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 HIV and Hepatitis.com Coverage of the
5
th IAS Conference on HIV Pathogenesis, Treatment and Prevention (IAS 2009)
 July 19 - 22, 2009, Cape Town, South Africa
 The material posted on HIV and Hepatitis.com about IAS 2009 is not approved by nor is it a part of IAS 2009.
Integrase Inhibitor Raltegravir (Isentress) Compares Favorably to Efavirenz (Sustiva) at 144 Weeks in Treatment-naive Patients

The integrase inhibitor raltegravir (Isentress), in combination with tenofovir/lamivudine, continued to exhibit potent anti-HIV activity at 144 weeks in treatment-naive patients, suppressing viral load as well as efavirenz (Sustiva) but associated with fewer side effects.

By Liz Highleyman

At the 5th International AIDS Society Conference on HIV Pathogenesis, Treatment, and Prevention (IAS 2009) this week in Cape Town, South Africa, researchers from Peru, Canada, and the U.S. presented a poster describing results from an ongoing Phase 2 study comparing the long-term efficacy, safety, and tolerability of raltegravir versus efavirenz in previously untreated patients.

In this double-blind, multicenter study, 198 treatment-naive participants were randomly assigned to receive 400 mg twice-daily raltegravir (the first 48 weeks were dose-ranging from 100 to 600 mg twice-daily) or 600 mg once-daily efavirenz, both combined with tenofovir (Viread) and lamivudine (3TC; Epivir).

Results

At 144 weeks, in a non-completer = failure analysis, 144, 78% of the 160 patients receiving raltegravir and 76% of the 38 patients taking efavirenz had sustained HIV RNA suppression < 50 copies/mL.
Only 3 patients met the study's definition of virological failure after week 96, 2 in the raltegravir arm and 1 in the efavirenz arm.
Participant in both arms experienced similar CD4 cell gains (252 vs 233 cells/mm3, respectively).
Drug-related clinical adverse events were less frequent in the raltegravir arm compared with the efavirenz arm, at 54% vs 76%, respectively.
Overall, the most common adverse events, reported by more than 10% of participants, were nausea, dizziness, and headache, which occurred with similar frequency in the 2 arms.
Neuropsychiatric adverse events were less frequent in the raltegravir compared with the efavirenz arm (35% vs 61%).
Laboratory adverse events were uncommon in both treatment groups.
Raltegravir had a minimal effect on total cholesterol, LDL ("bad") cholesterol, and triglyceride levels.

Based on these findings, the researchers concluded," In ART-naive patients, raltegravir with [tenofovir/lamivudine] had potent and durable antiretroviral activity, which was similar to [efavirenz/tenofovir/lamivudine] and was sustained to week 144."

"Raltegravir was generally well tolerated, they added. "[D]rug related adverse events were less frequent in patients treated with raltegravir compared to efavirenz."

These data indicate that raltegravir continues to be effective at 144 weeks, consistent with previously reported 48-week data. The U.S. Food and Drug Administration approved raltegravir for treatment-naive HIV patients earlier this month.

Hospital Nacionale Cayetano Heredia, Lima, Peru; Merck Research Laboratories, West Point, PA; Aaron Diamond AIDS Research Center, New York, NY; Hospital Nacionale Edgardo Rebagliati, Lima, Peru; Siriraj Hospital, Bangkok, Thailand; Canadian Immunodeficiency Research Collaborative, Toronto, Canada; Fundación Santafe de Bogota University Hospital, Bogota, Colombia; Clinical Research Puerto Rico, Inc., San Juan, Puerto Rico; Beth Israel Deaconess Medical Center, Boston, MA.

7/21/09

Reference
E Gotuzzo, BY Nguyen, M Markowitz, and others. Sustained antiretroviral efficacy of raltegravir as part of combination ART in treatment-naive HIV-1 infected patients: 144-week data. 5th International AIDS Society Conference on HIV Pathogenesis, Treatment, and Prevention. Cape Town, South Africa. July 19-22, 2009. Abstract MOPEB030.

 

 

 

 

 

 

 

 

 

 

 

 

 

 




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