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Author Topic: Weekly Pill - How Long?  (Read 1819 times)

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Offline Loa111

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Weekly Pill - How Long?
« on: February 25, 2019, 02:32:16 pm »
Perhaps our more scientific research understanding brethren can share some insight...

I'm wondering how many years it might be (if ever) for the weekly treatment pill to be released for use?

I was having a fantasy today of how amazing it would be just to have 2 bottles of pills for a full year! Looking at the 4 months of pill supplies crammed into the bottom of my already crammed wardrobe probably got me thinking of this!  :)

Offline Jim Allen

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Re: Weekly Pill - How Long?
« Reply #1 on: February 25, 2019, 03:15:47 pm »
If all goes well, and there is interest engough than  multiple years away at the very least.

I'll have a look at some specifics if you like after I get the kids to bed
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Offline Jim Allen

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Re: Weekly Pill - How Long?
« Reply #2 on: February 25, 2019, 09:05:39 pm »
I know there was the 2018 testing of a weekly delivery pill in pigs
https://www.nature.com/articles/s41467-017-02294-6

This was based on the 2016 development of the weekly pill delivery system, originally for malaria treatment adapted for HIV treatment. It got relatively a lot of media attention in 2016 & 2018

The next stage would realistically be non-human primate testing, if that works than perhaps a small safety study in humans and after that a stage 1 study in humans for treatment, than stage 2 & 3 and if all goes well and it get FDA approval to go to market its at least decade + away. That's presuming its commercially viable for anyone to produce

Next up would be MK-8591 https://forums.poz.com/index.php?topic=69260.msg
In 2018 the compound was tested in 12 HIV negative volunteers at daily dosage to investigate tissue absorption and in 8 primates (rhesus macaques) as PrEP Markowitz M et al. Low dose MK-8591

2019 publication
https://journals.lww.com/co-hivandaids/Abstract/2019/01000/Creating_demand_for_long_acting_formulations_for.4.aspx

Again sames as before really, the next stage would be non-human primates, combining the drug with an additional ART medication for HIV treatment, if that works than perhaps a stage 1 study in humans, than stage 2 & 3 . Than FDA approval and that's if its commercially viable for anyone to produce it.

So I personally believe, weekly pills are at least decade + away, that's if they ever do happen for HIV treatment. 

Jim
« Last Edit: February 25, 2019, 09:09:57 pm by JimDublin »
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Offline Loa111

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Re: Weekly Pill - How Long?
« Reply #3 on: February 26, 2019, 11:26:09 am »
Great info, Thanks Jim for checking it out for me.

Well, 10+ years (a maybe a tthat), lol well at least we might have something to look forward to in 2030!  ;)

Obviously meds are excellent today as it is. I do like to think that in decades to come, 20 years, maybe there will be a treatment that offers additional advantage or 30 years if I live that long, I'll be in my later 70s then, maybe there will be a new treatment that will get me another 30 years until I'm over 100.

Offline Jim Allen

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Re: Weekly Pill - How Long?
« Reply #4 on: February 26, 2019, 11:51:06 am »
"Live by taking this medication today and, when something better comes along you will take that instead, and so on ..."

That's near enough what My ID doctor says when asked about medication developments, or its what i can remember at least. 
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Offline virgo313

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Re: Weekly Pill - How Long?
« Reply #5 on: February 26, 2019, 01:09:13 pm »
I can only hope our government can buy better (newer) medication.... sigh
RVD Nov 2015. VL --> Log 5.32 HAART on 23/11/15
TDF+FTC+EFV / Chemo KS - 25/11/15 - 20/01/16.
CD4 - 4 (3/11/15) / VL - 225,000   ~ CD4 - 65 (7/03/16) / VL - UD
CD4 - 153 (8/09/16) / VL - UD (20) / CD4% -6%   ~   CD4 - 215 (11/03/17) / VL - No Result / CD4% -8%
CD4 - No Result (10/04/17) / VL - UD (20)   ~   CD4 - 455 (11/05/18) / VL - UD / CD4% -14%
CD4 + CD4% (18/10/18) - Dr not going to  do this anymore / VL - To test only yearly. This Sucks..!
CD4 - 472 (10/04/19) / VL - UD / CD4% - 42%

Offline Gladragsguy

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Re: Weekly Pill - How Long?
« Reply #6 on: February 27, 2019, 11:55:18 am »
As human trials take 10-12 years and they haven't even started yet, and there is not much incentive for the major drug companies to produce yearly rather than daily treatments...it will be quite a wait. But really millions of people take all manner of daily medication so its really not that bad. Dual and monotherapy seem to be the way forward. A drug to let people test negative for at least a short interval would be a real money maker...let me get right to work on that. VIRGO 313 where are you from?

Offline virgo313

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Re: Weekly Pill - How Long?
« Reply #7 on: February 27, 2019, 12:41:49 pm »
Hi Gladragsguy,

I am from Malaysia. Treatment is free. We only have these to select.  ;D

Single
(NRTI) - Abacavir ABC / Emtricitabine FTC / Lamivudine 3TC / Stavudine 3TC / Tenofovir disoproxil fumarate TDF / Zidovudine AZT or ZDV
(NNRTI) - Efavirenz EFV / Etravirine ETV / Nevirapine NVP / Rilpivirin RPV
(PI) - Atazanavir ATV / Darunavir DRV Lopinavir / ritonavir LPV/r Ritonavir RTV
(Integrase Inhibitors) - Raltegravir RAL / Dolutegravir DTG
(CCR5 Antagonist) - Maraviroc MVC
(Fusion Inhibitor) - Enfuvirtide T-20

Fixed Dose Combinations
Abacavir/Lamivudine (ABC/3TC) Kivexa
Abacavir/Lamivudine/Zidovudine (ABC/3TC/AZT) Trivizir
Lopinavir/Ritonavir (LPV/r) Kaletra
Tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) Truvada, Tenvir-Em
Zidovudine/Lamivudine (AZT/3TC) Combivir, Zovilam

Tks
RVD Nov 2015. VL --> Log 5.32 HAART on 23/11/15
TDF+FTC+EFV / Chemo KS - 25/11/15 - 20/01/16.
CD4 - 4 (3/11/15) / VL - 225,000   ~ CD4 - 65 (7/03/16) / VL - UD
CD4 - 153 (8/09/16) / VL - UD (20) / CD4% -6%   ~   CD4 - 215 (11/03/17) / VL - No Result / CD4% -8%
CD4 - No Result (10/04/17) / VL - UD (20)   ~   CD4 - 455 (11/05/18) / VL - UD / CD4% -14%
CD4 + CD4% (18/10/18) - Dr not going to  do this anymore / VL - To test only yearly. This Sucks..!
CD4 - 472 (10/04/19) / VL - UD / CD4% - 42%

Offline Loa111

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Re: Weekly Pill - How Long?
« Reply #8 on: February 27, 2019, 05:45:35 pm »
Dual and monotherapy seem to be the way forward.
 A drug to let people test negative for at least a short interval would be a real money maker...let me get right to work on thaT.

What’s Dual & Monotherapy?
Also what would a drug to allows us to test negative for a short period be used for?
Sounds intriguing!

Offline Jim Allen

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Re: Weekly Pill - How Long?
« Reply #9 on: February 27, 2019, 06:10:57 pm »
Quote
Also what would a drug to allows us to test negative for a short period be used for?

Job applications/visa requests ... Swingers party  ;D. Anyhow not that anything would be able to do this, certainly not in a pill form at least unless i am missing something.

https://forums.poz.com/index.php?topic=70708.msg

Quote
What’s Dual & Monotherapy?

Dual - A two-drug combination to suppress HIV instead of three

dolutegravir + rilpivirine (FDA Approves Juluca, the First Two-Drug HIV Regimen)
https://forums.poz.com/index.php?topic=68136.msg

dolutegravir + lamivudine
https://forums.poz.com/index.php?topic=69989.

Mono - A single drug combination to suppress HIV instead of three

http://www.aidsmap.com/Dolutegravir-monotherapy-fails-to-maintain-HIV-viral-suppression-but-dolutegravir-lamivudine-looks-good/page/3122291/

https://www.poz.com/article/treating-hiv-tivicay-alone-may-work-treated-early
« Last Edit: February 27, 2019, 06:17:25 pm by JimDublin »
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Offline JPM

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Re: Weekly Pill - How Long?
« Reply #10 on: February 28, 2019, 06:29:27 am »
Not a weekly pill, but a monthly injection is on the way, and it's due in the next year or two, rather than in a decade.

The only real downside is having to go see the doc every month and have an injection in the belly or butt, but the upside will be only 12 doses a year rather than 365!

https://www.pharmaceutical-technology.com/comment/viiv-secures-key-phase-iii-win-monthly-injectable-hiv-regimen/

Offline Jim Allen

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Re: Weekly Pill - How Long?
« Reply #11 on: February 28, 2019, 06:37:03 am »
Hiya JPM

Welcome to the forum, as you are a new member can you please open an introduction thread so you can introduce yourself, thanks  :)

You can do this in the  "I just tested positive" section if you are new to living with HIV or in "living with HIV" if you have been living with HIV for longer.

Introducing yourself can be daunting but perhaps you can answer some basics in your first thread like: How you are getting on? What treatment are you taking, how is that going? What your labs are like etc etc

Thank you.

On the weekly pills vs injection, there are a number of different views depending on the persons needs and access to care. We have a few threads on this topic. https://forums.poz.com/index.php?topic=70956.msg

Best, Jim
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Offline fabio

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Re: Weekly Pill - How Long?
« Reply #12 on: February 28, 2019, 07:23:09 am »
If that were to happen it would e.g. a dream come true.
When that happens and I have access to it,I will travel the world,maybe with a bike hehe :).

Offline Gladragsguy

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Re: Weekly Pill - How Long?
« Reply #13 on: February 28, 2019, 11:04:04 am »
'Also what would a drug to allows us to test negative for a short period be used for'

Lots of reasons and people would pretty much pay the moon for something that could remove the Scarlet H if even for a brief period of time.

As for the injectables I am not going to be first in line for that because the closest thing in pill form to the injectable now  would be JULUCA which is somewhere around US$2800 a month...CABOTEGRAVIR is something completely new so I wonder what the injections would cost? But would be nice if you win the lottery.

Offline Mightysure

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Re: Weekly Pill - How Long?
« Reply #14 on: February 28, 2019, 01:21:05 pm »
That's going to be interesting. They have to find a drug that, taken orally, will have an extremely long half life. I think it'll be more likely that an implant will be approved first, but after monthly or bimonthly injections get approved.

I don't know how that will go. Injection site pain is a common complaint, and I hope that that wont stop it from getting on the market.

Offline Loa111

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Re: Weekly Pill - How Long?
« Reply #15 on: March 04, 2019, 04:56:14 am »
Very interesting about Dual & Mono treatment.
So with me on Tivicay and Descovy I suppose that's a dual treatment?

My question is, as one progresses successfully with the treatment over the years remains UD supressed VL, would one eventually be switched to a Mono treatment regime?


Offline Jim Allen

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Re: Weekly Pill - How Long?
« Reply #16 on: March 04, 2019, 05:20:00 am »
Hiya

No, you are on standard triple ART (HAART)

Tivicay = Dolutegravir
Descovy  = emtricitabine + tenofovir alafenamide

So a 3 drug combo

Quote
My question is, as one progresses successfully with the treatment over the years remains UD supressed VL, would one eventually be switched to a Mono treatment regime?

No or at least not within the foreseeable future, there have been several recent Momo therapy studies in the past 2-3 years stopped due to too many people not controlling the VL and some gaining resistance to treatment. :'(

There is one study showing some promise but it's a very small sample size and limited to only those early dignoised and treated, I included it on the post earlier as 2nd ref.

Quote
Mono - A single drug combination to suppress HIV instead of three

http://www.aidsmap.com/Dolutegravir-monotherapy-fails-to-maintain-HIV-viral-suppression-but-dolutegravir-lamivudine-looks-good/page/3122291/

https://www.poz.com/article/treating-hiv-tivicay-alone-may-work-treated-early

Historical Mono therapy also failed long term for most, the late 80's was mono therapy until the triple ART aporoch was discovered to do the trick in the 94/95 era

Jim
« Last Edit: March 04, 2019, 05:22:05 am by JimDublin »
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Offline virgo313

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Re: Weekly Pill - How Long?
« Reply #17 on: March 04, 2019, 05:59:26 am »
Just curious why some call it "HAART" and some says "ART"? Thanks 
RVD Nov 2015. VL --> Log 5.32 HAART on 23/11/15
TDF+FTC+EFV / Chemo KS - 25/11/15 - 20/01/16.
CD4 - 4 (3/11/15) / VL - 225,000   ~ CD4 - 65 (7/03/16) / VL - UD
CD4 - 153 (8/09/16) / VL - UD (20) / CD4% -6%   ~   CD4 - 215 (11/03/17) / VL - No Result / CD4% -8%
CD4 - No Result (10/04/17) / VL - UD (20)   ~   CD4 - 455 (11/05/18) / VL - UD / CD4% -14%
CD4 + CD4% (18/10/18) - Dr not going to  do this anymore / VL - To test only yearly. This Sucks..!
CD4 - 472 (10/04/19) / VL - UD / CD4% - 42%

Offline Jim Allen

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Re: Weekly Pill - How Long?
« Reply #18 on: March 04, 2019, 07:15:21 am »
"ART" is antiretroviral

I always thought (not sure) "HAART" was used after 95 to indicate the usage of combined "ART's" as therapy/treatment .  "Highly active antiretroviral therapy"

Personally I tend to use both of them interchangeable, and that's most likely incorrect.  :-\ It was "HAART" when I started out so perhaps that's why it comes up when I am posting from time to time. 


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Offline leatherman

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Re: Weekly Pill - How Long?
« Reply #19 on: March 04, 2019, 07:23:04 am »
Just curious why some call it "HAART" and some says "ART"? Thanks
I'm guessing it's because a 25 yr old miracle just isn't exciting anymore. LOL

in 1995 we called it "highly active antiretroviral therapy" because it wasn't just one drug and it was new, exciting, and bringing people from near-death; and now, like everything else that gets shorthanded, we just call it "antiretroviral therapy" because it's the standard treatment upon HIV diagnosis.
leatherman (aka mIkIE)


chart from 1992-2017
Tivicay/Prezcobix

Offline virgo313

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Re: Weekly Pill - How Long?
« Reply #20 on: March 04, 2019, 08:10:57 am »
Ok, thanks everyone for the explanation.

I thought HAART is the newer ART because of the word “highly” meaning “more effective”. I was wrong.

Should just stick with the word ART because HAART can cause another “worrying point”. When I was at hospital, Dr says “we need to start you on HAART”. I pause for a while and with my eye wide open, I asked what is wrong with my HEART..  ;Du
RVD Nov 2015. VL --> Log 5.32 HAART on 23/11/15
TDF+FTC+EFV / Chemo KS - 25/11/15 - 20/01/16.
CD4 - 4 (3/11/15) / VL - 225,000   ~ CD4 - 65 (7/03/16) / VL - UD
CD4 - 153 (8/09/16) / VL - UD (20) / CD4% -6%   ~   CD4 - 215 (11/03/17) / VL - No Result / CD4% -8%
CD4 - No Result (10/04/17) / VL - UD (20)   ~   CD4 - 455 (11/05/18) / VL - UD / CD4% -14%
CD4 + CD4% (18/10/18) - Dr not going to  do this anymore / VL - To test only yearly. This Sucks..!
CD4 - 472 (10/04/19) / VL - UD / CD4% - 42%

Offline Jim Allen

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Re: Weekly Pill - How Long?
« Reply #21 on: March 04, 2019, 10:19:04 am »
Don't stress, terminology differences happen.  ;) 
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Offline leatherman

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Re: Weekly Pill - How Long?
« Reply #22 on: March 04, 2019, 12:27:56 pm »
Should just stick with the word ART because HAART can cause another “worrying point”. When I was at hospital, Dr says “we need to start you on HAART”. I pause for a while and with my eye wide open, I asked what is wrong with my HEART..  ;Du
this would be a good thing to mention to your doctor at some point. As both Jim and I pointed out these words have been interchangeable for close to 3 decades. For people who have been living with HIV for decades and doctors who have been treating HIV for decades, we have grown accustomed to the multitude of acronyms surrounding HIV (itself an acronym) and health care services. It's easy to spout out these letters without even remembering that some people in the audience don't know what they mean.

In most every (but not every) Ryan White quality management meeting I attend in North or South Carolina, the moderator usually remembers to say to the group that if you don't understand an acronym or something to speak up and ask. As just a Ryan White patient/advocate/consumer, I frequently have to ask the group (of doctors, case managers, ASO directors, nurses, and quality managers) what an acronym stands for. While they might understand the acronyms they work with daily in their job (MCM - medical case management; PE - Provide Enterprise software; HAB - HIV/AIDS Bureau; SCDHEC, NCDHHS, or whatever acronym is used for your state's health dpt) these acronyms (and all those related to HIV meds) are not something I use everyday.

Just comment to your doctor some time about how the word HAART worried you (especially while you were in the hospital! Been there, done that, and it's a confusing, scary situation to begin with) and that he should try to remember not to scare the newbies :) :D
leatherman (aka mIkIE)


chart from 1992-2017
Tivicay/Prezcobix

Offline virgo313

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Re: Weekly Pill - How Long?
« Reply #23 on: March 04, 2019, 02:24:15 pm »
Hi Mikie,
Yes & will bring it up to my Dr. Best will be email & bring this example to the HOD of the Infectious department so that he can hopefully can include this into hospital teaching guideline. Tks
RVD Nov 2015. VL --> Log 5.32 HAART on 23/11/15
TDF+FTC+EFV / Chemo KS - 25/11/15 - 20/01/16.
CD4 - 4 (3/11/15) / VL - 225,000   ~ CD4 - 65 (7/03/16) / VL - UD
CD4 - 153 (8/09/16) / VL - UD (20) / CD4% -6%   ~   CD4 - 215 (11/03/17) / VL - No Result / CD4% -8%
CD4 - No Result (10/04/17) / VL - UD (20)   ~   CD4 - 455 (11/05/18) / VL - UD / CD4% -14%
CD4 + CD4% (18/10/18) - Dr not going to  do this anymore / VL - To test only yearly. This Sucks..!
CD4 - 472 (10/04/19) / VL - UD / CD4% - 42%

Offline Grasshopper

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Re: Weekly Pill - How Long?
« Reply #24 on: March 06, 2019, 03:19:21 pm »
'Also what would a drug to allows us to test negative for a short period be used for'

Lots of reasons and people would pretty much pay the moon for something that could remove the Scarlet H if even for a brief period of time.



Dream on, you won't be able to achieve that with just a mere pill. It takes a stem cell transplantation to get there, like  Timothy Brown and recently the London patient:

"Antibodies against HIV decrease over time

Previously, we reported the loss of antibodies directed against the HIV polymerase as well as a decrease of HIV envelope and core-specific antibodies during the first 20 months after CCR5Δ32/Δ32 SCT.10 Immunoblot analysis revealed a continuing decline of HIV specific antibodies thereafter demonstrating the process of serodeconversion: whereas HIV core-directed antibodies (p17, p24) disappeared completely, the serum level of antibodies against the HIV envelope (gp41, gp120) further decreased. Today, the patient has only HIV envelope-specific antibodies."

http://www.bloodjournal.org/content/117/10/2791?sso-checked=true

Offline Gladragsguy

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Re: Weekly Pill - How Long?
« Reply #25 on: March 08, 2019, 10:41:30 am »
Yes always dreaming...10 years ago if you said there would be a 3 month injection in development they would have said the same thing.

Offline Grasshopper

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Re: Weekly Pill - How Long?
« Reply #26 on: March 08, 2019, 01:54:25 pm »
Glad that I only dream when I am asleep, and not when I am awake  :)

Offline Gladragsguy

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Re: Weekly Pill - How Long?
« Reply #27 on: March 09, 2019, 12:50:44 pm »
Those that change the world dream both day and night.

Offline Jim Allen

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Re: Weekly Pill - How Long?
« Reply #28 on: March 09, 2019, 01:29:11 pm »
"Vision without action" Perhaps its more vision without viable goal but before i knock it, i do suppose all dreams start like that.

Difference is the OP's question is regarding a possible commercially viable product being tested to treat a long-term manageable medical conditions, the idea (use) of longer lasting drugs be it injections or weekly pills etc etc, is not just limited to HIV.

The other just seems to be a dream to beat/mislead antibodies testing for whatever reason. I'm just not sure the two are going to have the same R&D focus or commercial value. Besides that if there was pill was invented / discovered to enable you to show negative on antibodies tests, than I am sure people, governments, organizations really seriously wanting to know peoples status would switch to other testing manners or find another way to test.

But nothing wrong with dreaming and hoping, for the things we would like in life.

We all dream for something, so ill dream that some R&D money stops going into futile "cures" and other dead end studies or dreams and instead it starts going towards free generic PrEP free globally to anyone at risk and, 100% global treatment of those living with HIV so the world together reaches the 90-90-90 goals and end this continuing miserable and still deadly epidemic.

Meaning in the long term, no need for anyone to dream of longer lasting HIV treatments or testing cheat drugs for that matter. ;)   

Jim
 
« Last Edit: March 09, 2019, 01:37:32 pm by JimDublin »
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Offline Jim Allen

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Re: Weekly Pill - How Long?
« Reply #29 on: March 09, 2019, 02:08:07 pm »
I apologize to both of you.

I'm frustrated with the money being spend on "water is wet" studies and novelty petri-dish treatments, however I should not have stuck my head in on this thread or taken it out here.

Sorry. Jim.
HIV 101 - Everything you need to know
HIV 101
Transmission and Risks:
HIV Transmission and Risks
Read more about Testing here:
HIV Testing
Read about Treatment-as-Prevention (TasP) here:
HIV TasP
You can read about HIV prevention here:
HIV prevention
Read about PEP and PrEP here
PEP and PrEP

 


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