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Author Topic: TAG/i-Base pipeline report for HIV, hepatitis C and TB  (Read 3199 times)

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Offline newt

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  • the one and original newt
TAG/i-Base pipeline report for HIV, hepatitis C and TB
« on: July 21, 2012, 02:27:32 PM »
The annual state-of-the-art review of HIV, hepatitis C and TB diagnostics and treatment, including for children, is now released:

Details on the i-Base homepage:

http://i-base.info/ (UK)

Treatment Action Group homepage (US):

http://www.treatmentactiongroup.org/

Or here, along with archived reports from 2011-2003:

http://www.pipelinereport.org/

Headlines:

– Recent advances in biomedical HIV, hepatitis C, and TB prevention and treatment are not reaching those who need them most

– Political leaders continue to break domestic and global health commitments

On HIV, the new drugs coming forward look disgustingly good overall. The financing is getting tighter, including in developed countries:

"...within a couple of years, there might be half a dozen single-pill, once-daily, fixed-dose combinations (FDCs). For a doctor to be able to say, “Which one of these six pills would you like to take each day?” is a significant achievement for anyone who remembers the complexities of early HAART..."

"...the second strand of development, progressing just as insistently, is the funding pressure on health services, especially in countries where they are based on public health..."

Happy nerdy reading.

- matt
"The object is to be a well patient, not a good patient"

Offline Common_ground

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Re: TAG/i-Base pipeline report for HIV, hepatitis C and TB
« Reply #1 on: July 21, 2012, 03:38:49 PM »
Newt, looking at meds in the pipeline described in the report, what combo/med do you find most interesting?


Dolutegravir seems to be given in 50 mg doses and the new Tenofovir 25mg(!), suddenly my 600mg Sustiva feels very outdated...

Quad not to make first line with Dolutegravir being approved?
« Last Edit: July 21, 2012, 03:40:57 PM by Common_ground »
2011 May - Neg.
2012 June CD4:205, 16% VL:2676 Start Truvada/Stocrin
2012 July  CD4:234, 18% VL:88
2012 Sep  CD4:238, 17% VL:UD
2013 Feb  CD4:257, 24% VL:UD -viramune/truvada
2013 May CD4:276, 26% VL:UD

Offline buginme2

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Re: TAG/i-Base pipeline report for HIV, hepatitis C and TB
« Reply #2 on: July 21, 2012, 04:20:05 PM »
looking at meds in the pipeline described in the report, what combo/med do you find most interesting?



I like:
1.  Dolutegravir.   Seems to be a good option for people with resistance issues.
2.  GS-7340.   Better penetration at a lower dose (maybe less likely to cause kidney and bone issues?)
3.  Cenicriviroc.  CCR5 and CCR2 inhibitor that inhibits HIV and reduced inflamation.

Those are my choices for "best in development" what are your choices?
"All I need are some tasty waves, a cool buzz, and I'm fine."

http://www.youtube.com/watch?v=6e0gcEC1TWE

Offline Common_ground

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Re: TAG/i-Base pipeline report for HIV, hepatitis C and TB
« Reply #3 on: July 21, 2012, 05:14:11 PM »
I would go with pretty much the same.

Seems like once-a-day is in the making with Dolutegravir, the combo would be:
Dolutegravir,Abacavir and 3tc in one pill. Very promising! First grabs!

Quad2 is the only combo I would consider a real competitor. For those of you who dont bother reading the report, the difference Quad - Quad2 is the tenofovir, Quad2 contains a new formula of the tenofovir called GS-7340.

Tenofovir I hope is a drug which we wont use in 2-3 years due to the possible effects on kidney and bones.
2011 May - Neg.
2012 June CD4:205, 16% VL:2676 Start Truvada/Stocrin
2012 July  CD4:234, 18% VL:88
2012 Sep  CD4:238, 17% VL:UD
2013 Feb  CD4:257, 24% VL:UD -viramune/truvada
2013 May CD4:276, 26% VL:UD

Offline surf18

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Re: TAG/i-Base pipeline report for HIV, hepatitis C and TB
« Reply #4 on: July 21, 2012, 06:12:31 PM »
Quad one is supposed to be out later this summer right? When is quad 2 scd. to come out?Thanks

Offline Common_ground

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Re: TAG/i-Base pipeline report for HIV, hepatitis C and TB
« Reply #5 on: July 21, 2012, 06:34:34 PM »
Quad will hopefully be approved by FDA August 22, so probably available shortly after.

Since the new GS-7340 is already in phase III its highly likely it will be sent for FDA approval maybe already next year(maybe even later this year). My guess is that once its approved Giled, the producer of Quad, will simply update the formula and incorporate it in the original Quad. If this becomes reality, Quad will , just like analysts anticipates, dominate the ARV market for the forseeable future. Atripla will be considered what we now think of AZT and ddl.

2011 May - Neg.
2012 June CD4:205, 16% VL:2676 Start Truvada/Stocrin
2012 July  CD4:234, 18% VL:88
2012 Sep  CD4:238, 17% VL:UD
2013 Feb  CD4:257, 24% VL:UD -viramune/truvada
2013 May CD4:276, 26% VL:UD

Offline newt

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  • the one and original newt
Re: TAG/i-Base pipeline report for HIV, hepatitis C and TB
« Reply #6 on: July 21, 2012, 06:58:33 PM »
Dolutegravir, it's a small pill, low amount of drugs to be effective and cheap to make. Let's see if it passes muster in Phase III tests.

- matt
"The object is to be a well patient, not a good patient"

Offline newt

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  • the one and original newt
Re: TAG/i-Base pipeline report for HIV, hepatitis C and TB
« Reply #7 on: July 21, 2012, 06:59:30 PM »
And GS-7340 the tenofovir pro-drug.

- matt
"The object is to be a well patient, not a good patient"

Offline Jmarksto

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Re: TAG/i-Base pipeline report for HIV, hepatitis C and TB
« Reply #8 on: July 21, 2012, 07:35:10 PM »
Newt;  Thanks for posting - I wasn't aware of these reports, they do all of my obsessive/compulsive web searching for me.

On a more serious note - I haven't started meds yet and don't see my doc until Sept. He gave me three options for meds, Atripla, Complera, and Truvada + Isent.  He did make a comment that I could wait for the new med coming out.  As I have researched these, I have been concerned about the phycological side effects of Atripla (nightmares, depression, etc.) and to some degree Complera (which I think has some of the same).  Any thoughts on waiting for the Quad?

Thanks,
JM
03/15/12 Negative
06/15/12 Positive
07/11/12 CD4 790          VL 4,000
08/06/12 CD4 816/38%   VL 49,300
08/20/12 Started Complera
11/06/12 CD4   819/41% VL 38
02/11/13 CD4   935/41% VL UD
06/06/13 CD4   816/41% VL UD
10/28/13 CD4 1131/45%  VL 25
02/25/14 CD4   792/37%  VL UD

Offline Dr.Strangelove

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Re: TAG/i-Base pipeline report for HIV, hepatitis C and TB
« Reply #9 on: July 22, 2012, 04:02:36 AM »
Thanks Matt for the overview.

JM, I'm in a similar situation. I have been diagnosed last year but my numbers are still good. I hope I can wait until the end of this year (or longer) to start with medication, hopefully the Quad pill.
I have a history of depression, so I am not sure if Atripla would work for me. And Complera needs to be taken with a meal...

Offline Common_ground

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Re: TAG/i-Base pipeline report for HIV, hepatitis C and TB
« Reply #10 on: July 22, 2012, 04:50:02 AM »
Quad will obviously be the best once-a-day when it hits the market. A decade or so on this pill wont make you go under, but personally I am not overly excited since the tenofovir is still there.

That being said, looking at other drugs/combos in the pipeline, the next years could bring remarkably better options. Believe me when I say, a few years down the line, Atripla will feel like a drug from 1996.

Still the meds we got today are good enough for now, short to medium term toxicities are well researched and tolerable.

If you start there is nothing that says you cannot switch. Go for Complera a year and then swith to Quad, how does that sound?

     
2011 May - Neg.
2012 June CD4:205, 16% VL:2676 Start Truvada/Stocrin
2012 July  CD4:234, 18% VL:88
2012 Sep  CD4:238, 17% VL:UD
2013 Feb  CD4:257, 24% VL:UD -viramune/truvada
2013 May CD4:276, 26% VL:UD

Offline Miss Philicia

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Re: TAG/i-Base pipeline report for HIV, hepatitis C and TB
« Reply #11 on: July 22, 2012, 12:36:21 PM »
Believe me when I say, a few years down the line, Atripla will feel like a drug from 1996.

Having been on meds in 1996, no I don't believe you. Atripla, for all its faults, will never feel like 1996.
"I’ve slept with enough men to know that I’m not gay"

Offline Common_ground

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Re: TAG/i-Base pipeline report for HIV, hepatitis C and TB
« Reply #12 on: July 22, 2012, 12:56:54 PM »
Having been on meds in 1996, no I don't believe you. Atripla, for all its faults, will never feel like 1996.
That being said I hope everyone gets that I wasnt speaking literally.
2011 May - Neg.
2012 June CD4:205, 16% VL:2676 Start Truvada/Stocrin
2012 July  CD4:234, 18% VL:88
2012 Sep  CD4:238, 17% VL:UD
2013 Feb  CD4:257, 24% VL:UD -viramune/truvada
2013 May CD4:276, 26% VL:UD

Offline friskyguy

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  • Posts: 103
Re: TAG/i-Base pipeline report for HIV, hepatitis C and TB
« Reply #13 on: July 22, 2012, 01:41:27 PM »
it may be difficult to say which combo will be the best......side effects are and will continue to be different for everybody......only hard clinical data will be the determining factor!....and that usually comes in time....unfortunately! :(

I am on Stocrin (Sustiva) and although its been around for quite some time it has some great supporting data.....but I know not everybody can take it.

I like it cause it especially penetrates into the spinal fluid and into the brain (has a high ranking of penetration). It therefore is one of better meds placed to stop HIV replication in CD4 and macrophage cells in both these areas and reduce low level inflammation......a real and not often discussed about enemy for us possies!!! HAND absolutely scares the bejesus out of me!!!!!! Having a more concentration of meds crossing into the brain the better!!!
Sero converted Sept '10 / Confirmed + Dec '10
Jan '11, VL 9,500 / CD4 482 (32%)
Feb '11, VL 5,800 / CD4 680 (37%)
start Atripla
Mch '11, VL UD / CD4 700 (42%)
Jun  '11, VL UD / CD4 750 (43%)
swap to Kivexa and Efav. due to osteopenia diag. (DEXA) / kidney issues ( decline in eGFR to 77 )
start supplements - Vit D3 / Omega 3 / multivitamin / mini aspirin
Dec '11,  VL UD <20 /  CD4 670 (49%)  / CD4:CD8 = 1.4
all labs now within normal ranges
Mch '12,  VL UD / CD4 600 (51%)
Sep '12,  VL UD / CD4 810 (51%)
Mch '13   VL UD / CD4 965 (56%)
Sep '13   VL UD / CD4 (not taken)
Dec '13   VL UD / CD4 901 (35%) / CD4:CD8 = 1.1  /  eGFR > 100

Offline Common_ground

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  • Posts: 288
Re: TAG/i-Base pipeline report for HIV, hepatitis C and TB
« Reply #14 on: July 22, 2012, 02:07:13 PM »
Frisky, I was also worried about the brain barrier/CNS penetration and it seems Stocrin/Sustiva is doing a good job on that aspect. But I dont know about Truvada and thus is it possible the CNS is "mono-treated", if Truvada does not penetrate the CNS as good?

In regards to this there is another thread in the Living with forum where Mishma describes his autoimmune problems and his VL being UD in plasma but in CNS over 10k. If I understood it right....
2011 May - Neg.
2012 June CD4:205, 16% VL:2676 Start Truvada/Stocrin
2012 July  CD4:234, 18% VL:88
2012 Sep  CD4:238, 17% VL:UD
2013 Feb  CD4:257, 24% VL:UD -viramune/truvada
2013 May CD4:276, 26% VL:UD

Offline newt

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  • the one and original newt
Re: TAG/i-Base pipeline report for HIV, hepatitis C and TB
« Reply #15 on: July 22, 2012, 02:53:16 PM »
Quote
Quad will obviously be the best once-a-day when it hits the market.

Sez who? New drugs have a habit of throwing up unexpected side effects and having the tarnish come off (efavirenz, qv). I'd rather swallow a known quantity with well characterised side effects and efficacy.

Plus, on Quad, cobicistat seems to have similar side effects to norvir.

The tenofovir pro-drug is really exciting cos it will avoid the toxicity issues of full does tenofovir and preserve it's otherwise very good utility.

As is (even) the (probably discontinued, lab test only) nanoformulation of d4T (yes I said d4T << a brilliant drug therapeutically but with too many toxicities to take in real life).

People need to think different

pro-drug = 100 times less compound, same treatment effect
nanoformulation = 1,000-10,00 times less drug, same treatment effect
long term delivery (patch, injection etc) = bye bye adherence, hello can't stop the drug for side effects til the dose wears off & extra visit to the nurse

etc etc

- matt

Now playing: Laid, James
"The object is to be a well patient, not a good patient"

Offline friskyguy

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Re: TAG/i-Base pipeline report for HIV, hepatitis C and TB
« Reply #16 on: July 22, 2012, 03:18:18 PM »
Hi CG, not qualified to answer you but here is a reply from (Dr Young) from thebody.com to my question on the issue a few months back

"different HIV medications seem to cross into the cerebrospinal fluid with different efficiencies. This observation has led to the development of the CNS Penetration Effectiveness ranking scale for antiretroviral medications. "

"Some medications cross into the CNS well, others less so. Increasingly, there seems to be a correlation between the CPE and risks of CNS problems (thought not universally agreed upon). "

"Part of the issue is that the meds with the highest CPE ranks are not ones that we typically use (AZT, indinavir, nevirapine), while some of our most commonly prescribed medications (tenofovir) are below average. Medications that have above average CPE rank include abacavir, emtricitabine, efavirenz, maraviroc and raltegravir. "

I am becoming more convinced as I ramp up on my HIV knowledge (still a long way to go!!! :P) that being UD (in plasma), maintaining normal CD4 counts, normal labs, sufficient exercise and excellent nutrition may not be enough for all of us to keep the nasties at bay.

We see out HIV specialist and we do the periodical clinic routine, receive a pat on the back and than back again for more in 3, 6 or 12 mths later. Not many of us would know if HIV is replicating elsewhere in the body unless we had a medical reason to test, and do a spinal tap and whatever they test in the brain to see if VL and that damn inflammation is lurking there and creating havoc. Sorry to hear about Mishma.

So I don't worry and do the best I can do. Yet I do have some input into the meds I am taking NOW and therefore with my specialist specifically chose those with a higher CNS ranking and with good clinical data to match. I want to keep my mind healthy and age gracefully and dignified. For me this is paramount! Until I read a clinical study to the contrary and if my body continues to be OK with the choice I have made, I will just continue on these current meds.

Sero converted Sept '10 / Confirmed + Dec '10
Jan '11, VL 9,500 / CD4 482 (32%)
Feb '11, VL 5,800 / CD4 680 (37%)
start Atripla
Mch '11, VL UD / CD4 700 (42%)
Jun  '11, VL UD / CD4 750 (43%)
swap to Kivexa and Efav. due to osteopenia diag. (DEXA) / kidney issues ( decline in eGFR to 77 )
start supplements - Vit D3 / Omega 3 / multivitamin / mini aspirin
Dec '11,  VL UD <20 /  CD4 670 (49%)  / CD4:CD8 = 1.4
all labs now within normal ranges
Mch '12,  VL UD / CD4 600 (51%)
Sep '12,  VL UD / CD4 810 (51%)
Mch '13   VL UD / CD4 965 (56%)
Sep '13   VL UD / CD4 (not taken)
Dec '13   VL UD / CD4 901 (35%) / CD4:CD8 = 1.1  /  eGFR > 100

Offline Common_ground

  • Member
  • Posts: 288
Re: TAG/i-Base pipeline report for HIV, hepatitis C and TB
« Reply #17 on: July 22, 2012, 03:23:55 PM »
Sez who? New drugs have a habit of throwing up unexpected side effects and having the tarnish come off (efavirenz, qv). I'd rather swallow a known quantity with well characterised side effects and efficacy.

Plus, on Quad, cobicistat seems to have similar side effects to norvir.

The tenofovir pro-drug is really exciting cos it will avoid the toxicity issues of full does tenofovir and preserve it's otherwise very good utility.

As is (even) the (probably discontinued, lab test only) nanoformulation of d4T (yes I said d4T << a brilliant drug therapeutically but with too many toxicities to take in real life).

People need to think different

pro-drug = 100 times less compound, same treatment effect
nanoformulation = 1,000-10,00 times less drug, same treatment effect
long term delivery (patch, injection etc) = bye bye adherence, hello can't stop the drug for side effects til the dose wears off & extra visit to the nurse

etc etc

- matt

Now playing: Laid, James


True.

But I doubt the same company who co-made Atripla would put a worse product on the market (Not sure! :P). Gilead will need to make sure people use this pill, and they will,I think. My view is derived from financial prognosis.

http://connection.ebscohost.com/c/articles/69595952/over-next-decade-dominance-bristol-myers-squibb-gileads-atripla-hiv-drug-market-will-be-challenged-by-gileads-quad-gilead-janssens-complera

http://www.thepharmaletter.com/file/113286/fda-advisory-thumbs-up-for-gileads-once-daily-quad-for-hiv.html

2011 May - Neg.
2012 June CD4:205, 16% VL:2676 Start Truvada/Stocrin
2012 July  CD4:234, 18% VL:88
2012 Sep  CD4:238, 17% VL:UD
2013 Feb  CD4:257, 24% VL:UD -viramune/truvada
2013 May CD4:276, 26% VL:UD

Offline madbrain

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Re: TAG/i-Base pipeline report for HIV, hepatitis C and TB
« Reply #18 on: September 10, 2012, 07:21:57 PM »
But I doubt the same company who co-made Atripla would put a worse product on the market (Not sure! :P). Gilead will need to make sure people use this pill, and they will,I think. My view is derived from financial prognosis.

One very good reason for Gilead to put out the new pill is that they own the patents to all the drugs in the Quad/Stribild. So no need to share revenue with anybody else. Time will tell if it's also better for the patients or not.

 


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