Background: Raltegravir (RAL) is a novel drug and first of the HIV integrase inhibitor class, gaining US market approval in October 2007. The current study evaluates the real world utilization patterns of RAL within the OPERA Clinical database.
Methods: The analysis population was defined as all HIV patients treated with antiretrovirals in the OPERA database, representing community-based, HIV specialty practices across the U.S. Patients who have ever taken RAL were identified and compared to the population not taking RAL at data freeze. Utilization patterns for raltegravir were assessed taking into consideration patient demographics, treatment history, clinical parameters and co-infection status.
Results: As of data freeze (02/02/09), 7,470 HIV patients had been treated with antiretrovirals in the OPERA database. Of these, 510 (6.8%) had ever been prescribed RAL. Median duration of RAL use was over 5 months with some patients exposed for over 2 years. Only one patient has discontinued use as of data freeze. Nearly half (47.0%) were 40-49 years of age and 19% were women, consistent with the overall treatment population. A total of 8.4% of RAL users were co-infected with hepatitis C. RAL was used primarily as salvage therapy (55% of total RAL users). However, substantial numbers of patients were using raltegravir early in therapy as well. A total of 8.4% and 12% of RAL users were on their first and second HIV regimen, respectively. Patients using raltegravir were most likely to have CD4 counts below 399. However, a subset of experienced patients initiated raltegravir regimens at CD4s > 600 cells/ml with undetectable VLs. RAL was most frequently prescribed with emtricitabine and tenofovir as Truvada along with ritonavir-boosted darunavir. The 2nd most common RAL regimen was with Truvada alone. Nonetheless, there were many diverse RAL combination regimens being prescribed in this population.
Conclusion: RAL use has steadily increased in the OPERA population since its approval. Interestingly, RAL has been used in both early and late therapy regimens as well as in novel regimens with few discontinuations.