Advertisement
The Body: The Complete HIV/AIDS Resource
Follow Us Follow Us on Facebook Follow Us on Twitter Download Our App
Professionals >> Visit The Body PROThe Body en Espanol
  
  • Email Email
  • Comments Comments
  • Printable Single-Page Print-Friendly
  • Glossary Glossary
  • PDF PDF

Rilpivirine Shows Potent Activity

Summer/Fall 2010

Rilpivirine (TMC278), an investigational next-generation non-nucleoside reverse transcriptase inhibitor (NNRTI) being developed by Tibotec, continued to show potent antiviral activity and good tolerability in previously untreated patients at 48 weeks, according to a pair of Phase III clinical trials presented at a late-breaker session at AIDS 2010 (abstract THLBB206).

Cal Cohen from the Community Research Initiative of New England reported pooled data from the ECHO (TMC278-C209) and THRIVE (TMC278-C215) trials. Together, these two multinational studies enrolled 1,368 treatment-naive participants. About 75% were men, 60% were white, and the median age was 36 years. The median CD4 cell count was about 250 cells/mm3 and patients had no known NNRTI resistance-associated mutations.

In ECHO, 690 people were randomly assigned to receive 25 mg once-daily rilpivirine or 600 mg once-daily efavirenz (Sustiva) in combination with tenofovir/emtricitabine. In THRIVE, 678 participants were randomly assigned to the same doses of rilpivirine or efavirenz, but had a choice of NRTI backbones; 60% used tenofovir/emtricitabine; 30% used zidovudine/lamivudine (Combivir), and 10% used abacavir/lamivudine (Epzicom).

Advertisement
People taking rilpivirine and efavirenz were equally likely to achieve viral load suppression (below 50 copies/mL) -- 84% vs. 82%, respectively -- among the highest rates observed in recent trials of first-line HIV treatment. CD4 cell gains were also similar (192 vs. 176 cells/mm3).

Overall, 9% of rilpivirine recipients and 5% of efavirenz recipients experienced virological failure, with a larger difference in ECHO (11% vs. 4%). At ICAAC in September, researchers reported that treatment failure was linked to high baseline viral load and poor adherence (abstract H-1810).

But rilpivirine was associated with fewer side effects than efavirenz, especially central nervous system symptoms. About half as many rilpivirine recipients (16% vs. 31%) experienced moderate-to-severe adverse events considered possibly related to study drugs; 3% vs. 8%, respectively, discontinued therapy due to adverse events. Rilpivirine also had a more favorable lipid profile than efavirenz. Serum creatinine levels changed little in either group and there was no difference in QT interval changes, a type of heart rhythm abnormality.

About 60% of rilpivirine recipients and about 50% of efavirenz recipients developed new NNRTI-resistance mutations, but people taking rilpivirine were twice as likely to develop NRTI-resistance mutations.

Based on these findings, Tibotec announced that it has submitted a New Drug Application for rilpivirine to the FDA. Tibotec and Gilead Sciences are also jointly developing a single-tablet regimen containing rilpivirine plus tenofovir/emtricitabine, which was submitted for European regulatory approval in September.

Liz Highleyman (liz@black-rose.com) is a freelance medical writer based in San Francisco.



  
  • Email Email
  • Comments Comments
  • Printable Single-Page Print-Friendly
  • Glossary Glossary
  • PDF PDF

This article was provided by San Francisco AIDS Foundation. It is a part of the publication Bulletin of Experimental Treatments for AIDS. Visit San Francisco AIDS Foundation's Web site to find out more about their activities, publications and services.
 
See Also
More News & Research on Edurant (Rilpivirine, TMC278)
Advertisement:
Find out how a Walgreens specially trained pharmacist can help you

No comments have been made.
 

Add Your Comment:
(Please note: Your name and comment will be public, and may even show up in
Internet search results. Be careful when providing personal information! Before
adding your comment, please read TheBody.com's Comment Policy.)

Your Name:


Your Location:

(ex: San Francisco, CA)

Your Comment:

Characters remaining:

Tools
 

Advertisement