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Author Topic: Complera (Btripla) Approved, One pill once per day is approved  (Read 5789 times)

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Offline DanMo

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  • Finally undetectable! ;D
Re: Complera (Btripla) Approved, One pill once per day is approved
« Reply #1 on: August 11, 2011, 07:12:10 PM »
http://www.aidsmeds.com/articles/hiv_complera_gilead_1667_20970.shtml

Right On

I know a guy that's been on "Btripla" in the research trials and says it's working really well for him. Glad to hear this news.
I tried to drown my sorrows, but the bastards learned how to swim, and now I am overwhelmed by this decent and good feeling. Frida Kahlo

11 Feb 2011 - Preliminary positive
07 Mar 11 - Inconclusive WB
14 Mar 11 - Diagnosed positive
05 Apr 11 - 355 (21%) / VL: 186,054
27 Apr 11 - 390 (20%) / VL: 285,095
06 Jun 11 - 298 (19%) / VL:  78,380
01 Aug 11 - > STARTED ATRIPLA <
30 Aug 11 - 699 (31%) / VL: 1,938
03 Nov 11 -                / VL: 645
27 Dec 11 - 559 (35%) / VL: 1,189
11 Jan 12 -                 / VL: <20
09 Apr 12 - 686 (40%) / VL: UD
11 Jul 12 - 793 (37%) / VL: 25

Offline Coolio_7

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  • Posts: 66
Re: Complera (Btripla) Approved, One pill once per day is approved
« Reply #2 on: August 11, 2011, 08:49:26 PM »
I'm excited about all the new one pill daily regimes that are coming out will continue to come out within the next couple years! Complera, the quad pill and a one pill combination of prezista, cobicistat, emtriva and the new investigational viread. That will be 4 once daily regimes within the next few years!! All involving Gilead in some way. That company will be racking in the money!!

I guess it will force other pharmaceutical companies to step up their game. Not that they don't have good drugs on the market, but to step up with combo pills comparable or with less side effects!

I'm just grateful for the medications that we have that can keep us alive and well until we see a successful therapeutic cure!

On another note! Dayum! Complera will be just as expensive as Atripla it seems. I read an article saying the cost would be around $1700 for a months supply!

Offline leatherman

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Re: Complera (Btripla) Approved, One pill once per day is approved
« Reply #3 on: August 11, 2011, 08:56:02 PM »
Complera will be just as expensive as Atripla it seems. I read an article saying the cost would be around $1700 for a months supply!
that's still cheaper than other options, like the Reyataz/Norvir/Truvada combo that I take that costs approx $2300 a month. Hopefully though, the competition between the two options (and the other up-n-coming combo pills) will cause both A and B Tripla to eventually fall in price.
leatherman (aka mIkIE)


chart from 1992-2013; updated 2/09/13  Reyataz/Norvir/Truvada

Offline mikeyb39

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Re: Complera (Btripla) Approved, One pill once per day is approved
« Reply #4 on: August 12, 2011, 03:43:08 AM »
i'm always happy to see the new drugs come out or new easier combination, but all these new drugs are for folks who are new to treatment.  What about the folks on the other end that have exhausted their options. I don't see much being down on that side of the spectrum.
« Last Edit: August 12, 2011, 03:44:42 AM by mikeyb39 »
11/02/2010  cd4-251, vl-591000
12/09/2010  started Atripla
02/18/2011  cd4-425, vl-800
06/10/2011  cd4-447, vl-70
10/10/2011  cd4-666, vl-80
01/05/2012  swiched med (prezista,norvir ,isentress, )
02/10/2012  cd4-733, vl-UD  Viread removed
06/10/2012  cd4-614, vl-UD
12/14/2012  cd4-764, vl-UD
09/01/2013  cd4-785, vl-UD
03/06/2014. cd4- 1078, VL-UD

Offline simpleguy

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  • Posts: 67
Re: Complera (Btripla) Approved, One pill once per day is approved
« Reply #5 on: August 12, 2011, 03:16:20 PM »
Just some useless quasi-ranting: The pill just got its name and various sources are already writing stuff like "commonly known as 'Btripla'" - funny how fast things become "commonly known." Besides, I don't see that logic in calling it Btripla, as it's called Complera it should logically be called Ctripla, right ;o)
2008 JUL: Sustiva OCT: Rayataz DEC: Kaletra 2009 Off meds 2011 Intelence 2012+ Complera

Offline surf18

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Re: Complera (Btripla) Approved, One pill once per day is approved
« Reply #6 on: August 12, 2011, 06:52:33 PM »
i dont know mike, this drug my dr was going to put me on and im into treatment for a year. he didnt seem to care if it was only approved for treatment naive.

Offline leatherman

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Re: Complera (Btripla) Approved, One pill once per day is approved
« Reply #7 on: August 12, 2011, 07:42:11 PM »
What about the folks on the other end that have exhausted their options. I don't see much being down on that side of the spectrum.
sometimes it depends on which options someone has exhausted. Some mutations actually make HIV less viable and unable to reproduce, so after an amount of time passes, the HIV cells with that specific mutation/resistance will be gone from your system and - poof! that resistance is no longer there. When someone has virological failure (current regimen is no longer suppressing the viral load)  geno- /pheno- type tests need to be used to re-determine the new current resistance profile rather than relying on what someone used to have resistance to.

Several of the resistance issues I had in the late 90s are gone now and I have been able to be switched to newer meds which, with less side effects and being more effective, have made me a lot healthy than I have been in a long time.

Of course, there are some who have exhausted too many options, and for them quite often adding another medication (upping a regimen to 4 or 5 meds) or using one of the newer inhibitors with their current regimen will do the trick.
leatherman (aka mIkIE)


chart from 1992-2013; updated 2/09/13  Reyataz/Norvir/Truvada

Offline austinguy

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Re: Complera (Btripla) Approved, One pill once per day is approved
« Reply #8 on: August 14, 2011, 08:44:12 PM »
I've been on a trial for this drug for 24 weeks. I am very pleased the with results. I was on Atripla before. Whether is is commonly referred to as Btripla or Ctripla this med is good stuff and I am thrilled that it has been approved. It is exciting to know there are now two one-a-day regimens.

Offline legolas613

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Re: Complera (Btripla) Approved, One pill once per day is approved
« Reply #9 on: August 14, 2011, 08:55:22 PM »
Complera -- approved only for the "treatment naive" only.

Why even bother specfying such a thing. The drugs are going to work the same on a treatment experienced individual w/o any NNRTI or Truvada resistance issues as it would in someone choosing it as their first regimen choice.

My doctor had no problem whatsoever allowing to select Intellence as part of my first regimen even though it's guidelines specifically state it is "not approved for the treatment naive". My Dr. is an HIV specialist who has been doing this since the late 80's and very knowledgeable. If I go to him at my next appointment next week and want to switch to Complera, I can gaurantee he would allow me to do so. He would jump at the chance to get me on a once a day pill regimen since he tried to talk me into starting with Atripla for that reason and when I didn't bite on that one he wanted to see me on Epzicom or Truvada and something else. I selected the meds I wanted liking the flexibility it offers me to break up dosages which I believe can only lessen severity of possible acute SE's associated with metabolizing the meds. If you had to take a martini, a bottle of beer and a long island ice tea (horrible combo but stay with me here, substitute alcohol for any HIV meds) in order to keep your VL undetectable; which way would probably make you feel worse/harder on your body? (a) all three at  the same time or (b) taking all 3 at different times in the day. At least that's just opinion and strictly a logical argument. Also I realize this combo has an excellent tolerability factor so my argument doesn't apply as strongly to Edurant in Complera as it would to any other "once a day meds" including keeping in mind Complera still contains truvada/viread which they're not as always as tolerable to everyone comparitively.

Great to get another, highly tolerable tool to help in the battle against HIV!
« Last Edit: August 14, 2011, 10:04:55 PM by legolas613 »
2009 Oct -- infected.
2009 Nov -- seroconverted.
2010 Feb -- tested HIV+. 
2010 Feb -- CD4=457,33% VL/WBC=3.8k/4.4
2010 Dec -- CD4=568,40% VL/WBC=3.6k/3.7
2011 Jan -- HLA B5071 test +; couldn't use Ziagen.
2011 Jan -- began Viread, Epivir and Intellence.
2011 May -- CD4=409,43% VL/WBC=UD/3.8
2011 Aug -- CD4=404,44% VL/WBC=8.8k/4.0
2011 Sept -- switched to Truvada & boosted Prezista. CD4 suppression, SE and adherance issues.
2011 Nov -- CD4=522,49% VL/WBC=2.3k/3.5
2012 Jan -- discontinued meds. SE and adherance issues, deciding on new regimen.
2012 Feb -- resistance testing revealed mutations: 3 NRTI (incl K65R), 4 NNRTI and 3 PI's.
2012 Apr -- CD4=599,41% VL/WBC=263/3.8
2012 May -- Shingles
2012 Oct -- CD4=493,36% VL/WBC=4.7k/4.4 (still my latest Dr. visit as of 2/01/2014)

Offline Miss Philicia

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Re: Complera (Btripla) Approved, One pill once per day is approved
« Reply #10 on: August 15, 2011, 11:10:14 AM »
When Isentress was first FDA approved four years ago it was only for treatment experienced patients. Same with Prezista. Obviously this changed over time, as will Complera. They run certain clinical trials first, then run others, or if they're running simultaneously they have different completion dates, etc.

It's always been like this -- it's not something new. If you're doctor prescribes it and it's not "technically" approved for a patient like you then the doctor is prescribing it "off label" which isn't uncommon if the doctor has a large patient load and is comfortable doing so. A doctor without a lot of HIV patients will generally stick to officially approved treatments.
« Last Edit: August 15, 2011, 11:12:14 AM by Miss Philicia »
"Ive slept with enough men to know that Im not gay"

Offline legolas613

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  • Posts: 20
Re: Complera (Btripla) Approved, One pill once per day is approved
« Reply #11 on: August 15, 2011, 07:51:06 PM »
Hi Miss Philicia, good to hear from you again.

The point I was ultimately trying to make was that the classification of for "treatment experienced" or "treatment naive" is really not relevant since meds still generally accomplish the goal of being UD regardless of the patients experience level with meds; only ones resistance issues &/or ability to not tolerate meds can cause issues with a regimens success. I understand it has always been like that (classifying HIV meds), but all I'm asking is that even necessary? To me the only justification to categorize who should get access to a drug should be for the drugs that are held in reserve for salvage treatments oonly or restrcting drugs deemed too difficult/not as tollerable (SE's) or easy to take (pill load) for the treatment naive since the first treatment regimen is usually rough for the first several months to get used to. Maybe they have some rationale behind these decisions, it would just be nice if they (FDA) would at least explain why it is only recomended for a certain group of patients.

Cheers ~ Gary

 
2009 Oct -- infected.
2009 Nov -- seroconverted.
2010 Feb -- tested HIV+. 
2010 Feb -- CD4=457,33% VL/WBC=3.8k/4.4
2010 Dec -- CD4=568,40% VL/WBC=3.6k/3.7
2011 Jan -- HLA B5071 test +; couldn't use Ziagen.
2011 Jan -- began Viread, Epivir and Intellence.
2011 May -- CD4=409,43% VL/WBC=UD/3.8
2011 Aug -- CD4=404,44% VL/WBC=8.8k/4.0
2011 Sept -- switched to Truvada & boosted Prezista. CD4 suppression, SE and adherance issues.
2011 Nov -- CD4=522,49% VL/WBC=2.3k/3.5
2012 Jan -- discontinued meds. SE and adherance issues, deciding on new regimen.
2012 Feb -- resistance testing revealed mutations: 3 NRTI (incl K65R), 4 NNRTI and 3 PI's.
2012 Apr -- CD4=599,41% VL/WBC=263/3.8
2012 May -- Shingles
2012 Oct -- CD4=493,36% VL/WBC=4.7k/4.4 (still my latest Dr. visit as of 2/01/2014)

Offline simpleguy

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Re: Complera (Btripla) Approved, One pill once per day is approved
« Reply #12 on: August 16, 2011, 04:04:27 AM »
According to Dr. Wohl @thebody.com, treatment nave or treatment experienced is a way of classifying pts. with our without resistance mutations.

What's the point of using terms like treatment experienced or nave? A nave patient could be infected with a virus from someone with resistance mutations. A friend of mine discussed the difference of being experienced or nave with his ID doc, saying that the only difference was whether a virus carried mutations or not, to which the doctor replied "no, it's not only that" but without specifying what else differentiated an experienced from a nave. Hmm...
2008 JUL: Sustiva OCT: Rayataz DEC: Kaletra 2009 Off meds 2011 Intelence 2012+ Complera

Offline legolas613

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  • Posts: 20
Re: Complera (Btripla) Approved, One pill once per day is approved
« Reply #13 on: August 16, 2011, 11:31:11 AM »
the classification of for "treatment experienced" or "treatment naive" is really not relevant since meds still generally accomplish the goal of being UD regardless of the patients experience level with meds; only ones resistance issues &/or ability to not tolerate meds can cause issues with a regimens success. 

Resistance is an issue for all with HIV. My Dr. Says it is rare for the people in my area to have a new HIV infection with resistance, most new infections are wild type virus. He told me when we were starting the meds that if I had resistance issues to any of my meds they would show up with the inability to control the VL but says it is rare in this area to inherit resistance so he generally doesn't do resistant testing for treatment naive patients.

treatment nave or treatment experienced is a way of classifying pts. with our without resistance mutations. What's the point of using terms like treatment experienced or nave? A nave patient could be infected with a virus from someone with resistance mutations.

Again resistance can be an issue as you already explained for those who haven't even started treatment but it can also be a non issue for someone on a stable drug regimen that is working for them for many years  that they would not have any resistance issues. To work under the assumption that someone has resistant mutations only because they are treatment experienced is absolutely misguided in my opinion.

Simpleguy -- you are the first person I've seen in these forums taking my regimen.  That is so cool, take care.

Cheers ~ Gary
 
2009 Oct -- infected.
2009 Nov -- seroconverted.
2010 Feb -- tested HIV+. 
2010 Feb -- CD4=457,33% VL/WBC=3.8k/4.4
2010 Dec -- CD4=568,40% VL/WBC=3.6k/3.7
2011 Jan -- HLA B5071 test +; couldn't use Ziagen.
2011 Jan -- began Viread, Epivir and Intellence.
2011 May -- CD4=409,43% VL/WBC=UD/3.8
2011 Aug -- CD4=404,44% VL/WBC=8.8k/4.0
2011 Sept -- switched to Truvada & boosted Prezista. CD4 suppression, SE and adherance issues.
2011 Nov -- CD4=522,49% VL/WBC=2.3k/3.5
2012 Jan -- discontinued meds. SE and adherance issues, deciding on new regimen.
2012 Feb -- resistance testing revealed mutations: 3 NRTI (incl K65R), 4 NNRTI and 3 PI's.
2012 Apr -- CD4=599,41% VL/WBC=263/3.8
2012 May -- Shingles
2012 Oct -- CD4=493,36% VL/WBC=4.7k/4.4 (still my latest Dr. visit as of 2/01/2014)

Offline mikeyb39

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  • Posts: 921
Re: Complera (Btripla) Approved, One pill once per day is approved
« Reply #14 on: August 17, 2011, 09:59:27 AM »
I feel that i have some time of super virus when i was infected, I always did an HIV test twice a year, once with my physical and once at the local HIV clinic, when i seroconverted and was sick as a dog, my initial CD4 was at 251 and VL was off the charts, I had just tested negative about 7 to 8 months previously. 

My resistance test came back ok for all meds with a few minor mutations here and  there, but I always wondered how my CD4 went so fast, but again we never check to see what they were previously, which is what my doctor tells me, maybe i just had a low percentage previously. 
11/02/2010  cd4-251, vl-591000
12/09/2010  started Atripla
02/18/2011  cd4-425, vl-800
06/10/2011  cd4-447, vl-70
10/10/2011  cd4-666, vl-80
01/05/2012  swiched med (prezista,norvir ,isentress, )
02/10/2012  cd4-733, vl-UD  Viread removed
06/10/2012  cd4-614, vl-UD
12/14/2012  cd4-764, vl-UD
09/01/2013  cd4-785, vl-UD
03/06/2014. cd4- 1078, VL-UD

Offline Miss Philicia

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  • celebrity poster, faker & poser
Re: Complera (Btripla) Approved, One pill once per day is approved
« Reply #15 on: August 17, 2011, 12:06:42 PM »
source

Edurant And Complera Are Classified As Alternative, Not Preferred, HIV Regimens

The Department of Health and Human Services (HHS) updated antiretroviral treatment guidelines to state that Edurant, which is also a component of Complera, is considered an alternative, but not preferred, antiretroviral for people starting HIV treatment for the first time.

Sustiva (efavirenz), which is in the same antiretroviral class as Edurant (rilpivirine) and an ingredient in Atripla (efavirenz/emtricitabine/tenofovir), is still considered the preferred treatment.

Edurant is a non-nucleoside reverse transcriptase inhibitor (NNRTI) marketed by Tibotec Pharmaceuticals, a subsidiary of Johnson & Johnson. Edurant was approved by the U.S. Food and Drug Administration (FDA) in May.

In addition, Edurant is a component of the once-daily combination pill Complera (rilpivirine/emtricitabine/tenofovir), which was approved by the FDA last week. Complera, which is marketed by Gilead Sciences, is intended as an alternative to Atripla, which is currently the most commonly prescribed first-line regimen for HIV.

Edurant and Complera were approved based on clinical trials showing that they are as effective as Sustiva and Atripla in people who have not previously been treated for HIV. However, the FDA noted at the time that the drugs were not as effective in people starting treatment with viral loads (amount of HIV in the blood) higher than 100,000 copies per milliliter.

In addition, patients taking Edurant or Complera who failed therapy were more likely to show drug resistance than patients taking Sustiva or Atripla.

As a result, HHS has decided to list Edurant as an alternative NNRTI for people starting treatment for the first time, while keeping Sustiva as the preferred NNRTI. The recommendation also affects Complera, which contains Edurant.

HHS defines an alternative regimen as one that is safe and effective but may have disadvantages compared to preferred regimens. Alternative antiretrovirals may be preferred for some individuals due to side effects, allergic reactions, drug resistance, or other factors.

HHS also noted that there is insufficient information on the safety and efficacy of Edurant and Complera in pregnant HIV-positive women. Edurant and Complera are not recommended for children under 18 because appropriate dosages have not yet been determined for this age group.

In addition, HHS warned against use of Edurant and Complera in combination with stomach acid reducers.  Specifically, the antiretrovirals should not be used with proton pump inhibitors, such as omeprazole (Prilosec) and Nexium (esomeprazole), and should be used with caution with antacids and H2 receptor antagonists, such as cimetidine (Tagamet) or famotidine (Pepcid).
"Ive slept with enough men to know that Im not gay"

Offline Ann

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    • Num is sum qui mentiar tibi?
Re: Complera (Btripla) Approved, One pill once per day is approved
« Reply #16 on: August 17, 2011, 12:09:47 PM »
I feel that i have some time of super virus when i was infected, I always did an HIV test twice a year, once with my physical and once at the local HIV clinic, when i seroconverted and was sick as a dog, my initial CD4 was at 251 and VL was off the charts, I had just tested negative about 7 to 8 months previously. 

Mike, it's not unusual for a newly infected person to have low CD4s and a high VL - it's not necessarily an unusually strong strain of hiv. Generally, the CD4s will go back up on their own and the VL will come down, even without meds. It just takes time for the body to adjust and get things under a semblance of control. Your robust response to Atripla is also typical of starting meds very early on in infection and if you had some sort of super strong virus, you wouldn't have had such a good response.
Condoms are a girl's best friend

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"...health will finally be seen not as a blessing to be wished for, but as a human right to be fought for." Kofi Annan

Nymphomaniac: a woman as obsessed with sex as an average man. Mignon McLaughlin

HIV is certainly character-building. It's made me see all of the shallow things we cling to, like ego and vanity. Of course, I'd rather have a few more T-cells and a little less character. Randy Shilts

Offline legolas613

  • Member
  • Posts: 20
Re: Complera (Btripla) Approved, One pill once per day is approved
« Reply #17 on: August 18, 2011, 12:01:48 AM »
Thanks for posting the info Miss Philicia! You're awesome.  ;)
2009 Oct -- infected.
2009 Nov -- seroconverted.
2010 Feb -- tested HIV+. 
2010 Feb -- CD4=457,33% VL/WBC=3.8k/4.4
2010 Dec -- CD4=568,40% VL/WBC=3.6k/3.7
2011 Jan -- HLA B5071 test +; couldn't use Ziagen.
2011 Jan -- began Viread, Epivir and Intellence.
2011 May -- CD4=409,43% VL/WBC=UD/3.8
2011 Aug -- CD4=404,44% VL/WBC=8.8k/4.0
2011 Sept -- switched to Truvada & boosted Prezista. CD4 suppression, SE and adherance issues.
2011 Nov -- CD4=522,49% VL/WBC=2.3k/3.5
2012 Jan -- discontinued meds. SE and adherance issues, deciding on new regimen.
2012 Feb -- resistance testing revealed mutations: 3 NRTI (incl K65R), 4 NNRTI and 3 PI's.
2012 Apr -- CD4=599,41% VL/WBC=263/3.8
2012 May -- Shingles
2012 Oct -- CD4=493,36% VL/WBC=4.7k/4.4 (still my latest Dr. visit as of 2/01/2014)

Offline Ostrowsky86

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  • Posts: 10
Re: Complera (Btripla) Approved, One pill once per day is approved
« Reply #18 on: September 28, 2011, 08:48:10 AM »
Hi Austinguy!  I am pretty new to the forum and have just be reading but not writing.  I joined the study for Complera 2 months ago (before it was approved for sale) and although it has now been approved, the trial I am on will continue for two years so they can still collect data on the all in one pill.  I think from reading your posts you did the trial of the individual components of Complera, correct?  Anyhow, within the first month I was undetectable and my CD4 is about 500.  I get my results for this month soon and hope to still be undetectable.  I was wondering if you could discuss what side effects you experienced?  I am not sure if the side effects I have would be considered minimal and I should just accept them or if they are abnormal.  The side effects I have are not debilitating in any way but they are annoying to say the least and I am hoping they go away after awhile.  Since starting the Complera, I have had headaches which come and go.  I have fatigue most of the day even if I got a good nights sleep.  As far as sleeping goes, I probably sleep well 5 out of 7 nights and then have a few random nights of insomnia or sometimes just have an ill feeling and wake up in the middle of the night restless.  Overall, most days I do not feel  like myself with varying degrees of just an overall ickyness for lack of a better way to describe it.  I had none of these symptoms before starting on Complera.  Now all of that said, my numbers are great and the side effects are bearable but I thought after two months these side effects would subside.  I am bummed that they have not really gotten less bothersome by now.  Will I ever feel like myself again?  I am otherwise healthy and in good shape.  What were your experiences with side effects or do you know anyone who has had similar experiences?  Thanks!
05/16/2011 - Confirmed HIV positive
05/23/2011 - VL 34,000 T-Cell 462 (23.1%)
06/13/2011 - VL 34,500, T-Cell 268  (23.7%)
07/18/2011 - VL 21,000 T-Cell 398
07/18/2011 - Started Complera
08/15/2011-  VL <50 T-Cell 475 (30.5%)
09/12/2011-  VL <50 T-Cell 543 (31.7%)
10/07/2011-  VL <50 T-Cell 584 (33.8%)
11/07/2011-  VL <50 T-Cell 625 (34.3%)

Offline Ostrowsky86

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Re: Complera (Btripla) Approved, One pill once per day is approved
« Reply #19 on: September 30, 2011, 09:59:20 PM »
 ;D ;D ;D

Got my new numbers today. 3 months on complera!  09/12/2011-  VL <50 T-Cell 543 (31.7%)
Hope everyone has a great weekend!
05/16/2011 - Confirmed HIV positive
05/23/2011 - VL 34,000 T-Cell 462 (23.1%)
06/13/2011 - VL 34,500, T-Cell 268  (23.7%)
07/18/2011 - VL 21,000 T-Cell 398
07/18/2011 - Started Complera
08/15/2011-  VL <50 T-Cell 475 (30.5%)
09/12/2011-  VL <50 T-Cell 543 (31.7%)
10/07/2011-  VL <50 T-Cell 584 (33.8%)
11/07/2011-  VL <50 T-Cell 625 (34.3%)

 


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