Pharmacokinetics of Efavirenz 600 mg Once Daily During Pregnancy and Post Partum in Ghanaian Women Living With HIV.

PURPOSE: The updated World Health Organization guidelines recommend efavirenz (EFV) 400 mg as the preferred alternate first-line antiretroviral therapy to dolutegravir, with EFV 600 mg recommended only in special situations. We examined the pharmacokinetic (PK) properties of EFV 600 mg/d during pregnancy and post partum to inform EFV dosing decisions in pregnant women. METHODS: Ghanaian pregnant women with HIV infection initiating tenofovir disoproxil fumarate 300 mg/lamivudine 300 mg/EFV 600 mg fixed-dose combination tablet once daily were enrolled. Efavirenz concentrations were measured at 4 weeks of antiretroviral therapy initiation during pregnancy and 6 weeks post partum using validated LC-MS/MS assays. Efavirenz PK parameters were calculated using noncompartmental analysis, and within-group parameters between the 2 periods were compared. FINDINGS: Of 25 enrolled women, 19 completed PK sampling during pregnancy and post partum. The Cmax, Cmin, AUC0-24h, and CL/F for EFV during pregnancy were similar to values at 6 weeks post partum. The pregnancy/postpartum geometric mean ratios for EFV Cmax, Cmin, AUC0-24, and CL/F were 1.10 (95% CI, 0.93-1.31), 0.88 (95% CI, 0.67-1.17), 0.84 (95% CI, 0.71-0.98), and 1.20 (95% CI, 1.02-1.40), respectively. Viral load suppression (HIV RNA <200 copies/mL) was achieved in 16 of 17 participants (94%) by the time of delivery. There was 1 maternal-to-child transmission. IMPLICATIONS: We found that the PK parameters of EFV 600 mg once daily during pregnancy were similar to those in the postpartum period. Our findings suggest that EFV dose adjustment during pregnancy is not necessary in our study population.

The long-term effects of adolescent pregnancies in a community in Northern Ghana on subsequent pregnancies and births of the young mothers.

BACKGROUND: In Ghana, adolescents represent 22% of the total population. The rates of adolescent pregnancies are high. Of all births registered in the country in 2014, 30% were by adolescents, and 14% of adolescents aged between 15 and 19 years had begun childbearing. Pregnancies and deliveries of adolescents are accompanied by more risks as compared to older women. The aim of the study was to explore the long-term effects of adolescent pregnancies on subsequent pregnancies and births and on the socioeconomic status of the women. METHOD: A cross-sectional interviewer-performed survey of a purposive sample of 400 women in one community of Northern Ghana was conducted. Relationships between the age at first pregnancy and complications such as cesarean section, preterm or stillbirth and others were explored in 143 patients using the statistical program SPSS (Statistical Package for the Social Sciences). RESULT: Results show that adolescent women (<19 years at their first pregnancy) have an 80% higher risk for a cesarean section for the first and subsequent births as compared to older women (≥ 19 years). Furthermore, younger mothers have a 45% higher risk of stillbirths and a 30% increased risk of losing their baby within the first 6 weeks after birth. There was no difference in the socioeconomic status between the two age groups. CONCLUSION: Adolescent pregnancies are risk factors for the outcome of subsequent pregnancies of these mothers. This study, for the first time, shows that not only the first pregnancy and birth of very young women are negatively influenced by the early pregnancy but also subsequent pregnancies and births. While this study is of a purposive sample of women in one community, the clinical relevance of this study should not only be interesting for healthcare practitioners in Northern Ghana and other African regions but also for prevention campaigns in these regions.

Humanitarian ventures or 'fistula tourism?': the ethical perils of pelvic surgery in the developing world.

The vesico-vaginal fistula from prolonged obstructed labor has become a rarity in the industrialized West but still continues to afflict millions of women in impoverished Third World countries. As awareness of this problem has grown more widespread, increasing numbers of American and European surgeons are volunteering to go on short-term medical mission trips to perform fistula repair operations in African and Asian countries. Although motivated by genuine humanitarian concerns, such projects may serve to promote 'fistula tourism' rather than significant improvements in the medical infrastructure of the countries where these problems exist. This article raises practical and ethical questions that ought to be asked about 'fistula trips' of this kind, and suggests strategies to help insure that unintended harm does not result from such projects. The importance of accurate data collection, thoughtful study design, critical ethical oversight, logistical and financial support systems, and the importance of nurturing local capacity are stressed. The most critical elements in the development of successful programs for treating obstetric vesico-vaginal fistulas are a commitment to developing holistic approaches that meet the multifaceted needs of the fistula victim and identifying and supporting a 'fistula champion' who can provide passionate advocacy for these women at the local level to sustain the momentum necessary to make long-term success a reality for such programs.

Trends in concurrent maternal and perinatal deaths at a teaching hospital in Ghana: the facts and prevention strategies.

OBJECTIVES: To determine the trend of concurrent maternal and perinatal mortality at the Korle-Bu Teaching Hospital (KBTH), Ghana, and to propose measures for its prevention. METHODS: A retrospective study, from January 1995 to December 2002, of all concurrent maternal and perinatal deaths in which the woman was 28 weeks' gestation or more (or, if gestational age was not known, the baby weighed 1000 g or more) and died either undelivered or in the perinatal period (within 1 week of delivery) at the KBTH. RESULTS: Over the 8-year study period, there was a total of 93 622 deliveries at the KBTH with 108 concurrent maternal and perinatal mortalities, giving a ratio of 115.4 concurrent maternal and perinatal deaths per 100 000 deliveries. More than 80% of the mothers who died had little or no formal education. Of the 108 mothers, 22 died undelivered. The leading cause of death was a medical condition in pregnancy along with eclampsia/gestational hypertension. Of the 86 delivered mothers, the leading cause of concurrent death was a medical condition in pregnancy. Approximately two-thirds (72/108) of the perinatal deaths were stillbirths. Over the study period, there was a rising trend of the obstetric disaster of losing both mother and baby. CONCLUSIONS: There is a rising trend of concurrent maternal and perinatal mortality at the KBTH. It is suggested that a regular antenatal clinic be established with both an internist and obstetrician to jointly see and manage women with medical problems. There is a need for improved and adequate resources to improve outcomes for both mother and baby. A waiver of user fees for maternity services may be one way to improve access for needy and at-risk mothers. Concurrent maternal and perinatal death is the latest negative reproductive health index of the deteriorating socioeconomic situation in developing countries and needs to be tackled decisively.