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Post Info TOPIC: Cabotegravir for HIV Prevention
Tig


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Good news on the HIV front!

 

Health Canada approves long-acting HIV treatment Cabenuva

 

Cabenuva is a once-monthly regimen that includes cabotegravir (ViiV Healthcare) and rilpivirine (Janssen). It is intended to take the place of a patient’s current antiretroviral regimen for those who are virologically stable and suppressed (defined as less than 50 copies/mL of HIV-1 RNA).

Health Canada has also approved Vocabria (cabotegravir oral tablets, ViiV) used for short time periods in combination with Cabenuva. According to a press release from the company, these approvals are the first for Cabenuva and Vocabria anywhere in the world. 

“Today’s approval marks a monumental step in the treatment of HIV and is a true testament to ViiV Healthcare’s [research and development] innovation,” Deborah Waterhouse, CEO of ViiV Healthcare, said in the release. “With Cabenuva, people living with HIV who are virologically suppressed now have an option to maintain that suppression with 12 treatments a year.”

The approval of Cabenuva comes after the phase III ATLAS and FLAIR trials, which examined efficacy and safety among more than 1,100 participants from 16 countries. According to the release, both studies found that Cabenuva, when given intramuscularly once a month, was as effective for maintaining viral suppression as daily oral antiretroviral regimens over the 48-week study period. 

“Cabenuva, an injectable treatment, has the potential to transform HIV care by offering monthly instead of daily treatment to suitable patients. It reduces the frequency of dosing and is as effective as daily, oral, three-drug regimens in maintaining viral suppression among adults living with HIV,” Chloe Orkin, MDconsultant physician and clinical professor at Queen Mary University of London and FLAIR principal investigator, said in the release. “Most participants in the clinical trials preferred it over their prior oral daily regimens.”

Previous investigations of Cabenuva in the United States led to the FDA denying approval of the treatment, citing “chemistry, manufacturing and controls (CMC)” as reasons. Janssen Pharmaceuticals and ViiV Healthcare said at the time that there had been no reported CMC-related safety issues and that the FDA’s response did not relate to the regimen’s clinical safety data that was submitted to the agency. – by Caitlyn Stulpin



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Tig

64 yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 6+ years!

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I hope they have success too. I have developed many RAV's over the years, Epzicom being one, but maybe Cabotegravir will be an option in my future. It would sure beat my current 6 pills per day with Sx's! Thanks for the link Tig. I'll be keeping an eye on this one.



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59 yo, geno 1a, Dx 1994 HCV-HIV co-inf, Dx 2013 decompensated cirrhosis
Tx #1 - 24wks Sov+Riba /SOT 7-24-2014/UND@EOT/DETECTED@EOT+16 wks
Tx #2 - 24wks Harvoni /SOT 7-25-2015/UND@EOT,+12,+24,+52,+115wks = SVR-115

Mike

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treatment and prevention

WoW ... I hope they have nothing but success!!

Dave



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63yy,HCV,2b,F3-A1, Sof/Riba,12wks Tx   SOT: 1/20/16, HCV-RNA 9,816,581, ALT 56, Hb 14.6

4wk: HCV-RNA <15 Detected, ALT 15, AST 17, Hb 13.6 EOT: 4/12/16, ALT 18 , Hb 12.9176a2f85d05d9c965eafe199f2ba9ba5.jpg SVR Achieved 7/8/16

 

Tig


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Cabotegravir (also known as S/GSK1265744) is an investigational drug that is being studied for the treatment and prevention of HIV infection.4  Current trials are underway.

https://aidsinfo.nih.gov/drugs/513/cabotegravir/0/patient



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Tig

64 yo GT1A - 5 Mil - A2/F3 - (1996) Intron A - Non Responder, (2013) Peg/Riba/Vic SOT:05/23/13 EOT:12/04/13 SVR 6+ years!

Hep C FAQ   Lab Ref. Ranges  HCV Resistance

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