Gay Lesbian Bisexual Transgender & Queer Jamaica: New single-tablet HIV treatment Genvoya wins FDA approval

The US Food and Drug Administration have approved a new single tablet as a complete treatment for the treatment of HIV-1 infection in people aged 12 years and over.

The new single-tablet HIV drug contains a new form of the powerful HIV inhibitor tenofovir.

The new treatment, called Genvoya, from Gilead Sciences, is a fixed-dose combination of elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide.

It is intended for patients aged 12 and over, weighing at least 35 kg (77 lbs) and who have never been treated forHIV before, or for infected adults whose HIV is currently suppressed.

The drug was tested against other HIV treatments approved by the Food and Drug Administration (FDA) in four clinical trials involving a total of 3,171 participants. Results showed that it reduced viral loads and was comparable to other treatments.

Genvoya contains a new version of tenofovir - a powerful HIV inhibitor - that has not been approved before. Gilead say that because the new version (called TAF) enters cells - including HIV-infected cells - more efficiently than the previous version (TDF), it can be given at a lower dose that results in 91% less tenofovir in the bloodstream.

The new drug was developed to reduce side effects, and the trial results show it appears to be associated with less kidney toxicity and reductions in bone density than previously approved drugs containing tenofovir.
Suitable for patients with moderate kidney impairment

The FDA note that while Genvoya is not recommended for patients with severe kidney impairment, those with moderate impairment can take Genvoya.

However, the US regulator also comments that "patients receiving Genvoya experienced greater increases in serum lipids (total cholesterol and low-density lipoprotein) than patients receiving other treatment regimens in the studies."

The drug's Boxed Warning says it can cause lactic acid to build up in the blood and lead to severe liver problems, both of which can be fatal.

The most common side effect is nausea, and serious side effects include new or worsening kidney problems, reduced bone mineral density, fat redistribution and changes in the immune system.

The warning also says Genvoya should not be given with other antiretroviral drugs and may interact with a number of commonly used medications.

Dr. Edward Cox, director of antimicrobial products in the Center for Drug Evaluation and Research at the FDA, said on Thursday:

"Today's approval of a fixed-dose combination containing a new form of tenofovir provides another effective, once daily complete regimen for patients with HIV-1 infection."

Estimates suggest around 1.2 million Americans aged 13 and over know they have HIV, and more than 150,000 others are infected but do not know it. In the last 10 years, the annual number of new HIV infections has remained relatively stable.

HIV-1 is the predominant strain of HIV that causes the vast majority of HIV infections worldwide. When people refer to HIV, they usually mean HIV-1.

Earlier this year, Medical News Today reported on a study that suggests drugs already being tested for the treatment of cancer could reawaken dormant HIV in cells of patients treated with antiretroviral drugs to allow complete eradication of the virus.

Written by Catharine Paddock PhD

ENDS

Video from Loop: VIDEO: Homeless gay men, rejected by their families, beg for place to live

With images such as that one above of one of our homeless MSM and the obvious emaciated state more evidence of the lack of interest in addressing homelessness and HIV/AIDS. I am reminded of when friends, colleagues and party patrons at my parties I DJ or promote used to drop like flies in the early nineties; when one would wonder who will be off the scene this month or week or if someone is missing the guess would be they are in the hospital; then when one actually finds them they are mere skin and bones. Sigh

We are told repeatedly of promises to deal with it or flimsy excuses that a space cannot be found etc, see:

Homeless Awareness Month: Flashback to New Kingston's Displaced MSM 2013

MSM/Trans homeless - From gully to graveyard Oct 2015

MSM Trans homeless - From gully to graveyard 04.10.15. by Djhowiejam on Mixcloud

Homeless Awareness Month 2015 ..... Recap & Concerns 07.11.15 by Djhowiejam on Mixcloud

Homeless Awareness Month 2015: Displaced MSM/Trans versus Cruisers

The Quietus ......... The Safe House Project Closes

And we continue to reap the world-wind for not addressing homelessness when it was manageable 2013

Reported homophobic cases: January - October 2015

Where is that "I am Not a Fish" documentary?

MSM/Trans homeless - From gully to graveyard

Complaint of "Freaky Gays" Harassing New Kingston Residents 2011

And The Machinery ...... The murder of Charms 2011

Hypocrisy from the pulpit on homeless MSM in Jamaica? yet the populations continue to languish while the priveleged religious and LGBT simply move on. Remember also that JASL received a major donation for such work,