Table 1.
Demographic and clinical characteristics of periconceptionally DTG- and EFV-exposed women at estimated date of conception, Brazil, 2015-2018.
| Only EFV regimen (N=1045) |
Any DTG regimen (N=382) |
P valuea | |
|---|---|---|---|
| Demographic Characteristics | |||
| Age in years, median [IQR] | 28·5 [23·3-33·3] | 26·6 [21·9-31·9] | 0·0003 |
| Race, n (%) | 0·86 | ||
| Mixed | 464 (44) | 157 (41) | |
| White | 379 (36) | 143 (37) | |
| Black | 116 (11) | 47 (12) | |
| Asian | 8 (1) | 2 (1) | |
| Indigenous | 5 (1) | 2 (1) | |
| Unknown | 73 (7) | 31 (8) | |
| Education levelb | 0·28 | ||
| 0-3 years | 70 (7) | 16 (5) | |
| 4-7 years | 335 (34) | 132 (36) | |
| 8-11 years | 458 (47) | 174 (48) | |
| ≥12 years | 122 (12) | 41 (11) | |
| Region | 0·81 | ||
| Southeast | 391 (37) | 147 (39) | |
| South | 308 (30) | 101 (26) | |
| Northeast | 159 (15) | 65 (17) | |
| North | 116 (11) | 43 (11) | |
| Midwest | 71 (7) | 26 (7) | |
| Year of conception | 2017 [2017-2017] | 2017 [2017-2018] | <0·0001 |
| ARV of Interest Exposure History | |||
| Days of DTG use during periconception window (maximum: 112 days) | 0 | 103·5 [76-112] | |
| Days of EFV use during periconception window (maximum: 112 days) | 112 [99-112] | 13 [8-22] | |
| Days of RAL use during periconception window (maximum: 112 days) | 0 | 13·5 [6-24] | |
| Any DTG use before periconception window | 2 (0) | 235 (62) | |
| Any DTG use after periconception window | 48 (5) | 292 (76) | |
| Any EFV use before periconception window | 771 (74) | 22 (6) | |
| Any EFV use after periconception window | 1026 (98) | 155 (41) | |
| Any RAL use before periconception window | 1 (0) | 49 (13) | |
| Any RAL use after periconception window | 132 (13) | 226 (59) | |
| HIV Medical History | |||
| Year of HIV diagnosisc | 2014 [2011-2016] | 2017 [2014-2017] | <0·0001 |
| Year of ART initiation | 2017 [2017-2017] | 2017 [2017-2017] | <0·0001 |
| Years since HIV diagnosisc | 2·8 [1·4-6·0] | 0·7 [0·3-2·7] | <0·0001 |
| Years since ART initiation | 0·4 [0·2-0·8] | 0·3 [0·1-0·6] | <0·0001 |
| CD4+ cell count (cells/μL)d | 604 [420-844] | 530 [375-751] | 0·0025 |
| HIV RNA below the limit of detectione | 465 (75) | 139 (58) | <0·0001 |
| History of opportunistic infection | 105 (10) | 52 (14) | 0·057 |
| Other Comorbidities | |||
| Psychiatric disease | 61 (6) | 31 (8) | 0·12 |
| Pulmonary disease | 46 (4) | 17 (5) | 0·97 |
| Hypertension | 36 (3) | 19 (5) | 0·18 |
| Diabetes | 16 (2) | 10 (3) | 0·17 |
| Other metabolic diseases | 31 (3) | 11 (3) | 0·93 |
| Epilepsy or use of antiepileptic medications | 16 (2) | 11 (3) | 0·098 |
| Cardiovascular disease | 12 (1) | 6 (2) | 0·53 |
| Pulmonary disease | 46 (4) | 17 (5) | 0·97 |
| Neurological disease | 8 (1) | 7 (2) | 0·080 |
| Autoimmune disease | 19 (2) | 4 (1) | 0·31 |
| Obstetrical History | |||
| Number of previous pregnancies | 2 [1-3] | 2 [1-3] | 0·043 |
| History of adverse pregnancy outcomef | 360 (34) | 128 (34) | 0·74 |
| Behavioral Variablesg | |||
| Tobacco use | 199 (19) | 78 (20) | 0·56 |
| Alcohol use | 171 (16) | 77 (20) | 0·094 |
| Illicit substance use | 113 (11) | 54 (14) | 0·084 |
| Crack/cocaine use | 21 (2) | 7 (2) | 0·83 |
Continuous variables examined using Wilcoxon rank-sum test and categorical variables examined using Chi square test of proportions.
Education data available for 1348 women.
Date of HIV diagnosis available for 1332 women.
CD4+ cell count within 6 months of estimated date of conception available for 943 women.
HIV RNA within 90 days of estimated date of conception available for 859 women. Limit of detection is 40 copies/mL.
Adverse pregnancy outcomes include abortion, stillbirth, preterm birth, birth defect, or neonatal death.
Behavioral variables coded as positive if use recorded as occurring before and/or during the pregnancy.
Abbreviations used:
EFV: efavirenz
DTG: dolutegravir
ART: antiretroviral therapy
IQR: interquartile range