Age no spoiler in switch to single HIV pill
Patients older than 40 do as well as younger patients on the fixed-dose antiretroviral combination of rilpivirine, emtricitabine, and tenofovir.
SAN FRANCISCO – Patients older than 40 did as well as younger patients on the fixed-dose antiretroviral combination of rilpivirine, emtricitabine, and tenofovir (Complera), researchers said here.
When virologically-suppressed patients were switched from a protease inhibitor combination to the simpler rilpivirine-based therapy, about 95% of those 40 or younger maintained undetectable plasma virus levels compared with 86% of that same age group who were taking boosted protease inhibitors, according to David Shamblaw, MD, director of the La Playa Medical Group and Clinical Research, in San Diego, and colleagues.
About 93% of all the patients older than 40 – on either regimen – maintained undetectable viral loads using the 50-copy/ml assay, Shamblaw said at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.
The differences between the two age groups were not statistically significant.
"Advancing age among HIV-infected persons necessitates careful analysis of antiretroviral regimen safety, specifically risks known to increase with age," Shamblaw explained. "In particular, antiretroviral simplification strategies need to be studied to evaluate risk:benefit ratios."
The researchers scrutinized outcomes in the so-called SPIRIT trial, stratifying patients on the basis of age. The overall median age in the study was 42, so Shamblaw used 40 as the break point in trying to determine if there was any difference for age. In the rilpivirine cohort, 142 participants were 40 or younger and 175 were older than 40. In the protease inhibitor group, 64 participants were in the younger group and 95 were in the older cohort.
When the researchers probed difference in tolerability on the basis of age, Shamblaw again observed no significant differences. Only one of the younger rilpivirine patients experienced serious adverse events; two individuals or 1.1% of the older cohort experienced a serious adverse event. In the protease inhibitor group, no serious adverse events occurred in either age group.
No discontinuations for adverse events occurred in the protease inhibitor patients; two occurred in each age group in the rilpivirine patients.
When lipid profiles were observed, the patients in both age groups on rilpivirine were able to significantly improve total cholesterol, low density lipoprotein cholesterol, and triglyceride levels (P<0.05 for each category).
"The simplification strategy of switching virologically-suppressed patients on boosted protease inhibitor-based regimens to the rilpivirine single-tablet regimen provides substantial benefit relative to safety concerns for ages 40 or younger and those older than 40," Shamblaw said.
Among those benefits:
About 37% of the patients on ritonavir-boosted protease inhibitor therapy were taking atazanavir (Reyataz), 33% were on lopinavir/ritonavir (Kaletra), and 20% were on darunavir (Prezista).
"The outcomes in the SPIRIT study give us more options," Mark Wainberg, PhD, director of the McGill University AIDS Center, Montreal, told MedPage Today. "And more options are better for patients."
The trial was sponsored by Gilead Sciences, Foster City, Calif.
Wainberg had no disclosures.
Shamblaw disclosed commercial interests with Janssen Pharmaceuticals and Gilead Sciences
By Ed Susman
Primary source: Interscience Conference on Antimicrobial Agents and Chemotherapy Source reference: Shamblaw D, et al "Switching to the single-tablet regimen emtricitabine/rilpivirine/tenofovir DF from a ritonavir-boosted protease inhibitor and two nucleoside reverse transcriptase inhibitors maintains HIV suppression and is well tolerated in HIV-1 subjects at week 24 regardless of age: SPIRIT study" ICAAC 2012; Abstract H-556.
Source: MedPage Today