July #72 : Combination Strategies - by Bob Lederer

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Table of Contents

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Is That All There Is to Approval?

Combination Strategies

Gimme Shelter

Bells, Books and Candles

Quickies

Calling All Angels

It's Raining Meds

Demand Results

S.O.S.

Parody Killed The Prevention Ad

Genes In The Bunch

Deaths

Shop Till You Drop

Gyn and Bitters

The Untouchables

Mailbox

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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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July 2001

Combination Strategies

by Bob Lederer

Chardelle Lassiter

Volunteer, DAAIR, Brooklyn, New York

TESTED POSITIVE: 1988

FIRST ANTIVIRAL: 2001

HOW I CHOOSE: The more I read up on HAART interactions and side effects, the more it seemed like six of one, half a dozen of the other. I told my doctor I wanted the simplest but most effective therapy. His prescription: Kaletra and Combivir. Since I was a kid, I've had difficulty swallowing pills, and when I asked the pharmacist to show me a sample Kaletra pill, I knew it would be too big, so I got my doc to prescribe the liquid form. Combivir pills are small enough to swallow with applesauce or pudding. I take my first dose of both tomorrow!

COMBO HISTORY: I'd still rather poke my eye with a sharp stick than take these medicines. For two years, I've had a depressed appetite and I'm now at my lowest adult weight ever, 129 pounds. I've had extremely low energy, rashes and neuropathy for months. Plus, my viral load is 200,000 and my CD4s dropped to 275. Until recently, I relied on alternative therapies. But now my body needs help to help itself. I'll also keep up with the vitamins, minerals, oils and herbs.

DIAGNOSTICS: I live in my body and it speaks to me all the time. When something's not right, I feel it. I'll continue to use test results as markers, especially now, but numbers are not the bottom line -- quality of life is.

DOC TALK: For three years, I consulted with a doctor at a community clinic who wanted me to start HAART, and I resisted. Because of time pressures and her unfamiliarity with alternative therapies, we never discussed the possibility of an integrated protocol. A PWA in my support group recommended his doctor, and in March I saw him as a consultant. This physician respects my feelings and concerns about taking meds. I usually go in with a list of questions, and call ahead with particular issues I want to discuss. So we're off to a good start.

Ron Mealy

Director, Carl Vogel Center buyers club, Washington, DC

TESTED POSITIVE: 1985

FIRST ANTIVIRAL: 1992

HOW I CHOOSE: My doctor and I have mutual respect and trust. I take major responsibility for the success of my treatment. I see my physician as a colleague, providing counsel. That doesn't mean I have to follow his recommendations. After all, it's my life, not his. So sometimes our relationship is good, sometimes it's adversarial.

COMBO HISTORY: Over the years, I've joined clinical trials of three experimental antivirals and one immune-modulator, and I take a ton of nutrients. In 1997, I started Crixivan/3TC/d4T, but I missed lots of doses on the three-times-a-day regimen. After 17 months, I had serious pill fatigue. Plus, I wondered how much my body could take of this chemotherapy. With my viral load at 10,000 and CD4s at 300, I stopped the drugs.

A year later, with my viral load at 100,000, I knew I needed to go back, and I now had the discipline -- but only if it was a twice-a-day regimen. My doctor and I looked for a combo that would leave me several options if I became resistant to one or two classes of drugs. We settled on an abacavir/nevirapine/ddI combo. My experience on those drugs was good, although I missed more doses than I should have. Last month, a genotypic test showed I was resistant to nevirapine and thus couldn't use any other NNRTIs, but my other two drugs were OK. Because my viral load was at 5,000, my doctor advised that I switch to Kaletra. I agreed because my research and talks with other HIVers confirmed that patients got quite a boost from it. But I didn't analyze my options in case Kaletra failed. In the managed-care era, you have to be quick.

DIAGNOSTICS: I use every tool at my disposal. I have all lab tests, including genotypes, done quarterly, because they take some of the guesswork out of decision-making. If every test suggests the drugs are working, that's empowering. It motivates me to keep taking my meds on schedule.

HINDSIGHT: Crixivan was a huge mistake. I don't have the discipline to take drugs three times a day. But I have no other regrets.

DO AS I SAY: If your community has a treatment education program, make an appointment. The specialists there might spend hours helping you sort through options. Most doctors are only paid to see you once. Don't be forced into something you're not ready to do, and do a mental health assessment. For instance, do you like getting smashed on Tuesday nights? You'll probably miss that dose. To test your discipline level, take advantage of the jelly-bean or pill-trial options offered by many adherence programs. You may then decide to go with a two- rather than three-times-a-day regimen.

Eric Sawyer

Advocate, HealthGAP Coalition, New York City

TESTED POSITIVE: 1987

FIRST ANTIVIRAL: 1987

HOW I CHOOSE: If I had to switch, I'd want a mix of classes, maybe including immune modulators. But my motto is: If it ain't broke, don't fix it. A lot of people panic at the first viral load or CD4 blip, but whenever I've waited out a small uptick, it's gone back down. It's the same for CD4s. Look at the total profile of your markers and symptoms, and be cautious about changing drugs.

COMBO HISTORY: I took a series of monotherapies until 1990. By early 1996, my CD4 count was 70 and my viral load was 775,000, and I had hairy leukoplakia, thrush and rashes. So I started on a weak formulation of saquinavir, plus nevirapine and AZT. My doc and I wanted to keep more powerful PIs in reserve -- this was before there was data on cross-resistance. A few months later, I switched to a more powerful regimen, ddI/d4T/nelfinavir. My viral load came down and my CD4s went up slightly. But I got bad neuropathy, and new data suggested it might be irreversible. After five months, I said, "Get me the hell off these drugs."

I switched to AZT/3TC/ritonavir, but three months later, my viral load was up again. My doc got a lab to run resistance tests, which weren't yet widely available. I was resistant to AZT and developing resistance to ritonavir. So I started on a five-drug combo: ritonavir, Crixivan, Sustiva, 3TC and abacavir, which included two PIs with different mutation patterns. I also took hydroxyurea for six months until data came out that its toxicity could be life-threatening.

My viral load has stayed undetectable with an occasional blip to 50. My CD4s are at 500, so I'm off prophylaxis. Overall health has been good, except for the neuropathy. I have to take anti-nausea and anti-diarrhea meds, and Sustiva gives me nightmares. And I now have a degenerated hip joint, source unknown.

DIAGNOSTICS: Symptoms and how you feel can be more important than viral load, because some people stay symptom-free at higher viral levels. Similarly, a really low CD4 count is more important than a high viral load in suggesting that a combo isn't working.

HINDSIGHT: Of course, monotherapy was a mistake. "Hit early, hit hard" was really dumb -- the drugs have horrible side effects and don't work forever. Also, I wish I'd never tried the D drugs, because of the irreversible neuropathy.

DO AS I SAY: I'd say don't go on therapy until your health is at risk, and be neurotic about adherence. Sometimes I get second opinions, even having the docs try to come up with joint recommendations.

David Stokes

Founder, Treatment Information Network, Boston

TESTED POSITIVE: 1987

FIRST ANTIVIRAL: 1987

HOW I CHOOSE: My most important factor is effectiveness, but side effects and scheduling are also significant. In recent years, my options have been limited by the large number of meds I've already used. I'm lucky that new classes of treatments have become available just when I needed them.

COMBO HISTORY: You could call me a salvage-therapy poster child. I started AZT in 1990 and zipped through multi-nuke combos until 1996, when my AZT-3TC duo failed. My viral load zoomed to 50,000, and I had nightsweats and fatigue. I entered the first PI combo trial -- ritonavir and saquinavir. My viral load went undetectable and my CD4s ranged from 200 to 300 for about 17 months. But then my viral load went up to 17,000, so I added d4T, ddI and 3TC to the two-PI combo.

Two months later, a phenotypic test showed resistance to both ritonavir and saquinavir. I dropped those and added a fourth nuke, abacavir, as well as a hydroxyurea booster. My counts were fine, but then I was hospitalized with congestive heart failure. The docs feared that the drugs had caused my the cardiomyopathy. For the next 10 months, I took only heart meds.

My CD4s plummeted to 94 and my viral load shot up to 40,000. I went back on my previous HAART regimen last August (minus the hydroxyurea, which seemed to stress my heart), with my cardiologist closely monitoring. Today, my CD4s are stable around 150, and my viral load is barely detectable. And my heart continues to improve. I've also used glutamine, milk thistle, alpha-lipoic acid and antioxidants.

DIAGNOSTICS: I go by the general rule that an increasing viral load will probably lead to decreasing CD4 cells over time.

HINDSIGHT: It's easy to look back and say that monotherapy and new drugs added to a failing regimen are not effective strategies. But I made the most of what was available, and I definitely believe that my meds-plus-nutrients approach is the best way.

DO AS I SAY: Take adherence seriously so your regimen can last as long as possible. When you need to switch, don't just change individual drugs, try to change to different classes.

ON DECK: I plan to stay on this regimen as long as I'm above 100 CD4s with a low viral load. I'm holding off on any non-nukes or new PIs until immune modulators come along. That way, I can switch to three new drugs at once.




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