TABLE 1.
Detection of NVP Resistance at 6–8 Weeks among Infants who were HIV Infected in Utero vs. Infants who were Diagnosed with HIV Infection at 6 Weeks: Four Studies, Ugandaa
| HIVNET 012b |
Repeat pregnancy |
Breast feeding | SWEN | Totalc | |
|---|---|---|---|---|---|
| Number infected by 6–8 weeks | 36 | 19 | 18 | 36 | 109 |
| Number with samples available | 24 | 17 | 17 | 24 | 82 |
| ViroSeq resultsd | |||||
| Number with resistance/number with results (%) | 11/24 (45.8) | 6/17 (35.3) | 7/15 (46.7) | 12/24 (50.0) | 36/80 (45.0)e |
| Number with resistance/number infected at birth (%) | 10/19 (52.6) | 5/11 (45.5) | 6/10 (60.0) | 7/10 (70.0) | 28/50 (56.0) |
| Number with resistance/number uninfected at birth (%) | 1/5 (20.0) | 1/6 (16.7) | 1/5 (20.0) | 5/14 (35.7) | 8/30 (26.7) |
| p valuef | 0.327 | 0.333 | 0.282 | 0.214 | 0.006 |
| LigAmp resultsg | |||||
| Number with resistance/number with results (%) | 15/23 (65.2) | 3/15 (20.0) | 8/14 (57.1) | 7/20 (35.0) | 33/72 (45.8) |
| Number with resistance/number infected at birth (%) | 13/18 (72.2) | 3/11 (27.3) | 6/10 (60.0) | 5/9 (55.6) | 27/48 (56.3) |
| Number with resistance/number uninfected at birth (%) | 2/5 (40.0) | 0/4 (0.0) | 2/4 (50.0) | 2/11 (18.2) | 6/24 (25.0) |
| p valuef | 0.297 | 0.517 | 1.0 | 0.16 | 0.022 |
Infants were enrolled in four studies; dates of enrollment are shown: HIVNET 012 (1997–1999, sdNVP arm only), 1 the Repeat Pregnancy study (2004–2006, prospective portion only), 13 the Pathophysiology of Breast Milk study (2003–2004), and the Ugandan component of the SWEN study (2004–2006, sdNVP arm only).14
This includes one set of twins; one infant had Y181C detected at 6–8 weeks; the other infant did not have any NVP resistance mutations detected at 6–8 weeks.
Seventy-two infants had test results from both ViroSeq and LigAmp; 39 of those 72 infants had at least one NVP resistance mutation (six infants had resistance mutations detected by ViroSeq only, seven infants had resistance detected by LigAmp only, and 26 infants had resistance detected by both assays).
Resistance detected by ViroSeq indicates detection of one or more NVP resistance mutation (A98G, L100I, K101E/P, K103N/S, V106A/M, Y181C/I/V, Y188C/H/L, G190A/S/C/E/Q/T/V, M230L, K103R+V179D). ViroSeq may not detect mutations present in minor virus subpopulations.
There was no significant difference in the proportion of infants with NVP resistance detected by ViroSeq in the four individual studies (p = 0.822).
p values for the association of resistance and timing of infection in individual studies were determined using Fisher’s exact test. The overall p values for the association between HIV infection timing and resistance in the four studies (total) were determined using the Mantel–Haenszel test, stratified by study. The common OR for ViroSeq was 4.6 (95% CI: 1.5–13.6) and the common OR for LigAmp was 4.0 (95% CI: 1.2–13.1).
Resistance detected by LigAmp indicates detection of one or more of the following mutations: K103N (AAC), Y181C (TGT), and G190A (GCA).