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Raltegravir (Isentress), Etravirine (Intelence), and Ritonavir-boosted Darunavir (Prezista) Is a Safe and Successful Salvage Regimen

A combination of the integrase inhibitor raltegravir (Isentress), the non-nucleoside reverse transcriptase inhibitor (NNRTI) etravirine (Intelence), and the ritonavir-boosted protease inhibitor darunavir (Prezista) was well-tolerated and highly effective as a "salvage" antiretroviral therapy (ART) regimen for patients with multidrug-resistant HIV, according to a study published in the August 3, 2009 advance online edition of the Journal of Acquired Immune Deficiency Syndromes.

Heavily treatment-experienced HIV patients -- especially those who started therapy when regimens were less potent -- may have developed resistance to multiple antiretroviral drugs, leading to treatment failure. Previous research has demonstrated that boosted darunavir plus etravirine in the DUET trials and raltegravir in the BENCHMRK trials produced high rates of virological response in patients with multidrug-resistant HIV, particularly when used with 2 or more other fully active antiretroviral drugs.

The present study looked at these 3 drugs in a combination regimen without other agents. The analysis included 32 consecutive heavily treated-experienced participants with multidrug-resistant HIV who started a new salvage regimen consisting of 400 mg twice-daily raltegravir, 200 mg twice-daily etravirine, and 600/100 mg twice-daily darunavir/ritonavir.

At baseline, the median age was 44 years, the median duration of ART was 13 years, and participants had used a median 9 prior ART regimens. The median CD4 cell count was 261 cells/mm3 and the median viral load was 4.2 log10 copies/mL.

All patients had HIV mutations conferring resistance to 3 classes of antiretroviral drugs. Three patients (9%) had HIV isolates with 3 etravirine resistance mutations. All participants were darunavir-naive and had a median of 1 darunavir resistance mutation. Half the patients had experience with enfuvirtide (T-20, Fuzeon) and 44% had used tipranavir (Aptivus).

Results

Percentages of patients achieving HIV RNA less than 50 copies/mL were as follows:
 
Week 4: 63%;
Week 12: 81%;
Week 24: 94%.
Median CD4 cell count increased by 30, 73, and 103 cells/mm3 at Weeks 4, 12, and 24, respectively.
Most adverse events were mild to moderate.
No patients experienced adverse events leading to discontinuation of the regimen.

In conclusion, the study authors wrote, "Raltegravir, etravirine, and darunavir/ritonavir is a well tolerated and highly effective antiretroviral combination in treatment-experienced and multidrug-resistant HIV-1-infected patients with few specific etravirine and darunavir resistance-related mutations."

Infectious Diseases Department and Microbiology Department, Hospital Universitari Vall d'Hebron, Universidad Autónoma de Barcelona, Barcelona, Spain; Infectious Disease Unit and Microbiology Department, Hospital Universitari Son Dureta, Palma de Mallorca, Spainn.

10/06/09

Reference
A Imaz, SV Del Saz, MA Ribas, and others. Raltegravir, Etravirine, and Ritonavir-Boosted Darunavir: A Safe and Successful Rescue Regimen for Multidrug-Resistant HIV-1Infection. Journal of Acquired Immune Deficiency Syndromes. August 3, 2009 (Epub ahead of print). (Abstract).