Janssen, ViiV Healthcare Formalize Rilpivirine + Cabotegravir Phase 3 as HIV Tre

[MahmoudK]

I'm not sure if this was posted over here, but here goes nothing! This is great news as far as I can see. I wonder when will it be available?

From the article:

"Janssen Sciences Ireland UC (Janssen), formalized its collaboration with ViiV Healthcare on phase III development and commercialization of a two drug regimen of two long acting, all-injectable formulations of rilpivirine (a non-nucleoside reverse transcriptase inhibitor by Janssen) and cabotegravir (ViiV Healthcare).

Janssen and ViiV Healthcare have been working together on this regimen, through a number of clinical trial agreements, for several years. Under this new agreement, the phase III development, to evaluate the efficacy, safety and tolerability of the regimen, will be led by ViiV Healthcare with support from Janssen. Each company will manufacture and supply their individual drug formulations following successful phase III completion and regulatory outcomes.

"Despite great progress in developing HIV treatments, the day-to-day burden of managing HIV remains high and poses challenges to ensure people living with HIV maintain an undetectable viral load," says Paul Stoffels, Chief Scientific Officer, Johnson & Johnson and Worldwide Chairman, Janssen Pharmaceutical Companies. "We are committed to making a real difference for those affected by HIV. The prospect of developing new therapies, such as long acting formulations which are broadly accessible, may offer hope to the many millions affected by HIV around the world."

At week 32, in an ongoing phase IIb study (LATTE 2, NCT02120352), the investigational long acting, all-injectable combination regimen, given every 4 or 8 weeks, showed comparable efficacy to a daily oral regimen of three HIV medicines (investigational cabotegravir and two nucleoside reverse transcriptase inhibitors (NRTIs)). If successfully developed and approved by regulatory authorities, people living with HIV who are virologically suppressed could be offered an alternative option to the standard oral daily regimen* of three drug therapy.

"While we work toward our long-term goal of developing a preventative HIV vaccine, we are excited to be able to continue to support people living with HIV through innovative improvements," said Wim Parys, Head of R&D, Global Public Health, Janssen. "Through this collaboration, we have the potential to develop the first long acting, all-injectable two drug regimen as an innovative option for HIV maintenance therapy."

Since the beginning of the HIV epidemic, almost 75 million people have been infected with the virus. It is estimated that 35 million people are currently living with HIV globally, with 2.5 million people becoming newly infected each year.

*Standard three drug oral therapy contains three active components taken daily: a backbone of two NRTIs, plus either a non-nucleoside reverse transcriptase inhibitor, a protease inhibitor (PI) or an integrase inhibitor (INI)."


Source: http://www.streetinsider.com/Corporate+News/Janssen,+ViiV+Healthcare+Formalize+Rilpivirine+%2B+Cabotegravir+Phase+3+as+HIV+Treatment/11201198.html

[Mightysure]

This is exciting.  A shot every month or two??  And possibly one drug?  I really hope this works out because I will be one of the first to see if I qualify. 
But to answer your question about when it's available,  I believe the makers of this drug said 2019?? I could be wrong though,  but it'll be three years I think.  Hopefully sooner. 
It's things like this that help me argue down conspiracy theorists about them holding out on a cure.  It seems like they're getting closer and closer and while at cure would hurt their treatment business,  they're in such competition to out do each other and there's some researcher out there wanting the fame and notoriety..lol. This isn't about that but it would be great if this became reality!

[harleymc]

While this would be good for some, I prefer the flexibility of daily oral medication, I can travel interstate or overseas and not be worried whether on not my travel clashes with the injection date.

[CaveyUK]

While this would be good for some, I prefer the flexibility of daily oral medication, I can travel interstate or overseas and not be worried whether on not my travel clashes with the injection date.

I agree, but it would make a huge difference if it were an injection every 2 or 3 months rather than every 4 weeks. An injection would take away some of the self-imposed stigma people feel about popping pills every day, and would naturally massively help with adherence in communities where that is a particular problem.

So it would be a massive breakthrough if this happens, and hopefully by the time it does then even better options will be undergoing trials...

[Jeff G]

I would be over the moon happy if we had an injectable option .

[Mightysure]

While this would be good for some, I prefer the flexibility of daily oral medication, I can travel interstate or overseas and not be worried whether on not my travel clashes with the injection date.

I'm sure if it's approved, there has to be some leeway as far as the time for the next dose.  I know some will prefer oral medication and it's probably a better option for them but I just love the idea of having more free days than medication days.

[Matts]

It looks as if the approval will be in 2018/19. Not a too long time anymore. The trials went very well.
The new interval of 8 weeks is a bit disappointing, because ViiV told so far, that it would be 3 months.

Anyway, it is still a new groundbreaking thing. I would use it immediately.
And the travel thing should be no problem -  there will be Cabotegravir and RPV still as normal oral pills.
Lets see what will happen.

[CaveyUK]

It looks as if the approval will be in 2018/19. Not a too long time anymore. The trials went very well.
The new interval of 8 weeks is a bit disappointing, because ViiV told so far, that it would be 3 months.

Anyway, it is still a new groundbreaking thing. I would use it immediately.
And the travel thing should be no problem -  there will be Cabotegravir and RPV still as normal oral pills.
Lets see what will happen.

I agree, there seems to be something psychologically better about it being a quarterly shot, rather than every other month. As you say though, it's groundbreaking stuff.

I have a friend with mild schizophrenia and he has anti-psychotics he has to take every day. I have a relative with Addisons disease and she needs to take steroid pills every 8hrs for the rest of her life. I have people I know with heart problems and diabetes who are on daily meds. I'm sure all of them would kill for a once-every-8-weeks injection

[CaveyUK]

Further thought....how much of this long lead time for new drug approval is due to the trials, and how much is red-tape by the relevant authorities?

I ask because I would have thought a treatment like this could have untold benefits to people living in certain communities where adherence is a problem, so getting this to market would be a huge boost not only to people living with HIV in those communities but also to prevent the spread of the virus by people who are not adherent to oral meds. And given the huge public health boost, could this be fast-tracked in any way (obviously fast-tracking the red-tape rather than the trials!)

[Jim Allen]

I think it great progress and wonderful to see that this has reached phase 3 testing.

The injection treatment every few weeks/months would not suit or work for me personally (Ill stick to pills) but it will be a great additional option to have for the wider community

[CaveyUK]

I think I'd be ok with an injection, from a psychological point of view it would be a boost I think. But it would have to have a back-up plan (daily oral version) for those times when it doesn't fit exactly with schedules.

Obviously a 3 monthly shot would fit nicely with routine clinic visits I suppose (eventually)

[Matts]

If You liked this thread, You might also like this:

http://www.ncbi.nlm.nih.gov/pubmed/26595538

A six-monthly shot of NNRTI "DAAN-14f" and Entry-Inhibitor "T1144". It is possible that they also can attack latent reservoirs. But it ist still in an early phase.

[elf]

I will stick to my one pill a day scheme.

[elf]

Janssen is renowned for marketing  injectable extended release / depot antipsychotics
(http://www.janssen.com/emea/sites/www_janssen_com_emea/files/about_xeplion_final.pdf)
and now they are jumping on the HIV bandwagon. It’s all about the profit.

[MahmoudK]

Janssen is renowned for marketing  injectable extended release / depot antipsychotics
(http://www.janssen.com/emea/sites/www_janssen_com_emea/files/about_xeplion_final.pdf)
and now they are jumping on the HIV bandwagon. It’s all about the profit.

Well, it's all about profit indeed. But neutrally thinking, It's a good thing, it keeps the big pharmas in a state of competition to find the next best treatment for a said disease. In our case, lets hope it keeps them motivated to find a cure.