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Brand Name: Viracept

Common Name: nelfinavir (NFV)

Class: HIV protease inhibitor

Standard Dose: 1,200 mg taken as either two 625 mg tablets or five 250 mg tablets twice-a-day with food. Take a missed dose as soon as possible, but do not double up on your next dose. Viracept Oral Powder also available for children and individuals unable to swallow tablets.

AWP: $726.40 / month for 625 mg

Manufacturer contact: Agouron Pharamaceuticals, a Pfizer company, www.viracept.com, 1 (888) 847–2237

AIDSInfo:1 (800) HIV–0440 (448–0440), www.aidsinfo.nih.gov

Potential side effects and toxicity:

Most common include: diarrhea (30–40% of patients), stomach discomfort, nausea, gas, weakness, and rash.

As seen with other protease inhibitors, there can be increased levels of cholesterol and triglycerides (except possibly unboosted Reyataz) which may be associated with an increased risk of heart disease. But it is important to remember the risk of heart disease is determined by many other factors, such as family history of heart disease, smoking, high blood pressure, diabetes, obesity, etc. HIV therapy should not be delayed due to this risk. Other possible side effects are lipodystrophy (body fat changes, including thinning of the face, arms and legs, with or without fat accumulation in the stomach, breasts and sometimes the upper back), onset of new cases or worsening of diabetes (see your doctor promptly), and increased bleeding in hemophiliacs.

Potential drug interactions:

In general, less severe interactions compared to other drugs in this class.

Do not take with Versed, Cordarone (amiodarone), Halcion (triazolam), Rifadin (rifampin), Prilosec (omeprazole), ergot derivatives (such as Cafergot, Wigraine and Methergine, D.H.E. 45, in any form), garlic supplements, or the herb St. John’s wort (hypericum perforatum). Do not use Zocor (simvastatin) or Mevacor (lovastatin); lipid-lowering alternatives are Lipitor (atorvastatin), Lescol (fluvastatin), and Pravachol (pravastatin), but they should be used with caution due to potential for liver toxicity. Viramune may decrease methadone levels but withdrawal rarely occurs; methadone doses may need to be increased.

Blood levels of Viracept are reduced by rifampin and may be reduced by phenobarbital, phenytoin, and carbamazepine (Tegretol and others), so it is important to inform your doctor if you are taking any of these medications. Invirase levels increase three-to-five-fold and Crixivan increases 50% (see Crixivan for potential drug interactions), so dose adjustments may be needed. Mycobutin (rifabutin) dose must be decreased when used with Viracept. Prescriber may need to adjust doses of any of these drugs accordingly.

Protease inhibitors increase blood levels of Viagra (sildenafil citrate), Cialis (tadalafil) and Levitra (vardenafil). Use with caution. Initially the Viagra dose should be 12.5 mg (1/2 of 25 mg tablet) and increased as needed and tolerated. It’s recommended that people on PIs do not exceed 25 mg of Viagra in a 48-hour period because of potential for serious reaction such as low blood pressure, visual changes, and prolonged erection leading to permanent tissue damage. Use Cialis at reduced doses of 10 mg every 72 hours and Levitra at reduced doses of no more than 2.5 mg every 72 hours, with increased monitoring for adverse events. Increased levels of the inhaled and nasal sprays with fluticasone, a steroid for asthma or allergies (found in Advair, Flonase, and Flovent), can occur and therefore should be used with caution. The effectiveness of birth control pills may be decreased; women and their male partners should consider the use of alternative or additional contraception methods. Also, increased levels of Desyrel (trazodone) can occur, which may lead to nausea, dizziness, low blood pressure, or loss of consciousness. A lower dose of Desyrel is recommended.

Tips:

Do not leave pharmacy without anti-diarrhea meds such as Immodium, Tums, or other calcium products. Taking a 500 mg calcium supplement with doses hugely decreases diarrhea. Also try Solgar oat bran tablets, psyllium husk fiber bars and pancreatic enzymes (all with meals). As an extra precaution, take a change of clothes with you everyday for the first several weeks—stick it out, most often symptoms improve after two or three weeks. The oral powder tastes horrible and requires a large amount for mixing into food. People using Viracept can crush adult tablets for use in children or dissolve tablets in a small amount of water. Acidic food or juice (e.g. orange/apple juice or apple sauce) not recommended in combination with Viracept, due to resulting bitter taste. To get the full benefit of Viracept by increasing its level in the body, it must be taken with a meal of at least 500 calories, with at least 20% to 50% of those calories coming from fat. Nelfinavir has been safely used in pregnant women to reduce the risk of transmission to their baby.

Doctor
Nelfinavir (NFV)—based regimens have generally been shown to be modestly inferior compared to efavirenz or boosted-PI regimens so use has been declining. By the time the newer formulation was available as well as a better understanding of the dosing recommendation relative to meals, the field of alternative attractive agents was crowded. GI side effects remain an issue with the new formulation. Advantages of nelfinavir include frequent preservation of PI sequencing options in the event of viral rebound, a good safety record in pregnancy, and demonstrated safety in patients with liver abnormalities.—Keith Henry, MD
Activist

We used to love this PI because it doesn’t require Norvir boosting, but geez the diarrhea really sucks. I took this one myself back in 1998. Highest T-cell count I ever had (over 700) but it got pretty frustrating not being able to take a normal poop for over two years… oh, the joys of the simple things in life. The new formulation, which was supposed to have less intestinal effect, came a little too late. It never really gained its ground back against Kaletra, although it is still used in pregnancy to prevent mother-to-child transmission. Too bad, this was a good drug, just had really crappy side effects.—Cathy Olufs

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