Study Summaries From ICAAC 2012
The following brief summaries on new drugs and treatment strategies include links to the ICAAC online abstracts and/or links to slidesets or articles posted at natap.org.
Dolutegravir Results Superior to Efavirenz at Week 48 in Treatment-Naive Patients
The top-line results from the randomised, double-blinded, placebo-controlled, non-inferiority, Phase 3 SPRING study were released in July just prior to the IAS conference.
Dolutegravir (50 mg once-daily) was paired with abacavir/3TC and compared to efavirenz/tenofovir/FTC (Atripla) in 674 treatment-naive patients, generally in early stage infection.
At week 48, the dolutegravir arm showed superiority with 88% vs 81% of patients suppresed to <50 copies/mL (difference +7.4%; 95%CI: +2.5, +12.3; p=0.003).
This result was driven by fewer discontinuations due to toxicity in the dolutegravir arm (2% vs 10%). Virological failure occured in 4% of patients in each group.
Ref: Walmsley S et al. Dolutegravir (DTG; S/GSK1349572) + abacavir/lamivudine once daily statistically superior to tenofovir/emtricitabine/efavirenz: 48-week results -- SINGLE (ING114467). 52nd ICAAC, 9-12 September 2012, San Francisco. Abstract H-556b.
Elvitegravir/Cobicistat Has No Clinically Significant Interactions With Methadone or Buprenorphine
Results from two small PK studies in patients on stable opiate substitution therapy (n=12 methadone; n=18 buprenorphine) reported no indications of an interaction between elvitegravir/cobicistat and methadone and only modestly increased buprenorphine levels that did not require dose modification.
Ref: Bruce RD et al. Pharmacokinetics of cobicistat-boosted elvitegravir administered in combination with methadone or buprenorphine/naloxone. 52nd ICAAC, 9-12 September 2012, San Francisco. Abstract A-1250.
Albuvirtide: Long-Acting Formulation T-20
The first in vivo virological data were presented for a new long-acting formulation of the fusion inhibitor T-20. This compound is in development with the Chinese company Chongquing Biotechnologies.
The limited information from the abstract reported results from a dose-finding study in Chinese HIV positive patients who received single IV injections daily for three days, followed by once-weekly injections for a further two weeks.
Mean maximum declines of 0.68 and 1.05 log copies/mL were reported with 160 mg and 320 mg doses respectively. In a single-dose study, viral reduction was maintained for 6-10 days, with albuvirtide showing a plasma half-life of 10-13 days.
Ref: Wu H et al. Albuvirtide, the first long-acting HIV fusion inhibitor, suppressed viral replication in HIV-infected adults. 52nd ICAAC, 9-12 September 2012, San Francisco. Abstract H554.
High Rates of Adherence and Virological Suppression With Once-Daily Raltegravir and Directly Observed Therapy (DOT) in IDU Patients
Although results of once-daily raltegravir studies did not support a label change or further research into this dosing option, a Canadian study reported very high rates of success in a cohort of 121 HIV positive treatment experienced injecting drug users (n=103 male) that also included comprehensive adherence support. DOT ws used by 81% of patients.
Over a median follow-up of 12 (6-18) months, 80% of the cohort achieved or maintained virologic suppression to <50 copies/mL (appromiately half the group switched with undetectable viral load at baseline.
Importantly, CD4 counts increased by a median 80 cells/mm3 from a median of 425 cells/mm3 (range 20-1600) at baseline. Adherence exceeded 90%. Virologic rebound to >400 copies/mL occurred in 10% of patients but resuppression was achieved in all cases over the subsequent three months. There were no cases of emergent raltegravir resistance.
Ref: Stewart K et al. Safety and efficacy of once daily raltegravir to enhance adherence and efficacy of HAART in vulnerable HIV-infected patients. 52nd ICAAC, 9-12 September 2012, San Francisco. Abstract H-884.
Role of HIV DNA, Recent Cellular Infection and Poor Immunological Responses Despite Viral Suppression
A group of French researchers looking at immunological non-responders despite viral suppression <50 copies/mL reported an association with HIV DNA as a marker of recent cellular infection and ongoing replication and overexpression of the activation marker CD38+, that was higher in patients with reduced CD4 responses on treatment. The natap report linked below report this study in detail.
Ref: Psomas KC et al. Poor CD4+ T-cell restoration linked to residual HIV-1 reverse transcription under antiretroviral therapy. 52nd ICAAC, 9-12 September 2012, San Francisco. Abstract H-1570a.
HIV-Infected Patients More at Risk for Early Onset and Late Diagnosis of Coronary Artery Disease, Study Suggests
This article was provided by HIV i-Base. It is a part of the publication HIV Treatment Bulletin. Visit HIV i-Base's website to find out more about their activities, publications and services.
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.)
The content on this page is free of advertiser influence and was produced by our editorial team. See our content and advertising policies.