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New Drug Comparison Chart

September 1997

‘96-’ NEW DRUGS And the Nominees for 1997 Are...


VIRAMUNE/
Nevirapine
RESCRIPTOR/
Delavirdine
VIRACEPT/
Nelfinavir
What kind of drug is this?
There are now three families of AIDS drugs:

nucleosides
NNRTIs
protease inhibitors


An NNRTI (non-nucleoside reverse transcriptase inhibitor). These work like nucleosides, but in a different way. NNRTIs vary in strength and seem to cause fewer side effects.Delavirdine is an NNRTI, much weaker than Nevirapine. It may delay or affect AZT-resistant HIV.Nelfinavir is a protease inhibitor.
What is the correct dose?200mg once a day for the first 2 weeks, then 200mg twice a day thereafter. This building up is to prevent a rash. Supposed to be taken with at least one nucleoside.400mg three times a day. Note: these are 100mg tablets, so this adds up to 12 pills a day. The pills can be crushed and mixed with water for easier consumption.750mg three times a day with food. Tablets are 250mg each. Dose for children: 20-30mg/kg daily not to exceed 750mg a day. Also in powder form to mix with water, milk, or pudding.
How to store it?Room temperature, tightly capped.keep in a cool dry place.Room temperature.
What is the effect on disease progression?Unknown. ACTG 241 (n=398) suggested better survival with Nev/ddI/AZT over AZT/ddI. ACTG 1931 (n=1314) found no survival benefit, but had a 74 percent dropout rate. (bad design!)Unknown. One Del/ddi study reported fewer opportunistic infections in the combo arm compared to ddI alone, but the number of deaths in both arms was similar.Unknown. Studies are currently underway to look at opportunistic infections and survival.
What is the effect on the virus?Strong combo. Nev/ddI/AZT dropped the virus to undetectable in 70 percent of PWAs (-1.4 logs) but it crept up during the year. Same triple dropped HIV in the lymph to undetectable in 3 of 4 PWAs. Good brain penetration. Maybe useful for stopping vertical transmission.Unclear. A Del/AZT combo lowered viral load more than AZT alone. A Del/ddI combo lowered viral load (-.8 log) but this effect didnít last. No data on lymph or brain penetration, but the manufacturer claims it gets in the brain.Strong in combo. A triple combo of Nel/AZT/3TC lowered the virus to undetectable in 80 per cent of participants at six months. in 8 out of 9 PWAs, brought virus to undetectable in the lymph nodes. no effect in brain.
How long does the antiviral effect last?In one study, 58 per cent on a triple drug combo (Nev/AZT/ddI) had undetectable levels of virus in their blood after one year. This was down from 70 per cent of participants at six months.Good question. Current data is unclear.Small studies, but one triple combo study showed that at 10 months, HIV remained below detection.
What is the effect on CD4 counts? (T cells)?Significant increase, better in people who havenít taken any anti-virals before. T cell boost didnít last as long in people with prior antiíHIV drug experience.Compared to other antivirals, the effect is small. A study of Del/ddI showed a moximum increase of 30 T-cells at 8 weeks, which didnít last. Another study in combo with AZT fared only slightly better.An average increase of a little over 100 T-cells noted in one study. This increase remained throughout study.
Can it be used with other anti HIV drugs?Must be used in combo with nucleosides (AZT, ddI ddC, d4T, or 3TC), preferably two, due to rapid resistance. May lower Crixivan levels, or other protease levels, so safety with protease combos is completely unknown.Can it! Must be taken with AZT or another nucleoside or resistance develops in a week or two. Safety with protease inhibitors is totally unknown, as it greatly increases their active blood levels.Should be taken in combo with nucleosides like AZT, ddI, 3TC, or d4T. Might work with other protease inhibitors by boosting their levels, but safety with protease is unknown right now.
Can it be used with other types of drugs?Donít take: Rifampin, Rifabutin, or Ketoconazole. Women on birth control pills should be aware that nevirapine may make birth control not work! Note: there;s an increased risk of rash if used with Fluconazole.Do not use with Seldane, Hismanal, Xanax, Versed, Halicon, Propulsid, Rifabutin, Rifampin, Dilantin, Phenobarbital, Tegretol, Tagamet, Pepcid, Axid, Zantac. ddI and all antacids need to be taken at least one hour apart from taking Delavirdine.Donít take: Rifampin, Seldane, Propulsid, Hismanal, Halcion, Versed, and birth control pills. Nelfinavir increases blood levels of Rifabutin 3 times. Current recommendations are to cut dose of Rifabutin in half.
What are the side effects?Mild, except for skin rash, which can be very serious. 20 per cent of trial participants had rashes, which mostly resolved in a few hours or days. 7 percent had very serious rashes which sometimes required hospitalization. Usually appears in first month of treatment. Also reported: fever, nausea, headache, and increased liver enzymes.Mild, except for skin rash, which usually occurs in 1-3 weeks after starting treatment. Rash usually gets better without reducing dose. Also reported: headache, fatigue, nausea, and diarrhea.Diarrhea. Described as mild by the researchers, which means 2-6 bowel movements a day. Usually controllable by Lomotil, but can be quite serious. Also reported: nausea and flatulence. Whereís that can of lemon-fresh Lysol?
How important is it to take the drug exactly as prescribed?Critical in order to get the maximum benefit form combination therapy. Taking anti-virals as prescribed is the only way to lessen the chance of developing resistance. do not take less than the full dose. But if you miss a dose - donít give up!To get the maximum benefit, itís best to take the dose exactly as prescribed in order to maintain strong enough blood levels.Critical in order to get the maximum benefit from combination therapy. Missing doses or taking lower doses might cause HIV resistance. Viracept was approved to be taken three times a day, so itís more flexible than the other protease inhibitors.
Can taking it make you resistant to other drugs (cross-
resistance)?
Possibly with Delavirdine, or new NNRTIs in development. No cross-resistance with nucleosides or protease inhibitors.Possibly with Nevriapine or other NNRTIs in development.Possible cross-resistance to other protease inhibitors, although it appears that the chance is less than with Crixivan, Ritonavir or Saquinavir. Too soon to know.
Where is the drug available?Most pharmacies in U.S. Patient assistance: 800-274-8651 (Roxane Reimbursement Services)Drug info: 800-542-6257 Most pharmacies. Patient assistance 800-711-0807 (Rescriptor reimbursement, free drug programs, SSI-like reqmíts)Drug info: 800-432-4702Most pharmacies Patient assistance 888-777-6634 (Viracept assistance and free drug program-hard to get through) Drug info: 888-847-2237
How much is it?Drug store prices vary between $2,500 to $3,000 per year.Drug store prices vary between $2,500 to $3,000 per yearDrug store prices vary between $5,700 to $7,000 per year. Brother, can you spare a dime!



  
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This article was provided by PWA Health Group.
 

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