March 17, 2011
From CROI, March 2011: Earlier results from the ANRS 139 TRIO study showed good control of HIV in those who took the regimen of Isentress (raltegravir), Intelence (etravirine) and boosted Prezista (darunavir + ritonavir). All three of these drugs were brought to market within the past five years, and in studies independently showed they controlled HIV well in people who had been on treatment for a long time.
Now, new second-year data of the regimen shows that nearly 9 out of 10 of them continued to have undetectable viral loads, a notable feat given the amount of resistant virus present before the start of the study. This type of regimen may give hope to some people who are having difficulty controlling HIV later in their stage of disease.
The second year of TRIO followed 100 people who continued to take the three-drug regimen with a background regimen of NRTIs should an individual also need them. The average age was 45, 89% were male, 2 out of 5 had an AIDS diagnosis, average CD4 count was 258, average lowest-ever CD4 was 80, and average viral load was ~16,000, and average time on treatment was 13 years.
Everyone in the study had multiple drug resistance, including major mutations for the classes of NRTIs and NNRTIs and protease inhibitors. All of them also had few mutations specific to Intelence and Prezista.
During the study, 19 people had detectable viral loads on at least two consecutive tests: 12 in the first year and 7 in the second. However, 14 of them were again undetectable by week 96. Two others had quit the study for unknown reasons and were considered as part of these 19. Average CD4 counts also increased by 180 cells by week 96.
The regimen continued to be well tolerated, with one person stopping the regimen due to a severe rash, which was in the first year of study. Side effects were mostly mild to moderate and very few severe side effects were seen in the second year.
Other good news included no changes in their levels of blood fats (lipids) such as cholesterol and triglycerides over the full study. This is encouraging news given the metabolic changes that HIV regimens can have on people as they continue to take HIV meds.
RESEARCH STUDY:
Long-term Follow-up of Patients Receiving RAL, ETV, and DRV/r in the ANRS 139 TRIO Trial. Fagard C, et al. Abstract #549.