Table 4.
Cumulative Rates of Progression
| Triple ARV From Delivery |
Triple ARV From ARV Cessation |
AZT/sdNVP |
|||||
|---|---|---|---|---|---|---|---|
| Endpoint | Time (weeks) | Events/At Riska (cumulative) | Rate (95% CI) | Events/At Riska (cumulative) | Rate (95% CI) | Events/At Riska (cumulative) | Rate (95% CI) |
| Among All Women | |||||||
| Death or WHO stage 4 | 0 | 0/384 | 0.0 | 0/384 | 0.0 | 0/405 | 0.0 |
| 26 | 0/381 | 0.0 | 0/368 | 0.0 | 3/381 | 0.8 (.2–2.3) | |
| 52 | 2/359 | 0.6 (.1–2.2) | 3/270 | 0.9 (.3–2.7) | 8/332 | 2.1 (1.1–4.2) | |
| 78 | 3/278 | 0.8 (.3–2.6) | 4/68 | 2.3 (.6–8.3) | 10/273 | 2.8 (1.5–5.1) | |
| 104 | 4/69 | 2.1 (.6–7.3) | NA | NA | 11/69 | 3.5 (1.8–6.4) | |
| Log-rank P value (triple ARV vs AZT/sdNVP) stratified for intent to BF and study site | .07 | .24 | |||||
| Death, WHO stage 4, or CD4+ count of <200/mm3 | 0 | 0/384 | 0.0 | 0/382 | 0.0 | 0/405 | 0.0 |
| 26 | 8/378 | 2.1 (1.0–4.1) | 11/358 | 2.9 (1.6–5.2) | 20/374 | 5.1 (3.3–7.8) | |
| 52 | 17/355 | 4.5 (2.8–7.2) | 25/265 | 7.0 (4.8–10.2) | 37/330 | 9.7 (7.1–13.1) | |
| 78 | 29/275 | 8.0 (5.6–11.4) | 36/66 | 15.0 (10.3–21.6) | 51/265 | 13.8 (10.7–17.8) | |
| 104 | 40/66 | 15.7 (11.1–21.9) | NA | NA | 71/65 | 28.3 (22.0–35.8) | |
| Log-rank P value (triple-ARV vs AZT/sdNVP) stratified for intent to BF and study site | .001 | .49 | |||||
| Triple-ARV |
AZT/sdNVP |
||||||
|---|---|---|---|---|---|---|---|
| Endpoint | Time (weeks) | Events/At Riska (cumulative) | Rate (95% CI) | Events/At Riska (cumulative) | Rate (95% CI) | Log-Rank P Value Stratified for Intent to BF and Study Site |
|
| According to CD4+ Cell Count at Entry (origin: cessation of ARVs) | |||||||
| CD4+ count <350 cells/mm3 | |||||||
| Death, WHO stage 4, or CD4+ count of <200 cells/mm3 | 0 | 0/214 | 0.0 | 0/224 | 0.0 | ||
| 26 | 11/197 | 5.2 (2.9–9.2) | 18/203 | 8.3 (5.3–12.8) | |||
| 52 | 23/145 | 11.3 (7.6–16.5) | 35/169 | 16.6 (12.2–22.4) | |||
| 78 | 32/25 | 24.0 (15.8–35.5) | 47/131 | 23.0 (17.8–29.5) | .24 | ||
| CD4+ count of ≥350 cells/mm3 | |||||||
| Death, WHO stage 4, or CD4+ count of <200 cells/mm3 | 0 | 0/168 | 0.0 | 0/181 | 0.0 | ||
| 26 | 0/161 | 0.0 | 2/171 | 1.1 (.3–4.4) | |||
| 52 | 2/120 | 1.4 (.4–5.5) | 2/161 | 1.1 (.3–4.4) | |||
| 78 | 4/41 | 4.9 (1.6–14.5) | 4/134 | 2.5 (.9–6.4) | .47 | ||
| Triple ARV |
AZT/sdNVP |
||||||
|---|---|---|---|---|---|---|---|
| Endpoint | Time (weeks) | Events/At Riska (cumulative) | Rate (95% CI) | Events/At Riska (cumulative) | Rate (95% CI) | Log-Rank P Value Stratified for Intent to BF and Study Site |
|
| Among Women with CD4+ Count of ≥350 cells/mm3 at Entry (endpoint: 2010 criteria for ART; origin: cessation of ARVs) | |||||||
| Death, WHO stage 3 or 4, or CD4+ count of <350 cells/mm3 | 0 | 0/156 | 0.0 | 0/173 | 0.0 | ||
| 26 | 9/144 | 5.9 (3.1–11.0) | 21/148 | 12.5 (8.3–18.5) | |||
| 52 | 26/95 | 17.8 (12.5–25.1) | 34/132 | 20.5 (15.1–27.5) | |||
| 78 | 36/29 | 31.8 (23. 2–42.6) | 45/100 | 28.1 (21.8–35.8) | .95 | ||
Abbreviations: ART, antiretroviral therapy; ARV, antiretroviral; AZT/sdNVP, zidovudine until delivery with single-dose nevirapine without postpartum prophylaxis; BF, breastfeed; CI, confidence interval; NA, not applicable; Triple ARV, zidovudine, lamivudine, and lopinavir/ritonavir during pregnancy and breastfeeding; WHO, World Health Organization.
a Cumulative number of events up to the given time / number of women still at risk of progression at the given time.