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Non-reactive HIV-1 self-tests after sustained viral suppression following early antiretroviral therapy


Author
Steffic et al.

Publication year
2017

Country

Type of approach
n/a

Type of assistance
n/a

Specimen
Fingerstick/whole blood

Study population
Other: People living with HIV

Study design
Feasibility/acceptability

Sample size
44

UNAIDS HIV prevalence (2017)
0.2 [0.2 - 0.2]

Methodology
Frozen serum samples were collected among HIV-infected patients enrolled at time of primary HIV-1 infection within the ANRS PRIMO cohort, who received immediate ART and presented an undetectable viral load for 36 months afterwards. Samples were tested using the following CE-marked tests: 2nd generation: Autotest VIH (self-test), 3rd generation: (INSTI HIV-1/HIV-2 Rapid Antibody Test [INSTI] and VIKIA HIV1/2 [VIKIA]), and the 4th-generation ARCHITECT HIV Ag/Ab Combo immunoassay (4thG ELISA).

Summary of findings
At diagnosis, median CD4 cell count, plasma HIV-RNA and cell-associated HIV-DNA were 372/mm3, 5.3 log10 copies/ml and 3.6 log10 copies/106 PBMC, respectively. ART was initiated at a median of 43 days (range 20-115) after estimated date of infection, corresponding to Fiebig stage II (5%), III (2%), IV (36%), V (21%) or VI (36%). HIV-specific serological response was evaluated after a median of 84 months (range 36-204) of successful treatment. Non-reactivity was found to be 30% for self-test, 9% for INSTI test and 7% for VIKIA test. All participants remained positive with 4thG ELISA (median index=48 [range:1.9-491]) but 7/44 had an index value < 10. We did not find any baseline- or on-treatment immunogical or virological factor associated with non-reactivity of self-test, except the 4thG ELISA index measured at the same time which was weaker for patients with non-reactive self-test (index: 23 vs 60, p=0.003). Cell associated HIV-DNA level at time of self-test was not associated with non-reactivity; of note it remained detectable for 9 of 13 patients (69%) with negative self-test.

Acceptability
n/a

Acceptability details
n/a

Willingness to pay
n/a

Willingness to pay details
n/a

Sensitivity
n/a

Specificity
n/a

Concordance
n/a

HIV positivity
n/a

Accuracy details
n/a

Social harm
n/a

Linkage to prevention, care and treatment
n/a


Study status
Completed