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New Expanded Access Drugs for Use in Combination Therapy

September 1998

These drugs are only available through expanded access programs. Therefore, they are experimental drugs and information about their best use, drug interactions and safety is limited.
September 1998 SUSTIVA/
Efavirenz
ZIAGEN/
Abacavir
PREVEON/
Adefovir
What kind of drug is this? nnRTI (non-nucleoside reverse transcriptase inhibitor, or non-nuke) similar to Viramune or Rescriptor. nRTI (nucleoside reverse transcriptase inhibitor) similar to AZT or 3TC. Nucleotide reverse transcriptase inhibitor similar in action to nRTIs but of a different chemical class.
What is the correct dose? 600 mg (three 200 mg capsules) once daily, recommended at bedtime because it may cause drowsiness. As with any HIV medication, take as prescribed. 300 mg (one tablet) twice daily. Take as prescribed. Not known. 120 mg daily (1 tablet) is being compared to 60 mg once daily (1 tablet). It must be taken with L-carnitine which is supplied by the company.
How should I store it? Room temperature, tightly capped. Room temperature, tightly capped. Room temperature, tightly capped.
How well does it work for people who have taken anti-HIV drugs before?

What about cross-resistance?

There is little information on using Sustiva in people with previous anti-HIV drug experience. However, if your virus is resistant to Viramune or Rescriptor, you are unlikely to benefit from Sustiva. There is little information on using Ziagen in people with previous anti-HIV drug experience. Early information suggests that the greater number of nRTIs (like AZT, ddI, d4T or 3TC) your virus is resistant to, the less likely you are to benefit from Ziagen. There is a bit more information here. On average, the addition of Preveon to existing combination anti-HIV drugs provides a modest additional anti-HIV effect.
How well does it work for people who have little or no anti-HIV drug experience? The combination of Sustiva/AZT/3TC reduced viral load and increased CD4 counts at least as well as Crixivan/AZT/3TC at 24 weeks after starting therapy -- which is pretty good. In one study, the combination of Ziagen/AZT/3TC reduced viral load and increased CD4 counts similar to that seen with other 3-drug anti-HIV combinations, but better than AZT/3TC at 48 weeks. However, results from direct comparisons to other 3-drug combinations have yet to be reported. With the limited information available, Preveon has modest anti-HIV effect similar to what has been seen with AZT or d4T when used alone. Combination studies are ongoing.
What is the effect on CD4 counts (T-cells)? The CD4 increases seen with Sustiva, when used in 3-drug combination therapy, are similar to those seen with protease inhibitor triple combination therapy. In one study a 3-drug combination of Ziagen/AZT/3TC produced CD4 increases similar to AZT/3TC -- approximately 90 cells. With the limited information available, Preveon provides a modest CD4 increase similar to what has been seen with AZT or d4T when used alone. Combination studies are ongoing.
How should it be used with other anti-HIV drugs? Sustiva should be used in combination with other anti-HIV drugs. If it is used with Crixivan, the Crixivan dose should be increased to 1,000 mg every eight hours. Sustiva lowers Fortovase levels by 60%, so using those two drugs together should be avoided. Ziagen should be used in combination with other anti-HIV drugs. So far, there are no known problems with any other anti-HIV drug, but the information is limited. Preveon should be used in combination with other anti-HIV drugs. So far, there are no known problems with any other anti-HIV drug, but the information is limited.
Is there information on using the drugs during pregnancy? No, but animal studies suggest a risk of birth defects. Not yet. Not yet.
Can it be used with other types of drugs? Once again, information is limited but the drug should not be used with Seldane, Hismanal or Propulsid. Sustiva reduced levels of Biaxen by 39%, so the Biaxen dose may need to be adjusted. Further studies are ongoing. No data are available on Sustiva's use with recreational drugs or methadone. Drinking alcoholic beverages increases Ziagen levels which could increase its side effects. Drugs that are processed by the liver in the same way as alcohol should be avoided: Antabuse, Parafon Forte, Thorazine, Chloral Hydrate and INH (for TB). No data are available on Ziagen's use with recreational drugs or methadone. Preveon is very stressful to the kidneys; therefore, using the drug in combination with other drugs which put strain on the kidneys may be a problem (for example, Cidofovir which is used for CMV infection, or certain antibiotics like amikacin or gentamicin). Studies are ongoing. No data are available on Preveon's use with recreational drugs or methadone.
What are the side effects? The most common side effects seem to be related to the nervous system. The drug can cause sleepiness, muddled thinking, dizziness, euphoria and nightmares, disorientation, even flashbacks. This may be problematic for people in recovery. Sustiva may also cause a rash, headache and nausea.

In animals, Sustiva caused serious birth defects. Therefore, it is important for women to avoid pregnancy while using Sustiva.

Nausea, vomiting, headache and fatigue appear to be the most common side effects. However, a small percentage of people (3 or 4 out of a hundred people treated) experience an allergic reaction, beginning with a low-grade fever along with nausea and a feeling of being run down. A red rash may be present within a day or two of the start of symptoms. IF THIS HAPPENS, CALL YOUR DOCTOR IMMEDIATELY! DO NOT TAKE ANOTHER DOSE OF ZIAGEN UNTIL YOU SEE YOUR DOCTOR. IF YOU STOP THE DRUG AND THE REACTION GOES AWAY, DO NOT RESTART THE DRUG. A very serious reaction happens if you take the drug again including very low blood pressure, liver and kidney problems, very high fevers, and problems with blood cells, which could require hospitalization and could be life-threatening. This drug is very hard on the kidneys. Close to 40% of people taking Preveon for six months or longer have reduced kidney function. If you take this drug, it is important that you and your doctor monitor your blood for phosphate and creatinine levels, markers of kidney problems. If kidney problems occur, they seem to get better once the drug is stopped although it can take months. Therefore it is important to be careful about using other drugs that are hard on kidneys when using Preveon (e.g., Cidofovir, amikacin, gentamicin). The 60 mg dose is being compared to the 120 mg dose to see if it is less toxic to the kidneys. Other side effects include increases in liver enzymes, nausea, vomiting and loss of appetite.
Is there any information on using the drug in children? Does it come with a liquid formulation? Sustiva is available in liquid formulation. Pediatric information was included in the company's application for approval but little is known about the proper dose at this time. Ziagen is available in a strawberry/banana liquid formulation. The dose for children is 8 mg/kg. In one study in children 3 mths to 12 years with previous anti-HIV drug experience, the combination of Ziagen/AZT/3TC lowered viral load in more kids than the combination of AZT/3TC alone at 16 weeks. However, only 13% of those taking 3-drug combination had viral loads below detection (<400). No information is available at this time. We will continue to follow.
Where is the drug available? Only through an expanded access program for those experiencing treatment failure with available therapies and with less than 400 T-cells: 1-800-998-6854. Only through an expanded access program "for people unable to put together an effective anti-HIV drug combination." Your doctor must call: 1-800-501-4672. Only through a randomized expanded access program. You could get the standard 120 mg or less studied 60-mg dose. Watch out! 1-800-GILEADS.
How much does the drug cost? Free in expanded access program. The company applied for approval in June, likely to be approved in the fall. Price unknown. Free in expanded access program. The company applied for approval in June, likely to be approved this fall. Don't know yet. Free in expanded access program. Filing for approval is expected at the end of 1998. Could be approved in 1999. Don't know yet.


  
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This article was provided by PWA Health Group.
 
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