November #86 : Ahoy, New Meds Ahead! - by Emily Bass

POZ - Health, Life and HIV
Subscribe to:
POZ magazine
E-newsletters
Join POZ: Facebook MySpace Twitter Pinterest
Tumblr Google+ Flickr MySpace
POZ Personals
Sign In / Join
Username:
Password:

Back to home » Archives » POZ Magazine issues




Table of Contents

Special Report: Takin' It to the Street

Special Report: Dangerous Council

Special Report: New Enemies List...

...And a Few Allies?

Magical Math

Tot Trials

Wan Free!

Talking Turkey

Faster, Pussycat, Die, Die!

Abbott On The Spot

IV in Vain:

Prison Plus:

Ahoy, New Meds Ahead!

Face It:

Vile Bodies:

Deep Kissing in the Deep South

Lip Service

Milestones:

Obituary:

Mailbox

Curiosity Thrills This Cat

Special Report:A Declaration of War



Most Popular Lessons

The HIV Life Cycle

Shingles

Herpes Simplex Virus

Syphilis & Neurosyphilis

Treatments for Opportunistic Infections (OIs)

What is AIDS & HIV?

Hepatitis & HIV


email print

November 2002

Ahoy, New Meds Ahead!

by Emily Bass

What with the new class of entry-inhibitors grabbing all the HIV-med headlines, you'd think there weren't any other pills prepping for FDA approval. Not so. In fact the next six months will be raining -- from a few fresh faces to some, er, face-lifted old dames. Private insurers and Medicaid will both cover these new drugs, though the feds take their own sweet time with the paperwork to bring big-ticket debutantes on board. However, state ADAPs don't have to spring for reformulations unless they cost the same as the old version -- and they often don't. On that cheery note, let's look at six products primping for the FDA runway.

Fuzeon (T-20)
Class: Entry inhibitor (EI)
Pitch: New class!
In stores: Roche/Trimeris filed its New Drug Application (NDA) in September, so Fuzeon's fast-track nod will come from four to six months later -- early 2003. A timely lifeboat for HIVers at the end of their treatment hope.
Big news? Hell, yes -- let's hope T-20's bite is as big as all the bark. First out of the EI gate, T-20, in trials, was part of a cocktail that squashed HIV to undetectable in 28 percent of treatment-tired patients vs. 14 percent among those on a non-T-20 combo.
Street talk: There's a sticking point: You gotta inject T-20 twice daily, which has led to problems ranging from injection-site irritation to ex-drug user heebie-jeebies. Catch No. 2: A rumored pricetag as high as $15K a year -- the costliest HIV med ever. Advocates predict that Roche will try to justify the bill by complaining about the umpteen-step production process -- and, in fact, the drug is hard enough to make that there may even be a post-approval shortage. Treatment wonks also worry that because it looks like T-20 pales next to Roche's second-in-line EI, T-1249, the company might put the breaks on the better drug.

Zerit (d4T) XR
Class: Nucleoside analog (nuke)
Pitch: Fewer pills
In stores: At presstime, Bristol-Myers Squibb (BMS) was betting on an FDA A-OK in October.
Big news? Un poco. XR is the same old Zerit, but with slower time-release to enable once-daily dosing rather than same old's twice.
Street talk: Watch BMS for dicey pricing? Bah, says BMS' David Rosen, adding that XR will have "price parity" with Zerit père. But BMS' self-imposed price freeze on AIDS drugs thaws next April. After that, the beleaguered behemoth can hike up both versions as high as they want.

GSK 908
Class: Protease inhibitor (PI)
Pitch: Fewer pills
In stores: FDA audition at year's end
Big news? Kinda, sorta. A GlaxoSmithKline/Vertex collab, 908 is the PI Agenerase tweaked to minimize some of its gut-related side effects -- and to cut its eight pills twice a day to a mere two. "GSK has something they think will make a significant impact," Dawn Averitt, the former AIDS Survival Project wonk, said with a wink. "I suspect we're going to be outraged by the price."
Street talk: Docs will likely prescribe 908 with a small Norvir "booster" dose to keep drug levels high -- but even with those extras, the combo offers a far smaller pill burden than Agenerase.

Viracept 625 mg
Class: Protease inhibitor (PI)
Pitch: Fewer pills
In stores: Filed for approval in June
Big news? Nah. This new version of Viracept cuts your twice-daily gulp from five to two pills.
Street talk: Activists grumble about how much Pfizer's acquisition of Viracept-maker Agouron delayed sending 625's NDA to the FDA. The scuttlebutt, according to Averitt: There's "not a lot of interest [in HIV]" at Pfizer. Say it ain't so.

Coviracil (FTC)
Class: Nucleoside analog (nuke)
Pitch: Once-daily dosing
In stores: NDA expected this fall
Big news? FTC's a kissing cousin to staple nuke 3TC (often taken with AZT, in Combivir), but with an extended half-life that allows for one-a-day dosing as opposed to one twice a day.
Street talk: Don't expect it to trounce 3TC, but, according to GMHC's Bob Huff, its long-release formulation poises it for pairing with other drugs, like Viread. If priced right, FTC's fortunes could rise once AZT's patent expires in 2005 and docs start dissing the mighty Combivir by twinning generic AZT with FTC. Plus, FTC's a high-staker for its maker, the troubled Triangle, whose recent losses, layoffs and the strange side effects of its promising HIV/hep B drug DAPD hint it's stuck in the Bermuda Triangle.

Zrivada (atazanavir)
Class: Protease inhibitor (PI)
Pitch: Fewer pills, more potent
In stores: Good question. Good news: "Taz" is now available to HIVers failing meds, with CD4s below 300 and virus over 5,000. Call 877.726.7327.
Big news? Could be. First, you only take two pills once a day. Then there's potency: In one study of 145 HIVers, taz pushed down virus that was resistant to three PIs!
Street talk: Proving it doesn't lift your lipids like old-school PIs is the only way taz can do what Averitt calls "blockbuster marketing" (à la Kaletra). After a 12-month trial, data were good, but get back to us after another 12.




[Go to top]

Join POZ Facebook Twitter Google+ MySpace YouTube Tumblr Flickr
Quick Links
Current Issue

HIV Testing
Safer Sex
Find a Date
Newly Diagnosed
HIV 101
Disclosing Your Status
Starting Treatment
Help Paying for Meds
Search for the Cure
POZ Stories
POZ Opinion
POZ Exclusives
Read the Blogs
Visit the Forums
Job Listings
Events Calendar


    CuteBoyinQns
    Jackson Heights
    New York


    zeze42
    Bay Area - Peninsula
    California


    OahuAJ
    Turlock
    California


    HOTROD2010
    houston
    Texas
Click here to join POZ Personals!
Ask POZ Pharmacist

Talk to Us
Poll
Do you work with your doc to design your own treatment regimen?
Yes
No

Survey
PrEP Course

more surveys
Contact Us
We welcome your comments!
[ about Smart + Strong | about POZ | POZ advisory board | partner links | advertising policy | advertise/contact us | site map]
© 2014 Smart + Strong. All Rights Reserved. Terms of use and Your privacy.
Smart + Strong® is a registered trademark of CDM Publishing, LLC.