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Raltegravir (Isentress), Etravirine (Intelence), and Boosted Darunavir (Prezista) Is Highly Effective for Treatment-experienced Adolescents

An antiretroviral therapy (ART) regimen containing 3 recently approved anti-HIV drugs -- the integrase inhibitor raltegravir (Isentress), the next generation non-nucleoside reverse transcriptase inhibitor (NNRTI) etravirine (Intelence), and the ritonavir-boosted protease inhibitor darunavir (Prezista) -- was well tolerated and produced good viral suppression and CD4 cell gains in heavily treatment-experienced adolescents, according to a study published in the November 13, 2009 issue of AIDS.

As previously reported, 2 recent studies demonstrated that a triple combination regimen of raltegravir, etravirine, and darunavir/ritonavir was well tolerated and produced high rates of virological suppression in heavily treatment-experienced adult HIV patients with extensively drug-resistant virus.

Now, French researchers have reported that the same regimen is also effective for older children and adolescents with HIV.

Isabelle Thuret and colleagues studies 12 highly treatment-experienced patients with an average age of 15 years who contracted HIV via perinatal transmission, and thus were infected for their entire lives. At study entry, the group had relatively advanced HIV disease, with a median viral load of about 100,000 copies/mL and a median CD4 cell count of 124 cells/mm³.

Participants had a history of virological failure and resistance to drugs in the first 3 antiretroviral classes (nucleoside/nucleotide reverse transcriptase inhibitors, NNRTIs, and protease inhibitors). All patients received raltegravir, etravirine, and darunavir/ritonavirthrough an expanded access program in France.

Results

• After a median follow-up period of 12 months, 6 of the 12 patients (50%) had undetectable HIV viral load < 50 copies/mL.
• 11 of the 12 (92%) had HIV RNA < 400 copies/mL.
• At 12 months, the median CD4 cell count had increased to 500 cells/mm³.
• No participants developed an AIDS-related illness or died during follow-up.
• No clinical side effects or laboratory abnormalities more serious than grade 2 (moderate) were reported.
• Only 1 participant discontinued therapy prematurely due to adverse events.

Based on these findings, the investigators concluded that "preliminary results in adolescents with extensive multidrug resistant virus are encouraging," and characterized the tolerability and efficacy of the regimen as "remarkable."

In their discussion, the authors wrote, "the majority of extensively treated adolescents can be virologically controlled with by a salvage regimen consisting of a combination of new drugs, despite a long record of suboptimal treatment and viral multi-resistance."

11/17/09

Reference

I Thuret, M-L Chaix, C Tamalet, and others. Raltegravir, etravirine and r-darunavir combination in adolescents with multidrug-resistant virus.AIDS 23(17): 2364-2366. November 13, 2009 (Abstract).