FYI: From some different sources
Ritonavir associated with possible kidney dysfunction
14 Sept 1998 12:07:39 -0500
From: Mary.Elizabeth@aegis.com
Although indinavir (Crixivan) is the protease inhibitor most associated
with kidney problems, a report from France suggests that ritonavir (Norvir)
may also have the potential to cause kidney
dysfunction.
In a letter appearing in the August issue of Clinical Drug Investigation,
French doctor G. Deray of the Groupe hospitalier Piti‚-SalpˆtriŠre in Paris
reported findings that suggest a link between ritonavir and kidney
problems. He reviewed the charts of 87 PHAs who were receiving ritonavir
and found that about 14% had high levels of creatinine in their blood,
suggesting the possibility of kidney damage. On average, 50 % of the
affected people developed elevated creatinine levels after 6 months of
ritonavir use. Although the connection between ritonavir and kidney
dysfunction remains to be confirmed, Dr. Deray suggests that patients using
ritonavir have their kidney function monitored "closely" so evidence of
kidney damage can be found before it becomes serious.
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RE: Remune
Entering a Trial
By Joel E. Gallant, M.D., M.P.H.
My doctor has invited me to participate in a Remune trial. I'm more than happy to do my part by participating because I owe my survival today to the past willingness of a lot of brave people. I'm fifteen years positive, six years on anti-virals, AZT, then DDC, then DDI, then D4T currently a year and a half on combo: Crix/D4T/3TC. My viral load is <50 and my CD4's hover around 500 and my overall percentage is about 21%. What I've read so far suggests that Remune is most effective for people newly converted. Is this a waste of time? Do you think I can expect to see some benefit? And by the way, I bet a lot of your patients develop crushes on you too. I've got a cyber one myself!
Answer:
If there's a benefit to Remune (and recent evidence suggests that there may be), I don't see any reason why it would be confined only to those who are recently infected. Data presented in Geneva suggest that Remune may decrease levels of tumor necrosis factor alpha and may increase HIV-specific T-cell proliferation. Since your viral load is undetectable already, there is probably little harm in enrolling in the trial.
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From: Ask Changing from 3tc, d4t Crix to 3tc, d4t,Fortovase, liquid Norvir
By Joel E. Gallant, M.D., M.P.H. Dear Dr.,
After having been on the first combo (3tc,d4t and crix)for 2 1/4 years, having been hospitalized twice, the last time this past May, my doctor and I decided to switch to a less kidney stone prone combination (Pardon me?). I might add that my t cells are 306 with a vl of 100 so it seems the combo was good except for side effects which were quite painful requiring hospitalization and operations both times.
I have been on the new formula 3tc, d4t, Fortovase and liquid Norvir (tastes absolutely awful but what can one do). for only a week. UP to 3.75 ml twice a day with the Norvir. I am almost drunk from this combo. I get so dizzy that I cannot perform routine daily tasks around my apartment. The pharmacy says that this is normal and takes time to adapt. also my vision is a bit off and every time I move my head suddenly it seems like the sensation of moving my head is behind the reality of the movement. What is causing this? How long should it take me to adapt. Are the capsules available and would they be better for me? Starting tomorrow I go up to 5 mls twice a day starting tomorrow and I really dread it. Should I go back to the crix or is it too late? Please advise and give your opinion.
Thanks,
DIZZY IN NEW YORK Dear dizzy,
Liquid Norvir does contain some alcohol, but I wouldn't think it would be enough to make you drunk. I haven't seen the problems you're describing in patients taking Norvir. There are still a few pharmacies around that have some of the capsules, but they're running out fast. You could call around and see if there's any to be had in your area.
Norvir side effects tend to get better after a few weeks, so it's not a good idea to give up too soon. However, if you really can't tolerate it, it seems like you'd still be a candidate for Viracept, since your presumably have no protease inhibitor resistance. It's considerably easier, especially compared to the liquid formulation of Norvir.
There a number of things that you can do to make liquid Norvir a little more palatable. Try sucking on some very sour candies (like Warheads--yucch!) or strong mints (like Altoids) before you take it. Drink chocolate milk or chocolate Ensure along with the Norvir. Afterwards, peanut butter can help to get rid of the aftertaste. Good luck!
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Spare the Protease but Keep the Price?
There is a petition being circulated among many organizations, addressed to Dupont and Glaxo, concerning the eventual pricing of abacavir (Ziagen) and the nNRTI efavirenz (Sustiva). There are rumors they will be priced like protease inhibitors. Here are some parts of the "Consensus Statement on the Pricing of Abacavir and Efavirenz"
We, the undersigned, have grave concerns regarding the overall cost
of therapy for HIV disease. While we are heartened by the progress
made in moving toward simpler, easier to use regimens, we are
dismayed by the possibility that prices of new drugs in the
nucleoside and non-nucleoside RT inhibitor class might be similar to
those of protease inhibitors, rather than other drugs in their own
respective classes.
Such inappropriate pricing will quickly outweigh
any possible added benefits of new drugs like (Ziagen) and efavirenz
(Sustiva). As drugs become available which might facilitate better
adherence and possibly more durable long-term treatment,
manufacturers should be planning to lower the daily cost of their
regimens, not increase them. The long-term survival afforded by the
present generation of therapies makes it possible for manufacturers
to set lower, or at lest stable prices, and still have adequate
incentive to reinvest in continued development of HIV/AIDS drugs.
To the best of our knowledge, the development costs of these drugs
were not comparable to those of the first protease inhibitors, nor is
on-going cost of product as high. Quite the contrary, because of the
efficiency of the new drugs, far fewer pills and thus much less
physical product is required for dosing on a daily basis. Similarly,
there has been nothing extraordinary about the cost of clinical
trials required to bring these drugs to market.
Abacavir and efavirenz are likely to be used by both treatment naive
and treatment experienced patient populations, making their potential
market very large. If the prices are high and either or both drugs
used in naive populations in place of existing drugs, the overall
cost of therapy will go up. An even greater cost penalty will occur
for treatment experienced patients, who are likely to use both drugs
together, often in combination with a protease inhibitor. This would
lead to an unacceptably high cost of therapy. We cannot stand idly
by while the price of living with HIV disease escalates so rapidly.
State ADAP programs have limited amounts of money allocated to them
each year. Many of the state's annualized programs are bankrupt prior
to fiscal year-end. Some state ADAP and Medicaid programs have
removed vital medications to prevent and treat opportunistic
infections from their formularies. State ADAP and Medicaid programs
are under close scrutiny by governmental panels in order to cut costs.
The price of one drug can affect the availability of other
medications. Increasingly, this same sad scenario is beginning to
affect the availability of drugs within HMO settings. The price of
these drugs will have a pervasive impact on the overall quality of
care people with HIV/AIDS receive in this country.
..Exploitative pricing will trigger widespread hostility, contentious
debate and closer scrutiny of industry practices in general. This
will have far reaching consequences. Have DuPont Pharma and Glaxo
Wellcome considered the possible repercussions of opening this
Pandora's box? Are you willing to risk the aftermath of ill will
within the community and to be held accountable within industry?
Therefore, we must clearly state for the record that the only
acceptable prices for these drugs must be in accordance with other
drugs of their respective classes. We urge manufacturers to
immediately begin a dialogue with the community about this pricing
issue and not presume it can simply announce a price immediately
prior to regulatory approval, without consequences, as a fait
accompli.
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