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Question #1: problems with first regimen Question #2: Nelfinavir
Jul 30, 1997

Question #1:

Dear Doctor, My wife began treatment with AZT + 3TC on 7th June. On 14th July she tried to add Crixivian but vomited violently after the very first dose. No other doses were taken. She took the Crixivain after a meal on the doctor's say. Is this the correct time for taking it? On 14th July she began Invarase upto now. This is being reasonably tolerated. However, I read that Invarase is very weak and resistance to it is also developed quickly. Even more importantly, I understand that there are many cross resistance problems with Invarase so that she may be ruining her chances to use other PIs in the future. Should we stop this? Nelfinavir is not available here yet and may not be available until early next year. (Have you got the email/web address for the company marketing Nelfinavir as I would like to ask them about this?). What do you think she should do? Her CD4/viral load before treatment in early June was 430/55,444. Can she stop all HIV drugs and restart again early next year with same nucleouds and Nelfinavir? What are the chances that she may have already developed resistance to AZT + 3TC? What are her options???

Question #2:

Dear Doctor, Nelfinavir is not available her. Can I buy it if I come to USA armed with a letter from the doctor/hospital. Do you see private patients from abroad. If so what are the costs? Thank you so much.

Response from Mr. Sowadsky

Hi. Thank you for your question. Only your wife's physician can answer these types questions. Nobody on the Internet can tell your wife what treatment options are best for her. This is because nobody on the Internet knows her entire medical history, all of the medications she is taking (not just antiviral medications) and all of her lab reports.

The decision as to what treatment options are best for your wife are based on several factors including (but not limited to):

What drugs are available in your country.

Her entire medical history. Not all people can take all drugs, and people with certain medical problems cannot take certain drugs. For example, people with liver or kidney disease may not be able to take certain medications.

Other drugs she is taking. Not all drugs are compatible with one another. For example, if a person is taking certain drugs for Tuberculosis (TB), they may not be able to take some of the Protease Inhibitors, due to drug interactions. Also, some of the antiviral drugs should not be taken together, due to drug interactions.

Your wife's viral load and CD4 cell counts. The decision whether she needs to change drugs are often based on any changes in these lab results over time. Trends in CD4 counts over time, and trends in viral load over time, are often the best indicators if changes in drug treatment are necessary. A drug that may work for one person may not work for another. For some people, Invirase may work great and for others, the drug may not work at all. The same can be said of ALL of the antiviral drugs, not just Invirase.

How well she tolerates a drug. For some people, they can tolerate a given drug very well, but another person taking that exact same drug, cannot tolerate it at all. All of our bodies are different from one another, and our bodies respond to drugs differently.

The strain of the virus she has makes a big difference in terms of treatment success. Some strains of HIV are sensitive to all of the antiviral drugs. Some strains are multi- drug resistant.

How long she has been infected. Generally speaking, the longer a person has been infected, the greater the chance that therapy will fail, if treatments are begun late in the disease. This is why we are promoting treatment early on in the disease, rather than later on.

What drugs she has taken in the past. If she was on medications for quite a long time, there is a greater chance for drug resistance. If she was previously on monotherapy (as was the standard of care years ago), she has a greater chance of treatment failure. Also cross-resistance can occur for a number of the antiviral drugs, not just Invirase. For example, cross resistance can also occur between Crixivan and Norvir (depending on the mutation causing the resistance). So depending on the drugs she was taking previously, this may limit her treatment options today.

There is no such thing as a "best" drug combination or cocktail. A drug combination that works great for one person may be useless (or have intolerable side effects) in another person. Often the best drug combinations for a specific individual are discovered through trial and error. Your wife should not change her treatment without discussing this with her personal physician first. If anyone on the Internet tells you, "your wife should take this drug, and she should not take that drug".....beware! Nobody on the Internet knows your wife's entire clinical history. If she were to stop taking a drug, or switch to another drug without talking to her doctor first, any drug changes can be harmful to her health. The drugs I'm talking about here do not just apply to prescription drugs. They also apply to alternative therapies. Some alternative therapies can interact with certain drugs, and can also have severe side effects.

One of the general guidelines that is now being followed is that once a person begins treatment, they should not stop taking treatment. This is because going on and off treatment can quickly lead to drug resistance with any of the antivirals (not just Invirase). A more potent form of Invirase is now being evaluated (tested) for use in the United States.

Regarding taking Crixivan and eating meals, according to the manufacturer:

"For optimal absorption, Crixivan should be administered without food but with water, 1 hour before or 2 hours after a meal. Alternatively, Crixivan may be administered with other liquids such as skim milk, juice, coffee, or tea, or with a light meal e.g. dry toast with jelly, juice, and coffee, with skim milk and sugar; or corn flakes, skim milk, and sugar.

To ensure adequate hydration, it is recommended that the patient drink at least 1.5 liters (approximately 48 ounces) of liquids during the course of 24 hours."

These are general recommendations, and they may not apply to all people. Of course, the best recommendation I could make is for your wife to follow the recommendations of her personal physician who is familiar with her entire medical history.

Regarding Nelfinavir (Viracept), this is manufactured by Agouron Pharmaceuticals (http://www.agouron.com/). If you want to find out the status of Nelfinavir being available in your country, my suggestion to you is to contact the company directly by visiting their website. Generally speaking a person cannot come to the USA to get a drug, unless the drug is prescribed by a physician within the USA (and the pharmacy will often only fill a prescription by a local physician). Physicians will usually not prescribe drugs for people they do not know, based primarily on potential harmful health consequences on the patient, and legal consequences on the physician. US prescription drug laws are very strict.

In the USA, the Federal Government is presently finalizing it's version of "Guidelines for the Use of Antiretroviral Agents in HIV-Infected Adults and Adolescents." A draft copy of these guidelines has already been released, but these are DRAFT guidelines, and are subject to change until the finalized version is released. The finalized document will most likely be released on the Internet when it is released in it's final form.

The bottom line is.........your wife must discuss your questions with her personal physician. Nobody on the Internet can provide you with medical advice on what she should do, since we do not know her entire medical history.

If you have any further questions, please feel free to call the Centers for Disease Control at 1.800.232.4636 (Nationwide).



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