December #66 : Protease Progeny - by Bob Lederer and Frank Romanelli, PharmD

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Table of Contents

The Viral Lowdown: Can You Believe What She Says?

The Viral Lowdown: Say What

The Viral Lowdown: Word Is Out For New HIVers

The Viral Lowdown: Dishing Out the Denial

The Viral Lowdown: Pharma Flubs Phase IV

The Viral Lowdown: Lack of Leadership Leaves Latinos In Lethal Lurch

The Viral Lowdown: Mystery: Partially Positive

The Viral Lowdown: Prison Death Prompts Probe

The Viral Lowdown: African AIDS Under a TAC

The Viral Lowdown: All Dolled Up: Rx Abuse High Among Gay HIVers

THE VIRAL LOWDOWN: WORLD AIDS DAY 2000

The Viral Lowdown: If Not Now, When? If Not Us, Who?

The Viral Lowdown: News Flash: The Sky Isn't Falling!

The Viral Lowdown: HIVers in Hock to Homophobia

Tales of the (Safer Sex) City

Clean, Sober...and Medicated?

The Secret Plot to Destroy African Americans

Mailbox

The Art Of Living

Summit, Some More

Channel Surfing

Shout Out

Lights! Camera! Handcuffs?

Quick Picks

Life Is Sweet

Packing Meat, Just Barely

A Cell of One’s Own

Milestones

Doing AIDS Justice

Petal Pusher

Carry On, MP

Milk Got You?

Comfort Zone

Big Science Kicker

Herb Of The Month

Protease Progeny

It Takes Guts

Between A Recovery And A Hard Place



Most Popular Lessons

The HIV Life Cycle

Shingles

Herpes Simplex Virus

Syphilis & Neurosyphilis

Treatments for Opportunistic Infections (OIs)

What is AIDS & HIV?

Hepatitis & HIV


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December 2000

Protease Progeny

by Bob Lederer and Frank Romanelli, PharmD

The newest PRODUCT on the protease inhibitor (PI) shelf arrived in September, when the FDA approved another much-needed treatment option for HIVers, Abbott Laboratories’ Kaletra (formerly ABT-378). The drug is actually a combo of the new PI lopinavir and a small dose of Abbott’s older PI, ritonavir (Norvir). The theory is that, as ritonavir does with other PIs, it can dramatically increase the body’s blood levels of lopinavir. Trial results so far show strong viral suppression, even in PWAs with drug resistance. The med is available in both  capsule and liquid form, and is approved for use in children as young as six months old. (HIVers using the “cotton-candy”–flavored liquid should note that the solution contains 42 percent alcohol.) Kaletra should be taken with food twice a day (three capsules or one teaspoon each dose). And like other PIs, it must be used in combination with nucleosides or NNRTIs. Some users may experience nausea, vomiting and diarrhea. As with most other PIs, Kaletra has been associated with above-normal blood sugar and cholesterol levels; there have also been some cases of pancreatitis (a dangerous inflammation of the pancreas) and elevated liver enzymes—so monitor your blood values regularly. Because of ritonavir’s ability to cause many drug interactions (some potentially harmful), Kaletra takers should inform their doc about all other meds they are taking.

Abbott charges wholesalers $6,500 for an annual supply of Kaletra pills (most pharmacies charge about 10 percent more). That’s $270 below the price of market leader nelfinavir (Viracept) and $400 less than Abbott’s own ritonavir—and, the company says, lower than first planned. Last spring, after the Fair Pricing Working Group, a coalition of AIDS advocates, submitted a letter with 250 organizational sign-ons calling for a modest price, Abbott agreed to a rare pre-marketing dialogue with Working Group members, including several state directors of AIDS Drug Assistance Programs (ADAPs). The discussion convinced Abbott, according to Arthur Higgins, president of the firm’s pharmaceutical division, that “for this product to gain rapid access to patients, we can’t increase the financial burden on ADAPs.” Project Inform’s Marty Delaney, a Working Group member, comments: “While the price is still too high, it’s a step in the right direction—the first time a new and better drug has been priced lower than the ones it’s replacing.” Abbott has a patient assistance program (800.222.6885) for those who can’t afford Kaletra.

For more info on Kaletra, click on  www.projinf.org/fs/lopinavir.html




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