International Study Finds Rectal Microbicide Gel Safe When Used Daily and With Sex

Participants as adherent to using gel with sex as taking a daily pill for HIV prevention

BOSTON, February 24, 2016 – A reduced glycerin formulation of tenofovir gel was found safe when used daily and around the time of sex, according to the first extended safety study of arectal microbicide for HIV prevention from anal sex. Presented today at the 23rd Conference on Retroviruses and Opportunistic Infections (CROI 2016), the study, led by the U.S. National Institutes of Health (NIH)-funded Microbicide Trials Network (MTN), also indicated that participants were as likely to follow through using the gel with sex as they were to using daily oral pre-exposure prophylaxis (PrEP) – a prevention strategy in which people who are HIV-uninfected take a daily pill to reduce their risk of infection.

The Phase II study, MTN-017, began in September 2013 and enrolled 195 men who have sex with men (MSM) and transgender women at sites in Peru, Thailand, South Africa and the United States, including Puerto Rico. MTN-017 participants –12 percent of whom were transgender women – cycled through three study regimens which each lasted eight weeks: reduced glycerin tenofovir gel used daily, reduced glycerin tenofovir gel used before and after anal sex, and daily use of the antiretroviral tablet Truvada® (emtricitabine/tenofovir disoproxil fumarate), developed by Gilead Sciences, Inc. This design allowed researchers to collect information about the gel’s safety and acceptability in the rectum, and compare it to the use of oral Truvada, which was approved for use as PrEP by the U.S. Food and Drug Administration in 2012.

Most side effects from study products in MTN-017 were minor, indicating the gel was safe, and there were no significant differences in adverse events among the gel regimens compared to oral Truvada. Overall, participants were highly adherent in MTN-017, with most following through in using their assigned products 80 percent of the time or more. Participants were similarly adherent to using gel before and after sex (93 percent) as they were to taking daily oral Truvada (94 percent). They were less adherent, however, when using the gel on a daily basis (83 percent). Adherence in MTN-017 was measured by a combination of responses to daily questions sent by text message, number of returned gel applicators and blood tests to confirm the presence or absence of drug.

When asked about preferences, participants reported they preferred oral Truvada to the gel, but found the before and after sex gel regimen as easy to use as oral Truvada. When asked about the likelihood that they would use the study products in the future, participants said that they would be as likely to use the gel before and after sex as they would to take oral Truvada. Forthcoming analyses from MTN-017 will shed light on how much drug was absorbed in the blood, rectal fluid and tissue, and assess whether use of the products caused changes in cells or tissue.

“The results from MTN-017 demonstrate there is a place for rectal microbicides used around the time of sex in future HIV prevention efforts,” said Ross D. Cranston, M.D., associate professor, University of Pittsburgh School of Medicine, who led the study with Javier R. Lama, M.D., M.P.H., investigator and director, HIV Prevention

Intervention Studies, IMPACTA PERU Clinical Trials Unit, Lima, Peru. “While we have more to learn from ongoing analyses of tissue and blood testing, the completion of this study was a significant undertaking and represents a major step forward in the development of a rectal microbicide for people at risk of HIV from anal sex.”

MTN-017 was a larger follow-up trial to a previous study, MTN-007, that found the reduced glycerin formulation of tenofovir gel was safe and acceptable to both men and women who used it in the rectum daily for a one-week period. The gel used in both studies was formulated with less glycerin to address gastrointestinal side effects experienced by some study participants who used an original vaginal formulation of tenofovir gel in an early study called RMP-02/MTN-006.

“The MTN-017 findings come at a pivotal time in the field of rectal microbicides, setting the stage for future studies and complementing ongoing research into new products and delivery methods,” said Ian McGowan, M.D., Ph.D., principal investigator of the MTN and professor of medicine, Division of Gastroenterology, Hepatology and Nutrition and Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh School of Medicine. “Research is already underway at MTN to expand the pipeline of rectal microbicide products in order to find the right product to move forward into an effectiveness study.”

Globally, racial and ethnic minorities, MSM and transgender women are disproportionately affected by HIV. Although most microbicide research has focused on products for vaginal use, the risk of becoming infected with HIV from unprotected anal sex may be 20 times greater than unprotected vaginal sex, in part because the rectal lining is only one-cell thick compared to the vagina’s multiple layers.

In addition to Drs. Cranston, Lama and McGowan, co-authors include Alex Carballo-Dieguez, Ph.D., Columbia University; Cindy Jacobson, Pharm.D., MTN; Sherri Johnson, FHI 360; Ratiya Kunjara Na Ayudhya, BSMT, MTN; Mark Marzinke, Ph.D., Johns Hopkins University; Jeanna Piper, M.D., Division of AIDS, National Institute of Allergy and Infectious Diseases (NIAID); and Barbra Richardson, Ph.D., University of Washington and Fred Hutchinson Cancer Research Center.

MTN-017 is funded by NIAID and the National Institute of Mental Health, both components of the NIH. Tenofovir gel was developed by Gilead Sciences, Inc., of Foster City, Calif., which assigned the rights for tenofovir gel to CONRAD, of Arlington, Va ., and the International Partnership for Microbicides of Silver Spring, Md., in December 2006. Clinical input and study supplies of reduced glycerin tenofovir gel were provided by CONRAD, with funding from USAID.

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More information and materials about MTN-017 and rectal microbicides are available athttp://www.mtnstopshiv.org/news/studies/mtn017.

About the Microbicide Trials Network

The Microbicide Trials Network (MTN) is an HIV/AIDS clinical trials network established in 2006 by the National Institute of Allergy and Infectious Diseases with co-funding from the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institute of Mental Health, all components of the U.S. National Institutes of Health. Based at Magee-Womens Research Institute and the University of Pittsburgh, the MTN brings together international investigators and community and industry partners whose work is focused on the development and rigorous evaluation of promising microbicides – products applied inside the vagina or rectum that are intended to prevent the sexual transmission of HIV – from the earliest phases of clinical study to large-scale trials that support potential licensure of these products for widespread use. More information about the MTN is available at www.mtnstopshiv.org.

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Lesbian fined for property damage of neighbour’s house despite lesbophobic provocation

In one of those cases that we could conclude justice was split in a sense a twenty seven year old woman of a Portmore address was fined some $63,000 in total at Spanish Town RM court last week for damage to a window after a stone throwing and a protracted spat with her neighbour who is said to be a church person. The incident had its genesis from 2014 when after a night of entertaining female friends the lesbian found herself the subject of taunts, one off comments even when none was solicited which grew over time to the September 2015 encounter with the woman who was singing a popular gospel song and interspersing her vocalizations with the chant of fire! The term of course suggests the hellfire and brimstone condemnation often used by Rastafarians and some Christians to condemn sinners especially homosexuals in the ever so visible religious homophobia.

The morning of the incident September 20, 2015 around 8am the lesbian had awakened and was about to throw away her garbage and other stuff from the lyme activity before when the homophobe made insulting remarks and proceeded to suggest she saw strange activity in her eyes of women supposedly kissing in the yard; bearing in mind this is private property and if any activity was on it was not her business and according to the lesbian one would have to outside near the fence or transfixed on her house from the angle the woman could see to actual witness any activity; which suggest deliberate prying by the mischief making neighbour.

The judge was also told this by the lesbian who in turn asked the woman whether she was prying on her alleged lesbian neighbour; she reportedly answered yes saying she had a right to stop evil and sinful behaviour. The judge reportedly intervened and told the woman she was wrong in as far as interference with a neighbour’s existence and peaceful, uninterrupted enjoyment of their property. The judge also continued that while the woman is entitled to her view she must temper those with live and let live as her current situation would not have occurred and a court case following.

The argument between the women continued for hours at a time on the same day until the lesbian lost her cool with the woman deliberately and persistently badgering her with taunts and slurs. The angered lesbian reacted and warned the woman to leave her alone to which the woman threatened to call the police and implied she would encourage them to treat the lesbian as a man since she wanted to become one. It was that comment that triggered the response from the lesbian and the stones flew (three of which) that broke the side window to her house which is the woman’s kitchen. The woman raised an alarm supposedly to have the other neighbours join her in her cause but surprisingly they were reticent and one even suggested she was an old trouble maker. The lesbian had only rented the house some eight months before so she was not aware of the history preceding her arrival. Some even suggested the lesbian was free to conduct her private business in her property she was paying rent for; a far cry from similar support being sought by other homophobes to support their hate.

The police were alerted and upon arrival asked the woman to go back to her property as she was in the yard of the lesbian making all kinds of unsubstantiated allegations; both women were asked to accompany the cops in separate vehicles to the Gregory Park precinct where a report was filed and some further interrogation. 

The cops were said to be fair for the most part and urged the women not to let it go further in terms of an encounter. The court date was made in January and the second hearing after estimates were presented and so on was where the fine was ordered by the judge with a warning to the lesbian to control her temper and patience as even though she was in the right she lost her high ground by snapping on the woman. The judge also told her she could have reported the annoyance to the cops as a matter of record as the stone throwing may have been treated differently as self defence in a sense.

The lesbian has reportedly said she is looking for somewhere else to rent so as to avoid the woman altogether. This is how it can be so easy from provocation that tempers can flare and unintended outcomes follow. The woman as far as I am concerned was fortunate as if it were some other women she may have had a far worse outcome as a four year old case came to mind where a lesbian actually drew her machete and warned her enemy in Kingston; the guilty party was eventually chopped and the lesbian ended up serving a short sentence for the injury.

John Public also needs to understand that LGBT people or at least not all of us are easy cherry pickings and are not prepared to put up with taunts, verbal assaults and abuse and are even prepared to go further if necessary either by deliberately responding or as in this case a snap loss of temper with a physical response.

Peace & tolerance

H

more on tolerant cops:

Gay man saved by cop (GJW)