Advertisement
Advertisement

TheBodyPRO.com covers CROI 2013

Second-Line Therapies for HIV: Two Studies Whose Impact Will Last Well Beyond CROI 2013

March 14, 2013

Several studies provided important advances in how to approach the treatment of individuals experiencing failure of first-line NNRTI-based treatment.

The SECOND LINE study (for which the poster presentation is available online) suggested that NRTIs might not be needed for second-line treatment. The study randomized 541 individuals failing NNRTI first-line treatment from 15 countries to receive either lopinavir/ritonavir (Kaletra) + two to three N(t)RTIs or the NRTI-sparing regimen of lopinavir/ritonavir + raltegravir (RAL, Isentress). The baseline CD4+ cell count of the participants was 190 cells/mm3 and 20% had a viral load greater than 100,000 copies/mL.

After 48 weeks, approximately 77% of the participants had virologic suppression below 50 copies/mL: 77.8% in the RAL arm vs. 76.8% in the 2/3 N(t)RTI arm (treatment difference 1.03% [95%CI: -6.04, +8.29]), therefore demonstrating the noninferiority of the nuke-sparing regimen. RAL recipients had significantly greater increases in CD4+ cell count (167 vs. 132 cells/mm3, P < .01).

Advertisement

Meanwhile, a phase 2 study showed superiority of the investigational integrase inhibitor dolutegravir (DTG) to RAL in second line treatment. The SAILING study (for which the poster is also available online) gave ART-experienced, integrase inhibitor-naive participants an optimized background regimen; participants were randomized to receive either RAL or DTG. Fifty percent of participants had three or more class drug resistance.

At a planned 24-week interim analysis performed after all participants reached week 48 of treatment, DTG was statistically superior to RAL, with 79% vs. 70% of participants achieving an undetectable viral load (treatment difference +9.7% [95%CI: 3.1, 15.9]). This difference (RAL vs. DTG) was driven by differences in adverse events (3% vs. 1%) and lack of efficacy (7% vs. 4%). There were fewer virologic failures and less detected drug resistance mutation in the DTG arm of the study. Actually, no participants developed phenotypic DTG resistance, while nine out of 10 participants failing RAL with genotypic data showed complete RAL resistance.

Which other studies presented at CROI 2013 will have lasting impact long after memories of the conference itself have faded? Read more of Dr. Llibre and Dr. Young's top picks.


Copyright © 2013 Remedy Health Media, LLC. All rights reserved.



 


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:


Please note: Knowledge about HIV changes rapidly. Note the date of this summary's publication, and before treating patients or employing any therapies described in these materials, verify all information independently. If you are a patient, please consult a doctor or other medical professional before acting on any of the information presented in this summary. For a complete listing of our most recent conference coverage, click here.

Advertisement