Friday, February 17, 2017
at 12:31 PM
from CROI 2017
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.
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.
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.
Podcasts You may have missed or want to re-listen
A look at the fear of the feminine (Effemophobia) by Jamaican standards & how it drives the homo-negative perceptions/homophobia in Jamaican culture/national psyche.
After catching midway a radio discussion on the subject of Jamaica being labelled as homophobic I did a quick look at the long held belief in Jamaica by anti gay advocates, sections of media and homophobes that several murders of alleged gay victims are in fact 'crimes of passion' or have jealousy as their motives but it is not as simple or generalized as that.
Listen without prejudice to this and other podcasts on one of my Soundcloud channels
Heteronormative Role Play, Power Differentials & Intimate Partner Violence in LGBT Groups 07.11.15 by Djhowiejam on Mixcloud
Aphrodite’s PRIDE JA tackles gender identity, transgender misconceptions .....
Nationwide New Network, NNN devoted some forty five minutes of prime time yesterday evening to discuss the issue and help listeners to at least begin to process some of the information coming from the most public declaration exercise as done by Jenner. Guests on the show were Dr Karen Carpenter Board Certified Clinical Sexologist and Psychologist, ‘Satiba’ from Aphrodite’s P.R.I.D.E Jamaica of which I am affiliated and Lecturer (Sociologist) and host of Every Woman on the station Georgette Crawford Williams (sister of PNP member of parliament Damian Crawford); one of the first questions thrown at Satiba by host Cliff Hughes was why has Jenna waited so long at 65 years old to make such a life changing decision?
Satiba responded that many transwomen have to hide their true identity in life .... given her life when she was younger she was a star athlete she would have been under tremendous precious to stay in from the expectations by the public and her team etc, also owing to the fact that she had a family as a man with children one may not want to upset the flow at that time until the kids are old enough. There is a lot of burden of guilt that some persons carry in weighing the decisions of coming out or transitioning so suppression of one’s true self is the modus operandi.
Dr Carpenter cautioned after a heated exchange:
“We really must remember as professionals we must stay in our lane I will never pronounce as a Sociologist cause I am not a Sociologist ............When we have an opportunity to speak publicly we must be careful of what we say unless it is extremely well informed......”
Aphrodite's P.R.I.D.E Jamaica, APJ launched their website
Aphrodite's P.R.I.D.E Jamaica, APJ launched their website on December 1 2015 on World AIDS Day where they hosted a docu-film and after discussions on the film Human Vol 1
audience members interacting during a break in the event
film in progress
visit the new APJ website HERE
See posts on APJ's work: HERE (newer entries will appear first so scroll to see older ones)
Dr Shelly Ann Weeks on Homophobia - What are we afraid of?
Former host of Dr Sexy Live on Nationwide radio and Sexologist tackles in a simplistic but to the point style homophobia and asks the poignant question of the age, What really are we as a nation afraid of?
It seems like homosexuality is on everyone's tongue. From articles in the newspapers to countless news stories and commentaries, it seems like everyone is talking about the gays. Since Jamaica identifies as a Christian nation, the obvious thought about homosexuality is that it is wrong but only male homosexuality seems to influence the more passionate responses. It seems we are more open to accepting lesbianism but gay men are greeted with much disapproval.
Dancehall has certainly been very clear where it stands when it comes to this issue with various songs voicing clear condemnation of this lifestyle. Currently, quite a few artistes are facing continuous protests because of their anti-gay lyrics. Even the law makers are involved in the gayness as there have been several calls for the repeal of the buggery law. Recently Parliament announced plans to review the Sexual Offences Act which, I am sure, will no doubt address homosexuality.
Jamaica has been described as a homophobic nation. The question I want to ask is: What are we afraid of? There are usually many reasons why homosexuality is such a pain in the a@. Here are some of the more popular arguments MORE HERE
Dr Shelly Ann Weeks on Gender Identity & Sexual Orientation
Sexuality - What is yours?
Promised conscience vote was a fluke from the PNP ........
SO WE WERE DUPED EH? - the suggestion of a conscience vote on the buggery law as espoused by Prime Minister (then opposition leader) in the 2011 leadership debate preceding the last national elections was a dangling carrot for a dumb donkey to follow.
Many advocates and individuals interpreted Mrs Simpson Miller's pronouncements as a promise or a commitment to repeal or at least look at the archaic buggery law but I and a few others who spoke openly dismissed it all from day one as nothing more than hot air especially soon after in February member of parliament Damian Crawford poured cold water on the suggestion/promise and said it was not a priority as that time. and who seems to always open his mouth these days and revealing his thoughts that sometimes go against the administration's path.
I knew from then that as existed before even under the previous PM P. J. Patterson (often thought to be gay by the public) also danced around the issue as this could mean votes and loss of political power. Mrs Simpson Miller in the meantime was awarded a political consultants' democracy medal as their conference concludes in Antigua.
War of words between pro & anti gay activists on HIV matters .......... what hypocrisy is this?
War of words between pro & anti gay activists on HIV matters .......... what hypocrisy is this?
A war of words has ensued between gay lawyer (AIDSFREEWORLD) Maurice Tomlinson and anti gay activist Dr Wayne West (supposed in-laws of sorts) as both accuse each other of lying or being dishonest, when deception has been neatly employed every now and again by all concerned, here is the post from Dr West's blog
This is laughable to me in a sense as both gentleman have broken the ethical lines of advocacy respectively repeatedly especially on HIV/AIDS and on legal matters concerning LGBTQ issues
The evidence is overwhelming readers/listeners, you decide.
Fast forward 2015 and the exchanges continue in a post from Dr Wayne West: Maurice Tomlinson misrepresents my position on his face book page and Blog 76Crimes
Tomlinson's post originally was:
Urgent Need to discuss sex & sexuality II
Following a cowardly decision by the Minister(try) of Education to withdraw an all important Health Family Life, HFLE Manual on sex and sexuality
I examine the possible reasons why we have the homo-negative challenges on the backdrop of a missing multi-generational understanding of sexuality and the focus on sexual reproductive activity in the curriculum.
Calls for Tourism Boycotts are Nonsensical at This Time
(2014 protests New York)
Calling for boycotts by overseas based Jamaican advocates who for the most part are not in touch with our present realities in a real way and do not understand the implications of such calls can only seek to make matters worse than assisting in the struggle, we must learn from, the present economic climate of austerity & tense calm makes it even more sensible that persons be cautious, will these groups assist when there is fallout?, previous experiences from such calls made in 2008 and 2009 and the near diplomatic nightmare that missed us; especially owing to the fact that many of the victims used in the public advocacy of violence were not actual homophobic cases which just makes the ethics of advocacy far less credible than it ought to be.
See more explained HERE from a previous post following the Queen Ifrica matter and how it was mishandled
Newstalk 93FM's Issues On Fire: Polygamy Should Be Legalized In Jamaica 08.04.14
debate by hosts and UWI students on the weekly program Issues on Fire on legalizing polygamy with Jamaica's multiple partner cultural norms this debate is timely.
Also with recent public discourse on polyamorous relationships, threesomes (FAME FM Uncensored) and on social.
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Violence & venom force gay Jamaicans to hide
a 2009 Word focus report where the history of the major explosion of homeless MSM occurred and references to the party DVD that was leaked to the bootleg market which exposed many unsuspecting patrons to the public (3:59), also the caustic remarks made by former member of Parliament in the then JLP administration.
The agencies at the time were also highlighted and the homo negative and homophobic violence met by ordinary Jamaican same gender loving men.
The late founder of the CVC, former ED of JASL and JFLAG Dr. Robert Carr was also interviewed.
At 4:42 that MSM was still homeless to 2012 but has managed to eek out a living but being ever so cautious as his face is recognizable from the exposed party DVD, he has been slowly making his way to recovery despite the very slow pace.
Thanks for your Donations
Thank you for your donations via Paypal in helping to keep this blog going, my limited frontline community work, temporary shelter assistance at my home and related costs. Please continue to support me and my allies in this venture that has now become a full time activity. When I first started blogging in late 2007 it was just as a pass time to highlight GLBTQ issues in Jamaica under then JFLAG's blogspot page but now clearly there is a need for more forumatic activity which I want to continue to play my part while raising more real life issues pertinent to us.
Donations presently are accepted via Paypal where buttons are placed at points on this blog(immediately below, GLBTQJA (Blogspot), GLBTQJA (Wordpress) and the Gay Jamaica Watch's blog as well. If you wish to send donations otherwise please contact: email@example.com or firstname.lastname@example.org
Activities & Plans: ongoing and future
- Work with other Non Governmental organizations old and new towards similar focus and objectives
- To find common ground on issues affecting GLBTQ and straight friendly persons in Jamaica towards tolerance and harmony
- Exposing homophobic activities and suggesting corrective solutions
- Continuing discussion on issues affecting GLBTQ people in Jamaica and elsewhere
- Welcoming, examining and implementing suggestions and ideas from you the viewing public
- Present issues on HIV/AIDS related matters in a timely and accurate manner
- Assist where possible victims of homophobic violence and abuse financially, temporary shelter(my home) and otherwise
- Track human rights issues in general with a view to support for ALL
Thanks again for your support.
Information & Disclaimer
Individuals who are mentioned or whose photographs appear on this site are not necessarily Homosexual, HIV positive or have AIDS.
This blog contains pictures that may be disturbing. We have taken the liberty to present these images as evidence of the numerous accounts of homophobic violence meted out to alleged gays in Jamaica.
Faces and names withheld for the victims' protection.
This blog not only watches and covers LGBTQ issues in Jamaica and elsewhere but also general human rights and current affairs where applicable.
This blog contains HIV prevention messages that may not be appropriate for all audiences.
If you are not seeking such information or may be offended by such materials, please view labels, post list or exit.
Since HIV infection is spread primarily through sexual practices or by sharing needles, prevention messages and programs may address these topics.
This blog is not designed to provide medical care, if you are ill, please seek medical advice from a licensed practitioner
Thanks so much for your kind donations and thoughts.
As for some posts, they contain enclosure links to articles, blogs and or sites for your perusal, use the snapshot feature to preview by pointing the cursor at the item(s) of interest. Such item(s) have a small white dialogue box icon appearing to their top right hand side.
Recent Homophobic Cases
Peace to you and be safe out there.
What to do if you are attacked (News You Can Use)
First, be calm: Do not panic; it may be very difficult to maintain composure if attacked but this is important.
Try to reason with the attacker: Establish communication with the person. This takes a lot of courage. However, a conversation may change the intention of an attacker.
Do not try anything foolish: If you know outmaneuvering the attacker is impossible, do not try it.
Do not appear to be afraid: Look the attacker in the eye and demonstrate that you are not fearful.
This may have a psychological effect on the individual.
The police 119
Crime Stop 311
Steps to Take When Contronted or Arrested by Police
a) Ask to see a lawyer or Duty Council
b) Only give name and address and no other information until a lawyer is present to assist
c) Try to be polite even if the scenario is tensed) Don’t do anything to aggravate the situation
e) Every complaint lodged at a police station should be filed and a receipt produced, this is not a legal requirement but an administrative one for the police to track reports
f) Never sign to a statement other than the one produced by you in the presence of the officer(s)
g) Try to capture a recording of the exchange or incident or call someone so they can hear what occurs, place on speed dial important numbers or text someone as soon as possible
h) File a civil suit if you feel your rights have been violated. When making a statement to the police have all or most of the facts and details together for e.g. "a car" vs. "the car" represents two different descriptions
j) Avoid having the police writing the statement on your behalf except incases of injuries, make sure what you want to say is recorded carefully, ask for a copy if it means that you have to return for it
What to do
a. Make a phone call: to a lawyer or relative or anyone
b. Ask to see a lawyer immediately: if you don’t have the money ask for a Duty Council
c. A Duty Council is a lawyer provided by the state
d. Talk to a lawyer before you talk to the police
e. Tell your lawyer if anyone hits you and identify who did so by name and number
f. Give no explanations excuses or stories: you can make your defense later in court based on what you and your lawyer decided
g. Ask the sub officer in charge of the station to grant bail once you are charged with an offence
h. Ask to be taken before a justice of The Peace immediately if the sub officer refuses you bail
i. Demand to be brought before a Resident Magistrate and have your lawyer ask the judge for bail
j. Ask that any property taken from you be listed and sealed in your presence
Cases of Assault:An assault is an apprehension that someone is about to hit you
The following may apply:
1) Call 119 or go to the station or the police arrives depending on the severity of the injuries
2) The report must be about the incident as it happened, once the report is admitted as evidence it becomes the basis for the trial
3) Critical evidence must be gathered as to the injuries received which may include a Doctor’s report of the injuries.
4) The description must be clearly stated; describing injuries directly and identifying them clearly, show the doctor the injuries clearly upon the visit it must be able to stand up under cross examination in court.
5) Misguided evidence threatens the credibility of the witness during a trial; avoid the questioning of the witnesses credibility, the tribunal of fact must be able to rely on the witness’s word in presenting evidence
6) The court is guided by credible evidence on which it will make it’s finding of facts
7) Bolster the credibility of a case by a report from an independent disinterested party.
Sexual Health / STDs News From Medical News Today
VACANT AT LAST! SHOEMAKERGULLY: DISPLACED MSM/TRANS PERSONS WERE IS CLEARED DECEMBER 2014
CVM TV carried a raid and subsequent temporary blockade exercise of the Shoemaker Gully in the New Kingston district as the authorities respond to the bad eggs in the group of homeless/displaced or idling MSM/Trans persons who loiter there for years.
Question is what will happen to the population now as they struggle for a roof over their heads and food etc. The Superintendent who proposed a shelter idea (that seemingly has been ignored by JFLAG et al) was the one who led the raid/eviction.
the CVM NEWS Story HERE on the eviction/raid taken by the police
also see a flashback to some of the troubling issues with the populations and the descending relationships between JASL, JFLAG and the displaced/homeless GBT youth in New Kingston: Rowdy Gays Strike - J-FLAG Abandons Raucous Homosexuals Misbehaving In New Kingston
also see all the posts in chronological order by date from Gay Jamaica Watch HERE and GLBTQ Jamaica HERE
GLBTQJA (Blogger): HERE
see previous entries on LGBT Homelessness from the Wordpress Blog HERE
May 22, 2015 update, see: MP Seeks Solutions For Homeless Gay Youth In New Kingston
THE BEST OF & Recommended Audioposts/Podcasts
THE BEST OF & Recommended Audioposts/Podcasts
Other sides to the msm homeless saga (2012)
Rowdy Gays Matter 21.08.11 more HERE
Ethical Professionlism & LGBT Advocates 01.02.12 more HERE
Portia Simpson Miller - SIMPSON MILLER DEFENDS GAY COMMENT 23.12.11
2 SGL Women lost, corrective rape and virtual silence from the male dominated advocacy structure
Al Miller on UK Aid & The Abnormality of Homosexuality 19.11.11
Homosexuality is Not Illegal in Jamaica .... Buggery is despite the persons gender 12.11.11 MORE HERE
MSM Homelessness 2011 ...my two cents
Black Friday for Gays in Jamaica More HERE
Bi-phobia by default from supposed LGBT advocate structures?
Homeless MSMs Saga Timeline 28.08.11 (HOT!!!) see more HERE
A Response to Al Miller's Abnormality of Homosexuality statement 19.11.11
UK/commonwealth Aid Matter & The New Developments, no aid cuts but redirecting, ethical problems on our part - 22.11.11
Homophobic Killings versus Non Homophobic Killings 12.07.12
Big Lies, Crisis Archiving & More MSM Homlessness Issues 12.07.12
More MSM Challenges July 2012 more sounds HERE
GLBTQ Jamaica 2011 Summary 02.01.12 more HERE
Homosexuality Destroying the Family? .............. I Think Not!
Lesbian issues left out of the Jamaican advocacy thrust until now?
Club Heavens The Rebirth 12.02.12 and more HERE
Should gov't provide shelter for homeless msm?
National attitudes to gays survey shows 78% of J'cans say NO to buggery repeal
1st Anniversary of Homeless MSM civil disobedience (Aug 23/4) 2012 more HERE
JFLAG's rejection of rowdy homeless msms & the Sept 21st standoff .........
Atheism & Secularism may cloud the struggle for lgbt rights in Jamaica more HERE
Urgent Need to discuss sex & sexuality II and more HERE
MSM Community Displacement Concerns October 2012
The UTECH abuse & related issues
Beenieman's hypocrisy & his fake apology in his own words and more HERE
Guarded about JFLAG's Homeless shelter
Homophobia & homelessness matters for November 2012 ................
Cabinet delays buggery review, says it's not a priority & more ...........................(November 2012) prior to the announcement of the review in parliament in June 2013 More sounds HERE
"Dutty Mind" used in Patois Bible to describe homosexuals
Homeless impatient with agencies over slow progress for promised shelter 2012 More HERE
George Davis Live - Dr Wayne West & Carole Narcisse on JCHS' illogical fear
Homeless MSM Issues in New Kgn Jan 2013 .......
Homeless MSM challenges in Jamaica February 2013 more HERE
JFLAG Excludes Homeless MSM from IDAHOT Symposium on Homelessness 2013
Poor leadership & dithering are reasons for JFLAG & Jamaica AIDS Support’s temporary homelessness May 2013 more HERE
Response To Flagging a Dead Horse Free Speech & Gay Rights 10.06.13