Antiretroviral therapy in pregnant women living with HIV: a clinical practice guideline.
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ABSTRACT:
SUBMITTER: Siemieniuk RAC
PROVIDER: S-EPMC5590100 | biostudies-literature | 2017 Sep
REPOSITORIES: biostudies-literature
Publications
Antiretroviral therapy in pregnant women living with HIV: a clinical practice guideline.
Siemieniuk Reed A C RAC Lytvyn Lyubov L Mah Ming Jinell J Mullen Rhonda Marama RM Anam Florence F Otieno Teresia T Guyatt Gordon H GH Taylor Graham P GP Beltrán-Arroyave Claudia C Okwen Patrick Mbah PM Nduati Ruth R Kinuthia John J Luma Henry Namme HN Kirpalani Haresh H Merglen Arnaud A Lesi Olufunmilayo A OA Vandvik Per Olav PO Agoritsas Thomas T Bewley Susan S
BMJ (Clinical research ed.) 20170911
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Project description:IntroductionThe rate of spontaneous preterm-birth among pregnant women living with HIV on antiretroviral therapy (ART) is 3- to 4-fold higher when compared to HIV-negative women. The pathophysiology of preterm-birth related to HIV or ART remains unknown, especially as women living with HIV are often excluded from preterm birth studies.Areas coveredThis review discusses the currently available evidence on the prediction and prevention of preterm-birth in pregnant women living with HIV. A review of the literature was conducted of primary articles between 2005 and 2021 measuring the association or lack thereof between combination ART and preterm birth, as well as of other predisposing factors to preterm birth in women living with HIV, including cervical length, vaginal microbiome, and cervico-vaginal biomarkers.Expert opinionFurther research into the effect of ART exposure on preterm-birth risk is critical, and development of preterm-birth predictive tools in this population should be a priority. Vaginal progesterone supplementation deserves further investigation as a therapeutic option to prevent recurrent preterm birth in pregnant women living with HIV. The ProSPAR study, a multicenter randomized controlled trial studying progesterone supplementation in pregnant women on protease inhibitor-based regimens, has been designed but is not yet recruiting patients.
| S-EPMC9133156 | biostudies-literature
Project description:ObjectiveTo assess the impact of various antiretroviral/antiviral regimens in pregnant women living with HIV or hepatitis B virus (HBV).DesignWe performed random effects meta-analysis for HIV-related outcomes and network meta-analysis for HBV outcomes, and used the Grading of Recommendations Assessment, Development and Evaluation (GRADE) framework to assess quality separately for each outcome.Data sourcesEmbase and Medline to February 2017.Eligibility criteriaFor maternal outcomes, we considered randomised controlled trials (RCTs) comparing tenofovir-based regimens with those with alternative nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs). For child outcomes, we included RCTs and comparative observational studies of tenofovir-based regimens versus alternative NRTIs regimens or, for HBV, placebo.ResultsTen studies (seven RCTs) met the inclusion criteria for maternal and child outcomes, and an additional 33 studies (12 RCTs) met the inclusion criteria for HBV-specific outcomes. The most common comparison was tenofovir and emtricitabine versus zidovudine and lamivudine. There was no apparent difference between tenofovir-based regimens and alternatives in maternal outcomes, including serious laboratory adverse events (low certainty) and serious clinical adverse events (moderate certainty). There was no difference between NRTIs in vertical transmission of HIV: 1 more per 1000, 8 fewer to 10 more, low certainty; or vertical transmission of HBV: 7 fewer per 1000, 10 fewer to 38 more, moderate certainty. We found moderate certainty evidence that tenofovir/emtricitabine increases the risk of stillbirths and early neonatal mortality (51 more per 1000, 11 more to 150 more) and the risk of early premature delivery at <34 weeks (42 more per 1000, 2 more to 127 more).ConclusionsTenofovir/emtricitabine is likely to increase stillbirth/early neonatal death and early premature delivery compared with zidovudine/lamivudine, but certainty is low when they are not coprescribed with lopinavir/ritonavir. Other outcomes are likely similar between antiretrovirals.Trial registration numberPROSPERO CRD42017054392.
| S-EPMC6027063 | biostudies-literature
Project description:ImportanceSince 1994, the US Department of Health and Human Services has published treatment guidelines for pregnant women living with HIV. Understanding how well prescribing patterns correspond with treatment guidelines could inform health policy and influence future clinical practice.ObjectivesTo compare antiretroviral prescribing practices over time among pregnant women living with HIV with Department of Health and Human Services treatment guidelines and identify factors associated with receiving recommended regimens.Design, setting, and participantsA prospective cohort study of 1582 pregnant women living with HIV were enrolled in the Pediatric HIV/AIDS Cohort Study Surveillance Monitoring of ART (antiretroviral therapy) Toxicities study between January 1, 2008, and June 30, 2017. The study was conducted at 18 academic research hospitals in the United States.ExposuresAntiretroviral medications (ARVs) prescribed during pregnancy.Main outcomes and measuresProportion of regimens prescribed to pregnant women living with HIV qualifying as preferred or alternative according to Department of Health and Human Services guidelines, stratified by timing of initiation.ResultsOf 1867 pregnancies (among 1582 pregnant women living with HIV with a mean [SD] age of 28.6 [6.1] years at conception), 1264 (67.7%) occurred among women self-identified as black, 480 (25.7%) self-identified as white, and 123 (6.6%) self-identified as other or unreported race/ethnicity. Antiretroviral medications were initiated prior to conception for 790 women (42.3%), resumed during pregnancy for 625 women (33.5%), and initiated during pregnancy for 452 women (24.2%). Only 925 pregnancies (49.5%) were associated with prescribed ARVs designated as preferred or alternative, while 492 (26.4%) involved ARVs with insufficient evidence for use during pregnancy and 136 (7.3%) involved ARVs that were not recommended during pregnancy. A higher proportion of treatment-naive pregnant women initiating ARVs were prescribed preferred or alternative ARVs compared with those resuming ARVs or those treated with ARVs before conception (316 of 452 [69.9%] vs 325 of 625 [52.0%] vs 284 of 790 [35.9%]; P < .001). A total of 91 of 452 women (20.1%) initiating ARVs during pregnancy were prescribed ARVs with insufficient evidence for use during pregnancy or not recommended during pregnancy. Among women resuming ARVs, those with a viral load greater than 1000 copies/mL early in pregnancy had higher odds of being prescribed guideline-recommended ARVs (adjusted odds ratio, 2.03 [95% CI, 1.33-3.10]) compared with those with a viral load of 400 copies/mL or less.Conclusions and relevanceThis study suggests that US ARV prescribing practices for pregnant women living with HIV do not align well with national guidelines. This finding is particularly concerning when treatment is initiated during pregnancy. Further research is needed to understand disparities between prescribing practices and evidence-based guideline recommendations.
| S-EPMC6991210 | biostudies-literature
Project description:ObjectiveIncreasingly, pregnant women with HIV (WHIV) initiate antiretroviral therapy (ART) before conception. We assessed the risk of adverse perinatal outcomes among pregnant WHIV initiating ART preconception or antenatally, compared with women without HIV or ART-naive WHIV.DesignSystematic review and meta-analysis.MethodsWe searched PubMed, EMBASE, CINAHL, and Global Health for studies published between 1 January 1980 and 14 July 2023. We assessed the association of preconception/antenatal ART initiation with preterm birth (PTB), very PTB (VPTB), spontaneous PTB (sPTB), low birthweight (LBW), very LBW (VLBW), small for gestational age (SGA), very SGA (VSGA), stillbirth and neonatal death (NND). Data were analysed using random effects meta-analyses. Quality assessments, subgroup and sensitivity analyses were conducted. PROSPERO registration: CRD42021248987.ResultsThirty-one cohort studies were eligible, including 199 156 women in 19 countries. WHIV with preconception ART were associated with increased risk of PTB [risk ratio (RR) 1.55; 95% confidence interval (CI) 1.27-1.90], VPTB (RR 2.14, 95% CI 1.02-4.47), LBW (RR 2.19, 95% CI 1.32-3.63), VLBW (RR 3.34, 95% CI 1.08-10.35), SGA (RR 1.92, 95% CI 1.01-3.66), and VSGA (RR 2.79, 95% CI 1.04-7.47), compared with women without HIV. WHIV with antenatal ART were associated with increased risk of PTB (RR 1.35, 95% CI 1.15-1.58), LBW (RR 2.16, 95% CI 1.39-3.34), VLBW (RR 1.97, 95% CI 1.01-3.84), SGA (RR 1.77, 95% CI 1.10-2.84), and VSGA (RR 1.21, 95% CI 1.09-1.33), compared with women without HIV. Compared to ART-naive WHIV, WHIV with preconception or antenatal ART were associated with increased risk of SGA (preconception: RR 1.40, 95% CI 1.12-1.73; antenatal: RR 1.39, 95% CI 1.11-1.74) and VSGA (preconception: RR 2.44, 95% CI 1.63-3.66; antenatal: RR 2.24, 95% CI 1.48-3.40).ConclusionAmong WHIV, both preconception and antenatal initiation of ART are associated with increased risks of adverse perinatal outcomes, compared to women without HIV and ART-naive WHIV.
| S-EPMC11902611 | biostudies-literature
Project description:ObjectiveThe objective of the study was to assess the relationship of depression at antiretroviral therapy (ART) initiation with mortality and clinical outcomes among Tanzanian women living with HIV.DesignWe conducted a prospective cohort study of 1487 women who initiated ART in Dar es Salaam, Tanzania.MethodsSymptoms of depression and anxiety were assessed using a Tanzanian-adapted and validated version of the Hopkins Symptom Checklist. Participants attended monthly clinic visits during the first 2 years of ART and CD4 T-cell counts were assessed every 4 months. Proportional hazard models were used to assess the relationship of depression with mortality and clinical outcomes.ResultsSymptoms consistent with depression were prevalent among 57.8% of women at ART initiation. After multivariate adjustment, including social support and stigma, depression at ART initiation was associated with increased risk of mortality [hazard ratio (HR): 1.92; 95% confidence interval (CI): 1.15-3.20; P = 0.01] and incidence of severe anemia (hemoglobin <8.5 g/dl; HR: 1.59; 95% CI: 1.07-2.37; P = 0.02). Under the assumption of causality, we estimate 36.1% (95% CI: 13.6-55.1%) of deaths among the study cohort were attributable to depression and its consequences. Depression was not significantly associated with trajectory of CD4 T-cell reconstitution or the risk of immunologic failure (P values >0.05).ConclusionElimination of depression may reduce mortality during the first 2 years of ART by one-third in our study cohort. Randomized trials and rigorous implementation studies are needed to evaluate the individual and population-level effects of integrated mental health interventions and HIV treatment approaches in resource-limited settings.
| S-EPMC5177498 | biostudies-literature
Project description:ObjectivesAdherence to antiretroviral therapy and retention in care significantly drop for women with HIV during the postpartum period. We have a limited understanding of how outcome expectancies influence maternal adherence and retention in care.MethodsWomen with HIV from an urban academic clinic completed in-depth interviews in the third trimester and at 3 to 9 months postpartum to evaluate outcome expectancies, facilitators, and barriers to antiretroviral therapy adherence and retention in care. Interviews were audio-recorded and analyzed for content. A codebook was created using deductive (based on the theory of reasoned action approach) and inductive (based on emergent themes) codes.ResultsWe conducted 21 interviews with 12 women during pregnancy and 9 women during postpartum period. Participants had a mean age of 31 (standard deviation = 5.7) and most were African American (75%). Outcome expectancies centered mostly around pediatric health to prevent perinatal transmission of HIV and to be healthy to raise their children. Other outcome expectancies included preventing transmission of HIV to their partners. Social support from partners served as a strong facilitator as they helped routinize pill-taking behaviors, provided reminders, and decreased social isolation. Barriers to antiretroviral therapy adherence included depression, the disruption of scheduling routines, and the physical demands associated with the postpartum period. These barriers were accentuated for women with multiple children.ConclusionWomen's commitment to pediatric health was the primary motive for antiretroviral therapy adherence. Partners also served an important role. These findings suggest that interventions linking pediatric and maternal health, and partner support can improve maternal HIV treatment in the postpartum period.
| S-EPMC8640315 | biostudies-literature
Project description:BackgroundThe World Health Organization recommends protease inhibitor (PI)-based antiretroviral therapy (ART) as second-line and third-line regimens in pregnant women living with HIV (WLHIV). US, European, and UK guidelines include PI-based ART as first-line regimens, but advise against the use of lopinavir/ritonavir (LPV/r)-based ART, citing an increased risk of preterm birth (PTB). We aimed to assess the risk of adverse perinatal outcomes in WLHIV receiving PI-ART and the comparative risks associated with different PI-ART regimens.MethodsWe conducted a systematic literature review by searching PubMed, CINAHL, Global Health, and EMBASE for studies published between Jan 1, 1980, and April 20, 2020. Two investigators independently selected studies and extracted data from studies reporting on the association of pregnant WLHIV receiving PI-ART with 11 perinatal outcomes: PTB, very PTB (VPTB), spontaneous PTB (sPTB), low birth weight (LBW), very LBW (VLBW), term LBW, preterm LBW, small for gestational age (SGA), very SGA (VSGA), stillbirth, and neonatal death. Pairwise random-effects meta-analyses examined the risk of each adverse perinatal outcome in WLHIV receiving PI-ART compared to non-PI-based ART (non-PI-ART), and comparisons of different PI-ART regimens. Quality assessments of studies were performed, subgroup and sensitivity analyses were conducted based on country income status and study quality, heterogeneity assessed, and the effect of adjustment for confounding factors assessed. The protocol is registered with PROSPERO, CRD42021248987.FindingsOf 94,594 studies identified, 34 cohort studies including 57,546 women met the inclusion criteria. Random-effects meta-analyses showed that PI-ART was associated with a significantly increased risk of SGA (Relative Risk [RR] 1.24, 95% CI 1.08-1.43; I2 =66.7%) and VSGA (RR 1.40, 1.09-1.81; I2 =0.0%), but not PTB (RR 1.09, 0.95-1.24; I2 =68.3%), VPTB (RR 1.30, 0.78-2.18; I2 =43.0%), sPTB (RR 1.91, 0.61-5.99; I2 =95.7%), LBW (RR 1.04, 0.85-1.27; I2 =63.9%), VLBW (RR 0.72, 0.37-1.43; I2 =37.9%), term LBW (RR 0.94, 0.30-3.02; I2 =0.0%), stillbirth (RR 1.04, 0.60-1.79; I2 =0.0%), and neonatal death (RR 1.82, 0.97-3.40; I2 =0.0%), compared to non-PI-ART. We found no significant differences in perinatal outcomes between ART regimens containing LPV/r, atazanavir/ritonavir (ATV/r), and darunavir/ritonavir (DRV/r), which are the most commonly used PIs.InterpretationPI-ART is associated with an increased risk of SGA and VSGA, but not PTB or other perinatal outcomes. No significant differences in perinatal outcomes were found between LPV/r, ATV/r, and DRV/r. These findings should inform clinical guidelines, and further efforts should be made to improve perinatal outcomes among pregnant WLHIV.FundingNone.
| S-EPMC9061981 | biostudies-literature
Project description:ObjectiveTo investigate women's values and preferences regarding antiretroviral therapy (ART) during pregnancy to inform a BMJ Rapid Recommendation.SettingPrimary studies reporting patient-reported outcomes relevant to decision-making regarding ART in any clinical and geographical setting.ParticipantsWomen living with HIV who are pregnant, postpartum or considering pregnancy.Outcome measuresQuantitative measurements and qualitative descriptions of values and preferences in relation to ART during pregnancy. We also included studies on women's reported barriers and facilitators to adherence. We excluded studies correlating objective measures (eg, CD4 count) with adherence, or reporting only outcomes which are not expected to differ between ART alternatives (eg, access to services, knowledge about ART).ResultsWe included 15 qualitative studies reporting values and preferences about ART in the peripartum period; no study directly studied choice of ART therapy during pregnancy. Six themes emerged: a desire to reduce vertical transmission (nine studies), desire for child to be healthy (five studies), concern about side effects to the child (eight studies), desire for oneself to be healthy (five studies), distress about side effect to oneself (10 studies) and pill burden (two studies). None of the studies weighed the relative importance of these outcomes directly, but pill burden/medication complexity appears to be a lower priority for most women compared with other factors. Overall, the body of evidence was at low risk of bias, with minor limitations.ConclusionsWomen who are or may become pregnant and who are considering ART appear to place a high value on both their own and their children's health. Evidence on the relative importance between these values when choosing between ART regimens is uncertain. There is variability in individual values and preferences among women. This highlights the importance of an individualised women-centred approach, such as shared decision-making when choosing between ART alternatives.Trial registration numberInternational Prospective Register of Systematic Reviews:CRD42017057157.
| S-EPMC5988094 | biostudies-literature
Project description:BACKGROUND:HIV-status disclosure is widely encouraged by counseling services, in part because it is thought to improve antiretroviral therapy (ART) adherence and thus HIV viral suppression. However, few longitudinal studies have examined the impact of disclosure on HIV viral load (VL) during pregnancy and postpartum. METHODS:We explored these associations among 1187 women living with HIV, enrolled between March 2013 and June 2014 in Cape Town, South Africa. RESULTS:Among women who tested HIV-positive before pregnancy, we observed no association between disclosure and VL at entry into antenatal care among those already on ART, nor at delivery and 12 months postpartum among those initiating ART. Among women who tested HIV-positive during pregnancy and initiated ART subsequently, disclosure to a male partner was associated with a reduced risk of VL ≥50 copies/mL at delivery (adjusted risk ratio: 0.56; 95% confidence interval: 0.31 to 1.01). After stratification by relationship status, this association was only observed among women who were married and/or cohabiting. In addition, disclosure to ≥1 family/community member was associated with a reduced risk of VL ≥50 copies/mL at 12 months postpartum (adjusted risk ratio: 0.69; 95% confidence interval: 0.48 to 0.97) among newly-diagnosed women. CONCLUSIONS:These findings suggest that the impact of disclosure on VL is modified by 3 factors: (1) timing of HIV diagnosis (before vs. during the pregnancy); (2) relationship to the person(s) to whom women disclose; and (3) in the case of disclosure to a male partner, relationship status. Counseling about disclosure may be most effective if tailored to individual women's circumstances.
| S-EPMC6594888 | biostudies-literature
Project description:The Breast Cancer Disease Site Group of Cancer Care Ontario identified the need for new guidelines for the adjuvant systemic therapy of early-stage breast cancer. The specific question to be addressed was "What is the optimal adjuvant systemic therapy for female patients with early-stage operable breast cancer, when patient and disease factors are considered?" A systematic review was prepared based on literature searches conducted using the medline and embase databases for the period January 2008 to March 5, 2012, and updated to May 12, 2014. Guidelines were located from that search, from the Standards and Guidelines Evidence directory of cancer guidelines, and from the Web sites of major guideline organizations. The literature located was subdivided into the broad categories of chemotherapy, hormonal therapy, and therapy targeted to her2 (human epidermal growth factor receptor 2). Although several of the systemic therapies discussed in this guideline can be considered in the neoadjuvant setting, the review focused on trials with rates of disease-free and overall survival as endpoints and thus excluded several trials that used pathologic complete response as a primary endpoint. Based on the systematic review, the working group drafted recommendations on the use of chemotherapy, hormonal therapy, and targeted therapy; based on their professional experience, they also drafted recommendations on patient and disease characteristics and recurrence risk. The literature review and draft recommendations were circulated to a consensus panel of medical oncologists who had expertise in breast cancer and who represented the regions of Ontario. Items without initial consensus were discussed at an in-person consensus meeting held in Toronto, November 23, 2012. The final recommendations are those for which consensus was reached before or at the meeting. Some of the key evidence was revised after the updated literature search. Evidence reviews for systemic chemotherapy, endocrine therapy, and targeted therapy for her2-positive disease are reported in separate articles in this supplement. The full three-part 1-21 evidence-based series, including complete details of the development and consensus processes, can be found on the Cancer Care Ontario Web site at https://www.cancercare.on.ca/toolbox/qualityguidelines/diseasesite/breast-ebs.
| S-EPMC4381792 | biostudies-literature