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Top 10 HIV Clinical Developments of 2012

December 2012

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Simplify

A review of:

Frank J. Palella Jr., et al. SPIRIT Study: switching to Emtricitabine/Rilpivirine/Tenofovir DF (FTC/RPV/TDF) single-tablet regimen (STR) from a Ritonavir-boosted protease inhibitor and two nucleoside reverse transcriptase inhibitors (NRTIs) maintains HIV suppression and improves serum lipids in HIV-1 infected subjects at week 24. 19th International AIDS Conference; Washington, DC; July 22-27, 2012; Abstract TUAB0104.

Calvin J. Cohen, et al. Switching from efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) single tablet regimen (STR) to emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF) STR in virologically suppressed, HIV-1 infected subjects. 13th European AIDS Conference; Belgrade; 2011; Abstract LBPS10/4.

I have never been one to mess much with success. In the past, I have played with the HIV therapies of patients doing well, and on more than a few occasions I have been burned. The viral load may go up despite the greater convenience and potency of the newer regimen. Maybe there is a pharmacy mixup, or the patient -- despite instructions that include pictures of suns and moons -- misunderstands and takes the medication wrong. I thought folks who did stuff like induction therapy followed by more compact maintenance regimens were meshuga, or had patient populations as obedient as border collies.

But I am now getting more adventurous. Mostly, I have had no choice: I could not stand by while patients on more cumbersome regimens labored on with twice-a-day dosing and a fistful of meds, while those entering care could walk out of their pharmacy with a three-month supply of HIV therapy that could fit in a Flintstones vitamin bottle. Plus there were the low-rumble side effects. So, out went the AZT/3TC. And those lopinavir/ritonavir refills? Replaced with once-a-day PI therapies. And it was good.

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This year we have seen simplification go to a new level -- and, I must admit, I am hooked. Several studies show us that, in addition to moving from twice-a-day to once-a-day PI therapies, we can also take advantage of sleek new formulations for many (but certainly not all) of our patients.

For example, the SPIRIT study has, so far, showed us that taking folks on stable boosted PI-based therapies and switching them to TDF/FTC/rilpivirine can work. At 24 weeks, 94% of those who switched to TDF/FTC/rilpivirine had a viral load below 50 copies/mL compared to 90% of those who stayed on their entry regimen (achieving non-inferiority). Historic baseline viral load (i.e., before initiating the entry regimen) above or below 100,000 copies/mL did not influence the efficacy results, indicating that pre-treatment viral load (a prickly problem in the ECHO Trial) is not an issue when switching stably suppressed patients to this regimen. As expected, gastrointestinal symptoms and lipids improved with the switch from PI therapy. Another study looked at a switch to the same regimen from TDF/FTC/efavirenz, with similar reassuring results.

Now, these swaps are not for everyone, and we must recall our oath: primum non nocere. Those with, or likely to have, significant NNRTI mutations archived away -- as well as those who are either not adherent or on proton pump inhibitor therapies -- are not candidates for this particular switch.

With the Quad, we have an additional switch option, but less data to guide us. Again, common sense is advised. New drugs come with new risks for side effects, and drug interactions make combining the Quad with other HIV meds a setup for tears.

But, there will be more drugs to come. The availability of cobicistat as a stand-alone tablet in early 2013 will shake things up at the pharmacy. Ditto for the release of dolutegravir, a once-a-day integrase inhibitor. Coformulations will soon abound, making for even more seductive switches. It is all enough to make this reluctant switcher more of a cowboy when it comes to messing with my patient's meds.

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Reader Comments:

Comment by: Ashley (QMsiijnYJx) Thu., Jan. 10, 2013 at 10:18 am EST
the HIV virus is very fragile once it is oudtsie of the human body. when it is exposed to the air, it dies in about 2 hours. so, dried semen will only have dead HIV cells. you are safe.
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Comment by: Mani (UubwaSyASLWZnBAlN) Thu., Jan. 10, 2013 at 9:29 am EST
I've talked to both my patrens about it at differnt times. My mom thinks it nessasary. She knows that teens r going to have sex and they need to be educated.My dad thinks its better to be educated then to not know anythingI think sex-ed is needed for everyone. I never though my dad (the republican who was in the army) Would be so libral
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Comment by: harleymc Tue., Dec. 25, 2012 at 11:02 pm EST
I was very happy to read this article.
I'm someone who's been on combinations containing boosted PIs and suffer badly with them. When my current script runs out in a few days I'll be switching to TDF/FTC/rilpivirine + raltegravir (already on the raltegravir). It was reassurring to read of an improvement in outcomes.

It's one thing to have a fabulous viral load but when side effects are both vile and life threatening, a change sounds brilliant.
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Comment by: Anonymous Mon., Dec. 17, 2012 at 10:48 am EST
good message of hope
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Comment by: Sean (Dublin, Ireland) Fri., Dec. 14, 2012 at 6:38 am EST
Thanks for the section called "The Cure Agenda". If YOU are feeling optimistic, that makes me feel optimistic.

Happy Yule!
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Comment by: Patrick D (South Deerfield, MA) Thu., Dec. 13, 2012 at 3:56 pm EST
Dr. Wohl writes "In the past, I have played with the HIV therapies of patients doing well, and on more than a few occasions I have been burned," then describes some of the benefits that may come from switching from a more complex drug regime to a more simplified one. Dr. Wohl clearly has his patients best interests in mind, but I want to remind him that when a switch in meds fails (temporarily or permanently) for patients who had been doing well on an older regime, it isn't the doctor who gets burned, it's the patient. I have had occasion to remind my own doctors of this, when they seem to want to fiddle with a regime that is working perfectly well, with negligible side effects, for no other reason than to put their signature on my treatment.

It can indeed be a benefit to simplify a drug regime, especially for patients who have trouble taking their meds in the first place. But as I've reminded several doctors, for many HIV patients, HIV drugs are not the only drugs we're taking (and that's not taking supplements into account), so simplifying the HIV drug regime alone doesn't result in not taking other drugs at other times of the day, and thus may not be a strong reason for changing a regime that's working.
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