A new multi-site study reveals patients with drug-resistant HIV can safely achieve viral suppression - the primary goal of HIV therapy - without incorporating the traditional class of HIV medications into their treatment regimen. Karen Tashima, M.D., director of the HIV Clinical Trials Program at The Miriam Hospital, served as study chair.
The AIDS Clinical Trials Group (ACTG) Network's OPTIONS Trial proves, for the first time, that treatment-experienced patients can leave out this class of medication, known as nucleoside reverse transcriptase inhibitors (NRTI), as part of the regimen. These results could change treatment guidelines, lessen side effects and increase adherence rates, the researchers say.
Tashima and colleagues presented the results from the 48-week study at the annual Conference for Retroviruses and Opportunistic Infections (CROI) in Atlanta on March 6.
"We are so comfortable clinically with the NRTI class that we think we must always use at least one drug from this class in treatment. However, some patients have developed within-class resistance, making the NRTIs less effective overall. Therefore, drugs from this class may not be needed if the new treatment plan contains more effective medications," said Tashima, who also leads ACTG's clinical research site at The Miriam Hospital.
"There were a few new drugs coming out at the same time and we decided to turn the question around. Instead of having patients take their current medications from the NRTI class as well as these new drugs from different classes, we asked half of the study participants to add NRTIs and half of them to leave out NRTIs from their new treatment plan. We were able to take the usual study paradigm and turn it around," she added.
Treatment-experienced patients can develop resistance to therapy due to poor adherence, said Richard Haubrich, M.D., the study's co-chair and professor of medicine at University of California at San Diego. Designing a treatment plan using new drugs from new classes and omitting NRTIs leads to fewer pills, and hopefully, better adherence.
"There are several options for treatment na-ve patients, but not as many for treatment-experienced. The HIV research field accepted that nucleosides would be an important component for multiple class-experienced patients," said Haubrich. "However, our results were very clear. We can safely exclude NRTIs, giving physicians a new paradigm for ART prescription in clinic and potentially changing treatment guidelines."