- Category: HIV Treatment
- Published on Tuesday, 08 October 2013 00:00
- Written by Liz Highleyman
People with HIV who have their viral load and CD4 T-cell count monitored every 6 months were no more likely to experience virological failure or to change their antiretroviral regimens than those monitored every 4 months, researchers reported at the Second IDWeek meeting last week in San Francisco.
U.S. and European HIV treatment guidelines have traditionally recommended that people receiving antiretroviral therapy (ART) should have their viral load and CD4 count monitored as often as every 3 months. Current guidelines note that less frequent monitoring may be adequate for patients who are doing well, but this has not been extensively studied in wealthy countries.
Kamla Sanasi from the University of South Carolina and colleagues designed a study to compare outcomes among people with HIV on stable ART who were randomly assigned to undergo laboratory monitoring every 4 or every 6 months.
Less frequent monitoring could reduce cost and improve quality of life by requiring fewer medical appointments, but conversely adherence could decline and virological failure or toxicities could continue longer before they are detected, the researchers noted as background.
This analysis included 165 people with HIV seen at a single clinic in the southern U.S. south who had CD4 counts of at least 250 cells/mm3 and were on combination ART with undetectable viral load (<200 copies/mL) for at least 1 year. All patients who met these criteria were included, not only those who were expected to do well with less frequent monitoring.
Most participants (about 70%) were men, nearly 60% were black, 38% were white, the average age was 47 years, and they had been HIV positive for an average of 12 years. Nearly half were taking NNRTIs and one-third were taking protease inhibitors. More than half had resistance mutations at baseline. The mean baseline CD4 count was approximately 575 cells/mm3, with a nadir (lowest-ever) of 244 cells/mm3. One-quarter had 2 or more co-morbid conditions, including 15% with hepatitis B and 17% with hepatitis C.
At each scheduled visit participants completed an adherence survey, a quality of life questionnaire that included physical and mental health components, and a questionnaire about other medical care they received. Follow-up continued for an average of 20 months.
The primary study endpoint was percentage of participants with virological failure at two years, defined as 2 consecutive detectable viral loads. Other outcomes included self-reported adherence, quality of life, number of healthcare visits, emergence of new viral resistance mutations, and percentage of people who needed to change or stop ART.
- There were no significant differences in the proportion of participants with virological failure or in time to virological failure in the 4-month and 6-month monitoring groups.
- Only a single participant in the 6-month group experienced sustained HIV rebound.
- Quality of life was also the same in both groups, with similar physical health scores (54 vs 53) and mental health scores (51 in both groups); scores did not change significantly from baseline in either group.
- Participants reported no difference in adherence in the 6-month and 4-month monitoring groups (adherence scores of 12 vs 13); again, adherence did not change significantly from baseline in either group.
- Only a small proportion of participants changed or stopped ART, with no significant differences between the 4-month and 6-month groups; 2 people switched regimens due to viral breakthrough, 1 due to poor adherence, and 12 for other reasons; none changed to due side-effects.
- 1 person in each group acquired a new resistance mutation.
- Participants randomized to monitoring every 4 months actually had 23% more HIV-related medical visits overall, a significant difference; the 16% increase in non-HIV-related visits did not reach statistical significance.
"At follow up, there was no difference in virologic failure, quality of life scores, time to detectable viral load, or change in HAART when stable patients are monitored every six months versus every four months," the investigators summarized."Monitoring stable HIV patients on HAART with undetectable viral loads every six months is safe."
"Patients with longer intervals between HIV visits did not compensate with more visits to other providers," they added.
These findings have potential implications for healthcare policies and resource utilization, the study team concluded. At their clinic, which sees about 2000 patients, reducing monitoring for stable individuals from 3 to 2 visits per year would save more than $787,000 annually. These funds could be redirected to HIV screening, linkage to care, adherence counseling, and other social issues, they suggested.
On a national level, a recent study by Emily Hyle from Massachusetts General Hospital and colleagues, published in the August 26, 2013, online edition of JAMA Internal Medicine, found that reducing CD4 cell monitoring for stable patients from every 6 months to once per year could save $10.2 million annually, or more than $225 million over a lifetime.
After the presentation Paul Volberding from the University of California at San Francisco noted that some experts are talking about not monitoring CD4 counts at all in stable patients, just viral load.
This approach has been studied with good results in resource-limited settings (including Cameroon and Thailand) where regular CD4 monitoring is not logistically feasible. More recently a U.S. study published in the May 1, 2013, Clinical Infectious Diseases found that there was a 99% probability that people with viral load suppression and a CD4 count above 300 cells/mm3 would maintain a CD4 level well above the danger zone for opportunistic infections over 5 years.
K Sanasi, VSeshadri, D Parker, et al. Randomized-controlled trial of every 4 month versus every 6 months monitoring in HIV-infected patients controlled on highly active antiretroviral therapy. 2nd ID Week Conference (IDWeek 2013). San Francisco. October 2-6, 2013. Abstract 673.
HB Gale, SR Gitterman, HJ Hoffman, et al. Is frequent CD4+ T-lymphocyte count monitoring necessary for persons with counts >300 cells/μl and HIV-1 viral suppression. Clinical Infectious Diseases 56(9):1340-1343. May 1, 2013.
E Hyle, P Sax, and R Walensky. Potential savings by reduced CD4 monitoring in stable patients with HIV receiving antiretroviral therapy. JAMA Internal Medicine. August 26, 2013 (Epub ahead of print).
G Jourdain et al. PHPT-3: a randomized clinical trial comparing CD4 vs viral load ART monitoring/switching strategies in Thailand. 18th Conference on Retroviruses and Opportunistic Infections (CROI 2011). Boston. February 27-March 2, 2011. Abstract 44.
C Kouanfack et al. HIV viral load, CD4 cell count, and clinical monitoring vs clinical monitoring alone for ART in rural hospitals in Cameroon: Stratall ANRS 12110/ESTHER trial, a randomized non-inferiority trial. 18th Conference on Retroviruses and Opportunistic Infections (CROI 2011). Boston. February 27-March 2, 2011. Abstract 45LB.