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HIV Drugs in the Pipeline

A Concise Summary of Drugs Further Along in Development

March/April 2009

A note from TheBody.com: Since this article was written, the HIV pandemic has changed, as has our understanding of HIV/AIDS and its treatment. As a result, parts of this article may be outdated. Please keep this in mind, and be sure to visit other parts of our site for more recent information!

HIV Drugs in the PipelineOver the last two years the release of three new HIV medications has been providing new treatment options and hope for treatment-experienced patients. It is reassuring to know that there are several medications further along in the pipeline that provide an expansion of existing classes, as well as the addition of new classes.

Amdoxovir is an experimental nucleoside reverse transcriptase inhibitor (NRTI), currently in Phase 2, that is being developed by RFS Pharma. The medication is being studied either at doses of 300 mg or 500 mg twice daily and has been shown to be active against HIV strains that are resistant to Retrovir (zidovudine) and Epivir. Apricitabine is another NRTI, currently in Phase 2b, which is currently under development by Avexa. It is similar in chemical structure to Epivir and Emtriva, and is being shown active against strains resistant to Retrovir and Epivir. Side effects noted so far have been congestion, nausea, diarrhea, and modest increases in triglycerides.

Elvitegravir is an integrase inhibitor, currently in the planning stages of Phase 3, being developed by Gilead. The medication is dosed at 150 mg twice daily, boosted with 100 mg Norvir. So far few side effects have been noted. Gilead is planning to begin study of the first "quad fixed dose combination," a four-in-one-drug combining elvitegravir, Truvada and a new boosting compound being developed by Gilead. Watch for another potential blockbuster combination pill (one pill, once daily) which would be especially useful for those who can't take Atripla.

RDEA806 is a new non-nucleoside reverse transcriptase inhibitor (NNRTI), now in Phase 2, that is being developed by Ardea. The medication has been shown to be effective against strains resistant to Sustiva and has an added beneficial effect of reducing uric acid levels. IDX899, another NNRTI by Idenix, currently in Phase 2, has been shown to be potent, and is less susceptible to resistance compared to Sustiva and Viramune. [Editor's note: GSK acquired the rights to IDX899 as PA went to press.] Tibotec's NNRTI rilpivirine (TMC-278), currently in Phase 3, has been shown to cause minimal changes in lipids and glucose levels during the course of a 48-week treatment.

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Vicriviroc, the newest CCR5 antagonist being developed by Schering-Plough, is currently in Phase 3. The medication is boosted significantly by Norvir, and has been shown to be active against strains that are resistant to other medications, including Fuzeon.

Bevirimat (PA-457), a derivative of the Chinese herb Syzigium claviflorum, is part of a new class called maturation inhibitors that is being developed by Panacos. Currently in Phase 2 trials, it could be useful for treatment in new and experienced patients. So far, the medication is only available in liquid form due to issues with tablet formulation. Panacos was recently acquired by Myriad Pharmaceuticals, which has another maturation inhibitor in early development, vivecon (MPC-9055).

PRO 140 is an entry inhibitor, currently in Phase 2, being developed by Progenics, that is administered intravenously. The medication contains engineered antibodies called monoclonal antibodies that bind to the CCR5 receptors on CD4 cells to prevent entry by HIV. TNX-355 is the entry inhibitor that was being developed by Tanox, which was bought out by Genentech. It is also administered intravenously, every 2 weeks. Since the mechanism of action is different for this class, it can be used when resistance to other treatments is present.

Although there are a number of new medications that are under development, it will be a few years before they would be available. In the meantime, it is important to be compliant to your current regimen.

Drugs in the Pipeline* **

Agent Class Sponsor Status
AMD11070
CXCR4 blocker
Anormed

Suspended / Phase 2

amdoxovir
NRTI
RFS Pharma
Phase 2
apricitabine
NRTI
Avexa Limited
Phase 2 / 3
bevirimat (PA-457)
Maturation inhibitor
Panacos / Myriad
Phase 2
elvitegravir
Integrase inhibitor
Gilead Sciences
Phase 2
IDX899
NNRTI
Idenix Pharmaceuticals
Phase 2
KP-1461
Viral decay accelerator
Koronis Pharmaceuticals
Suspended / Phase 2
PRO 140
Entry inhibitor / monoclonal antibody
Progenics Pharmaceuticals
Phase 2
RDEA806
NNRTI
Ardea Biosciences
Phase 2
rilpivirine (TMC-278)
NNRTI
Tibotec Pharmaceuticals
Phase 3
TNX-355
CD4 blocker / monoclonal antibody
Genentech
Phase 2
vicriviroc CCR5 antagonist Schering-Plough Phase 3
* Taken in part from the 2008 Pipeline Report by Treatment Action Group (TAG). Visit www.treatmentactiongroup.org for the complete report.

** Many other compounds are in pre-clinical and early development that are not included in this article or table.


Got a comment on this article? Write to us at publications@tpan.com.

A note from TheBody.com: Since this article was written, the HIV pandemic has changed, as has our understanding of HIV/AIDS and its treatment. As a result, parts of this article may be outdated. Please keep this in mind, and be sure to visit other parts of our site for more recent information!



  
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This article was provided by Positively Aware. It is a part of the publication Positively Aware. Visit Positively Aware's website to find out more about the publication.
 
See Also
More on HIV Medications
HIV Drugs in Development

Reader Comments:

Comment by: William (Portland, OR) Thu., Oct. 29, 2009 at 11:05 pm EDT
Hey, great comment by Lee from Minneapolis.
Well, reality is that whatever we take from these labs, it's still synthetic "stuff" and there's always a price. People complain about the toxicity but, on the other hand, what choice is one left with? Do we remember about the ones going through Chemotherapy in order to stay alive?
I don't mean to be harsh, but it's time for us to become humble and try to make the best out of what is offered to us. First and foremost, we are still around and we are to celebrate that. Let's see this condition as a test of courage and determination, leaving no room for complaints because that can only make our lives miserable and may well bring unnecessary grief. Just LIVE. As a nurse once told me when I told her that I was afraid of dying, she killed my argument with the following reply: Everybody will die someday. None of us knows for sure when that day will come and being seropositive does not necessarily mean that we are on the eve of our deaths. HIV is not a death sentence anymore as it used to be. We are to keep one thing in mind: everything can change in the blink of an eye. The only definitive thing in this life is death - with or without HIV/AIDS.
Remember above everything else that we are spiritual beings.
If you are depressed over various reasons that I can't list here, keep the song "EVERYTHING MUST CHANGE" in mind.
The toxicity of these drugs are not strong enough to break one's spirit. There's a much bigger meaning behind all this. Believe me. If you have the will to live, YOU WILL LIVE. And so, HIV/AIDS will be the one to face defeat.
Reply to this comment


Comment by: Don (Spokane, WA) Mon., Oct. 5, 2009 at 12:29 am EDT
KP-1461 has been greenlighted once again. Koronis' research produced the same HIV ablation results as the original lab tests. Phase 2a concluded, showing a reduction in viral load of 0.4 log as opposed to placebos. Preparations are now underway to begin Phase 2b trials as soon as they are through adjusting dosing levels. This is great news, and hopefully this one makes it to the shelves. In the last two years, I've been to three of my HIV+ friends' funerals (HIV- myself), and have lost several others over the years.
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Comment by: Lucia (Miami,Florida) Wed., Aug. 12, 2009 at 3:55 pm EDT
Is true that this drugs combination can and will give you time to live longer maybe you get to grow old unfortunately many of us will not. Take in to consideration that the medical community don't care if you have facial wasting or side effects as long as you take this drugs that are highly toxic. The Drugs companies don't want to kill there golden goose after all they are making millions why ruin a good business. Physician get free trips,fancy dinners and kick backs the whole thing make me truly sick.
Get involved and remember is your life fight back.
FIND A CURE FOR AIDS NOW.
Reply to this comment


Comment by: Richard (OH) Fri., May. 15, 2009 at 9:43 pm EDT
What we also need is for the current drugs to also be easier to take as proscribed. Why can't they be smaller for the same dose? I feel like I'm taking horse pills. A lot of my medicine is huge. One time I choked and one of them went up my nose, and stayed there until it dissolved 2 hours later. Needless to say, it was quite painful.
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Comment by: Tom (london) Fri., May. 15, 2009 at 9:14 am EDT
What about Yamamoto and his Gc-Maf ?
Yamamoto will be present at FOCIS 2009 in San Francisco. I remember very well that he has been the only one researcher that has published in a peer-review scientific magazine a research that confirm hiv eradication in humans.
Reply to this comment


Comment by: TDHLF (Portland Oregon) Sun., May. 10, 2009 at 8:52 am EDT
Having been on these meds for 9 years and now experiencing the liver and kidney problems as well as cardio problems and focusing difficulties... low energy levels etc. I am really ready for the gene therapy procedures and use of stem cell. For those people who are negative leaving comments about how the drugs have improved the quality of life and living... You are not taking these drugs or having to deal with the side effects. ASIDE FROM BEING UNDETECTABLE... I am also becoming increasingly unable to work either physically or mentally. I am 37 years old. Try taking these drugs with anti-hypertension drugs. It's exhausting dealing with the mineral imbalances in my body and extreme fatigue. Since being put on Viread, I have not been able to sleep for more then two hours per night. It's like I can not sleep no matter how I try. I certainly don't want to add another drug to the regime to sleep. The Viread makes me hyper, exhausted and anxious all at the same time. I never experienced any of this priot to taking the drugs for HIV. I've recently found that not taking my meds once a week helps me to mellow out and actually get some sleep.
Reply to this comment


Comment by: teo (vancouver,bc canada) Sun., May. 10, 2009 at 2:08 am EDT
There is joy in my heart to be alive, and big gratitude goes out to the scientists. This is a big leap from ten years ago and there will be another big leap or two if we are lucky, in the next ten years. Take your meds, eat well, get your feet on the ground and we'll be there to celebrate. Everyone who is HIV is on borrowed time, but we are together, and don't forget to demand a cure!!
Reply to this comment


Comment by: Paul (UK) Sat., May. 9, 2009 at 6:07 pm EDT
One of the biggest problems for people living with HIV is that of facial/body wasting (Lipoatrophy/Lipodystrophy). What concerns me is that nothing & I mean 'nothing' is being done in the scientific research field to overcome this dibilitating condition. Why is that? I find this totally unacceptable in this day and age. The lives of people living with HIV need to improve by concentrating on areas like this!
Reply to this comment


Comment by: Carles (Barcelona) Sat., May. 2, 2009 at 1:44 pm EDT
I know KP1461 hasn't had a good process and who knows what happened there from the begining but I guess you missed one really amazing being developed now: VRX-496. It's having Phase I & II & I/II clinical trials and seems to be good!
Reply to this comment


Comment by: Wed., Apr. 29, 2009 at 7:35 pm EDT
I'm currently not on medications and hopefully I won't need to for a while but my doctor who's very caucious always says that with current medications and treatment, if a drug is doing good for you and you follow the cure thoroughly without skipping, there is no possibility for the virus to become resistant because resistance comes from letting the virus replicate and evolve into a different, resistant version. So if you strictly follow prescription the virus doesn't replicate.
Reply to this comment


Comment by: Lora (Cape Town, SA) Wed., Apr. 29, 2009 at 9:10 am EDT
Drugs got me up from the death bed so I believe strongly in taking them and taking care of myself. Thumbs up to the scientists!
Reply to this comment


Comment by: Lee (Minneapolis) Wed., Apr. 29, 2009 at 1:53 am EDT
Just be happy for every day you live and think POSITIVE. Life is terminal with no cure for anyone, so appreciate every second you have, and don't concentrate on what you don't have.
Reply to this comment


Comment by: brian (new york) Tue., Apr. 28, 2009 at 12:21 pm EDT
l think we really need a step up in money to support science and better hiv treatments, gene therapy is very costly but looks the way to go with stemm cell treatment,

the current meds are far to toxic.... come on scientist come up with something unique to bring happiness to millions of people
Reply to this comment


Comment by: gianni (italy) Sat., Apr. 25, 2009 at 8:35 am EDT
the real difference would be made only when gene therapy would kick in hopelly soon.....sorry for my inglish.
Reply to this comment


Comment by: Brian (Toronto) Fri., Apr. 24, 2009 at 5:53 pm EDT
21 years on meds and still breathing boys.. Think good thoughts..
Reply to this comment


Comment by: john (San Diego) Fri., Apr. 24, 2009 at 5:49 pm EDT
The clinical trial for KP1461 has been entirely halted. Unfortunately the drug had no effect on HIV in vivo.
Reply to this comment


Comment by: david (Washington DC) Mon., Apr. 20, 2009 at 5:34 pm EDT
Once a person passes 6-8 years of taking these rigorous drug combinations it takes a toll in different forms. Coronary events including death, liver toxicity leading to transplant or death, kidney toxicity leading to dialysis, transplant or death. Bone density issues for some leading to broken limbs, hip replacements, tooth loss. Yeah these drugs are GREAT. That is a big denial. These drugs are life saving and toxic. Talk about irony. I hope that drugs without these side effects come soon as I am on haart 14 years and running out of time.
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Comment by: Daniel (Australia) Mon., Apr. 20, 2009 at 1:12 pm EDT
Disappointing? What about KP-1461? Sounds like pretty exciting stuff to me if it gets ahead!
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Comment by: fred (los angeles) Mon., Apr. 20, 2009 at 9:43 am EDT
who needs the meds and side effects of today,

everyone knows the cure waits with gene therapy and stem cell treatment, trials are starting now and l will be putting my hand up to start
Reply to this comment


Comment by: John Christian (Abia, Nigeria) Mon., Apr. 20, 2009 at 8:34 am EDT
I am happy that the pipeline is still active and has
something to offer, hope very soon we will
have the cure for HIV.
Reply to this comment


Comment by: frank (baltimore) Sun., Apr. 19, 2009 at 2:23 am EDT
This is a bit disappointing. i think these are more of the same. where is the innovation and new ideas? people are no better off taking these drugs. they just fill the gap once u are resistent to your current meds.
Reply to this comment


Comment by: hivnegativeman (pa) Sat., Apr. 18, 2009 at 5:21 pm EDT
you are too ungrateful about these new life saving meds.
Reply to this comment


Comment by: D (tampa) Fri., Apr. 17, 2009 at 5:58 pm EDT
i am happy to see that i could be able to die of old age not from HIV. Thanks of the info
Reply to this comment


Comment by: Kennedy (Harare) Fri., Apr. 17, 2009 at 3:36 am EDT
Tend to agree with Nelson, until there is a cure, my guess is we are stuck in a rut. The positive side however, is that current medication has, without a doubt, improved the quality of life for people infected with HIV.
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Comment by: Nelson (Dallas) Thu., Apr. 16, 2009 at 9:43 am EDT
I'll be impressed when one of these drugs actually cures HIV. Until then it's just more of the same.
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Comment by: Nelson (Houston) Wed., Apr. 15, 2009 at 11:50 pm EDT
I guess the pipeline is not as dry as we thought. Too bad most of them are fancy "me too" drugs
Reply to this comment


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