Practicing Good Nutrition Habits When Using Fortovase

Treatment News

With many people with HIV using protease inhibitors, more attention needs to be paid to the nutrition considerations of taking and coping with these medications.

As a registered dietitian specializing in HIV care, I have found that the focus of my work has shifted. More time is spent assisting clients coordinating their medication and meal schedules, choosing appropriate foods when taking medications and reducing or managing side effects from medications through dietary modification. When successful, these efforts contribute to reducing the risk of drug resistance.

Many people with HIV are now taking Fortovase, the new soft gel formulation of the protease inhibitor saquinavir. The usual adult dosage for Fortovase is six 200 mg capsules three times a day with a full meal.

When taking Fortovase with other protease inhibitors or other drugs, as many doctors prescribe, the number of capsules and how often it is taken may vary. Always check your individualized dosage with your prescribing physician.

Fortovase will be kept refrigerated by the pharmacy and once received can be kept it at 77 degrees Fahrenheit or less (room temperature). Once brought to room temperature, Fortovase must be used within three months. Fortovase must be stored in its tightly closed bottle.

If you live in a warm climate, or the temperature gets warmer than 77 degrees Fahrenheit in the summer or in the sun, store Fortovase in the refrigerator to be safe. As we live in beautiful sunny Southern California, storing Fortovase in the refrigerator would be better to do.

If stored in the refrigerator, between 36 and 46 degrees Fahrenheit (2 to 8 degrees Celsius), it can be used until the expiration date on the bottle. If you need to carry this medication, consider using an insulated cold thermal container.

Fortovase is much better absorbed than Invirase, the older formulation of saquinavir. While the absolute bioavailability of Fortovase (1,200 tid) has not been assessed, it estimated to be eight times that of Invirase (600 tid). Invirase has a bioavailability of 4 percent.

Bioavailability of any drug will be affected by the amount of the drug taken and how often, the health of the individual taking the drug and other factors. Bioavailability of saquinavir will be affected by the amount and kind of food eaten when the drug is taken or soon after. According to the package insert provided with each Fortovase container, "patients should be advised that Fortovase should be taken within two hours after a full meal."

The soft gel formulation combines the medication with mono- and diglycerides, fats, in order for the drug to be more rapidly absorbed. Further, studies by the manufacturer indicate Fortovase blood levels to be six times greater when the drug is taken after a "heavy" meal, than on an empty stomach. A "light" meal was reported to have a reduction of blood levels by 40 percent compared to the heavy meal.

The definition of these meals were:

Protein, G
Fat, G
Carbohydrate, G

The Fortovase package insert reports on results of a feeding and fasting study using healthy volunteers where drug levels were 6.7 greater for those who took a single dose 800 mg of Fortovase with breakfast over those who took the drug in a fasting state. The "English breakfast" was a bowl of corn flakes, 3.33 ounces whole milk, two strips of lean bacon, two fried eggs, two slices of toast with butter and five ounces of tea or coffee, which computed to 48g protein, 60g carbohydrate, 57g fat and 1,006 calories.

While clinical studies of Fortovase have included instructions to patients to "take their saquinavir with a meal or a substantial snack," diet analysis has not been a part of most of these studies, so it is unknown what people were actually eating and how diet impacted the results of studies.

According to Neil Buss, Roche Laboratories International medical director, "In all likelihood, your chance of successful therapy with Invirase/Fortovase is better if you observe the dietary suggestions. However, the 'expected' or 'anticipated' activity of Fortovase relates to clinical studies which would have included a wide range of diets and dietary habits which would be typically determined by each individual patient."

Other than taking Fortovase three times a day with a full meal, there is no requirement to take this medication at a certain time. In an effort to maximize blood levels, clients are encouraged by some treatment advocates to take this medication spread out over the 24-hour period.

The effect of grapefruit juice on Fortovase is much less than its effect on Invirase. When quadruple-strength 5 ouncesgrapefruit juice was given with 600mg Fortovase and then 5 ounces one hour later, bioavailability of Fortovase was increased by only 54 percent. For Invirase, double-strength grapefruit juice increased blood levels by 220 percent. Quadruple-strength grapefruit juice doesn't seem worth taking when the drug's bioavailability is already improved.

Still, if you are taking grapefruit juice in an effort to increase Fortovase blood levels, let your primary care provider know. Grapefruit juice may alter levels of other drugs you are taking.

Your doctor must coordinate the dosages of all prescriptions carefully. Ritonavir, nelfinavir, indinavir and clarithromycin are some of the drugs that have been shown to increase drug levels of Fortovase when taken at the same time. Delavirdine and ketoconazole were studied using Invirase.

Reducing blood levels of the medication should be avoided as much as possible. Avoid:

  • Not taking the drug

  • Missing a dosage of the drug or taking less of the amount of drug prescribed.

  • Not eating a meal within two hours of taking the drug.

  • Not having that meal be a full meal, that is, a meal or substantial snack high in calories, fat and protein.

Adverse events are more common with Fortovase than with Invirase. Nausea, vomiting, diarrhea, abdominal discomfort, digestion difficulty (dyspepsia), gas, headaches, fatigue and insomnia are some of the side effects that patients have reported. Changes in body composition have also been reported for some persons taking combination therapies with or without a protease inhibitor. Report any fat or muscle changes to your physician.

Levels of triglycerides and blood sugars may become elevated and should be monitored closely. Because Fortovase is metabolized in the liver, people using Fortovase who have problems with the liver should be closely monitored and avoid alcohol.

Fortovase does not contain lactose, but lactose intolerance may become a problem. Taking lactose-reduced dairy products or a lactase enzyme may help.

People with HIV have an increased need for more fluid, although no specific recommendation for fluid intake has been made for Fortovase. Intake goals are 10-12 cups (8 oz. per cup) of safe drinking water for men and 9-11 cups of safe drinking water for women. Caffeine in coffee and other foods can speed up the gastrointestinal tract, creating looser stools with a potential fluid loss from both excretion and urination. Also, many people experience a reduction of appetite after eating foods containing caffeine. This can result in skipping important meals or snacks.

Tips to taking meds on time:

  • Write down your own regular meal and medication schedule.

  • Figure out a daily routine of eating and taking meds that works for you. Practice your routine each day.

  • If you cannot keep to a routine, talk to a health care professional or a friend about where it gets hard.

  • Make adjustments and try again.

  • Make eathing and taking meds your priority.

  • Use a timer to remind you when to take your meds and when to eat.

  • Use a pill box with compartments.

  • Use a daily check list or journal to track that you have taken each med, meal and snack.

  • Buy lots of portable snacks that do not spoil easily.

  • Keep food within easy reach: at the side of your bed, by the phone, by your TV or computer.

  • Put a snack in your pack anytime you leave home: to work, appointments, errands, socializing.

  • Communicate your needs to anyone with a demand on your time. Say, for example: "I need to eat first."

  • Set up meals with friends during times you can eat.

Possible mean / med schedule
7 a.m.Breakfast (high fat, high protein) and Fortovase
9:30-10 a.m.Snacks (low to non-fat. Ex: fruit, juice, nonfat yogurt, plus protein)
NoonLunch (moderate to low fat, high protein)
2:30 p.m.Snack (high fat) and Fortovase
6-8 p.m.Supper (moderate to low fat, high protein)
10 p.m.Evening snack (high fat, high protein)
11 p.m.Fortovase
Sample high calorie, high fat meals
1 cup whole milk1/2 cups whole milk1 cup whole milk
3 egg omlet1 cup cooked pasta2 servings baked sole or flounder
1 ounce cheese1 cup marinara sauce1 cup summer squash, steamed
1 pat butter3 tablespoons Parmesan cheese2 pats butter
1 sausage link3 soft bread sticks1 cup brown rice
2 slices toast1 pat butter1 pat butter
2 pats butter1 cup snap green beans1 whole wheat roll
1 tablespoon jam2 tablespoons Italian salad dressing1 pat butter
1 orange 1 tossed green salad
  2 tablespoons salad dressing
  1 cup Franch vanilla ice cream
883 calories1,102 calories1,288 calories
40g protein30g protein85g protein
54g fat55g fat57g fat
62g carbohydrate115g carbohydrate112g carbohydrate
Some high fat snack ideas
1/4 c Brazil nuts, 1 oz. cheddar cheese, 5 Ritz crackers452 calories, 14g protein, 36g fat
1 avocado, 2 oz. Monterey jack cheese on whole wheat bread with mayonnaise754 calories, 23.6g protein, 62g fat
Peanut butter & jam sandwich on whole wheat (3 tbsp. of peanut butter, 2 of jam) with Scandishake (a food supplement) using whole milk1,092 calories, 29g protein, 52g fat
1 serving of commercial frozen pizza160 calories, 5g protein, 6g fat
1/2 c macadamia nuts471 calories, 5.5g protein, 50g fat
This article has been reprinted at The Body with the permission of AIDS Project Los Angeles (APLA).