with gonorrhea, 39 (10 percent) with syphilis, and 5 (1 percent) with hepatitis C virus (HCV).

Research suggests Hep C can transmit sexually among MSM, and there isconsiderable evidence of an emerging epidemic of sexually transmitted HCV among HIV-positive MSM. HIV-negative MSM appear to be at lower risk, for reasons that are poorly understood. Two people out of more than 600 MSM receiving PrEP through a San Francisco clinic have contracted hep C, apparently sexually, leading to a call from physicians for regular screening of the virus among PrEP users.

Sixteen participants contracted HIV during the IPERGAY study, two in the Truvada group (for an incidence of 0.91 per 100 person-years) and 14 in the placebo group (for an incidence of 6.6 per 100 person years). This meant the Truvada group had an 86 percent lower risk of HIV. The estimate range for this risk reduction was wide, 40 to 98 percent, which means that the true risk reduction may lie anywhere in between those figures.

The two members of the Truvada arm who did contract HIV were not taking the drug at the time: At the visits when they tested positive for the virus, they returned a respective 60 and 58 of the 60 pills they were given at the study visit eight weeks prior, and neither had detectable Truvada in their blood.

No one in the study experienced grade 3 or 4 adverse health events. Gastrointestinal side effects, including nausea, vomiting, diarrhea, abdominal pain and other GI disorders, occurred among 14 percent of the participants in the Truvada group, compared with 5 percent in the placebo group.

Thirty-five members (18 percent) of the Truvada group and 20 members (10 percent) of the placebo group experienced elevations in serum creatinine levels, an indication of potential problems with kidney function. All but one of these elevations were grade 1 and none led the participants to discontinue participation in the study. Two participants (1 percent) in the Truvada group had a transient decrease in creatinine clearance to below 60 milliliters per minute.

To read the study, click here.

Jamaica's National Flower Lignum Vitae Found to Have Bio-activity to Fight HIV

Jamaica’s national flower the Lignum Vitae has been found to contain properties that could be used to treat persons living with the Human Immune Virus, HIV, the virus that causes Acquired Immune Deficiency Syndrome, AIDS, by depleting the immune systems of infected persons the researchers who worked on the discovery were led by noted Jamaican scientist and entrepreneur Dr Henry Lowe, the research team noted that the Lignum Vitae has potent bioactivity that could work against HIV.

The study outlined in part:

Aim: Jamaica is rich in medicinal plants. Guaiacum oficinale is the “National Flower”, with reported uses in folk medicine for the treatment of various conditions including inflammation. In our search for plants with anticancer and anti-infective properties, we evaluated Guaiacum oficinale for activity against HIV-1.

Methodology: The leaf, seed and twig extracts of G. oficinale were screened for anti HIV-1 properties in primary peripheral blood mononuclear cels (PBMCs) infected with the reference HIV-1 BaL strain.

Results: Al the tested extracts inhibited HIV-1 p24 production by infected cells, with EC50 concentrations of 2.35µg/ml, 23.42µg/ml and 25.04µg/ml, respectively for the leaf, seed and twig extracts. As comparison, Betulinic acid had an EC50 value of 27.50µg/ml. The tested extracts had IC50/EC50 selectivity index (SI) values of ≥ 3, which compared favorably to Betulinic acid SI value of 1.09.

Conclusion: The results of this study suggest that extracts of G. oficinale may provide leads for the discovery of new drug agents against HIV-1.

Dr Henry Lowe

A statement from Dr Lowe’s Environmental Health Foundation, EHF Group of Companies said that although known from last year test results were repeated several times to ensure data accuracy it says since then the findings were published April 2014 issue of the prestigious European Journal of Medicinal Plants, according to the statement since publication a significant amount of data has been developed, the work of Dr Lowe and his research team has been lauded by Dr Joseph Bryant of the Institute of Human Virology at the University of Maryland Medical School where the global viral network is located. Dr Bryant said Dr Lowe and his researchers need to be recognised and commended for bringing a gift of a major potential magic bullet from a Jamaican tree to the potential management of HIV.

The EHF Group says it is currently pursuing potential drugs from the Lignum Vitae in collaboration with the US based National Products Division of the Research Triangle International which is known for its discoveries of anti HIV drugs, based on this collaboration the EHF Group believes it is one the verge of discovering a potent major anti HIV drug from the plant, Dr Lowe who is the founder and the scientist at the Kingston based Biotech R & D Institute plans to do further research on the isolates of the Lignum Vitae this in order to develop a treatment that could be used alone or as part of a cocktail for the management of HIV/AIDS.

In the interim a nutraceutical product is being developed the EHF group says a US patent has so far been filed in order to protect this vital intellectual property.

The tree is found almost everywhere and in even dry rocky conditions, it is also available in the United States and the Caribbean but as different varieties and is a home remedy for tonsillitis by soaking the bar until the water turns red then gargle or drunk for fever, in the Virgin Islands it is used for fish poisoning and in other parts of the Caribbean for even abortion when specially prepared, it seems this plat we have here and I have no doubt many others have properties that we must explore and unearth. Some parts of Latin America use the leaves for tea to treat stomach aches or as an energy booster when soaked overnight and drunk unsweetened. It is also said to have anti bacterial properties in a subsequent interview with Dr Lowe on Nationwide radio.

He said in that interview also that it could be a potential foreign exchange earner for Jamaica.

Another household use in Jamaica is that of a makeshift broom when a few branches are tied together and is an excellent insect repeller in kitchens in a similar bunched set of green leaves and used to chase away flies and such from meats and fruits. It is rested and amongst fruits, tubers and other foods to supposedly slow down drying out of them when stored in a container or typical food basket and also chasing away fruit flies, moths that feed or surround the aforementioned. During Christmas it attracts thousands of butterflies to its purple flowers and said thousands of caterpillars can be seen on its trunk and branches as they feed prior to pupating.

the trunk often used to make a tea or broth or bark is stripped off and used separately

It seems this plant has some properties just by its natural use and the attraction or repulsion of insects and so on. Not to mention its use as a disciplinary tool for whipping but cut in very slim stick strips as it does not break easily.

Hope we can find the active properties and develop on this as an alternative for the other manufactured and still expensive antiretroviral and highly active antiretroviral therapies available and given the push on PrEP as treatment cheaper drugs are needed as Truvada locally is not so cheap and is partially distributed via the free national system.

Download the PDF file on the research HERE written by Dr Henry Lowe

Peace and tolerance

H

PrEP doesn't lead to increases in risky sex among gay men in the US

Michael Carter
Published: 15 April 2013

Taking HIV pre-exposure prophylaxis (PrEP) does not lead to increased levels of sexual risk behaviour among gay men, investigators from the United States report in the online edition of the Journal of Acquired Immune Deficiency Syndromes. Numbers of sexual partners fell, as did the proportion of men reporting unprotected anal sex.

“We found no evidence of risk compensation among at-risk MSM [men who have sex with men] initiating PrEP,” comment the authors. “Mean numbers of partners and the proportion of men reporting UAS [unprotected anal sex] decreased significantly from baseline during 24 months of follow-up.”

PrEP is an emerging HIV prevention technology. It involves HIV-negative individuals taking daily antiretroviral therapy to reduce their risk of infection with the virus. In 2010, results of the iPrEx trial involving gay and other MSM showed that daily PrEP with Truvada (FTC and tenofovir) reduced the risk of infection with HIV by 44% overall, with high efficacy seen in people with the best treatment adherence. Although the results of PrEP studies involving heterosexuals have been mixed, the United States Food and Drug Administration approvedTruvada for use as PrEP by adults with a high risk of HIV infection.

However, there is concern in some quarters that use of PrEP may lead to increases in sexual risk behaviour. Mathematical models suggest that even modest increases in the proportion of gay men reporting unprotected sex could wipe out the beneficial effect of PrEP at a community level. However, the precise impact of PrEP on sexual risk taking is highly controversial.

Data gathered during a PrEP safety study allowed investigators to explore the impact of PrEP on the sexual risk behaviour of HIV-negative gay men with a high risk of infection with HIV.

A total of 400 men were recruited to the study between 2005 and 2007. All reported anal sex with another man in the preceding twelve months. The study was double blind and placebo controlled. Participants were randomised either to start treatment immediately or to wait for nine months. The men were interviewed at baseline and then every three months about their sexual risk behaviour and use of recreational and erectile dysfunction drugs. The study lasted 24 months.

At baseline, the men reported a mean of 7.25 sexual partners in the previous three months. This fell significantly during follow-up to a mean of 6 partners between months 3 and 9 and a mean of 5.71 partners between months 12 and 24 (p < 0.001). These declines were similar in the immediate- and delayed-treatment arms.

The mean number of reported HIV-positive partners or partners of an unknown status fell from 4.17 at baseline to 3.51 partners between months 3 and 9 and 3.37 partners between months 12 and 24 (p = 0.01). There was also a significant fall in the number of reported partners believed to be HIV negative.

Use of poppers (p < 0.001), erectile dysfunction drugs (p < 0.001) and a higher perception of the efficacy of PrEP (p = 0.04) were all associated with reporting higher numbers of sexual partners during follow-up.

At the start of the study, 57% of men reported unprotected anal sex in the previous three months. The proportion fell to 48% between months 3 and 9 (p = 0.001) and to 52% between months 12 and 24 (p = 0.03).

The proportion of men reporting unprotected sex between months 3 and 9 was similar between the immediate- and delayed-treatment arms.

There was also a fall in the proportion of men reporting unprotected sex with an HIV-positive partner, from 29% at baseline to 21% between months 3 and 9 and 22% between months 12 and 24 (p < 0.001). Declines in unprotected sex with HIV-positive partners were seen in both the immediate- and delayed-treatment arms.

Factors associated with reporting unprotected sex during follow-up included younger age (p = 0.01), use of poppers (p = 0.02), erectile dysfunction treatments (p < 0.001) and methamphetamine (p < 0.001).

Participation in the study did not lead to an increase in the number of reported episodes of unprotected anal sex, which remained steady between months 3 and 9 and months 12 and 24 in both the immediate- and delayed-treatment arms.

There was a fall in reported episodes of unprotected sex with HIV-positive partners from two in the previous three-month period at baseline to 1.37 between months 12 and 24 (p = 0.05). This was the case for both the immediate- and delayed-treatment study arms.

In contrast, the number of episodes of unprotected anal sex with partners thought to be HIV negative increased between baseline and months 12 and 24 (2.75 Vs. 4; p = 0.01).

“These changes may represent a possible increase in seroadaptive practices, in which men preferentially have more episodes of UAS with assumed HIV-negative partners,” comment the authors.

They also note “men in this study received risk-reduction counseling, condoms and lubricants, regular HIV/STI testing, and linkage to prevention services…which may explain the observed risk reduction and could explain the observed risk declines and could mitigate any potential for risk compensation.”

Despite this, the investigators were encouraged by their results, which they believe “provide important information on changes in risk practices among MSM in the US initiating PrEP in a clinical trial setting”.

Reference

Liu AY et al. Sexual risk behavior among HIV-uninfected men who have sex with men (MSM) participating in a tenofovir pre-exposure prophylaxis randomized trial in the United States. J Acquir Immune Defic Syndr, online edition, DOI: 10.1097/QAI.0b013e31828fo97a, 2013.

Navigating Treatment as Prevention

by Trenton Straube

Treatment as prevention (TasP) can refer to several bio-medical strategies. In both pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP), HIV-negative people take daily regimens of antiretrovirals (ARVs) to reduce the risk of a possible infection. In prevention of mother-to-child transmission (PMTCT), pregnant women with HIV take meds so the virus isn’t passed to their babies.

Last but not least, TasP also can refer to the idea that treating people with HIV not only improves their health but also prevents transmission of the virus. It’s this notion of TasP that most people seem to associate with the phrase—and it’s this aspect that remains the most misunderstood.

The concept has been floating around for years—after all, if ARVs dramatically reduce the virus in bodily fluids, then it follows that HIV is less likely to be spread during sex—but it gained backing five years ago with the so-called “Swiss Statement.” Authored by four of that country’s HIV experts, it claimed that an HIV-positive person on ARVs and with an undetectable viral load and no sexually transmitted infections cannot transmit HIV through sexual contact.

The statement, however, was based on “review of the medical literature and extensive discussion.” In 2011, the supporting data arrived from the HIV Prevention Trials Network when its HPTN 052 trial found that, for heterosexual couples, starting early treatment led to a 96 percent reduction in HIV transmission to the negative partner. The news made global headlines. The journal Science named it “the 2011 Breakthrough of the Year,” and Time magazine listed treatment as prevention as the year’s No. 3 medical breakthrough.

In December 2012, Chinese scientists claimed that TasP indeed prevented infections—but by 26 percent, not 96. So which is it? What’s more, given that anal sex is 10 to 20 times riskier than vaginal sex and that the studies were based on heterosexuals, how do the findings apply to gay men? The flood of recent data might seem overwhelming, but on closer inspection, a clearer picture emerges on the horizon.

HPTN 052 researchers, led by Myron Cohen, MD, the director of the Institute for Global Health and Infectious Diseases at the University of North Carolina, enrolled 1,763 serodiscordant couples—in which one person has HIV and the other doesn’t—in nine countries. The study, which began in 2005, is ongoing. The couples were divided into two groups: In one, the positive partners started treatment immediately; in the other, they waited till their CD4 counts dropped below 250 or they had an AIDS-related illness. Everyone received regular counseling and care—any sexually transmitted infections, for example, were treated—and they were provided with and encouraged to use condoms (although there were more than 200 pregnancies). All HIV-positive participants attained an undetectable viral load.

By February 2011, the study recorded 28 cases of HIV infection linked to the positive partner. An additional 11 negative participants contracted HIV, but the virus was not genetically linked to their positive partner, which illustrates that the couples were not necessarily monogamous. Only one of the 28 cases occurred in the early treatment group, and it took place shortly after the trial began, when the positive person was probably not yet undetectable.

HPTN 052 is a clinical trial following highly motivated and monitored participants. How will its results hold up in the real world? To find out, Chinese scientists looked at already existing data on nearly 39,000 serodiscordant couples from 2003 to 2011. Despite lacking crucial details, such as whether people with HIV were undetectable, the researchers found an overall prevention benefit of 26 percent. Cohen sees this as “a positive message—that at a population level, you still see a benefit.”

On an individual level, the news looks even brighter. In January 2013, the U.K. Health Department published position papers by two leading AIDS groups—the British HIV Association (BHIVA) and England’s Expert Advisory Group on AIDS (EAGA)—stating that when the positive person is on successful treatment and three criteria are met, the risk of transmitting the virus through vaginal transmission is “extremely low”—as in, it’s “as effective as consistent condom use.” Those three conditions, according to what’s already being called “the U.K. Statement,” include:

• There are no sexually transmitted infections (STIs) in either couple.
• The positive person has a viral load below 50 copies/mL (considered to be
undetectable) for more than six months and on the most recent test.
• Viral loads must be tested every three to four months.

Fulfilling these criteria may seem straightforward, but there are caveats. For example, it’s possible to have an STI and not be aware of it. STIs are problematic because they increase inflammation, spurring both the amount of HIV and the number of CD4 cells—the very cells that HIV latches onto.

Similarly, although viral loads are likely to remain undetectable as long as the meds are taken regularly, treatment regimens can fail. “I’ve had my virus break through the medications a number of times,” says Jim Pickett, director of prevention advocacy and gay men’s health at AIDS Foundation of Chicago, who’s been on meds since 1997 and considers himself very adherent. “And yet, when I became detectable I didn’t know until I was tested—you don’t just one day have a headache and then know you’re detectable. You don’t know.” Hence, testing for STIs and viral load are essential.

How does all of this apply to gay men—and to anal sex? (Remember, it’s the sexual act, not the sexual orientation, that poses the HIV risk.) In the United States, men who have sex with men (MSM) comprise 63 percent of new infections, and globally, anal sex among heterosexuals is an often-overlooked driver of the epidemic. Although no TasP studies have concerned gay men or anal sex, Pickett says, we’re accumulating real-world data and their implications. Indeed, a meta-analysis by London researchers found that treatment can reduce the risk of transmission during anal intercourse by up to 99.9 percent. The U.K. Statement reached a similar conclusion.

Treatment as prevention works really well as a strategy for individuals who meet all the requirements. (Think about it: If it weren’t for the single person in HPTN 052, who technically wasn’t on successful treatment yet, that trial would have reached 100 percent success.) As a population strategy, however, myriad challenges—including the cost of the meds—can sink the prevention potential.

Of the 1.1 million people with HIV in the United States, almost 20 percent are unaware of their status. What’s more, only between 60 and 68 percent are linked to care, between 30 and 41 percent remain in care, and a dismal 16 to 34 percent have suppressed viral loads. (This collection of diminishing numbers is often referred to as “the cascade data.”)

To fully realize TasP, HPTN’s Cohen says, “you have to go through the process of testing people, treating them—in my mind, treating them immediately—making sure they remain adherent and making sure that their viral load is suppressed. If you do all that, I suspect transmission will go down to an unbelievably low rate.”

And while TasP may be a pivotal step in reaching the goal of “an AIDS-free generation,” the opportunities for misuse also exist. Leading thinkers such as the Global Network of People Living With HIV/AIDS (GNP+) have raised concerns. For example, will those living with the virus be coerced into starting treatment? Will they always be informed of their options? Will testing remain voluntary and confidential?

“Providing treatment to people living with HIV infection to improve their health must always be the first priority,” notes the Centers for Disease Control and Prevention (CDC) in a January 2013 background brief on TasP. But such statements are expected when it’s understood that placing people on treatment for a public health purpose is a violation of human rights.

“[I’m] very concerned that the priorities have been skewed, in part by pharmaceutical companies seeking larger markets and in part by a political and public health environment looking for an easy way out,” says POZ founder and Sero Project executive director Sean Strub. “It’s like they want to buy a can of pharmaceutical Raid and spray it on everybody to stop the transmission of HIV. But that still leaves all the other circumstances that facilitate HIV’s spread unaddressed, as well as creates a host of new problems.” We can ensure that people with HIV are making empowered decisions, Strub says, by measuring their treatment literacy once they start taking meds.

When to start treatment is another big question. HTPN 052 found a benefit to starting right away, and the U.S. Department of Health and Human Services recommends treatment for everyone, regardless of CD4 count. But others go by different benchmarks. The data for starting therapy when CD4 counts fall below 350 is stronger than that for starting above 350, says Tim Horn, the HIV project director at Treatment Action Group, and it’s even stronger than data for starting above 500—or regardless of CD4s. Nonetheless, Horn concludes: “All of that said, I simply can’t imagine that we’ll find that [starting early] is actually harming people living with HIV on a large scale.”

In 2010—a year before the HPTN 052 results—San Francisco became the first U.S. city to adopt a policy of universal ARV access. In other words, of offering treatment to everyone regardless of CD4 count, which many people view as TasP. The decision, according to Brad Hare, MD, the medical director of the HIV/AIDS Clinic at the San Francisco General Hospital, was based on their own real-world data and on-the-ground experiences as well as the input of community groups such as Project Inform and the state agency that oversees the AIDS Drug Assistance Program (ADAP).

The HIV clinic sees 3,000 patients; it’s a public health setting where none of the clients has private insurance and there are high rates of active substance abuse, homelessness and mental illness. “It’s a tough patient population,” Hare admits. So how’s the new policy panning out? “It’s working pretty well,” says Hare, explaining that 92 percent of clients are prescribed ARVs and of those, 82 percent have undetectable viral loads (this compares with the nationwide average of between 16 and 34 percent). Citywide, new infections are decreasing. In fact, looking at data from 2004 to 2011, researchers writing in the Journal of Acquired Immune Deficiency Syndromes recently concluded: “‘Treatment as Prevention’ may be occurring among [men who have sex with men] in San Francisco.”

However, Hare points out, the successes cannot be attrib-uted solely to the city’s universal ARV policy. San Francisco has also invested in its testing and treating programs, and it offers a health benefits program to people with HIV. Also, MSM comprise 90 percent of the city’s HIV epidemic, and the local activist community remains informed and involved. “San Francisco is a unique place,” Hare says, “and [our policy] may not apply to others. But there are a lot of generalities we can learn. First of all: This can work.”

Hare has observed that his clients decide to start treatment for a variety of reasons. Some hope that the meds will help them maintain cardiovascular health. Others want to stave off mental decline. He recalls one patient who initially declined ARVs because his blood work was good but then changed his mind after two incidences of condom failure resulted in his negative partner taking HIV meds as post-exposure prophylaxis.

When speaking with his patients, Hare stresses that the evidence points to personal health benefits for starting treatment as soon as they’re ready. Then, as if it’s almost a “by the way” aside, he mentions the prevention benefits for their partners and the community. In fact, he says, “I don’t see our policy as written as a treatment as prevention policy. It is clearly based on the benefits of the individual [with HIV].” In other words, it’s treatment as treatment.

PrEP: time to rethink prevention, effectiveness and ethics?

By Marsha Rosengarten


PrEP: time to rethink prevention, effectiveness and ethics?


One of the more controversial interventions proposed for HIV prevention in those who test HIV antibody negative and perceived to be at risk is pre-exposure prophylaxis (PrEP) – a daily pill comprising one or two antiretroviral drugs manufactured by Gilead Inc.  Besides the mixed results from multi-site randomised controlled trials (RCTs) seeking to establish the efficacy of PrEP (see iPrEX versus Fem-PrEP), concerns have been raised about PrEP’s potential to undermine condom use, its cost implications in locales where treatment provision is still lacking and elsewhere, its potential to cause unwanted drug side-effects as well as possible drug resistance in those it fails to protect.


Nevertheless, continuing new infections and evidence that high adherence produces a strong protective effect are mobilising many public health authorities to devise feasible implementation models.


Most remarkable about the growing interest in PrEP is the exclusion of the social sciences from major forums where this work is taking place.  One such example is a two-day forum held in the UK by IAPAC on the dual topics of treatment as prevention (TasP) and PrEP.  The only non-biomedical speakers listed on the programme were a psychologist (speaking on adherence), a bioethicist, activists and public health officials linked to various national epidemics.


Indeed it won’t come as a surprise to many to know that despite the millions of dollars to support RCTs for PrEP, the Bill and Melinda Gates Foundation have so far declined to support a substantial programme of social research on PrEP.  In fact if we consider the bioethical requirements imposed on the conduct of RCTs for PrEP and other biomedical interventions, there is no ethical requirement for research on the social dimensions of the intervention during or post RCTs. This applies even when RCTs demonstrate candidate efficacy.


The multiple ways in which PrEP will unfold across the epidemic and the absence of social scientific approaches to grapple with this multiplicity is worrying. Without doubt it underscores the need for this particular blog and other forums designed to enliven the social science contribution and increase its visibility. But the absence of social science also raises the question of what sort of social research should be called upon in response to the biomedicalisation of the epidemic.


Although not wanting to diminish what has already been achieved to date by the social and biomedical sciences, it is worth pointing out that much of this work has relied on the presupposition of an ‘HIV prevention user’ who exists prior to and remains largely distinct from the means of prevention or RCT technology.  Always already conceived as independent of the means of prevention, ‘she’ or ‘he’ is assessed according to whether ‘she’ or ‘he’ does or does not utilize prevention. If not, it is because:


i)      She/he is deficient in knowledge or understanding necessary for adopting safe practices.


ii)    She/he is deficient due to asymmetries in power and situated in such a way to be without services that help mitigate against unsafe practices, for example: housing, food, education, safe forms of employment without discrimination.


iii)  She/he is deficient in responsibility causing her or him to be unable to act safely.


Leaving aside any preferences we may have for one or even two of these accounts of ‘the user’, all can be said to assume and, indeed, enact HIV risk as if consisting of ‘stand-alone entities.’ These entities— for example, users, bodies, knowledge, rights, HIV, condoms, drugs, routes of transmission and so on—are imagined as present in a stable form prior to the risk event and ontologically distinct. 


This thinking is especially prevalent in RCT design, sometimes even the explanation for failure. The MIRA trial (Methods for Improving Reproductive Health in Africa) found that women in the candidate arm who were asked to use a diaphragm with a condom in sexual intercourse were less likely to sustain condom use than women in the placebo arm who were recommended to use only condoms.  In other words, the combining of presumed distinct prevention technologies gave rise to women in the candidate arm being more at risk of HIV infection than those in the placebo arm. 


Here the ‘additional’ object (the diaphragm) did not enhance but, instead, diminished the capacity of the more protective object (the condom).[1] In sum, a logic of ‘stand-alone’ entities undermined prevention in the candidate arm, rendered ineffectual the statistical calculations necessary to a worthwhile trial and, it can be argued, raises the question of whether the logic of ‘stand-alone’ entities leads to a practice devoid of satisfactory ethics.


Importantly, the women in the MIRA trial, like many others negotiating the demands of HIV in the midst of complex and sometimes competing social relations, remind us that ‘objects’ such as condoms, diaphragms, pills etc. are not stable and distinct but emerge with heterogeneous effects in their relations with other phenomena.


Ironically, biomedicine also offers a reminder of the dynamic co-affective nature of the epidemic, even if those practicing it fail to fully comprehend their objects in this way: the virus is of consequence when it is with the human body or in a laboratory study, not when it is independent of other phenomena. Similarly antiretroviral drugs are made effective in their use; or through the monitoring of adherence; or through their capacity to induce ‘side effects’ and so on.  They, too, acquire their effect only in relation to other phenomena and, moreover, it is their effect that we are concerned with.


As a guide to how we might extend the social science of prevention, I want to propose a rethinking of prevention as that which is effective because it is ethical.  By hinging effectiveness to ethics, the relational aspects of intervention come into view.  Put simply, if prevention is to take place—in this instance through the uptake of PrEP—it must perform an aligning with the varying interests of those it is intended for and, at the same time, affecting. More specifically, it must weigh in on some affects—most likely those of pleasure although this is complex territory in itself —well over others—such as coercion and homophobia —and do so by appealing in such a way that the effective user is able to emerge as such.[2]


By anticipating ethics as immanent in the affective work of practice it also becomes possible to become sensitized to dynamics that work against prevention. Particularly pertinent here is the manner in which PrEP has emerged. Its controversial nature cannot be disentangled from the technology of the ‘efficacy’ testing RCT and the legitimation of this process by bioethics. The legitimizing of RCTs in their current form where only a delimited set of effects are of concern—those that may incur more risks than benefits within the parameters of the RCT—excludes precisely that which the more everyday use of the candidate may generate.  Here I am thinking in particular of concerns that PrEP may give rise to what is termed ‘risk compensation’ or may alter gender relations in such a way that women take responsibility for prevention as has happened with the contraceptive pill.[3] Crudely put, how has it come to be ethically legitimate to spend millions of dollars on the efficacy testing of a biomedical agent[4] without providing research into how it will affect the epidemic? Or, to turn the gaze on those who would otherwise neglect us and, at the same time, open for consideration the achievement of biomedical prevention more generally:  has bioethics usurped the role of social science as such by granting biomedicine greater license for its activities but less viability for its products?  


These questions and a host of others could become part of a different approach to prevention, effectiveness and ethics. To reiterate, by conceiving of effectiveness as an achievement of ethical design it may be possible to shift the logic of the stand alone as evident in the deficit individual and as exemplified in the MIRA trial   and begin to work with PrEP as a highly relational entity. Working with PrEP means attending to how it emerges, including how it does so through the design of RCTs and, possibly, as part of the everyday relations involved in its uptake.




[1] Rosengarten M, Michael M, Mykhalovskiy E & Imrie J (2008)‘The Challenges of Technological Innovation in HIV’ Lancet Aug 2;372 (9636):357-8.


[2] See for example: Race, K (2009) Pleasure Consuming Medicine: The Queer Politics of Drugs, Duke University Press, Durham & London; Gomart, E. (2004) ‘Surprised by Methadone: In Praise of Drug Substitution Treatment in a French Clinic’, Body & Society, 10 (2–3): 85–110.


[3] Rosengarten, M. & Michael, M. (2009) ‘The performative function of expectations in translating treatment to prevention: the case of HIV pre-exposure prophylaxis or PrEP’ Social Science & Medicine, Volume 69, Issue 7, October: 1049-1055.


[4] Peters A JTP, Micevska-Scharf M, Van Driel FTM, Jansen WHM (2010) ‘Where does public funding for HIV prevention go to? The case of condoms versus microbicides and vaccines’ Globalization and Health 6, 23:1-10