FDA Approves Juluca, the First Two-Drug HIV Regimen

[Jim Allen]

Cool interesting and an option for people who can't or don't want NRTIs

FDA Approves Juluca, the First Two-Drug HIV Regimen

The single-tablet regimen contains ViiV’s Tivicay (dolutegravir) and Janssen’s Edurant (rilpivirine)

For the first time, the U.S. Food and Drug Administration (FDA) has approved an HIV treatment regimen that contains only two antiretrovirals (ARVs), instead of the standard three or more drugs. Juluca (dolutegravir/rilpivirine), a combination of drugs from ViiV Healthcare and Janssen, is approved as a new option for people with HIV who have been virally suppressed on their current ARV regimen for at least six months.

Additionally, individuals considering Juluca should have no history of HIV treatment failure and no known viral mutations associated with resistance to either of the drugs in the regimen.

More details/full story: https://www.poz.com/article/fda-approves-juluca-first-twodrug-hiv-regimen

[den2542]

Can someone explain the difference btwn nuke and non nuke and why one is better or worse. I sure to get confused. I under stand PI and integrasee inhibitors but the ABC of all the meds are messing with my head. Don't get me wrong I'm grateful, and without them I'd be dead. Just sort of need to understand.

[leatherman]

https://www.poz.com/basics/hiv-basics/hiv-medications
lots of answers 

[den2542]

Thanks so much.

[awakening]

What kind of reasons would one not want an NRTI (aside from a resistance issue)? What advantage would there by if any to switching from a Tivicay-based med that's with an NRTI (such as Triumeq) to something like Edurant? Edurant is considered a second generation drug whereas Abacavir and Lamiviudine are first gen (1995/1998). Is Edurant associated with fewer short/long-term side effects?

[Jim Allen]

It highly depends on the person themselves and their unique medical history and needs.  Short example, if I as example were to have pre-existing heart problems, than I might want to reconsider Abacavir if possible.

Long term, 2 drug combinations might be more affordable as well, however I would not expect to see that benefit to filter to consumers anytime soon.

[bocker3]

What kind of reasons would one not want an NRTI (aside from a resistance issue)? What advantage would there by if any to switching from a Tivicay-based med that's with an NRTI (such as Triumeq) to something like Edurant? Edurant is considered a second generation drug whereas Abacavir and Lamiviudine are first gen (1995/1998). Is Edurant associated with fewer short/long-term side effects?

Well, my virus came with, at least minor, resistance to just about all nukes, so I will be talking with my doc about this new drug.  I am taking a non-nuke (Sustiva), two nukes (Descovy) and a boosted-PI (Reyataz/Norvir) because of the Nuke resistance.  Perhaps I don't need to take all these drugs anymore.  Two drugs vs. four (5, if you count the Norvir boost) sounds good to me.

Will have to do some more research on Juluca before my appointment in February.

Mike

[loneranger]

Hi guys

Thought you may be interested to know that I've been trialling a two drug combination since last March in the UK. I was taking Triumeq but decided to drop the Abacavir element after reading about successful two drug regimen trials. I now take two tablets each morning, dolutegravir and Lamivudine. I have remained undetectable since starting this regimen 8 months ago. Seems to me to be logical to take less drugs long term if I can. Plus I wasn't comfortable with the increased risk of heart issues with Abacavir.

[Jim Allen]

Odd reason to drop a med.

What is the name of the study your in? Or do you mean your self-experimenting?

Jim 

[loneranger]

Hi Jim

I discussed dropping Abacavir with my HIV specialist and after a detailed discussion of the potential pros and cons, I decided to take the risk and trial taking two drugs instead of three. So in essence, yes self experimenting. Don't quite follow why you think my reasons odd to drop one med. There is strong evidence to suggest that a two drug cocktail performs equally as well as three and as there is a strong history of heart disease in my family, I am happy to avoid Abacavir.

http://hivinsite.ucsf.edu/insite?page=hmq-1704-03

[Jim Allen]

Yeah, odd as in I had not heard of this drug trial definitely not at your location, anyhow also if there is no pre-existing heart concern than abacavir is quite safe. Maybe a few years ago regarding abacavir it was a bigger debate but that has really been settled with all newer studies have shown its relatively safe.
 
The other reason was, as i noted is i had not heard of a drug trial for this combo of duo-therapy. This recent combo aside of the moment, (hopefully a few more to come tested and tried) self juggling is not for everyone, its not a trial of course as its just you and not something normally recommended. Its like the recent mono-therapy massive flop for most, did work for a very few, some doctors (people claimed) also did it outside the drug trial (risky move) would definitely not encourage anyone to try.

Anyhow wishing you all the best and if this combination is fitting for you and gives you peace of mind so much the better.

Jim


https://www.poz.com/article/hiv-abacavir-heart-17023-5792
https://www.poz.com/article/hiv-abacavir-heart-20134-4073
https://www.poz.com/drug/triumeq

https://www.poz.com/basics/hiv-basics/hiv-heart
https://www.drugs.com/sfx/abacavir-side-effects.html

https://www.google.ie/search?q=poz.com+abacavir+heart&ie=utf-8&oe=utf-8&gws_rd=cr&ei=f5bnV774BeuPgAayi7qADQ

 

[awakening]

The 2-drug combo of Dolutegravir and Lamivudine has entered stage 3 trials. If all goes as well as it did in stage 2 it is slated to be released in 2019.
https://www.aidsmap.com/Dolutegravir-plus-lamivudine-dual-therapy-works-well-as-initial-HIV-treatment/page/3074283/

Since I am on Triumeq I asked my ID doc about possibly switching to a 2-drug combo in the future. He leans toward the new Dolutegravir/Rilpivirine over other options, but will wait 6 months before prescribing it to see how it plays out in the real world.

[Jim Allen]

Indeed, this would be the combinations I would be most interested in seeing future updates on. Its just wait and see how it pans out.

Jim

https://forums.poz.com/index.php?topic=66233.0

"After 48 weeks of treatment, a respective 89.5 percent and 79.7 percent of those in the dual and triple therapy arms had not failed treatment"

For the ongoing GEMINI 1 and 2 study it will be intressting to see publications once conculded at 48 weeks and than also the 148 weeks total from the study to see the long-term efficiency and the safety.

Jim

https://www.poz.com/article/viiv-begins-phase-iii-trial-twodrug-hiv-regimen

[xinyuan]

I'm also deeply interested in this combination for a different reason.

It's another pathway to the long-acting injectables (cabotegravir, riplivirine) for Viiv/GSK.

[Jim Allen]

?

Why and how do you figure that this ART combination of drugs already in use in other combo's would lead to a totally different unrelated injection combo ?

Maybe I'm not understanding the point?

Jim

[awakening]

https://www.marketwatch.com/story/eu-approves-glaxosmithkline-jvs-juluca-hiv-drug-2018-05-21

GlaxoSmithKline PLC (GSK.LN) said that its majority-owned joint venture ViiV Healthcare has been granted marketing authorization by the European Commission for its HIV treatment Juluca.

[awakening]

100 week results for the Juluca SWORD trials were released:

https://www.businesswire.com/news/home/20180724005381/en/ViiV-Healthcare-announces-SWORD-100-week-data-Juluca

The results confirm the ability of Juluca to maintain efficacy over a 100-week period and importantly support that the long-term safety profile of this regimen is consistent with the respective labels of the component medicines. This 100-week data should provide physicians with further confidence that they may be able to reduce the number of antiretroviral drugs required to effectively maintain virologic suppression in their patient’s HIV.”