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TreatmentUpdate 173

Volume 21 Issue 4

2009 May/June

I ANTI-HIV AGENTS: D. Raltegravir as initial therapy

Raltegravir has shown that it can be a useful part of combination therapy for treatment-experienced people. And when tested as part of combination therapy for first-line treatment against a regimen containing efavirenz (Sustiva), it was found to be as effective.

Study details

Researchers in North and South America, Europe and the Asia-Pacific region enrolled 562 HIV positive people who had not previously used anti-HIV drugs and randomly assigned them to one of the following groups:

raltegravir group: raltegravir with a fixed-dose combination of tenofovir and FTC (Truvada) – 281 volunteers
efavirenz group: efavirenz with a fixed-dose combination of tenofovir and FTC – 282 volunteers

The average profile of participants at the start of the study was as follows:

19% female, 81% male
age – 37 years
CD4+ count – 208 cells
viral load – 100,000 copies
7% had hepatitis B or C
15% had a history of AIDS

Results

After one year, the proportion of participants in each group who had a viral load below the 50-copy mark was as follows:

raltegravir group – 86%
efavirenz group – 82%

Changes in CD4+ counts after one year were as follows in each group:

raltegravir group – 189 additional cells
efavirenz group – 163 additional cells

Based on the design of this study (a non-inferiority design) and the results, it is clear that combination therapy containing raltegravir is “no worse than” combination therapy containing efavirenz. This result suggests that both drugs have near-equal effectiveness.

It is noteworthy that the raltegravir-containing regimen had fewer overall drug-related side effects. As well, researchers also pointed out the following about raltegravir:

It had significantly fewer side effects that affected the central nervous system (brain and spinal cord).
It was safe in people co-infected with hepatitis B or C viruses.
It was effective against strains of HIV that are commonly found outside of high-income countries.

As raltegravir is tested in more people for first-line therapy in the coming years, it will likely be approved for this use in HIV positive people.

REFERENCE:

Lennox J, Dejesus E, Lazzarin A, et al. Subgroup analyses from STARTMRK, a Phase III study of raltegravir-based vs. efavirenz-based combination therapy in treatment-naïve HIV-infected patients. In: Program and abstracts of the 16th Conference on Retroviruses and Opportunistic Infections, February 8-11, 2009, Montreal, Canada. Abstract 573.

Created on: 2009 June 9

Author: Hosein SR

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