FDA advisory committee recommends Descovy for PrEP

[SubHornyBottom]

But not for women ? Could the government agency be laser targetting gay men so that we can all get HIV and die off ? I am really worried. Why do they approve Descovy for PrEP only for gay men but not women !!! Do they only want heterosexual cisgender women to live ??? !!! 

[Guest]

I've been in this study for the past 2.5 years.  There were 5,000 men who have sex with men in the study around the world (just 30 in Atlanta).  The clinical phase of the trial ended last month (50/50 chance I was on Descovy or the placebo - truvada).  Descovy is equally effective but fewer side effects for kidney issues and long term bone density issues.  The study continues while they keep monitoring side effects, but EVERYONE still in the study is now definitely taking Descovy.  I was told at my visit in August it would probably be approved by the end of Sept.  It won't necessarily become the "default" Prep drug due to insurance company formularies (pricing), but it will probably become an alternative for guys that couldn't take Truvada. 

It's only approved for men because that's all that was included in the study group.  I had to answer a lot of screening questions before being "accepted" for the study group.  The screening basically wanted to make sure I barebacked enough to be a worthy test subject and high risk enough.   I kept getting stds in the ass before the study even started, so the PA who I always met "recommended" me to apply to be in the study.  Every visit they ask (on an ipad) how many times have you topped and bottomed unprotected and how many partners since the prior visit.  I kept a log book the first 6 months or so, which was kinda hot to look back at each 3 months, but that's not the point

The study was just men with men because that's who was in the study (they sought out high risk test subjects).  I told the Dr in charge that I bareback all the time (before I even took the questionnaire).  He said "good, that's what they want".  If I used condoms or didn't have enough partners I would not have been accepted.  They will study women in a different study.   I learned a lot about these trials.  Every single drug out there has to get tested for quite a while.  I'd jump at the chance to do another one.  At this point in life I honestly wouldn't be "bugged" if I ended up poz ( not sure how I made it this far still neg anyway), so I'm kind of the ideal candidate to be a guinea PIG

 

[SubHornyBottom]

36 minutes ago, justsexnowatl said:

I've been in this study for the past 2.5 years.  There were 5,000 men who have sex with men in the study around the world (just 30 in Atlanta).  The clinical phase of the trial ended last month (50/50 chance I was on Descovy or the placebo - truvada).  Descovy is equally effective but fewer side effects for kidney issues and long term bone density issues.  The study continues while they keep monitoring side effects, but EVERYONE still in the study is now definitely taking Descovy.  I was told at my visit in August it would probably be approved by the end of Sept.  It won't necessarily become the "default" Prep drug due to insurance company formularies (pricing), but it will probably become an alternative for guys that couldn't take Truvada. 

It's only approved for men because that's all that was included in the study group.  I had to answer a lot of screening questions before being "accepted" for the study group.  The screening basically wanted to make sure I barebacked enough to be a worthy test subject and high risk enough.   I kept getting stds in the ass before the study even started, so the PA who I always met "recommended" me to apply to be in the study.  Every visit they ask (on an ipad) how many times have you topped and bottomed unprotected and how many partners since the prior visit.  I kept a log book the first 6 months or so, which was kinda hot to look back at each 3 months, but that's not the point

The study was just men with men because that's who was in the study (they sought out high risk test subjects).  I told the Dr in charge that I bareback all the time (before I even took the questionnaire).  He said "good, that's what they want".  If I used condoms or didn't have enough partners I would not have been accepted.  They will study women in a different study.   I learned a lot about these trials.  Every single drug out there has to get tested for quite a while.  I'd jump at the chance to do another one.  At this point in life I honestly wouldn't be "bugged" if I ended up poz ( not sure how I made it this far still neg anyway), so I'm kind of the ideal candidate to be a guinea PIG

 

I guess that's good ? I really do want to see more information. Particularly about how long it takes for Descovy to be effective. Descovy and Truvada's PK data is very different...So...

[Guest]

I was having kidney issues due to truvada and I switched over to Descovy in August. So far so good! 

[viking8x6]

3 hours ago, SubHornyBottom said:

But not for women ?

I think this is likely because there's not much testing data on women and it looks like the FDA is in the midst of trying to reconfigure their process for recommendations about pregnancy. Here's what the drug labeling says:

Quote

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

 

[SubHornyBottom]

9 minutes ago, Passalaque said:

I was having kidney issues due to truvada and I switched over to Descovy in August. So far so good! 

Oh wow, nice...May I ask did the doctor give any advice on how many days to take it to be effective before barebacking