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Switching to Sustiva Viread Videx
Aug 9, 2003

I'm sorry this is so long, but it's been a long time since I changed regiments, am somewhat worried, and want to give you my whole picture before asking a bunch of questions. Thank you so much for reading through this and in advance for any answers you might have.

I am currently on Videx EC 400mg (1x day), Lipitor (1x day), Fortovase (2x day), Viracept (2x day) and Zerit (2x day), and have been taking these for at least 4 years, diagnosed in 1993 and have taken only a few other mono-therapy drugs back then like AZT, with likely infection since 1983 or before that. My T cells are currently at 443 and my viral load is 393. My BIA results are BMI-28.73, phase angle 7.8 (other things are on that report as well, but I think that's the important stuff). During the last 4 years my T cells have remained in the high 300's to middle 400's. I've been living with a buffalo hump, thin veiny arms/legs, big tummy, shrunk butt for at least 4 years, plus continuous diarrhea (just didn't want to take one more pill, and I had control over the diarrhea events). In February 2003, a blip up to 1600 viral load made us do a genotype test which surprisingly showed that I was only resistant to AZT. My lab results in March/April 2003 showed a return to nearly undetectable viral load. I suspect the cause was stress and not a compliance issue.

I've been good about not missing doses outright, but admit to some accidental shifting of dose-time-of-day by up to 2 to 3 hours, rarely to occasionally. I drink alcohol but not every day, and when I do it's 1 to 2 drinks followed soon after or with food. I've been maintaining a mediocre exercise regiment consisting of strenuous yard-work, lots of stair climbing, infrequent visits to the gym, occasional sessions with a trainer. I've had a high-quality-food diet (salad, lean meat, veggies, fairly low fat) but admit to overeating the good food, late-night snacking, for years. I've cut back and exercised more over the last 8 months. I've switched to a diet, recommended by my HIV dietician, to get down to 172 lbs from my 210 lbs, lose more fat, add more muscle. She's conducted two BIA tests over the last 5 months, and tells me that my muscle mass was initially fairly good, close to 'normal' for male/48 yrs/6 feet tall and the latest test shows improvement. I know that I need to improve my exercise, especially cardio in order to have the greatest effect on my lypo tummy.

I am switching to Sustiva, Viread and Videx EC 250mg, keeping Lipitor, all 1x day. My doctor didn't offer the combo Sustiva/Viread/Epivir. My reasons for wanting to make this change are the hope of losing the buffalo hump, less likelihood of having diarrhea, and most importantly the need to improve my 393 viral load. All three medications are labeled 'take 1 at bedtime'. My plan is to take the Viread with my last meal of the day at 8:00 pm, and the Sustiva/Videx at midnight when I go to bed.

I saw in one of your responses that it's important to keep Viread 1 to 2 hours away from the Videx, which I will do (I wish I could have a true once-a-day-all-at-once regiment). Should I keep taking the Lipitor with this new regiment? Is it OK to take the Videx with the Sustiva at the exact same time? Can I instead take the Sustiva with the Viread (which is with food) and would there be any benefit to doing so? Am I correct that Sustiva can be taken with or without food? Why wouldn't my doctor offer the combo including Epivir? My new dosage Videx is labeled 'at bedtime' whereas my old dosage wasn't - couldn't I continue to take it 1st thing in the morning as I have been so that my stomach will definitely be empty? I've previously been taking the Videx with water, followed shortly by coffee with 1/2 1/2 - has that been inappropriate? My new 250mg Videx bottle is labeled 'do not drink alcohol when taking this medication' - is that 'not at all' or do I need to stage my drinking to occur a particular amount of hours away from the Videx, and perhaps the other drugs also? Sometimes I take Ambien, prescribed by my doctor to help me get to sleep - is it OK to continue rarely taking it? Can I go back to my original regiment or parts thereof someday? MOST importantly, should I be making this regiment change? I greatly value your opinion and need to know what you think. Thank you so much in advance.

Response from Dr. Aberg

That's okay that you have a long note with lots of questions. You raise several important concerns that will be good to discuss. I will attempt to address things in order but there may be some overlap.

1. You start out mentioning that your genotype shows you are only resistant to AZT. I doubt this is true. Typically when one has resistance to AZT, you have resistance to other nucleosides. Some of the mutations may not be revealed as they can disappear when you off that drug. So, for instance, if you were to take 3TC again, the M184V would be present under the selective pressure of that drug. So, be cautious about genotypes, that is why it is important to get them when people are actively taking drug and as one changes regimens, genotypes may appear differently at different times. It is very important to know the drug history. That is why your doctor did not want to give you 3TC as you mention later on.

2. You also mention your BIA and say your dietician is following this. There is little to no scientific data supporting the clinical utility of this test in HIV patients with lipodystrophy and most experts would recommend that you get a DEXA scan. CT and MRI scans are used in some clinical trials and if you have access to a clinical trial, you may want to consider this option.

3. There are a few reports suggesting that lipoatrophy (thinning of limbs, facial wasting) is reversible but so far, there is no evidence that switching from a PI to a non-nucleoside will resolve a buffalo hump. The switch that has looked promising for reversal of lipoatrophy is d4T to abacavir. Staying on Videx (ddI, didanosine) is not going to improve your lipoatrophy. The fact that you are on lipitor tells me that you had abnormal lipids and Sustive (EFV, efavirenz) has been associated with abnormal lipids. The AIDS Clinical Trials Group is in the midst of analyzing drug interaction data from a study looking at the effect of EFV on statins. The hypothesis is that EFV may decrease the drug levels of the some of the statins which is opposite of what the protease inhibitors did. We should know the results in a few months so be on the look out for this. In the interim, I think if your lipids do not improve on that new regimen, you may have to increase your lipitor (atorvastatin) or if it is just your triglkycerides that are high, switching to a fibrate. If they do normalize, I certainly would try to stop the lipitor and recheck fasting lipids after 4-8 weeks off the lipitor. If the lipids are abnormal, then I would treat with the appropriate drug (statin for abnormal LDL or fibrate for abnormal triglyceride).

4. As far as a once a day regimen, you are correct that in the combination you are switching to, that the recommendations are that you space the TDF (Viread, tenofovir) and ddI. Recently, Bristol-Myers-Squibb announced that you can take atazanavir 300 mg boosted with ritonavir 100 mg, tenofovir 300 mg and ddI 250 mg all at once with food. This may be another option for you. The small amount of ritonavir does not seem to contribute to lipid abnormalities when given with atazanavir. Atazanavir has not been associated with lipid or glucose abnormalities. If you switched to this regimen, then I think it would be more likely that you would be able to stop your lipitor.

5. Back to questions about the 3TC. Again, my guess is that your doctor is concerned that you have 3TC resistance even though it did not show up on your genotype. I am assuming you were on it in the past. As far as when you can take ddI, you can take it on an empty stomach in the morning or night. It does not matter. Many people prefer to take it at night because they may want to eat sooner than recommended. You should space out your coffee to at least one hour after taking ddI. As far as alcohol, the main point is that ddI has been associated with pancreatitis and so has alcohol. The two together is not a good thing. Occasional alcohol is fine but do not take your medicine with alcohol and space out the time by a few hours. Obviously drink in moderation, alcohol can lead to serious health consequences and it is really important to have as healthy of a lifestyle as possible.

6. It is okay to occasionally take ambien. I am not aware of any serious drug interactions with this and your medications. You can become tolerant to ambien and then it will not continue to be effective.

7. As for switching, I think we could make your regimen easier. Your initial regimen was working but you clearly are experiencing metabolic complications associated with the medications. I personally do not like the combination of zerit (d4T, stavudine) and protease inhibitors if it can be avoided due to its strong association with lipid abnormalities. Also, the combination of ddI and d4T is not recommended due to the potential of liver function abnormalities and higher risk of lactic acidosis. I definitely would recommend switching provided there are other options. I don't have your complete history so I cannot definitively say what would be best for you. Based on the information you provided, I think the switch your doctor recommended is fine. I also think you have the option of going on atazanavir which may be more "lipid friendly" and thus you may be able to stop the lipitor. Plus it would be a true once daily regimen.

Good luck with everything. Send us an update in a few months to let us know what you decided and how well it is working.



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