HIV Digest	HIV Digest Archive

Although the news of the past year has been good for many people with HIV, the new drugs don't work for everyone. Many who have used the new antiviral combinations have failed them because of HIV drug resistance. Others have been unable to tolerate the drugs or schedule them into their lives due to complicated dosing requirements. Fortunately there are new antivirals for those seemingly without options. Expanded access programs are now offering these new drugs to those who can't afford to wait.

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Expanded access

Expanded access programs enable patients who are seriously ill and have failed available therapies use of experimental drugs. In previous expanded access programs, people with HIV usually gained access to one experimental antiviral at a time, which was usually then used alone or added into an already failing drug combination. It's now known that because of how HIV develops resistance, using antivirals in this way is a mistake. So it's recommended that when switching to a new drug regimen you use at least two new antivirals, preferably powerful ones, to which HIV has not become cross-resistant.

Unfortunately, if you have failed all the current drugs then chances are your HIV may be resistant to at least one and possibly two of these new drugs. If so, then enrollment in more than one expanded-access program is recommended-- and preferably all three. Doing so will help insure that you assemble a strong and effective regimen against HIV. Even if your HIV is somewhat resistant to these new drugs, the combination of all three may still be powerful enough to stop the virus.

New drugs on the block

Abacavir (formerly known as U89-1592) is a nucleoside analog reverse transcriptase inhibitor or nuke RT Inhibitor. Nuke RT inhibitors like Abacavir stop the virus at the same point as drugs like AZT or DDI, but Abacavir is far more powerful. It appears that if you have already failed the nukes DDI or D4T, Abacavir still can help. When tested in such people, it brought the amount of virus down by 97% (1.5 log). Unfortunately, if you've failed AZT or AZT-3TC, Abacavir alone appears to offer little help in suppressing HIV (.05 log or 10% reduction in virus). The current access program for Abacavir is expected to expand in size early this year. Details on entrance criteria were not available at press time. Call Glaxo-Wellcome at 800-501-4672.

Sustiva (or DMP266) is a non-nucleoside reverse transcriptase inhibitor, or NNRTI, from Dupont-Merck. Non-nukes like Sustiva stop the virus at the same point in the viral life cycle as the nukes. Data suggest that Sustiva may still work if you've failed the other non-nukes, Nevirapine and Delavirdine (1.5 logs drops or 97%), although Dupont-Merck is claiming otherwise. Sustiva requires only once-daily dosing. You may be eligible for the Sustiva program if at any time you've had a CD4 cell count of less than 400 cells/mm3, you are failing or intolerant to your current treatment regimen, and your doctor is not able to assemble a treatment combination without Sustiva that is likely to produce a sustained reduction in viral load. Call 800-998-6854 for more information.

Adefovir (Preveon or PMEA) is of a whole new class of antivirals called nucleotide RT Inhibitors. Adefovir also blocks the virus at the same point as the nukes and the NNRTIs, but, as a nucleotide, it needs less processing by the body than the other RT inhibitors for the drug to change into its active form. Although Adefovir does not seem to be very powerful at suppressing HIV, dropping the amount of virus by only about 0.7 logs or 70%, it has two advantages over current antivirals. Adefovir is slower to develop resistance than current drugs, so it can suppress HIV for longer periods of time. Adefovir is also a broad-spectrum antiviral that suppresses other viruses that contribute to HIV-disease progression. And it appears that if you've failed the current drugs, Adefovir may still work for you. Adefovir only needs to be taken once a day. But because it depletes the body's stores of the amino acid L-carnitine, you will be required to take a daily 500 mg L-carnitine supplement with the drug. An additional potentially serious side effect of Adefovir is kidney toxicity. To qualify for the Adefovir program you must have failed at least two nucleoside analog RT inhibitors and one protease inhibitor, and within the last two months have had a CD4 count of 50 or less, and a viral load of at least 30,000 by PCR. There are other criteria as well. To find out more, call Gilead Sciences at 800-445-3235.

What's at stake

It's important to have a doctor who is willing to use expanded access programs to get you the drugs you need to keep the virus at bay and stay alive. Patients without treatment options should never be denied access to therapies that may save their lives. If youar provider is unwilling or unable to register you for any of these programs, call the numbers above to find out which doctors in your area are enrolled.

Author Profile:  Robert Folan-Johnson
Robert Folan-Johnson is a member of the AIDS Writers Group.
Email:	rofojo@sfac.org