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Routine viral load monitoring almost halves risk of virologic failure in 18-month Kenyan study
Lesley Odendal, 2013-03-12 06:30:00
Six-monthly viral load testing of patients taking antiretroviral therapy (ART) at primary health clinics in rural Kenya reduced the risk of virologic failure at 18 months of follow-up by 46%, according to the results of the Clinic-based ART Diagnostic Evaluation (CLADE) randomised controlled trial conducted in rural Kenya at seven district-level clinics. Dr Frederick Sawe of the Kenya Medical Research Institute presented the findings to the 20th Conference on Retroviruses and Opportunistic Infections (CROI 2013) in Atlanta last week.
Routine viral load monitoring is still the exception rather than the rule in resource-limited settings owing to a number of barriers to implementation. The lack of point-of-care viral load testing, coupled with the need to send blood samples to laboratories that can carry out the test, make it difficult to carry out viral load testing for every patient.
WHO guidelines recommend the use of HIV-1 RNA viral load to confirm ART treatment failure, and routine viral load tests every six months where available. Kenya Ministry of Health (MoH) guidelines recommend targeted viral load if treatment failure is suspected. However, the WHO guidance is based on “low quality evidence”. Randomised controlled trial data, including cost effectiveness in rural settings where the majority of the HIV burden exists, are lacking.
The CLADE study randomised 820 treatment-naive patients to receive standard-of-care clinical and immunologic monitoring with confirmatory or targeted viral load (Routine Care Arm), or clinical and immunological monitoring with concurrent viral load at every six months (Viral Load Arm). Participants were followed up for 18 months.
The study took place in seven rural district clinics, five of which are managed by the Kenyan Ministry of Health and two of which managed by faith-based organisations. The clinics are primarily staffed by clinical officers and nurses. The baseline characteristics were similar between the two groups, with 57% of participants being female, 37 years being the median age and the median CD4 count being between 164 and 168 cells/mm3 in both groups. Just under one-third had advanced HIV disease (WHO stages 3 or 4 HIV disease).
Viral load testing was carried out at a central laboratory in Kericho.
Viral failure (HIV-1 RNA greater than 1000 copies/ml)in the Routine Care Arm was 15.2% (51 of 336) compared to 8.7% (28 9f 321) in the Viral Load Arm (p = 0.006). Overall, 12% of all study participants (79 of 657) experienced viral failure. Multivariate analysis showed that the 18-month risk of viral failure in the viral load monitoring arm was 0.54 (0.35 – 0.87) when compared to the standard-of-care arm.
Of the 820 patients enrolled in the study, 34 (4.1%) had treatment failure and began second-line ART. Four (0.9%) of these were in the Routine Care Arm and 30 (7.3%) were in the Viral Load Arm (p<0.01). Overall, 336 (82.2%) in the Routine Care Arm and 321 (78.5%) in the Viral Load Arm completed the per-protocol, 18-month final visit within the 21-day window.
The study also found that 15.4 people needed to be screened in order to prevent one viral failure.
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