Isoniazid Preventive Therapy in HIV-Infected Pregnant and Postpartum Women

CITATION: Gupta, A. et al. 2019. Isoniazid Preventive Therapy in HIV-Infected Pregnant and Postpartum Women. The New England Journal of Medicine, 381(14):1333-1346. doi:10.1056/NEJMoa1813060The original publication is available at https://www.nejm.org/BACKGROUND: The safety, efficacy, and appropriate timing of isoniazid therapy to prevent tuberculosis in pregnant women with human immunodeficiency virus (HIV) infection who are receiving antiretroviral therapy are unknown. METHODS: In this multicenter, double-blind, placebo-controlled, noninferiority trial, we randomly assigned pregnant women with HIV infection to receive isoniazid preventive therapy for 28 weeks, initiated either during pregnancy (immediate group) or at week 12 after delivery (deferred group). Mothers and infants were followed through week 48 after delivery. The primary outcome was a composite of treatment-related maternal adverse events of grade 3 or higher or permanent discontinuation of the trial regimen because of toxic effects. The noninferiority margin was an upper boundary of the 95% confidence interval for the between-group difference in the rate of the primary outcome of less than 5 events per 100 person-years. RESULTS: A total of 956 women were enrolled. A primary outcome event occurred in 72 of 477 women (15.1%) in the immediate group and in 73 of 479 (15.2%) in the deferred group (incidence rate, 15.03 and 14.93 events per 100 person-years, respectively; rate difference, 0.10; 95% confidence interval [CI], −4.77 to 4.98, which met the criterion for noninferiority). Two women in the immediate group and 4 women in the deferred group died (incidence rate, 0.40 and 0.78 per 100 person-years, respectively; rate difference, −0.39; 95% CI, −1.33 to 0.56); all deaths occurred during the postpartum period, and 4 were from liver failure (2 of the women who died from liver failure had received isoniazid [1 in each group]). Tuberculosis developed in 6 women (3 in each group); the incidence rate was 0.60 per 100 person-years in the immediate group and 0.59 per 100 person-years in the deferred group (rate difference, 0.01; 95% CI, −0.94 to 0.96). There was a higher incidence in the immediate group than in the deferred group of an event included in the composite adverse pregnancy outcome (stillbirth or spontaneous abortion, low birth weight in an infant, preterm delivery, or congenital anomalies in an infant) (23.6% vs. 17.0%; difference, 6.7 percentage points; 95% CI, 0.8 to 11.9). CONCLUSIONS: The risks associated with initiation of isoniazid preventive therapy during pregnancy appeared to be greater than those associated with initiation of therapy during the postpartum period. (Funded by the National Institutes of Health; IMPAACT P1078 TB APPRISE ClinicalTrials.gov number, NCT01494038. opens in new tab.)https://www.nejm.org/doi/full/10.1056/NEJMoa1813060Publisher’s versio

Incidence of respiratory syncytial virus-associated lower respiratory tract illness in infants in low- and middle-income regions during the Coronavirus disease 2019 pandemic

DATA AVAILABILITY : Study data and documents can be requested for further research from www.clinicalstudydatarequest.com.BACKGROUND : Incidence data of respiratory syncytial virus–associated lower respiratory tract illness (RSV-LRTI) are sparse in low- and middle-income countries (LMICs). We estimated RSV-LRTI incidence rates (IRs) in infants in LMICs using World Health Organization case definitions. METHODS : This prospective cohort study, conducted in 10 LMICs from May 2019 to October 2021 (largely overlapping with the coronavirus disease 2019 [COVID-19] pandemic), followed infants born to women with low-risk pregnancies for 1 year from birth using active and passive surveillance to detect potential LRTIs, and quantitative reverse-transcription polymerase chain reaction on nasal swabs to detect RSV. RESULTS : Among 2094 infants, 32 (1.5%) experienced an RSV-LRTI (8 during their first 6 months of life, 24 thereafter). Seventeen (0.8%) infants had severe RSV-LRTI and 168 (8.0%) had all-cause LRTI. IRs (95% confidence intervals [CIs]) of first RSV-LRTI episode were 1.0 (.3–2.3), 0.8 (.3–1.5), and 1.6 (1.1–2.2) per 100 person-years for infants aged 0–2, 0–5, and 0–11 months, respectively. IRs (95% CIs) of the first all-cause LRTI episode were 10.7 (8.1–14.0), 11.7 (9.6–14.0), and 8.7 (7.5–10.2) per 100 person-years, respectively. IRs varied by country (RSV-LRTI: 0.0–8.3, all-cause LRTI: 0.0–49.6 per 100 person-years for 0- to 11-month-olds). CONCLUSIONS : RSV-LRTI IRs in infants in this study were relatively low, likely due to reduced viral circulation caused by COVID-19–related nonpharmaceutical interventions. CLINICAL TRIALS REGISTRATION : NCT03614676.https://academic.oup.com/ofidhj2024Medical MicrobiologySDG-03:Good heatlh and well-bein

Metabolic syndrome, biochemical markers, and body composition in youth living with perinatal HIV infection on antiretroviral treatment.

People living with HIV who are on antiretroviral treatment are at increased risk of developing premature cardiovascular disease. Children with perinatal HIV infection (PHIV) have survived through their adolescence and are entering adulthood. We determined the prevalence of metabolic syndrome, abnormal biochemical markers, and characterized body composition parameters in youth living with perinatal HIV infection. This cross-sectional study was conducted at the Research Institute for Health Sciences, Chiang Mai University, Chiang Mai, Thailand from December 2017 to February 2018. PHIV-youths between 15 <25 years of age who were receiving ART were enrolled. Data collection included ART-related history, blood pressure, and anthropometric measurements. Body composition including android, gynoid fat mass, and total body fat were measured by dual-energy X-ray absorptiometry. Fasting blood was drawn to test for lipid profile, glucose, and high sensitivity c-reactive protein (hsCRP). One hundred and twenty PHIV-youths (48% female) were enrolled. Their mean age and the median duration on ART were 20.3 (SD2.6) and 14.1 (IQR 10.4-14.9) years, respectively; 76 (63%) were on first-line non-nucleoside reverse transcriptase inhibitors-based regimens. Thirty-three (28%), 74 (62%), and 13 (11%) of PHIV-youths were underweight (BMI < 18.5 kg/m2), normal (BMI 18.5-24.9 kg/m2), and overweight (BMI ≥ 25.0 kg/m2), respectively. The prevalence of metabolic syndrome was 10.6% (95%CI 5.0-16.0). Seventy-six of 113 (67.3%) of PHIV-youths had lipid alteration; the most prevalent types being low HDL (46.9%) and increased triglycerides (27.4%). Overall 43 (35.9%) had increased hsCRP (16.7% with immediate and 19.2% with high risk for CVD). Females had significantly higher percentage of android and gynoid fat, but lower Android to gynoid ratio (AGR) compared to males. There were 77%, 31%, and 21% of PHIV-youths in the overweight, normal weight, and underweight group with AGR in tertile 3, respectively. In conclusion, we documented presence of metabolic syndrome in 10.6% of PHIV-youths on ART. Increase AGR representing abdominal obesity was detected even in youths with normal BMI or underweight

Patterns of Sexual Behavior in Lowland Thai Youth and Ethnic Minorities Attending High School in Rural Chiang Mai, Thailand.

INTRODUCTION:The rural areas of Northern Thailand are home to a large cultural diversity of ethnic minority groups. Previous studies have shown that young people in rural Thailand have low levels of knowledge on HIV/AIDS and high sexual risks. We compared sexual behaviors between the lowland Thai youth and the youth from ethnic minority groups. METHODS AND FINDINGS:This is a cross-sectional quantitative study conducted among high-school Thai and ethnic students in Chiang Mai. From a total 1215 participants, 487 (40.1%) were lowland Thai and 728 (59.9%) were from ethnic minorities. Overall, 17.9% of respondents reported "ever had sex." Lowland Thai adolescents were more likely to have ever had sex compared with ethnic minority adolescents (AOR, 1.61; CI, 1.06-2.45; P< 0.01). A higher proportion of lowland Thai respondents reported having ≥ 2 lifetime sexual partners (51.9% vs. 33.3%, P = 0.003), or currently having a boy/girlfriend (59.9% vs. 45.3%, P< 0.001) compared to ethnic minority adolescents. Consistent condom use was low in both groups (22.6%). The common significant factors associated with "ever had sex" in both groups were "ever drunk alcohol in the past year" and "currently having a boy/girlfriend." Specifically, for lowland Thai youth, being around the age of 17 or 18 years and "ever used methamphetamine in the past year" were associated with increased odds of "ever had sex". For ethnic minority adolescents, being female and belonging to religions other than Buddhism were associated with decreased odds of "ever had sex". CONCLUSION:A substantially higher proportion of lowland Thai engage in risky sexual behaviors when compared to ethnic minorities. However, both groups remained vulnerable to HIV and other sexually transmitted infections. To minimize sexual risks, education program and school-based interventions are warranted to increase awareness of young people about risky behaviors and to promote essential life skills