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44d mutation & question about Epivir
Dec 31, 2003

Please refer to question and answer: follow up ?(VL - change meds? (Jun 26, 2003) Posted: Jun 30, 2003

Dear Gerald? My last VL test was 286 (BUT I had a flu virus within 2 weeks of taking the test- 2 prior were <500 - i didn't do ultra sensitive!!)...I convinced my doc NOT to switch meds "now" but do another VL test Jan 2. My current meds: Epivir, Viramune, Viread. I have a possible resistance from my Genotype (prior to treatment) to Epivir-- 44d. Have you heard of anyone switching to Emtriva when they have this 44d? OR is it so similar that it has no effect? I wrote Gilead about this and they wouldn't give me any documentation. You also said to "intensify" treatment if I don't get VL to under 50. What exactly did you meant by that? What might you change? Thank you!

Response from Dr. Pierone

Hello, I remember your original post which led me on a quest for information on the elusive 44d mutation. If your repeat viral load is less than 75 copies (the commercial tests go as low as 75 now, not 50 copies) then you can stay on the same regimen.

If the viral load continues to be in the 75 to 400 range the best course of action is not clear. The choices are continue the same regimen, switch one medication in the regimen, intensify by adding another agent (to create a 4 drug regimen), or completely revamp the cocktail by changing two or more drugs. A repeat resistance test is helpful whenever a regimen change is planned, but when viral load is this low it can't be accomplished.

Emtriva should not be expected to be better than Epivir in this situation, so a simple switch would not be best. Intensification is when one drug is added in order to augment the strength of a regimen. Some HIV providers would add a drug like Ziagen (abacavir) or Videx EC as a 4th agent in order to achieve a viral load less than 75. This would probably work, but would come at additional cost and potential side effects. Completely revamping by switching to a protease inhibitor-based combination would also likely work, but would be overkill.

An alternative is to leave things alone and let the viral load fluctuate between 75 and 400 copies. There are cohort studied showing that clinical outcomes in HIV-infected patients even with viral loads of 400 to 10,000 are roughly the same are those with undetectable viral loads. Based on studies like this, it is not a stretch to see that having a viral load in the range of 75 to 400 this range is not a bad place to be. However, the risk is that viral resistance will be more likely to develop in this range compared with suppression less than 75 copies. There have been no studies comparing intensification versus watchful waiting that I am aware of, so it comes down to a judgment call.

In my practice, I have used both approaches for patients in situations like yours. In some cases I intensified with Ziagen and others I have left on 3 drugs (difference in approach based mainly on patient preference and individual factors). Both groups have done well, although after several years there is a tendency for more breakthrough to greater than 400 copies in those on the 3 drug regimen (as one might expect). In your specific situation I would be inclined to intensify because you had some evidence of transmitted resistance with the 44d mutation. But if the repeat viral load comes back less than 75 then ignore this and carry on. Let us know how things turn out and best of luck!



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