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Norvir

Ritonavir, with trade name Norvir®, is an antiretroviral drug from the protease inhibitor class used to treat HIV infection and AIDS. more...

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Ritonavir is frequently prescribed as the protease inhibitor component in HAART because it inhibits the same host enzyme that metabolizes NRTIs and NNRTIs. This inhibition leads to higher plasma concentrations of these latter drugs, allowing the clinician to lower their dose and frequency.

History

Ritanovir is manufactured as Norvir® by Abbott Laboratories. Research that led to the drug's development was financed in part by a $3,500,000 federal grant through the National Institutes of Health (NIH). The Food and Drug Administration (FDA) approved ritanovir on March 1, 1996, making it the seventh approved antiretroviral drug in the United States.

In 2003, Abbott raised the price of a Norvir course from USD $1.71 per day to $8.57 per day, leading to claims of price gouging by patients' groups and some members of Congress. Consumer group Essential Inventions petitioned the NIH to override the Norvir patent, but the NIH announced on August 4, 2004 that it would not invoke its legal right to allow generic production of Norvir, citing potential adverse effects on the pharmaceutical market.

Method of action

Ritanovir is exceptional as the only antiretroviral drug that inhibits a liver enzyme that normally metabolizes away protease inhibitors, Cytochrome P450-3A4 (CYP3A4). The drug's molecular structure inhibits CYP3A4, so a low dose can be used to enhance any other protease inhibitors. This effect does come with a price: it also affects the strength of numerous other medications, making it difficult to know how to administer them concurrently. In addition it can cause a large number of side-effects on its own. It is now rarely used for its own antiviral activity but remains widely used as a booster to other protease inhibitors.

Read more at Wikipedia.org


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Abbott plans for Norvir® capsule shortage
From Drug Store News, 8/24/98

Abbott Laboratories is experiencing manufacturing difficulties with the capsule formulation of its protease inhibitor Norvir(r) (ritonavir). An undesirable crystalline structure that affects how the capsule dissolves was discovered recently. Abbott announced that Norvir capsules currently in distribution are not affected by this issue.

Until the problem is solved, Abbott is preparing for a shortage of Norvir capsules by increasing production of Norvir liquid. Norvir liquid is available in a strength of 80 mg/ml. Abbott states that six Norvir capsules (100 mg each) are equal to 7.5 ml or one and a half teaspoons of Norvir liquid. The liquid is stored at room temperature and is stable for 30 days after dispensing. To ensure that patients receive proper dosing, advise patients to shake the liquid well before each use. Palatability may be of concern to some patients. In an open letter to Norvir consumers, Abbott recommends mixing Norvir liquid with chocolate milk, Ensure or Advera within one hour of dosing.

COPYRIGHT 1998 Reproduced with permission of the copyright holder. Further reproduction or distribution is prohibited without permission.
COPYRIGHT 2004 Gale Group

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