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Treatment News

Three New Drugs Approved by FDA

November/December 2003

A note from The field of medicine is constantly evolving. As a result, parts of this article may be outdated. Please keep this in mind, and be sure to visit other parts of our site for more recent information!

Gerry Hoyt

Three new drugs have been approved by the FDA for the treatment of HIV, which makes a total of 24 medications now available.

Fuzeon -- A New Class of Drugs

Enfuvirtide, also called Fuzeon or T-20, is the first new class of drug to be introduced since Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) were introduced in the mid-1990s. Fuzeon is manufactured by Roche and Trimeris, Inc. This new class of drug is called a "fusion inhibitor." According to the New Mexico AIDS InfoNet, "When HIV infects a cell, it attaches to the outside of the cell. Then it 'fuses' or joins itself with the cell. Enfuvirtide stops this process of fusion. This means that HIV cannot infect that cell."

They also state, "The HIV virus is sloppy when it makes copies of its genetic code (RNA). Many new copies of HIV are mutations: they are slightly different from the original virus. Some mutations can continue to multiply even when you are taking an antiviral drug. When this happens, the drug will stop working. This is called 'developing resistance' to the drug."

If taken alone, resistance to Fuzeon can develop quickly. In the 2003 Guidelines for the Use of Antiretroviral Agents in HIV-1 Infected Adults and Adolescents (Department of Health and Human Services, June 2003), monotherapy is not recommended under the current standard of care. On page 22 of these guidelines it states, "All single-drug regimens are considered contraindicated because none have demonstrated potent and sustained antiviral activity."

With combination therapy, we know that HIV mutates much more slowly. Therefore, resistance is slower in developing. As with any antiviral medication, Fuzeon should be taken according to the directions, on schedule and without skipping doses or altering the dose taken. Fuzeon does not have cross-resistance with any other antiviral drug.

Fuzeon is injected subcutaneously twice daily. It is especially useful for folks who have exhausted other antiviral medication options. In the Spring-Summer Pull-Out Drug Adherence Chart published by, daily dosing for adults is 90 mg subcutaneously, twice daily. In children ages six to sixteen, 2 mg per kg of body weight (maximum 90 mg), twice daily.

Side effects include diarrhea, nausea and fatigue. The most common side effect of Fuzeon is skin reactions at the sites where the drug is injected. These vary from a very mild redness, which might include minor itching, to a swelling, hardening of the skin and lump, which can last up to a week.

In a conversation with Dr. Jean Robinson, P.H.M.D., pharmacist and patient educator at Pride Medical, Inc., here in Atlanta, she stated, "Most of these bumps can be prevented by massaging the site for five to fifteen minutes after injected the drug." Dr. Robinson will join a panel of patients and medical professionals for a Lunch & Learn on Wednesday, November 12 at AIDS Survival Project from 12 noon to 2:00 p.m. This forum, sponsored by Roche, is designed as a question and answer panel for those patients who are either on Fuzeon or considering using the drug in the near future. Community advocates and health care professionals are also invited to attend. This Lunch & Learn is another free program of ASP. Please RSVP by Monday, November 10 at (404) 874-7926 so we can have an accurate count for lunch.

For patient support, visit or call toll-free (877) 438-9366.


Atazanavir or Reyataz (formerly known as BMS-232632) is manufactured by Bristol-Myers Squibb. As with other protease inhibitors, Reyataz prevents the protease enzyme from working. Again quoting from the New Mexico AIDS InfoNet (Fact Sheet Number 447), "HIV protease acts like a chemical scissor. It cuts the raw material for HIV into specific pieces needed to build a new virus. Protease inhibitors 'gum up' these scissors."

Recommended dosing is 400 mg by mouth once per day, taken with food. Reyataz is available in capsules of 100 mg, 150 mg and 200 mg. As with other protease inhibitors, Reyataz should be taken in combination with other antivirals to avoid cross-resistance. Reyataz provides blood levels that are high enough to control HIV that has already developed some resistance to other protease inhibitors. Again, follow label instructions as well as the recommendation of your health care provider.

This fact sheet continues by stating, "The side effects reported in clinical trials include high levels of bilirubin on over 30% of patients who took the drug. The liver produces bilirubin when old red blood cells are broken down. High levels of bilirubin can cause yellow skin or eyes (jaundice). This occurred in about 10% of patients.

"High bilirubin can be a sign of liver damage. However, this is not the case for people taking Reyataz. The drug blocks normal removal of bilirubin. Less than 1% of patients stopped taking atazanavir due to high bilirubin levels."

Because Reyataz is processed in the liver, it can interact with other drugs broken down via the liver. Drugs to be aware of which may contraindicate with Reyataz include Viagra, several antihistamines, sedatives and drugs to lower cholesterol and antifungal drugs. Remember to inform your health care providers about all medication you are taking.

Other precautions when combining Reyataz with other drugs include:

  • When taking the original form of ddI, the latter should be taken two hours before or after the former. You should also allow one hour between taking this with an antacid.

  • Sustiva lowers blood levels of Reyataz. It is recommended that when combining these two drugs, the dose of the latter will need to be changed and probably a small dose of Ritonavir will be added.

  • There are no data presently showing contraindications with birth control pills.

  • St. John's Wort lowers the blood levels of some protease inhibitors. Again, keep your health care providers aware of all medications you are taking.

For patient information, contact, or for their Patient Assistance Program, call toll-free (877) 758-7877.


Emtricitabine, also known as Emtriva and formerly known as FTC, is manufactured by Gilead Sciences and is a nucleoside analog reverse transcriptase inhibitor, or "nuke." These drugs block the reverse transcriptase enzyme, which changes HIV's genetic material (RNA) into the form of DNA. This has to occur before this code gets inserted into a cell's own genetic code. The drug is approved for persons with HIV over age 18. Emtriva has not been approved for use in younger people or people co-infected with HBV (hepatitis B), and there have been reports of those with HIV/HBV co-infection whose hepatitis B worsened after discontinuing Emtriva.

Cross-resistance has been shown with 3TC. As mentioned above, follow directions and notify your health care provider of all medications you are taking.

Emtriva is available in 200 mg tablets. The normal dose is 200 mg daily: one tablet once a day, taken either with food or between meals. Notify your health care provider about any history of kidney problems, as this may indicate a lowering of the prescribed dose.

Side effects reported include headaches, high blood pressure or general malaise. These usually subside or disappear in time. Some reports of nausea and rash as well as increased levels of lactic acid in the blood (lactic acidosis). Liver problems including "fatty liver" may also occur. All of the information above can be found on Fact Sheet Number 420 from the New Mexico AIDS InfoNet ( There are no significant interactions reported when combining this drug with other antivirals.

For further information, you may contact Gilead Sciences, Inc., at

For more information about these and other treatments, remember that our Treatment Resource Center is open Monday to Friday from 10:00 a.m. until 5:00 p.m. Or, you may call either George Burgess at ext. 19 or me at ext. 13 to access information.

Finally, a note about our last Treatment Forum on Thursday, November 20 here at ASP from 12:00 noon until 2:00 p.m. about smoking cessation and the effects of tobacco on those living with HIV. This is the "Great American Smoke-Out." We promise no guilt -- just the facts and some alternatives to "cold turkey," just in time for Thanksgiving!! Please RSVP by Tuesday, November 18 so we may have an accurate count for lunch.

A note from The field of medicine is constantly evolving. As a result, parts of this article may be outdated. Please keep this in mind, and be sure to visit other parts of our site for more recent information!

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This article was provided by AIDS Survival Project. It is a part of the publication Survival News.
See Also
More on HIV Medications
More on Fuzeon (Enfuvirtide, T-20)