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Top 10 HIV Clinical Developments of 2012

December 2012

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Dolutegravir

A review of:

Sharon Walmsley, et al. Dolutegravir (DTG; S/GSK1349572) + abacavir/lamivudine once daily statistically superior to tenofovir/emtricitabine/efavirenz: 48-week results -- SINGLE (ING114467). ICAAC 2012; Abstract H-556b.

While the Quad is finding its place in the HIV treatment landscape, the excitement regarding dolutegravir, an integrase inhibitor that is not yet FDA approved, is looming over the horizon. In the final phases of development, the drug made a splash at ICAAC, where the 48-week results of the SINGLE trial were presented.

The SINGLE results showed statistical superiority of dolutegravir paired with abacavir/3TC over efavirenz/TDF/FTC in treatment-naive patients. Tolerability of the drug was excellent -- in fact, it drove the difference in the primary outcome between the study arms, as there were more patients who experienced treatment-limiting toxicities with the efavirenz-based therapy (10%) compared to the dolutegravir-based therapy (2%).

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Most impressive was the complete absence of detected integrase or reverse transcriptase (RT) resistance mutations among the few participants experiencing virologic failure while on dolutegravir. In vitro data suggest a relatively high bar to drug resistance for this new integrase inhibitor. However, it should be noted that the study procedures regarding monitoring and responding to increases in viral load may have allowed for virologic failure to be caught early, reducing the time that resistance could be selected for and emerge on testing.

Earlier in the year, 48-week data from the SPRING-2 study, which compared dolutegravir plus two NRTIs to raltegravir plus two NRTIs, were presented. They found no significant difference in rates of viral suppression between the arms. Again, integrase and RT resistance was not seen in those on dolutegravir while 1 of 18 and 4 of 19 participants in the raltegravir arm with paired baseline and failure samples available had integrase and RT mutations detected, respectively.

It is expected that a stand-alone dolutegravir tablet will be approved and available in the first half of 2013, with a fixed-dose combination with abacavir/3TC to follow. A potent, once a day integrase that behaves like a boosted protease inhibitor when it comes to resistance may be too good to be true, but it seems is something that providers are yearning for. It certainly will spice things up for 2013.

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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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