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Study Summaries From ICAAC 2012

By Simon Collins

September/October 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.

www.abstractsonline.com/Plan/ViewAbstract.aspx?sKey=e1c18d5b-830f-4b4e-8671-35bcfb20eed5&cKey=af219b7d-2171-46b2-91ef-b8049552c9e5&mKey=%7b6B114A1D-85A4-4054-A83B-04D8B9B8749F%7d

www.natap.org/2012/ICAAC/ICAAC_06.htm


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.

www.abstractsonline.com/Plan/ViewAbstract.aspx?sKey=a96a704b-ee24-44df-8955-f1688acf7663&cKey=7c849c73-6efd-4fce-9e2c-218df03ff40c&mKey=%7b6B114A1D-85A4-4054-A83B-04D8B9B8749F%7d

www.natap.org/2012/ICAAC/ICAAC_40.htm


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.

www.abstractsonline.com/Plan/ViewAbstract.aspx?sKey=e1c18d5b-830f-4b4e-8671-35bcfb20eed5&cKey=70d14bcc-bad6-4754-b4b1-66b7d2559a23&mKey=%7b6B114A1D-85A4-4054-A83B-04D8B9B8749F%7d

www.natap.org/2012/ICAAC/ICAAC_27.htm


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.

www.abstractsonline.com/Plan/ViewAbstract.aspx?sKey=e47a6478-452a-4c7c-9ebc-86a50a648cc7&cKey=8eb48052-2257-4337-8e1d-51658c50fefe&mKey=%7b6B114A1D-85A4-4054-A83B-04D8B9B8749F%7d

www.natap.org/2012/ICAAC/ICAAC_21.htm


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.

www.abstractsonline.com/Plan/ViewAbstract.aspx?sKey=0bc31dda-3bfe-443f-8051-1788529cb053&cKey=e7b3f725-db08-4db9-953e-126811e32026&mKey=%7b6B114A1D-85A4-4054-A83B-04D8B9B8749F%7d

www.natap.org/2012/ICAAC/ICAAC_35.htm




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