POZ Community Forums
Main Forums => Living With HIV => Topic started by: Tim Horn on June 23, 2006, 06:48:52 pm
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New Protease Inhibitor Prezista (Darunavir) Approved
https://www.poz.com/article/Protease-Inhibitor-Prezista-Approved-7206-1723 (https://www.poz.com/article/Protease-Inhibitor-Prezista-Approved-7206-1723)
The U.S. Food and Drug Administration (FDA) announced on June 23 that it has approved Prezista™ (darunavir), a new drug for adults whose infection with the HIV has not responded to treatment with other antiretroviral drugs. Prezista, a new protease inhibitor developed and manufactured by Tibotec, Inc., is approved to be taken with a low-dose of Norvir® (ritonavir) and other active anti-HIV agents.
"This approval offers new hope to HIV patients who too often urgently need new therapies in order to maintain their health," said Andrew C. von Eschenbach, MD, Acting Commissioner of Food and Drugs. "This drug is not a cure, but when combined with other standard therapies, it presents one more major step in our effort to help patients combat the effects of the disease."
The accelerated approval is based on evidence from two randomized, controlled studies comparing the safety and effectiveness of a Prezista/Norvir combination with other Norvir-boosted protease inhibitor combinations. Patients in both arms of these trials also used other anti-HIV agents (nucleoside reverse transcriptase inhibitors) with or without Fuzeon® (enfuvirtide), a fusion inhibitor that inhibits the virus from entering the cell. In these studies, patients on a Prezista/Norvir combination experienced higher rates of reduction of their HIV viral load than patients on other Norvir-boosted protease inhibitor combinations. Seventy percent of treatment-experienced patients achieved a virologic response, improving the treatment outcome, with Prezista/Norvir in combination therapy compared to 21% in control group at week 24.
The most common side effects reported by patients on the Prezista-ritonavir regimen included diarrhea, nausea, and headache. Approximately 7% of patients on this combination therapy experienced skin rashes ranging from mild to serious.
The risks and benefits of Prezista have not been established for adults who are starting HIV treatment for the first time, or for children.
As a condition of the accelerated approval, the manufacturer is required to conduct post-marketing trials to verify and describe the clinical benefits of Prezista. Other postmarketing studies that the manufacturer has committed to conduct include studies in children, studies to better define certain drug-drug interactions, and to evaluate the drug in patients with varying degrees of liver impairment to identify appropriate dosing for this patient population.
Patients are advised to take Prezista/Norvir with food, and not to use the combination therapy together with St. John's wort or various other drugs, including certain anticonvulsants, antihistamines, sedatives, and a few of the protease inhibitors.
And a link to the new Prezista drug page on POZ.com:
https://www.poz.com/drug/prezista
Tim Horn
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a new drug for adults whose infection with the HIV has not responded to treatment with other antiretroviral drugs.
Now that's what I like to hear, thanks for posting Tim.
cheers
Matt
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Its about time! I am glad we are making incremental progress. This is a HUGE increment too, especially if the long term side effects are as mild as the short term.
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And especially with things not looking too great on the CCR5 front.
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Hello Tim,
Great news ! Thanks !
Ray
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i am in my fourth week of taking this drug. I have been throwing up and been nauzed 24/7, but I think its the truvada.
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Is this the drug formerly known as TMC 114?
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Rocky:
Yes, this is the drug formerly known as TMC-114.
Tim
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Thanks for the update Tim! Considering I've been on PI therapy only it's nice to know that there are more drugs I can use as a back up until I eventually need to switch to the non nukes.
Cheers,
Alan
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Thanks for the info... I have long awaited this drug's approval. I will now be able to drop Invirase and Kaletra and for Prezista, Norvir and Epizicom. Woohoo! One less drug overall!
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Tim or anyone, I have a question... So, I understand this to be MONUMENTAL in addressing resistance and reading the data sounds like this will be the beginning of something new? Is this a "Pandora's box" of new possibilities in treatment?? A whole different way of approaching resistance?? Don't be to technical for us less understanding, how this all fits into the future picture of HIV/AIDS.... ;)
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Eric:
Well, I wouldn't really classify Prezista as a panacea, if you will.
For starters, this is a brand-spanking-new drug. We still have quite a bit to learn about how well it performs -- and how long its benefits last -- in people with drug-resistant HIV. And there's a clincher here, too: for Prezista to be truly effective, it absolutely must be combined with other drugs that the virus is sensitive to. For people at the end of their treatment rope, meaning that they've developed HIV resistance to pretty much all of the agents currently available, adding Prezista is on a par with "monotherapy" (taking a single drug), and we know from experience that HIV quickly becomes resistant to agents used as monotherapy.
For people currently dealing with HIV resistance to several drugs, a lot of fancy footwork is going to be required -- using things like drug-resistance testing and expertise -- to make sure that Prezista is used wisely, in combination with drugs that the person's virus is at least partially sensitive to.
For people new to HIV treatment, the availability of Prezista is also a breath of fresh air. Even if Prezista is eventually approved for people new to treatment (its current approval is only for those with previous treatment experience and protease inhibitor resistance), just knowing that its a viable, effective option for use down the line is important. Treatment can now be sequenced better than ever before, knowing that if a first-, second-, or even third-line regimen fails, tried and true options are being developed and becoming available. Not to be presumptious, but this really does mean that treatment can potentially buy many years of healthier living for people with HIV.
Many folks who have been following Prezista's development have been pleased with it, especially when using Aptivus (tipranavir) as a comparison. Aptivus, like Prezista, was primarily studied in clinicial trials involving people with resistance to older protease inhibitors. While Aptivus performed relatively well, the side effects are noteworthy, as are the drug interactions. Prezista, thus far, seems to be nicely tolerated and won't likely suffer from the same mind-boggling interactions as Aptivus. The dose of Norvir used with Prezista is also lower than the Norvir dose used with Aptivus, which is also a good thing.
As for the future of drug development, let's all keep our fingers crossed. Some nifty three-dimensional studies found that Prezista binds to HIV's protease enzyme differently than other PIs, which likely accounts for its activity against HIV resistant to other PIs. One would hope that pharmaceutical companies, including Tibotec itself, is capitalizing on these imaging studies to develop a whole new crop of PIs with activity against drug-resistant HIV.
Tim Horn
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Hi Tim,
If I read your last thread correctly, does Prezista have to be boosted with Norvir? I myself failed my first combo (Nelfinavir + Combivir) way back when and have had to boost past PI therapies with Norvir. However, Norvir kept buggering up my lipids (on top of Kaletra) as well as furthering the development of myopathy as a result of long term azt use. Presently I'm on Atazanavir + Kivexa/Viread. Originally I had a Norvir boost but it would not allow the lipids to return to normal. Anyway, I guess what I am wondering is if you have heard if Prezista HAS to be boosted and if so, what other options are there instead of Norvir. I'm just curious in case I find myself going down this drug path one day.
Cheers,
Alan
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Hi Alan:
Yes, Prezista must be boosted with Norvir. The dose is two 300mg tablets, plus one 100mg Norvir capsule, twice a day.
This is actually a pretty low dose of Norvir, but certainly enough Norvir to cause lipid problems. It's not clear if Prezista, itself, causes lipid problems, as it has only been studied in combination with Norvir. Reyataz (atazanavir) seems to have limited (if any) effects on lipids... but with Norvir (a must if using Reyataz and have become resistant to other drugs in the past), there is an increased risk of lipid problems.
If you do need to go the Prezista route, it may necessary to keep an eye on your lipids. In clinical trials, Prezista didn't seem any less likely to cause lipid increases than other Norvir-boosted PIs... but, fortunately, it didn't seem to be any worse than other Norvir-boosted PIs in this regard.
Tim Horn
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I have been on TMC-114 now for a little over 2 months and my labs have been night and day. Well, I have to say it's been with Fuzeon and TMC-114 together (norvir booster and truvada, the latter I've been on for a year or so). I'm one of those people who has showed resistance to all PI's since they started genotyping me. Oddly even with resistance my cd4s still kept increasing modestly to around 500 but my VL has never been below 30,000 though it's maintained that fairly constantly.
Even within the FIRST month of TMC-114 my cd4s increased by 65% and my vial load went to undectable. Color me very impressed indeed. I'm also in a support group of people (small group) who have been on this combo for a year in trails and all have kept their numbers up for the duration.
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just got back my first labs from tmc114(it does have to be boosted with norvir)and I am undetectable, my cd4s remain unchanged at 230. I have been on lipitor for at least 8-9 years but recently on Kaletra my cholesterol went to mid 200s. My cholesterol on tmc114 is back down to 170,which is good. My trys are up over 300. So one out of two isnt bad. I am a glass half full kinda of person today.
Sides are minimal so far. Even the miracle of solid bowel movements!
I went undetectable on Kaletra in the first month also, and then it started climbing in the third month, so I will wait till I get excited about the real results.
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Yes, my bowels have miraculously changed as well. The only side effects I've noticed, and I don't know if it's due to fuzeon or TMC (and others in my support group have as well) is an increase in body sweat. I'm always overly sweaty which is dreadful in this year's higher summer heat.
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I am having same problem. I have been sick lately with a bad cold,have no fever, but have been breaking out in a full sweat while sitting in my a/ced house all day long. really wierd. I thought it was the nyquil but maybe its the tmc.