Jamaica's buggery law not among the most severe in the Caribbean region .............

A letter appeared in the Gleaner earlier today on a study conducted by JFLAG on the Buggery Law in the Caribbean making comparisons to other states as to severity. Here is the letter firstly, meanwhile the antigay spin doctors try to twist the narrative that of Jamaica being mislabeled as the most homophobic place on earth. 

The letter:

THE EDITOR, Sir:

Research around the application of Jamaica's buggery law reveals it is not among the most severe in the Caribbean region. The findings, which are contained in a study conducted by J-FLAG titled 'Criminalizing Private Consensual Intimacy II', help to challenge the decades-old belief that Jamaica is the most homophobic place on earth.

The study found that when compared to similar laws in other Commonwealth Caribbean countries, Jamaica is neither the best nor the worst as it relates to the criminalisation of private, consensual same-sex conduct. Six Caribbean countries criminalise both male-to-male and female-to-female consensual sexual activity. They are Antigua & Barbuda, Barbados, Dominica, St Lucia, St Vincent and the Grenadines, and Trinidad & Tobago. In Jamaica, only male-to-male consensual sexual activity is criminalised, in addition to the criminalisation of anal sex regardless of gender.

J-FLAG undertook the study to review statistics on the use of the buggery law in the justice system, explore the treatment of similar laws internationally, and compare the severity of the local buggery law to others in the Commonwealth Caribbean.

Sentences vary across the Caribbean. In Barbados, for example, the offence of buggery can attract a maximum sentence of life in prison, while in Trinidad and Tobago, a maximum sentence of 25 years. This is significantly more severe than the maximum 10 years in Jamaica.

NOT AS HARSH

The fact that Jamaica's punishment for buggery is not as harsh as some Caribbean neighbours does not mean the law must not be amended.

This is by no means an indication that the law does not affect LGBT people across the country. The buggery law continues to be a locally and internationally recognised symbol of state-sanctioned discrimination against LGBT Jamaicans. Reform of this unjust law remains urgent, since the provisions do not align with the fundamental rights to privacy and equality before the law as secured in the Charter of Fundamental Rights and Freedoms.

This is particularly true of Section 80 of the Offences Against the Person Act, which legalises wanton arrests of gay men and trans women. Fixing this and other laws, and creating a welcoming legal and policy environment for LGBT Jamaicans, are steps in the right direction.

DANE LEWIS

GLENROY MURRAY

J-FLAG

ENDS

 the article that got most persons in a bind

How the article was misrepresented is part and parcel of how the already existing homonegative feelings led to the deceptive narrative by ignorant religious fanatics (that make honest church fol look stupid) is why there is hardly any serious movement in changing hearts and minds. The social media firestorm is now sending a narrative that JFLAG et al were lying on Jamaica all along and further justification for no change to the buggery law, repeal or amendment.

JFLAG tried to clarify its agenda though somewhat late as the public and homophobic groups kept using the full repeal arguments instead of the change in position, the J took too long to adjust themselves in my view.

Also see: Is ‘The Most Homophobic Place on Earth’ Turning Around? (2015), Buggery law referendum baiting by JLP in #Javote2016 campaign and J-FLAG now advocating for decriminalisation of same-sex acts

The Star News still couldn't help themselves despite some slight forward thinking in recent years, they headlined the story, when it is the law that is being discussed and not the inherent multi-generational homophobia:

Jamaica not the most homophobic country

In the face of calls for Jamaica’s buggery laws to be repealed, one of the main organisations that supports homosexuality has discovered that Jamaica is not the most homophobic place on Earth.

Having conducted a study, titled, Criminalising Private Consensual Intimacy, J-FLAG found that in Barbados, the offence of buggery can attract a maximum sentence of life in prison. In Trinidad and Tobago, the maximum sentence for buggery is 25 years in prison, while in Jamaica the maximum penalty is 10 years imprisonment.

“This is by no means an indication that the law does not affect LGBT people across the country,” Dane Lewis, J-FLAG’s executive director said.

“The buggery law continues to be a locally and internationally recognised symbol of state-sanctioned discrimination against LGBT Jamaicans. Reform of this unjust law remains urgent since the provisions do not align with the fundamental rights to privacy and equality before the law as secured in the Charter of Fundamental Rights and Freedoms,” he said.

ENDS

Good to see the attempt by the goodly JFLAG to provide some figures and a more balanced comparison but the public's response despite way heightened visibility shows me we have a long road ahead.

Peace & tolerance

H 

Integrase Inhibitor Bictegravir Matches Dolutegravir for First-Line HIV Treatment

from CROI 2017

Bictegravir, an investigational integrase inhibitor from Gilead Sciences, was highly potent, well tolerated and worked as well as dolutegravir (Tivcay) in a Phase 2 clinical trial, according to study results presented at the 2017 Conference on Retroviruses and Opportunistic Infections (CROI) this week in Seattle and published online in The Lancet HIV.

Integrase inhibitors, also known as integrase strand transfer inhibitors (INSTIs), are a class of antiretroviral drug designed to block the action of integrase, a viral enzyme that inserts the viral genome into the DNA of the host cell. Since integration is a vital step in retroviral replication, blocking it can halt further spread of the virus. Integrase inhibitors were initially developed for the treatment of HIV infection, but they could be applied to other retroviruses.

The discovery and development of integrase inhibitors led to the first integrase inhibitor approval by the U.S. Food and Drug Administration (FDA) on October 12, 2007, for raltegravir (brand name Isentress). Research results published in the New England Journal of Medicine on July 24, 2008, concluded that "raltegravir plus optimized background therapy provided better viral suppression than optimized background therapy alone for at least 48 weeks."

Since integrase inhibitors target a distinct step in the retroviral life cycle, they may be taken in combination with other types of HIV drugs to minimize adaptation by the virus. They are also useful in salvage therapy for patients whose virus has mutated and acquired resistance to other drugs.

Due to their high potency and good tolerability, integrase strand transfer inhibitors are an increasingly important part of initial antiretroviral therapy and are included in most recommended regimens for first-line treatment in U.S. and European HIV treatment guidelines.

Bictegravir (formerly GS-9883) is an investigational integrase inhibitor that can be taken once-daily and does not require a booster -- unlike Gilead's older integrase inhibitor elvitegravir, which must be boosted with cobicistat.

As previously reported, bictegravir demonstrated high potency against wild-type and resistant strains of HIV, favorable pharmacokinetics, and an improved resistance profile compared to older integrase inhibitors. In a 10-day monotherapy study, it rapidly reduced viral load by more than 2 login people with HIV.

At CROI Joseph Custodio from Gilead reported that bictegravir was safe and well-tolerated at doses ranging from 5 mg to 600mg in healthy volunteers. Bictegravir inhibits renal tubule transporters, which lowers creatinine levels and leads to a decline in estimated glomerular filtration rate, but it does not cause actual kidney function impairment, he explained.

Bictegravir is metabolized equally bythe CYP3A4 and UGT1A1 pathways. Custodio said it has low potential to be either a "victim" or "perpetrator" of drug-drug interactions. Bictegravir levels rose by more than 300% when administered with both CYP3A4 and UGT1A1 inhibitors, and fell by up to 75% when given with both CYP3A4 and UGT1A1 inducers. The drug had a half-life of approximately 18 hours, indicating it is suitable for once-daily dosing. Bictegravir had no effect on a common oral contraceptive or ledipasvir/sofosbuvir (Harvoni) for hepatitis C, and administering it 2 hours before or after minimises interactions with antacids.

Paul Sax of Brigham and Women's Hospital in Boston and colleagues conducted a Phase 2 placebo-controlled clinical trial comparing bictegravir to dolutegravir for initial HIV therapy.

The study included 98 previously untreated adults. Almost all were men, more than half were white, and the median age was about 32 years. They generally had asymptomatic HIV infectionwith a median CD4 T-cell count of approximately 450 cells/mm3 and a median viral load of about 4.4 log copies/mL at baseline. They had normal kidney function and people with hepatitis B or C coinfection were excluded.

Participants in this double-blind study were randomly assigned (2:1) to receive 75 mg bictegravir or 50 mg dolutegravir, each with matching placebos. Both drugs were combined with 25 mg tenofovir alafenamide (TAF) and 200 mg emtricitabine, taken once daily with or without food for 48 weeks. The primary endpoint was the proportion of people with HIV RNA below 50 copies/mL at 24 weeks.

Results

Both treatments were highly effective.

97% of participants in the bictegravir arm and 94% in the dolutegravir arm achieved viral suppression at 24 weeks.

97% and 91%, respectively, had undetectable HIV RNA at 48 weeks.

Given the small number of patients, these differences were not statistically significant and this study was not powered to determine full non-inferiority.

1 person in the bictegravir arm and 2 in the dolutegravir armhad HIV RNA >50 copies/mL, but no significant resistance was detected in either arm.

CD4 cell gains were 258 cells/mm3 in the bictegravir arm compared 192 cells/mm3 in the dolutegravir arm, not a significant difference.

Both regimens were generally safe and well-tolerated, with no treatment-related serious adverse events and no deaths.

The most frequent adverse events were diarrhea (12% in each arm) and nausea (8% with bictegravir and 12% with dolutegravir).

1 bictegravir recipient with a previous history of allergic dermatitis stopped treatment early due to hives after 24 weeks.

Estimated glomerular filtration rate declined by -7.0 mL/min in the bictegravir arm and -11.3 mL/min in the dolutegravir arm at week 48, but there were no discontinuations due to kidney-related adverse events and no cases of tubulopathy.

Bictegravir and dolutegravir taken with TAF and emtricitabine "both demonstrated high virologic response rates at week 24 that were maintained at week 48," the researchers concluded. "Both treatments were well tolerated, and no significant safety signal was detected in either arm."

These results were promising enough to proceed with Phase 3 trials using a single-tablet regimen of bictegravir, TAF, and emtricitabine. Custodio noted that optimising the formulation allowed for a lower 50 mg bictegravir dose in the coformulation.

Sax said that 4 Phase 3 studies are now fully enrolled; 2 of these are similar to the current study but will use the bictegravir single-tablet regimen rather than separate pills. Another is comparing the bictegravir single-tablet regimen against a coformulation of dolutegravir, abacavir, and lamivudine (Triumeq).

"The high virologic response rates seen in this study show that the pairing of bictegravir with [TAF/emtricitabine] could potentially offer patients and physicians a new HIV treatment option with pre-clinical data supporting few drug interactions and a high barrier to resistance," Sax said in a Gilead press release.

2/14/17

Sources

H Zhang, JM Custodio, X Wei, et al. Clinical Pharmacology of the HIV Integrase Strand Transfer Inhibitor Bictegravir. Conference on Retroviruses and Opportunistic Infections. Seattle, February 13-16, 2017. Abstract 40.

P Sax, E DeJesus, G Crofoot, et al. Randomized Trial of Bictegravir or Dolutegravir with FTC/TAF for initial HIV therapy. Conference on Retroviruses and Opportunistic Infections. Seattle, February 13-16, 2017. Abstract 41.

PE Sax, E DeJesus, G Crofoot, et al. Bictegravir versus dolutegravir, each with emtricitabine and tenofovir alafenamide, for initial treatment of HIV-1 infection: a randomised, double-blind, phase 2 trial. The Lancet HIV. February 14, 2017 (online ahead of print).

Gilead Sciences. Gilead Presents New Phase 2 Data on Bictegravir, an Investigational Integrase Strand Transfer Inhibitor for the Treatment of HIV. Press release. February 13, 2017.

Concerns Mount As Transsexual Adolescents Push Up Jamaica's HIV Rates ................

As usual the transgender community is still being lumped with MSM either by the response and by populations overall it seems and it makes the previous studies on MSM HIV prevalence rates of 32% in 2007 and others since problematic while it may be higher trans-persons who merge into the MSM community get counted as gay. The article below touches the very conflation and to think the very named agency is partly guilty of not making the stark differences between the groups even as trans voices screamed to them to pay attention.

The Gleaner carried this:

As a HIV-positive transgender youth, 22-year-old *Tory belongs to the at-risk group that is considered to be most in need of intervention if Jamaica has any hope of seeing further reductions in the number of persons living with HIV/AIDS.

According to a study that was released last week by the Jamaica AIDS Support for Life (JASL), transgender persons who are HIV-positive are more likely to experience homelessness, stigma, forced sex and physical violence. Of the 71 transgender participants polled, more than 52 per cent were involved in sex work for accommodation and food, among other things.

"Now we are seeing where they are at increased risk more than gay men, and more than sex workers, of course, and so it's really just about how we are going to ensure that our programmes are attending to the needs of these persons," said executive director of JASL, Kandasi Levermore.

A UNAIDS report ahead of the commemoration of World AIDS Day on December 1 warned that 15-24 years is a dangerous time for women. It noted that an estimated 45 per cent of all new HIV infections globally in 2014 were among members of key populations and their sexual partners, and warned that new HIV infections are continuing to increase among people who inject drugs and men who have sex with men. The report went on to say that HIV was not declining in sex workers and transgender people.

Tory, a male who identifies as a female, has found himself in several of these categories. He became homeless at 16 years old and became a sex worker shortly after to provide for himself. His clients were mostly professional men, and at 18, he decided to go and live with a police officer who he said was a "regular buyer". He said he contracted HIV from the lawman.

"Being 16 and a sex worker, you get more clients because you are young, because you are new, because they like young people because they think you are not very smart. But I was very smart. Why I was homeless is because I was kicked out of high school because of my sexual orientation," he told The Sunday Gleaner.

MISTREATMENT AT CLINIC

He said due to the mistreatment he received at the first clinic he visited after his diagnosis, he did not take any medication for the first year. He, however, went to a different clinic where the attitude of health professionals was better, and he has since seen vast improvement in his health. He said he is now focused on becoming stable because his greatest desire now is to have a child, although he admitted that he had never had sexual intercourse with a woman.

"I am gay because I won't be in a long-term relationship with a woman," said Tory, before explaining that he is open to having sex with a woman for the sake of having a child.

"I want a child with my genes. Adoption is so hard in Jamaica at this point. She can be a lesbian or she can also be positive and virally suppressed, like myself. So there is a lot of hope to get a child if I want a child when I am ready," he said.

According to a report released recently by JASL, which was funded by the Canadian Institute of Health Research, there is very little knowledge about the HIV prevalence among transgender women in Jamaica.

However, the National HIV/STI programme noted that, "In contrast with the estimated HIV prevalence of 0.4 and 0.5 per cent reported in adolescent girls and boys aged 15-19 at the national level through the UNAIDS 2014 estimates, the HIV prevalence among gay and bisexual adolescent boys is estimated to be 14 per cent, while HIV prevalence in transgender adolescents is estimated to be 27 per cent."

Renae*, who came out as a transgender at 21 years old, said he is concerned that HIV is highest among transgender youths, and blamed this on the fact that those who adopt this lifestyle were often stigmatised or forced to engage in transactional sex.

"Being gay is a taboo, but being transgender is a greater taboo, and because of that, you have a lot of parents who actually do put out their children for these type of things, and you are out on the streets, you have no formal education, you have no way to really provide for yourself," he said.

"So you have to come up with means and ways to provide for yourself, and one of those methods is to become prey to sexual predators out there, or to offer yourself up as collateral, and oftentimes it is to persons who maybe know that they have the virus, but they don't care."

Although Renae was born male, he identifies as a female and is now an advocate for those living in the transgender community. He believes that while there have been improvements in access to treatment for those who are HIV-positive, stigma and discrimination are still forcing some to go underground instead of seeking help.

"That's why I work so hard within the health sector to make things better for trans people on a whole," he said.

[* Names changed to protect identity]

ENDS

And the signs continue to show us that the forward thinking in as far as the NGOs are concerned is still lacking and why are more persons being captured way better given the resources?

The more things change the more they stay the same.

Peace & tolerance

H

also see:

Continued oversight or deliberate overlooking of Jamaican SGL Women in HIV Prevention ............ 

Continued Trans erasure/invisibility by Jamaican advocates ......... 2012

Antibody that neutralises nearly all HIV strains identified

source: elife

SCIENTISTS from the National Institutes of Health (NIH) have identified an antibody from an human immunodeficiency virus-infected person that potently neutralised 98 per cent of HIV isolates tested, including 16 of 20 strains resistant to other antibodies of the same class.

The remarkable breadth and potency of this antibody, named N6, make it an attractive candidate for further development to potentially treat or prevent HIV infection, say the researchers.

The scientists, led by Mark Connors, MD, of NIH’s National Institute of Allergy and Infectious Diseases (NIAID), also tracked the evolution of N6 over time to understand how it developed the ability to potently neutralise nearly all HIV strains. This information will help inform the design of vaccines to elicit such broadly neutralising antibodies.

Identifying broadly neutralising antibodies against HIV has been difficult because the virus rapidly changes its surface proteins to evade recognition by the immune system. In 2010, scientists at NIAID’s Vaccine Research Centre (VRC) discovered an antibody called VRC01 that can stop up to 90 per cent of HIV strains from infecting human cells. Like VRC01, N6 blocks infection by binding to a part of the HIV envelope called the CD4 binding site, preventing the virus from attaching itself to immune cells.

Findings from the current study showed that N6 evolved a unique mode of binding that depends less on a variable area of the HIV envelope known as the V5 region, and focuses more on conserved regions which change relatively little among HIV strains. This allows N6 to tolerate changes in the HIV envelope, including the attachment of sugars in the V5 region, a major mechanism by which HIV develops resistance to other VRC01-class antibodies.

The new findings suggest that N6 could pose advantages over VRC01, which currently is being assessed as intravenous infusions in clinical trials to see if it can safely prevent HIV infection in humans. Due to its potency, N6 may offer stronger and more durable prevention and treatment benefits, and researchers may be able to administer it subcutaneously (into the fat under the skin) rather than intravenously. In addition, its ability to neutralise nearly all HIV strains would be advantageous for both prevention and treatment strategies.

ARTICLE:

J Huang, BH Kang, E Ishida, T Zhou et al. Identification of a CD4-binding site antibody to HIV that evolved near-pan neutralization breadth. Immunity DOI: 10.1016/j.immuni.2016.10.027 (2016).

WHO:

NIAID Director Anthony S. Fauci, M.D., is available to comment on the research. Mark Connors, M.D., chief of the HIV-Specific Immunity Section in NIAID’s Laboratory of Immunoregulation and the senior author of the paper, also is available.

The research team included scientists from NIAID’s Laboratory of Immunoregulation and Vaccine Research Center.

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.

Tenofovir Vaginal Ring Provides Protection Against HIV in Women

An intravaginal ring loaded with tenofovir disoproxil fumarate (TDF, Viread) provided mucosal tenofovir concentrations high enough to protect against ex vivo HIV challenge in a 14-day placebo-controlled trial that enrolled healthy women. Product-related adverse events were all grade 1.

TDF with or without emtricitabine has proved effective as oral pre-exposure prophylaxis (PrEP) in women and men. The high tissue and cell penetration of TDF and its long intracellular half-life make it a good candidate for intravaginal ring administration, which could promote better adherence than daily or as-needed oral or gel TDF. Also, TDF retains anti-HIV activity in the presence of seminal plasma. A TDF intravaginal ring completely protected macaques from 16 weeks of intravaginal simian SIV challenge.

U.S. academic researchers recruited 30 healthy, sexually abstinent women 18 to 45 years old and randomized them after cessation of menses in a 1:1 ratio to insert a polyurethane reservoir intravaginal ring bearing TDF or to insert a placebo ring. Participants gave blood and vaginal swab samples on study days one, three, seven and 14, and they removed rings on day 14. They provided additional samples two to four and seven days after ring removal. Researchers also collected an ectocervical biopsy on day 14 for pharmacokinetic analysis and rectal swabs on days seven and 14.

Age averaged about 29 years in study participants and body mass index about 25 kg/m2. One woman withdrew from the study. Rings remained in place for 14 days in all other women, all of whom reported it was very easy or somewhat easy to wear.

Researchers recorded 29 adverse events in 12 women randomized to the TDF ring and 14 adverse events in seven women randomized to placebo. Eight events judged to be product related occurred in six women randomized to TDF and in one randomized to placebo. All product-related events involved cervical or vaginal discharge and were grade 1. There were two nonproduct-related grade 2 adverse events and no grade 3 or 4 or serious adverse events.

The TDF ring provided high tenofovir disoproxil (TFV-DP) and tenofovir concentrations in cervicovaginal fluid (CVF) from the vagina, ectocervix and introitus within one day of insertion, and concentrations remained high through day 14. After ring removal, median initial tenofovir half-life in CVF from the vagina, ectocervix and introitus stood respectively at 14, 12 and 11 hours. Median tenofovir concentrations remained above 1000 ng/mL two to four days after ring removal, a finding suggesting that the ring could protect women who remove the device before sex.

Median tenofovir and TFV-DP concentrations in ectocervical biopsies collected on day 14 were respectively 5.4 ng/mg and 120 fmol/mg. Rectal tenofovir could be measured in five of five participants who agreed to anoscopy on day seven and in four of five on day 14. Median CVF vaginal-to-rectal fluid ratio was 104 on day seven and 240 on day 14.

An ex vivo model using T cells challenged with HIV-1 in the presence of CVF collected from the cervix indicated 29% median inhibitory activity at enrollment, 96% inhibitory activity on day seven and 94% inhibitory activity on day 14.

The researchers conclude that the TDF ring "is safe, well tolerated, and results in mucosal tenofovir concentrations that exceed those associated with HIV protection." On the basis of their results, the authors "anticipate that the ring will continue to deliver ~5-6 mg/day of TDF for 30-45 days and will result in very rapid steady state tissue TFV-DP concentrations that exceed those achieved following oral TDF PrEP in adherent women, but with significantly lower systemic concentrations, thus avoiding potential toxicities."

There goes Dr Orville Taylor again! .............. Increase In Gay Hatred? Get The Fact Out!

So Dr Orville Taylor decided to go to town via RJR’s radio talkshow Hotline which he hosts on a Monday and Tuesday following his article appearing in the Sunday Gleaner regarding the recently reported on study commissioned by JFLAG on Attitudes and Awareness on homosexuality. I had only commented on one such report as to the drip drop method of sharing the study when previous such studies were released in full via PDF for public review; such a method of release as done this time around only serves to raise the very cynicism and stigmatization that JFLAG et al are supposed to be counteracting, oh how the ammunition is so easily handed to the opposition. Other public commentators have said or asked where is the full study so as to compare it to the previous two and sometimes I wonder if the goodly folks at the J are really thinking and that their actions are closely scrutinized for any flaw.

Dr Taylor did not go down his regular route as he normally would by opposing the efficacy of reports of homophobia or the perception that lobbyists are lying by riding the wave of the Time Magazine article questioning whether Jamaica is the most homophobic place on earth; but instead he went after public displays of affection while pretending he is against violence towards LGBT people but declaring days later on Hotline if a man calls to him he would just say to him no but if he got physical then that would be another matter.

The feedback via text messaging and call in were clear as usual as such topics evokes far more attention and ratings than other subjects do.

Here is the article published on Sunday April 17, 2016 in the Gleaner, see what you make of it:

Increase In Gay Hatred? Get The Fact Out!

I don't like beef, chicken, goat and pork. Cheese and milk make my stomach sick. Eating hot dogs is nasty, and I would never put even a Vienna sausage in my mouth. And yes, seafood is a big source of protein for me, but swallowing slimy oysters is gross and no one can make me suck the conch from its shell.

So, what does that make me? And I make black jokes, and fun of Jamaicans, Chinese, Africans, Indians, women, men and almost anybody or anything on creation. Indeed, I even offered my blind friend Floyd Morris my car keys. And, of course, I make gay jokes, too.

True, it is a thin line between humour and humiliation, but I'm an equal-opportunity satirist. By the way, I tell the Ras to remove the cloth from his head and stop smoking that nasty-smelling bush weed. So what if smoking the 'ishen' is an integral part of the 'livity' (lifestyle) of Rastafarians? It is hazardous activity and carries a small but significant risk of mental illness and lung disease.

So tell me. Do I hate eaters of meat or the animals themselves? And am I Rastaphobic simply because I disapprove of a something that the Natty Man does?

Last week, one of my colleague reporters cited a study carried out by the reputed Don Anderson-led Market Research Services Ltd and published a story with the headline that began, 'Study says Jamaicans hate gays ... .' However, they can be converted. The major finding reported that since the last study done in 2011, there was a 50 per cent increase in 'hate or rejection' of gays in Jamaican and, therefore, that community should expect higher levels of intolerance in the near future.

This story was very disturbing because, growing up in Catholic schools and with a father who acted as a consultant to God, I was taught that one should never hate any other human. 'Hate', a verb, is 'to feel extreme enmity towards or to have a strong aversion to.' Christians take comfort in saying that they hate the sin but not the sinner.

SIMPLY DISINGENUOUS

Being repugned or repulsed by people of the same sex 'doing the nasty' cannot mean that one hates them. It is simply disingenuous to conflate dislike for homosexual activity with hatred of gays.

As a member of the Gleaner fraternity, I got a small glimpse of the survey and saw nothing to convince me that we 'hate' gays any more than we did. Some of the findings are not surprising. Around 90 per cent of Jamaicans believe that anal sex between a man and woman is wrong. Similar numbers report the view that homosexuality is a sin. It, therefore, is not unexpected that 75 per cent of us believe that homosexuality should be outlawed. However, it is significant that the same three-quarters of Jamrockers believe that two women to one man sexually is also wrong. So what do we call this nominal disapproval of multiple partners? 'Promiscuophobia?'

Let's be honest: Hatred and dislike are not the same. Hatred must be accompanied by a feeling that something material should be done to the persons. In law, that is called malice, even if without the 'cut eye'.

In fact, there might be more evidence that we are a much more tolerant society towards gays than is being portrayed. More than 60 per cent of Jamaicans do not make any effort to avoid gays; almost 60 per cent say they would not respond violently to being approached; 82 per cent do not tease or make fun of gays; around 80 per cent do not speak bad things about them; 93 per cent have never threatened to damage property of gays; and 86 per cent say they would never stop talking to our friends if they found out that they were gay.

SCIENTIFICALLY DISHONEST

By the way, Jamaican employers are even more tolerant, and 64 per cent of them indicate that they have in place anti-discrimination policies at the workplace. Indeed, how often do you hear that people are dismissed based on sexual orientation? For good measure, in more than 30 American states, one can legally fire workers for being gay. Surprised?

So, tell me where is the hatred? In social research, we recognise that flawed concepts and definitions give incorrect and spurious results. The survey includes the faulty Riddle Homophobia Scale, which equates rejection of homosexual relationships with hatred of them. This is academically and scientifically dishonest.

Regarding the buggery law, less than 40 per cent feel that it either should just remain, or they were unsure or had no opinion. It would have made much more sense if we knew what actual percentage opposed its repeal.

Seven years ago, when I completed a study and made recommendations to the Government regarding protection of Jamaican workers from discrimination based on HIV status, my position was that the emphasis should be on action and not attitude. Trying to 'normalise' anal sex, which is the most efficient means of transmitting HIV (which infects 33 per cent of gay men), is a waste of good resources. True, it got my colleague Brendan Bain fired, but fact is fact. More important is to prevent discriminatory acts.

Nevertheless, the buggery law is stupid and an ass. Two men can legally do all manner of sexual repugnance, including fellatio, as long as there is no penetration. However, if a freaky pastor decides to procure entry via the alternative route, he is guilty of a crime, although it is not a sin. And lesbians are scot-free under the sheets and the law.

By the way, another major finding is that most Jamaicans believe that gay people can be changed. In another article, I will address the 'born gay' argument, but let me ask my gay friends: When you proposition someone who has been straight all his/her life, aren't you also accepting that sexuality is changeable?

- Dr Orville Taylor, senior lecturer in sociology at the UWI and a radio talk-show host, is the author of 'Broken Promises, Hearts and Pockets'. Email feedback to columns@gleanerjm.com and tayloronblackline@hotmail.com.

ENDS

So much for changing hearts and minds with persons like Dr Taylor lecturing at one of our major Universities.

Sigh

previous related entries with Dr Taylor:

UWI Sociologist on Buggery And AIDS: A Lot Of Bull (GJW)

J-FLAGging A Dead Horse? (Gleaner article) 2013

Fish, Foul Swimmer And Scammers ...... 2012

Antibody Mediated Prevention Study ...........

source Gettyimages

AMP stands for Antibody Mediated Prevention. This is the idea of giving people antibodies to see if they will protect against HIV infection.

This study, also referred to as HVTN 704/HPTN 085, tests a new idea for HIV prevention. In traditional vaccine studies, we give people a vaccine and wait to see if their bodies will make antibodies against HIV in response. In this study, we’ll be skipping that step, and just giving people the antibodies directly. We will do this through an infusion, which some people know better as getting an IV or getting a drip. This is the first study testing whether this antibody can prevent HIV infections in people.
READY TO GET AMPED?

HVTN and HPTN Announce initiation of antibody mediated prevention (AMP) study
SEATTLE and DURHAM, N.C. - The HIV Vaccine Trials Network (HVTN) and the HIV Prevention Trials Network (HPTN) today announced the initiation of HVTN 704/HPTN 085, also known as Antibody Mediated Prevention (AMP), a Phase 2b clinical trial to evaluate the safety and efficacy of VRC01, a broadly neutralizing monoclonal antibody (bnAb). AMP is the first study to evaluate whether bnAbs are effective in reducing acquisition of HIV-1 infection among at risk populations.

"Injections or infusions of antibodies to prevent acquisition of an infectious disease have been utilized in medicine for decades," said Larry Corey, M.D., study chairperson for HVTN 704/HPTN 085 and principal investigator for the HVTN. "The remarkable advance in technologies to isolate and manufacture human monoclonal antibodies in concentrations high enough to potentially prevent HIV is a major advance and provides the underlying principle for our enthusiasm for these trials."

The clinical trial is a randomized, double-blind, placebo-controlled, multi-center, global effort conducted in the U.S., Brazil, and Peru and will enroll 2700 men or transgender persons (TG) who have sex with men or TG persons. Study participants will be randomized to receive VRC01 or placebo by intravenous (IV) infusion every eight weeks. Infusions will continue for 72 weeks for HIV-uninfected participants in all groups, with follow up for 20 additional weeks. A parallel study, HVTN 703/HPTN 081, will be initiated later this year in sub-Saharan Africa and will enroll 1500 sexually active women.

AMP is being sponsored and funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. The NIAID Vaccine Research Center discovered the VRC01 antibody and manufactured it for this trial.

"This study represents an important next step in developing agents that can prevent HIV infection by using bnAbs," said Myron Cohen, M.D., study chairperson for HVTN 704/HPTN 085 and principal investigator for the HPTN. "AMP will leverage the research expertise, resources and reach of two NIAID-funded HIV prevention trial networks, and underscores our commitment to innovation and identification of new interventions to prevent HIV transmission."

"New HIV infections have continued to increase in our most vulnerable populations in the United States including African American men who have sex with men," said Srilatha Edupuganti, M.D. M.P.H., co-chairperson of HVTN 704/HPTN 085 and associate professor of medicine, Emory University School of Medicine. "The use of bnAbs offers new hope to stem that tide as we have for other at-risk populations here and around the world."

###

About HVTN

The HIV Vaccine Trials Network (HVTN) is the largest worldwide clinical trials network dedicated to the development and testing of HIV/AIDS vaccines. The HVTN is an international collaboration that conducts all phases of clinical trials, from evaluating experimental vaccines for safety and the ability to stimulate immune responses, to testing vaccine efficacy. Support for the HVTN comes from the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health (NIH). The Network's HIV Vaccine Trial Units are located at leading research institutions in 27 cities on four continents. The Network's headquarters are at the Fred Hutchinson Cancer Research Center in Seattle, Washington. For more information, visit http://www.hvtn.org.

About HPTN

The HIV Prevention Trials Network (HPTN) is a worldwide collaborative clinical trials network that brings together investigators, ethicists, community and other partners to develop and test the safety and efficacy of interventions designed to prevent the acquisition and transmission of HIV. HPTN studies evaluate new HIV prevention interventions and strategies in populations and geographical regions that bear a disproportionate burden of infection. The HPTN research agenda is focused primarily on the use of integrated strategies: use of antiretroviral drugs (antiretroviral therapy and pre-exposure prophylaxis); interventions for substance abuse, particularly injection drug use; behavioral risk reduction interventions and structural interventions. For more information, visit http://www.hptn.org.

also see: Newly Discovered "Teenage" Antibody Could Mean Knocking Out HIV for Good

HOPE for the Vaginal Ring: Follow-Up Studies on New HIV-Prevention Method for Women Announced

More than 300 members of the Microbicide Trials Network (MTN) were gathered in a hotel conference room in Rockville, Maryland, earlier this month and, somewhat unexpectedly, the assembled scientists had something to celebrate. On March 13, four days after the National Institutes of Health (NIH) convened a stakeholder meeting of African women, researchers, advocates and statisticians, it announced that it would indeed fund follow-up studies to the ASPIRE dapivirine (TMC120) antiretroviral ring trial.

The results of ASPIRE and its sister trial, The Ring Study, were released during CROI 2016 at the end of February. Then, this month the NIH held its meeting. When Sharon Hillier, Ph.D., one of ASPIRE's principal investigators, announced the results to MTN staff, "people literally cheered -- they just stood up and cheered," she said.

That's because, after many attempts and several disappointing trial results, this was one of the few microbicide trials -- and one of the fewer designed specifically for women -- to move on to open-label extension trials and potentially lead to availability for those women who need HIV prevention most.

"Everyone is so anxious to take this next step, to see -- can we realize the promise we think we have [with the ring]? And can we build on this to do even better?" she said. "No one is happy with 27% [overall effectiveness rate]. And we think we can do better than 27%."

ASPIRE and HOPE

When ASPIRE's results came out at CROI 2016 last month for the dapivirine ring, the 27% reduction in HIV acquisition sounded modest to say the least.

But, when researchers parsed the data further, they discovered that efficacy went up with a woman's age. For women aged 21 and under, the ring provided no benefit. For women 21 to 25, effectiveness shot up to 56%. For women older than that, the rate was 61%.

That 61% was the foundation for moving forward with additional studies, said Anthony Fauci, M.D., director of the NIH's National Institute of Allergy and Infectious Disease.

"Everyone went in to the [NIH] meeting saying, 'We need to first examine the data -- is there really a pathway forward?'" he said. "It's clear there is, even though it's confusing when you look at the data. Twenty-seven percent is rather weak, but when you break it down by women older than 25 and women younger than 21, the 61 percent effectiveness is good enough to move forward. That's as good as circumcision in some respects."

Specifically, the NIH funded two follow up studies. One, ASPIRE's open-label extension trial, named HOPE, will seek to recreate the first study, but with some twists. Each of the 2,629 women in Malawi, South Africa, Zimbabwe and Uganda who participated in the original trial will be offered the dapivirine ring. The hope, said Fauci, is that if women know that they are getting a ring with active drug in it and that it's been proven to reduce HIV acquisition, then more women will use the ring, which may change overall protection rates. It's happened before.

However, the study will also tackle adherence another way: by asking the women to once again consent to the study, but this time also asking them candidly whether they're participating in the study because they really want to reduce their risk for HIV, or whether the study is the only way for them to get regular sexual and reproductive health care.

"By re-consenting them, we're saying, 'We get it,'" he said. "'So tell you what: Sign up for the study, but be honest, tell us if you have any intention or not of using the ring.' So then they'll be able to separate out the people who are really using it from those who aren't."

Study participants who say they don't intend to use the ring will still receive health care, but their intention not to adhere will be factored into results.

Then, the study will check in with participants every month for three months, changing out the ring and checking how much less dapivirine is in it after 30 days than when it was distributed -- a sign that participants have actually used it. The idea is to remove the incentive to lie to get health care and use drug levels to test for adherence.

Finally, the study will have a divided design: In those first three months, participants will come to the clinic every month to get a new ring. For the second three months, participants will be given a pack of three rings and be instructed to change the ring out themselves. Then, participants will be asked to bring back the rings, and total drug depletion will be measured.

"It's clever," Fauci said. "It will give [researchers] a chance to compare a clinical trial setting, where [women] are seen every month, versus a real-world setting, where we give them three rings. The bottom line is to figure out what role adherence plays in efficacy and what are the motives to participate."

Robust Discussion

Dazon Dixon Diallo, president and founder of SisterLove, Inc., and convener of the U.S. Women and PrEP (Pre-Exposure Prophylaxis) Working Group, was at the NIH meeting and described it as a robust discussion of both the science and women's reproductive health needs.

Unlike the VOICE trial, which was designed to test the ability of combination tenofovir/emtricitabine (Truvada) to prevent HIV in women, but was stopped early due to lack of adherence, there was no effort to blame participants for not using the drug. The question was, "How do we design these trials in a way that does not design it to fit the research, but is also meant to fit into women's lives?"

"It was not about blaming them," Dixon Diallo said. "It was really looking at the full implications of a large clinical trial like this, and how nimble can it be to really understand and shift as needed to make sure that the trial itself is fitting into women's lives in such a way that makes them want to be more adherent and to participate."

In particular, she pointed to the comment of one 18-year-old participant, who had asked the ages of the counselors who worked with women during the trials. The implication, said Dixon Diallo, was that mixing peer support and relatable staff could improve social connections and change how younger women, especially, perceive the trials.

For her part, Hillier said that the NIH's decision to fund the studies was not just a win for ASPIRE, but also for the technology in general, which will receive follow up separately in The Ring Study.

"With these two positive results in two separate studies, if [the NIH] didn't move forward, it was really closing the book on this kind of research," Hillier said. But now, she said, everyone on the team is excited about next steps. "We're feeling like we have a ton of work to do, but we're really excited we get to do it."

What a Young Woman Wants

When the NIH announced its funding of HOPE, it also announced funding for another trial, one meant to ask a different question: Why did the dapivirine ring show no effectiveness in women under 21, the group of women at highest risk for HIV?

It could be that younger women weren't using the ring. But it could also be that there's something biologically different about young women that makes the dapivirine ring ineffective. So MTN-035, also funded by the NIH this month, will seek to determine if it's preference or biology.

The 18-month study will be divided into three sections. For the first six months, women will get to choose either tenofovir/emtricitabine pills or the dapivirine ring for HIV protection. For the next six months, they will switch. Then, at the end of the year, they will be asked which method they prefer -- "or neither, obviously," Hillier added.

At the same time, when women attend their monthly clinic visits, researchers will take biological samples -- vaginal fluid samples, for instance, or swabs -- to study the immune cells in the vagina and other biomarkers of HIV risk. That data will be broken down further into very young women aged 16 to 17 and women 18 to 21, to assess whether biological markers and efficacy differ by prevention type.

"So we're trying to give women a sense of agency," said Hillier, "that they're going to be empowered to select what works for them."

Heather Boerner is a health care journalist based in San Francisco and author of Positively Negative: Love, Pregnancy and Science's Surprising Victory Over HIV.

New EU FRA report highlights crucial role public authorities for LGBT equality

In a new report launched in the European Parliament today, the EU’s Fundamental Rights Agency (FRA) highlights that prevailing negative attitudes towards LGBT people endanger their fundamental rights and hamper efforts to counter discrimination and hate crime.

The report analyses the views and attitudes of the ‘duty bearers’ towards LGBT persons in the field of law enforcement, education and healthcare.

Some of the key findings that emerged that can be found in the ‘Professionally speaking: challenges to achieving equality for LGBT people’ report include:
All professional groups have low levels of awareness and knowledge about LGBT needs, while social attitudes are often hostile towards LGBT people. This affect the actions of public officials and professionals.

There is a need for professional training to help counter prejudice in healthcare. Healthcare services to trans people are spread unevenly across the EU and there is a need to strengthen capacity and awareness of healthcare providers.
There is a lack of objective information on sexual orientation and gender identity inschools, which can result in bullying, and force LGBT youths to hide their sexual orientation or gender identity. Member States should work with education authorities and schools to formulate targeted campaigns to help make schools a safer and friendlier place for LGBT people.

Law enforcement personnel often lacks awareness about the discrimination LGBT people face and have insufficient knowledge of their vulnerability to hate crimes.
EU law and policy are seen as major drivers supporting national efforts to promote LGBT equality.

Reacting to the report, LGBTI Intergroup Vice Chair Fabio Massimo Castaldo MEP, said: “Why do some doctors still believe homosexuality is a disease? Why are schools too often still unsafe places for LGBTI people?”

“This report analyses very thoroughly the difficulties LGBT people may face when it comes to access to basic institutions in everyday life: education, healthcare and police. We need to work much harder to ensure that the rights to education, to healthcare and fair treatment is equally enjoyed by all.”

Sirpa Pietikäinen MEP, also Vice-Chair of the Intergroup on LGBTI Rights, added: “The results of this report are a good reminder that despite improvements in the legal situation, we are not there. Prejudice, discrimination and violence still hold back LGBTI people from accessing school, hospitals and the police.”

“I call on the EU and its Member States to take this report to the heart, and use it systematically to act on their duty to deliver high quality service to end discrimination and hate crime many LGBT people have faced.”

Read more
Read the report ‘Professionally speaking: challenges to achieving equality for LGBT people’

Read earlier posts on the Fundamental Rights Agency

Combination Inhibitor BMS-986197 Demonstrates Good Anti-HIV Activity in Early Study

A long-acting bioengineered "combinectin" molecule with a triple mechanism of action demonstrated potent antiviral activity and worked against HIV that developed resistance to any of the 3 separate mechanisms in a laboratory study, and lowered viral load in humanized mice, according to research presented at theConference on Retroviruses and Opportunistic Infections (CROI 2016)last month in Boston.

Modern antiretroviral therapy is highly safe and effective for most people with HIV, but there is still room for more convenient agents that could help improve adherence, as well as drugs for people with highly resistant virus.

BMS-986197 is an injectable biologic agent which investigators think could potentially be self-administered as a long-acting subcutaneous injection; combining different modes of action in a single agent could avoid the need for multiple injections.

Mark Krystal, formerly of Bristol-Myers Squibb and now at ViiV Healthcare, presented findings from early laboratory and animal studies of BMS-986197, which is part of the portfolio of Bristol-Myers Squibb's investigational HIV agents recently acquired by ViiV.

BMS-986197 is made up of adnectins, small proteins with modifiable binding loops resembling certain antibody regions. Researchers combined adnectins targeting the CD4 cell surface receptor and HIV's gp41 protein subunit, along with a peptide fusion inhibitor, to build a so-called combinectin inhibitor that uses independent mechanisms to interfere with 3 routes of HIV entry. Finally, this combinectin was attached to human serum albumin to improve its pharmacokinetics.

The anti-CD4 adnectin appears to allow HIV's gp120 envelope protein to bind to the receptor, but prevents conformational changes needed for binding to co-receptors (CCR5 or CXCR4). The second adnectin attacks the N17 sequence of the HIV gp41 envelope protein subunit. The fusion inhibitor component works similarly to enfuvirtide (T20 or Fuzeon).

The EC50, or 50% effective concentration, of the anti-CD4 adnectin, the anti-gp41 adnectin, and the fusion inhibitor peptide were 8.5, 5.4, and 0.4 nM (nanoMolar), respectively. Linking these 3 inhibitors into a single molecule led to synergistic effects greater than the sum of the parts. The optimal combination of the 2 adnectins increased potency by more than 100-fold, while adding the fusion inhibitor appeared to increase the barrier to resistance. The addition of human serum albumin decreased potency but made the combinectin last longer in the body.

In the laboratory BMS-986197 demonstrated antiviral activity against a wide range of clinical virus isolates of different subtypes obtained from people with HIV. It retained potency against viruses that were resistant to any 1 of the 3 separate entry inhibition mechanisms and it showed no loss of potency in human blood serum.

In bio-engineered mice with humanized immune systems BMS-986197 produced dose-dependent decreases in viral load, and at the highest dose most became undetectable. Cell receptors remained occupied and pharmacokinetics were consistent over 36 days. In cynomologous monkeys a subcutaneous injection had a half-life of 30 hours and the researchers projected a half-life in humans of about 40 hours -- potentially adequate for once-weekly dosing.

"BMS-986197 is a long-acting (projected weekly dose) biologic molecule containing 3 individual inhibitors of HIV-1 entry that can be dosed subcutaneously," the researchers concluded. "BMS-986197 is effective at lowering viral loads in a mouse model of infection."

3/14/16

Reference

M Krystal, DWensel, Y Sun, et al. HIV-1 Combinectin BMS-986197: A Long-Acting Inhibitor With Multiple Modes of Action. Conference on Retroviruses and Opportunistic Infections. Boston, February 22-25, 2016. Abstract 97.