Chemical structure of nelfinavir
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Viracept


Nelfinavir (Viracept®) is an antitretroviral drug used in the treatment of the human immunodeficiency virus (HIV). Nelfinavir belongs to the class of drugs known as protease inhibitors (PIs) and like other PIs is generally used in combination with other antiretroviral drugs; the other major group of antiretrovirals is the reverse transcriptase inhibitors. Nelfinavir is presented as the mesilate (mesylate) ester prodrug. more...

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History

Nelfinavir was developed by Agouron Pharmaceuticals, at the time a division of Japan Tobacco but now a subsidiary of Pfizer. It was granted FDA approval for therapeutic use in 1997. Agouron's patent on the drug will expire in 2014.

Mode of action

Nelfinavir is a protease inhibitor: it inhibits HIV-1 and HIV-2 proteases. This protease is an enzyme which cleaves viral protein molecules into smaller fragments, and it is vital for both the replication of the virus within the cell and also the release of mature viral particles from an infected cell. Though this mode of action is common to all protease inhibitors, the precise mode of binding of nelfinavir to the enzyme may be sufficiently unique to reduce cross-resistance between it and other PIs. Also, not all PIs inhibit both HIV-1 and HIV-2 proteases.

Toxicity

Nelfinavir can produce a range of adverse effects. Common (experienced by more than one in one hundred patients; greater than 1%) are flatulence, diarrhoea or abdominal pain. Infrequent (experienced by one in one thousand to one in one hundred patients; 0.01 - 0.1%) adverse effects are fatigue, rash, mouth ulcers or hepatitis. Rarely (less than one in one thousand patients; under 0.01%) nephrolithiasis, arthralgia, leucopenia, pancreatitis or allergic reactions may occur.

Interactions

Nelfinavir's interaction profile is similar to that of other protease inhibitors. Most interactions occur at the level of the Cytochrome P450 isozyme 3A4, by which nelfinavir is metabolised.

Read more at Wikipedia.org


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HIV drug approvals increase options for adults, children - protease inhibitor Viracept is approved for HIV-infected children and adults - Brief Article
From FDA Consumer, 5/1/97

A new protease inhibitor for treating HIV infection--not only in adults but children, as well--has been approved by FDA. In addition, the agency has given "pediatric use" labeling to an already approved protease inhibitor for adults.

New protease inhibitor Viracept (nelfinavir) and the previously approved Norvir (ritonavir) are some of the most powerful medicines against HIV, the virus that causes AIDS.

FDA granted the approvals March 14. Viracept's approval came about three months after FDA received the drug application. Its labeling will include a "pediatric use" statement that gives doctors specific dosage recommendations for patients 2 to 13.

"[These] actions not only add another powerful weapon to our arsenal for treating HIV infection but provide us with critical information on using these cutting edge drugs to help HIV-positive children," HHS Secretary Donna E. Shalala said.

Viracept received "accelerated" approval, a regulatory mechanism in which FDA bases early approval for a product on laboratory markers (such as plasma HIV RNA, a measure of viral load) until clinical endpoints (such as disease progression or rates of death) are available.

The drug's "pediatric use" labeling stems from a 1994 regulatory reform measure designed to ease the process of including drug label information to help doctors treat pediatric patients with serious or life-threatening diseases. Pediatric labeling information can now be included when evidence suggests that the course of the disease and effects of a drug are similar in children and adults.

In clinical studies of up to 24 weeks, the new drug was active when used alone or with other antiretroviral drugs for HIV. But because its antiviral activity is increased when used with the other drugs, combination therapy is recommended.

The most common side effect is diarrhea, which can usually be controlled with over-the-counter medicines. Other side effects include nausea, vomiting and weakness.

The drug cannot be used concurrently with several other drugs because of possible drug interactions that cause serious, potentially life-threatening irregular heartbeats or prolonged sedation. The potential drug interactions will be clearly highlighted on the package label.

Viracept is marketed by Agouron Pharmaceuticals, of La Jolla, Calif. Norvir is marketed by Abbott Laboratories, of Abbott Park, Ill.

COPYRIGHT 1997 U.S. Government Printing Office
COPYRIGHT 2004 Gale Group

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