PRNewswire - Sunday September 27, 1998

"We found that between 1995 and 1997, quarterly mortality rates dropped from almost 5 percent to less than 1 percent, and average monthly costs of patient care stabilized at approximately $1,400 per patient among persons with HIV enrolled in several managed care health plans in California and Texas," said Diane Lapins, MPH, vice president for Strategic Services, Clinical Partners, Inc., a San Francisco-based company that provides data support and HIV case management services to managed care organizations nationwide.

The study was conducted in response to growing interest among managed care payors in determining the cost implications of the new antiretroviral agents and combination therapy in treating patients with HIV in the managed care environment. The study was conducted in collaboration with Merck & Co., Inc.

Average Monthly Per Patient Cost of HIV Care Stabilized

The patient population included HIV-positive non-Medicaid and non-MediCal adult males and females who were enrolled in various capitated, non-capitated and preferred provider health care plans managed by Clinical Partners in California and Texas from January 1, 1995, through December 31, 1997. Over this period, the number of patients enrolled each month ranged from 474 to 723.

The study found that the average monthly per patient cost of treating a person with HIV disease stabilized in the managed care population that was analyzed. "Although the introduction of triple combination therapy led to a rise in patient-per-month drug costs from $200 to $1,100, this increase was accompanied by a corresponding decrease in average monthly non-drug costs from almost $1,300 to about $200, including hospital, professional, laboratory and home care services," explained Ms. Lapins. "In fact, the overall average monthly cost of treating HIV patients held stable at about $1,300 over the last 14 months of this 36-month study."

Costs of HIV Patient Care Includes Many Factors

"As many managed care organizations tend to view drug budgets and drug costs independently of other operational costs, these data underscore the need for viewing the per patient cost of HIV care as a whole," Ms. Lapins concluded.

"It is important to recognize that HIV care encompasses many other components of care, such as indirect costs to community services, employers, friends and families."

Merck & Co., Inc., is a global research-driven pharmaceutical company that discovers, develops, manufactures and markets a broad range of human and animal health products, directly and through its joint ventures, and provides pharmaceutical benefit services through Merck-Medco Managed Care.

The patient prescribing information for Crixivan follows.

CRIXIVAN(R)* (indinavir sulfate) Capsules

Patient Information about CRIXIVAN (KRIK-sih-van) for HIV (Human Immunodeficiency Virus) Infection Generic name: indinavir (in-DIH-nuh-veer) sulfate

Please read this information before you start taking CRIXIVAN. Also, read the leaflet each time you renew your prescription, just in case anything has changed. Remember, this leaflet does not take the place of careful discussions with your doctor. You and your doctor should discuss CRIXIVAN when you start taking your medication and at regular checkups. You should remain under a doctor's care when using CRIXIVAN and should not change or stop treatment without first talking with your doctor.

What is CRIXIVAN?

CRIXIVAN is an oral capsule used for the treatment of HIV (Human Immunodeficiency Virus). HIV is the virus that causes AIDS (acquired immune deficiency syndrome). CRIXIVAN is a type of HIV drug called a protease (PRO-tee-ase) inhibitor.

How does CRIXIVAN work?

CRIXIVAN is a protease inhibitor that fights HIV. CRIXIVAN can help reduce your chances of getting illnesses associated with HIV. CRIXIVAN can also help lower the amount of HIV in your body (called "viral load") and raise your CD4 (T) cell count. CRIXIVAN may not have these effects in all patients.

CRIXIVAN is usually prescribed with other anti-HIV drugs such as ZDV (also called AZT), 3TC, ddI, ddC, or d4T. CRIXIVAN works differently from these other anti-HIV drugs. Talk with your doctor about how you should take CRIXIVAN. CRIXIVAN has been studied in adults. The safety and effectiveness of CRIXIVAN in children and adolescents have not been established.

How should I take CRIXIVAN?

There are six important things you must do to help you benefit from CRIXIVAN:

1. Take CRIXIVAN capsules every day as prescribed by your doctor. Continue taking CRIXIVAN unless your doctor tells you to stop. Take the exact amount of CRIXIVAN that your doctor tells you to take, right from the very start. To help make sure you will benefit from CRIXIVAN, you must not skip doses or take "drug holidays." If you don't take CRIXIVAN as prescribed, the activity of CRIXIVAN may be reduced (due to resistance).

2. Take CRIXIVAN capsules every 8 hours around the clock, every day. It may be easier to remember to take CRIXIVAN if you take it at the same time every day. If you have questions about when to take CRIXIVAN, your doctor or health care provider can help you decide what schedule works for you.

3. If you miss a dose by more than 2 hours, wait and then take the next dose at the regularly scheduled time. However, if you miss a dose by less than 2 hours, take your missed dose immediately. Then take your next dose at the regularly scheduled time. Do not take more or less than your prescribed dose of CRIXIVAN at any one time.

4. Take CRIXIVAN with water. You can also take CRIXIVAN with other beverages such as skim or non-fat milk, juice, coffee, or tea.

5. Ideally, take each dose of CRIXIVAN without food but with water at least one hour before or two hours after a meal. Or you can take CRIXIVAN with a light meal.

Examples of light meals include: dry toast with jelly, juice, and coffee (with skim or non-fat milk and sugar if you want) cornflakes with skim or non-fat milk and sugar

Do not take CRIXIVAN at the same time as any meals that are high in calories, fat, and protein (for example -- a bacon and egg breakfast). When taken at the same time as CRIXIVAN, these foods can interfere with CRIXIVAN being absorbed into your bloodstream and may lessen its effect.

6. It is critical that you drink at least six 8-ounce glasses of liquids (preferably water) throughout the day, every day. CRIXIVAN can cause kidney stones. Having enough fluids in your body should help reduce the chances of forming a kidney stone.

Call your doctor or other health care provider if you develop kidney pains (middle to lower stomach or back pain) or blood in the urine.

Does CRIXIVAN cure HIV or AIDS?

CRIXIVAN is not a cure for HIV or AIDS. People taking CRIXIVAN may still develop infections or other conditions associated with HIV. Because of this, it is very important for you to remain under the care of a doctor. Although CRIXIVAN is not a cure for HIV or AIDS, CRIXIVAN can help reduce your chances of getting illnesses, including death, associated with HIV. CRIXIVAN may not have these effects in all patients.

Does CRIXIVAN reduce the risk of passing HIV to others?

CRIXIVAN has not been shown to reduce the risk of passing HIV to others through sexual contact or blood contamination.

Who should not take CRIXIVAN?

Do not take CRIXIVAN if you have had a serious allergic reaction to CRIXIVAN or any of its components.

What other medical problems or conditions should I discuss with my doctor?

Talk to your doctor if:

-- You are pregnant or if you become pregnant while you are taking CRIXIVAN.

-- We do not yet know how CRIXIVAN affects pregnant women or their developing babies.

-- You are breast-feeding. You should stop breast-feeding if you are taking CRIXIVAN.

Also talk to your doctor if you have:

-- Problems with your liver, especially if you have mild or moderate liver disease caused by cirrhosis.

-- Problems with your kidneys.

-- Diabetes

-- Hemophilia

Tell your doctor about any medicines you are taking or plan to take, including non-prescription medicines.

Can CRIXIVAN be taken with other medications?**

Drugs you should not take with CRIXIVAN:

SELDANE(R) HISMANAL(R) (terfenadine) (astemizole)

VERSED(R) HALCION(R) (midazolam) (triazolam)

PROPULSID(R) Ergot medications (cisapride) (e.g., Wigraine(R) and Cafergot(R)

Taking CRIXIVAN with the above medications could result in serious or life-threatening problems (such as irregular heartbeat or excessive sleepiness).

In addition, you should not take CRIXIVAN with rifampin, known as RIFADIN(R), RIFAMATE(R), RIFATER(R), or RIMACTANE(R).

Table 1. Drugs you can take with CRIXIVAN include:

RETROVIR(R)	EPIVIR(TM)
(zidovudine, ZDV	(lamivudine, 3TC)
also called AZT)	----
ZERIT(R)	isoniazid
(stavudine, d4T)	(INH)
BACTRIM(R)/SEPTRA(R)	DIFLUCAN(R)
(trimethoprim/sulfamethoxazole)	(fluconazole)
BIAXIN(R)	ORTHO-NOVUM 1/35(R)
(clarithromycin)	(oral contraceptive)
TAGAMET(R)	----
(cimetidine)	----

VIDEX(R) (didanosine, ddI) -- If you take CRIXIVAN with VIDEX(R), take them at least one hour apart.

MYCOBUTIN(R) (rifabutin) -- If you take CRIXIVAN with MYCOBUTIN(R), your doctor may adjust both the dose of MYCOBUTIN and the dose of CRIXIVAN.

NIZORAL(R) (ketoconazole) -- If you take CRIXIVAN with NIZORAL(R), your doctor may adjust the dose of CRIXIVAN.

Talk to your doctor about any medications you are taking.

What are the possible side effects of CRIXIVAN?

Like all prescription drugs, CRIXIVAN can cause side effects. The following is not a complete list of side effects reported with CRIXIVAN when taken either alone or with other anti-HIV drugs. Do not rely on this leaflet alone for information about side effects. Your doctor can discuss with you a more complete list of side effects.

Some patients treated with CRIXIVAN developed kidney stones. In some of these patients this led to more severe kidney problems, including kidney failure or inflammation of the kidneys. Drinking at least six 8-ounce glasses of liquid (preferably water) each day should help reduce the chances of forming a kidney stone. Call your doctor or other health care provider if you develop kidney pains (middle to lower stomach or back pain) or blood in the urine.

Some patients treated with CRIXIVAN have had rapid breakdown of red blood cells (hemolytic anemia) which in some cases was severe or resulted in death. Some patients treated with CRIXIVAN have had liver problems including liver failure and death. Some patients had other illnesses or were taking other drugs. It is uncertain if CRIXIVAN caused these liver problems.

Diabetes and high blood sugar (hyperglycemia) have occurred in patients taking protease inhibitors. In some of these patients, this led to ketoacidosis, a serious condition caused by poorly controlled blood sugar. Some patients had diabetes before starting protease inhibitors, others did not. Some patients required adjustments to their diabetes medication. Others needed new diabetes medication.

In some patients with hemophilia, increased bleeding has been reported.

Clinical Studies

Increases in bilirubin (one laboratory test of liver function) have been reported in approximately 10% of patients. Usually, this finding has not been associated with liver problems. However, on rare occasions, a person may develop yellowing of the skin and/or eyes.

Side effects occurring in 2% or more of patients included: abdominal pain, fatigue or weakness, flank pain, feeling unwell, nausea, diarrhea, vomiting, acid regurgitation, loss of appetite, dry mouth, back pain, headache, trouble sleeping, dizziness, taste changes, rash, upper respiratory infection, dry skin, and sore throat.

Swollen kidneys due to blocked urine flow occurred rarely.

Marketing Experience

Other side effects reported since CRIXIVAN has been marketed include: abdominal swelling; inflammation of the kidneys; increased fat appearing in areas such as the neck, abdomen, and back; change in skin color; severe skin reactions; hair loss; crystals in the urine; and allergic reactions.

Tell your doctor promptly about these or any other unusual symptoms. If the condition persists or worsens, seek medical attention. How should I store CRIXIVAN capsules?

-- Keep CRIXIVAN capsules in the bottle they came in and at room temperature (59 degrees - 86 degrees F).

-- Keep CRIXIVAN capsules dry by leaving the small desiccant "pillow" in the bottle. Keep the bottle closed.

This medication was prescribed for your particular condition. Do not use it for any other condition or give it to anybody else. Keep CRIXIVAN and all medicines out of the reach of children. If you suspect that more than the prescribed dose of this medicine has been taken, contact your local poison control center or emergency room immediately.

This leaflet provides a summary of information about CRIXIVAN. If you have any questions or concerns about either CRIXIVAN or HIV, talk to your doctor.

** The brands listed are the registered trademarks of their respective owners and are not trademarks of Merck & Co., Inc.

Issued February 1998 West Point, PA 19486, USA

SOURCE: Merck & Co., Inc.
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PR980920

Always watch for outdated information. This article first appeared in 1998. This material is designed to support, not replace, the relationship that exists between you and your doctor.

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