Adverse Effects of Antiretrovirals in HIV-Infected Pregnant Women
Bibliographic record
Abstract
BACKGROUND: Current guidelines for the use of antiretroviral (ARV) therapy during pregnancy recommend that women be offered treatment with combination ARV therapy used in nonpregnant HIV-infected individuals. It is unclear whether the risk of ARV-related adverse drug reactions (ADRs) is increased during pregnancy. OBJECTIVE: To evaluate the frequency and severity of ADRs likely caused by ARV therapy in pregnant women who are HIV-positive. METHODS: A retrospective analysis of HIV-infected women who received ARV therapy during pregnancy and delivered between January 1997 and February 2006 was conducted. Incidence of maternal ADRs was determined through evaluation of laboratory findings, documented physical examinations, and patient self-reports. An AIDS Clinical Trials Group severity grading scale was applied to the ADRs. Cause-effect relationship was adjudicated based on the Naranjo probability scale and, if causality was found, that information was included. RESULTS: There were 103 women who accounted for 133 pregnancies that resulted in deliveries. Of the 111 pregnancies in which treatment was received, regimens included 26 nucleoside reverse transcriptase inhibitor monotherapy, 40 nonnucleoside reverse transcriptase inhibitor (NNRTI)-based, 44 protease inhibitor (PI)-based, and 1 PI/NNRTI combination therapy. Ninety-eight ADRs were documented in 49 pregnancies. The most common ADRs were gastrointestinal (n = 48), followed by central nervous system symptoms (n = 15), anemia (n = 15), elevated liver/pancreatic enzyme levels (n = 11), and cutaneous reactions (n = 8). Severe ADRs included elevations in liver/pancreatic enzymes (n = 3), nausea and vomiting (n = 3), and anemia (n = 2). Seven women required a change in therapy due to an ADR. CONCLUSIONS: Approximately 7 ADRs were reported for every 10 pregnancies in this cohort. Most ADRs were mild to moderate. Short exposure times in most women (second and third trimester) may have accounted for the lack of long-term toxicities. Although ADRs did not pose a major barrier to use of ARVs in pregnancy, close monitoring of pregnant women receiving ARV therapy continues to be warranted.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.004 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.001 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".