Being Alive; April 1997

Protease inhibitors are a new type of antiretroviral (drugs that stop the reproduction of hiv in your body). Protease drugs work by blocking a part of hiv called protease. Without protease, hiv makes copies of virus that can't infect new cells. Studies (clinical trials) of protease inhibitors have shown that these drugs, taken alone or in combination with other antiviral drugs (AZT, ddI, ddC, d4T, 3TC), can lower viral load (the amount of hiv in your blood) and raise T-cells (CD4 cells). The greatest effect was seen in people taking combination therapy. However, it's important to remember that more studies are needed to better understand how to use these drugs.

When Should I Start Taking Protease Inhibitors?

No one knows yet the best time to begin taking protease inhibitors. One study of people with aids who have low T-cells (100 or lower) showed that those who took a protease inhibitor lived longer (by approximately six months) than those who did not take a protease inhibitor. Based on these results, if you have 1) low T-cells, 2) high viral load, 3) symptoms of illness, and/or 4) have had hiv disease for a long time, you may want to talk with your doctor about starting a protease combination.

Doctors do not yet know whether taking these drugs early in hiv disease-when T-cells are high and viral load is low-will help prolong life or prevent the development of aids. In theory, starting a protease drug when viral load is low could allow the drug to be more effective.

Can Drug Resistance Occur with Protease Inhibitors?

hiv eventually learns to work around the effect of the drug. This is called drug resistance. Resistance causes the drug to work less well or not to work at all. Resistance does not go away. Also, developing resistance to one protease drug will often mean that you are resistant to other protease drugs as well. This is called cross-resistance.

Some studies show that taking protease inhibitors in combination with other anti-hiv drugs may greatly reduce the chance of developing resistance. But the best way, at this time, to avoid or delay the development of drug resistance is to make sure you take the drugs properly. Skipping doses, taking lower than prescribed doses, not following food guidelines, and not taking the drugs on schedule, all encourage the development of drug resistance. If you think that you are not able to follow the treatment routine which you and your doctor have put together, then you might want to wait until you feel you really need the drugs or are better prepared to take the drugs properly.

Dose

The standard dosage is two 400 mg capsules taken every eight hours (3 times a day-e.g., 8 am, 4 pm, 12 midnight). Crixivan must be taken on an empty stomach or, if necessary, with a light, low-protein, low-fat meal (e.g., corn flakes, skim milk, apple juice, dry toast, coffee or tea; do not take with grapefruit juice). Take each dose with a large glass of water and drink at least six more large glasses of liquid throughout the day.

In studies, the greatest effect was seen with Crixivan in combination with AZT/3TC. Other combinations may also be useful but have not been tested yet. In deciding which combination to take, think about possible side effects and, if possible, look for a combination that you have not taken before.

Storage and Cost

Keeping capsules dry in their bottle is very important. To do this, put the small cloth package or cotton that comes in the bottle back after every use.

Crixivan sells for about $6,000 a year. Most Medicaid programs and private insurers cover it. Crixivan is covered by the ADAP program in California. Merck, the company that makes Crixivan, runs a patient-assistance program that will supply the drug at no cost if you meet certain qualifications. Call 1.800.927.8888 Monday-Friday, 9 am-8 pm, for more information regarding patient assistance.

Side Effects

Nephrolithiasis (defined as pain in the sides, blood in urine or kidney stones) occurred in 4% of people in clinical studies. Drinking at least eight large glasses of water throughout the day can help prevent nephrolithiasis. Other side effects include nausea, abdominal pain, headache, weakness/fatigue, diarrhea, taste changes and back pain. Less than 2% of patients reported having these side effects in clinical studies.

Drug Interactions

Most drugs can be taken with Crixivan. Rifabutin and ketoconazole (Nizoral) will require a change in the amount of medication taken.

Rifampin, terfinadine (Seldane), astemizole (Hismanal), cisapride (Propulsid), triazolam (Halcion) and midazolam (Versed) should not be taken with Crixivan.

Speak to your doctor about other possible drug interactions.

This information is reprinted from a GMHC Fact Sheet. For other Fact Sheets or more information contact Gay Men's Health Crisis, 129 W. 20th St., New York, NY 10011 or call 212.337.3530.

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