The new integrase inhibitor raltegravir (Isentress) has been granted marketing approval for use as a first-line HIV treatment in the European Union, manufacturer Merck Sharp & Dohme (MSD) announced today.
Raltegravir is one of the new class of antiretroviral drugs that blocks HIV from integrating its genetic material into human cells. It is already approved for use in treatment-experienced adults in Europe.
The drug was approved for first-line treatment in combination with other antiretroviral drugs after data from the STARTMRK phase III study showed that patients treated with raltegravir were just as likely to achieve and maintain a viral load below 50 copies/ml after 48 weeks when compared to patients treated with efavirenz.
Further 96-week results from the STARTMRK study were presented this week at the Interscience Conference on Antimicrobial Agents and Chemotherapy, and show that raltegravir continued to maintain parity with efavirenz at 96 weeks, but was better tolerated.
Patients who received raltegravir were less likely to report central nervous system problems such as dizziness and abnormal dreams, and had significantly smaller increases in total and LDL cholesterol levels (although there was no significant difference between the drugs after 96 weeks in the ratio of total cholesterol to HDL cholesterol, which is considered to be one of the key measures of cardiovascular risk).
Lennox J et al. Raltegravir demonstrates durable efficacy through 96 weeks: results from STARTMRK, a phase III study of raltegravir-based vs efavirenz-based therapy in treatment-naïve HIV+ patients. Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), San Francisco, abstract H924b, 2009.