Dr. Michael Saag presented data on behalf of the Center for Infectious Disease Research in Zambia (CIDRZ) about a randomized trial of routine versus discretionary viral load monitoring among adults starting antiretroviral (ART) in Zambia Wednesday at the 19th Conference on Retroviruses and Opportunistic Infections.
In mid-2004 when ART was rolled out, the decision was made to try to treat as many people as possible with the resources available, so viral load testing was not included in the standard of care and only used on a discretionary basis in the face of clinical symptoms or failure to improve on ART after six months of therapy. The study was embedded in routine clinical care with 12 clinics participating – six performing routine viral load testing and the other six offering standard of care. The patients enrolled in the clinics were all new to treatment. The primary end point of the study was mortality and the secondary end point was the switch to second-line therapy.
Mortality dropped dramatically in both groups with the advent of ART, and overall mortality was the same in both groups during the 36-month study period. Patients in the intervention arm were more likely to switch to second line therapy during the study period than those in the standard of care arm. Notably, it took more than twice as long for patients in the control group or standard of care arm to be switched from failing regimens. Those in the control group remained on failing regimens for about 560 days before a switch was made.
Saag concluded that viral load monitoring might have an important role for identifying patients who require targeted adherence support measures. He also noted that the study highlights the potential for operational research with a direct bearing on clinical practice to be successfully embedded into routine care.