Pregnancy rates and birth outcomes among women on efavirenz-containing highly active antiretroviral therapy in Botswana

BACKGROUND: Millions of HIV-infected women in developing countries are in need of safe and highly effective antiretroviral therapy. Pregnancy rates are usually high in developing countries, and efavirenz (EFV) use in women of childbearing age is of concern because of its potential teratogenicity. METHODS: As part of a prospective study comparing 6 initial highly active antiretroviral therapy (HAART) regimens, 3 of which contained EFV, pregnancy and birth outcomes were evaluated among female participants enrolled in a randomized clinical trial in Botswana. Before enrollment, all female participants indicated a willingness to avoid pregnancy for the 3-year duration of the study. Monthly urine pregnancy testing and regular contraceptive education and counseling were given to all women on study. RESULTS: Four hundred fifty-one (69.4%) of 650 enrolled study participants were female and experienced 71 pregnancies, for a rate of 7.9 per 100 person-years during the study. The mean time from HAART initiation to time of first pregnancy was 385 days. The median birth weight of babies was 2950 g (interquartile range: 2700-3250 g); the gender of babies (24 female and 15 male) and occurrence of early pregnancy loss (42%) and stillbirths (3%) did not differ between EFV- and non-EFV-exposed pregnancies (P=0.7). First-trimester EFV exposure occurred in 38 (53.5%) of the 71 pregnancies; 22 (57.9%) of these 38 pregnancies resulted in live births. One infant (4.5%) of the 22 EFV-exposed live births had a congenital abnormality with right limb shortening that was assessed to be unrelated to EFV exposure. CONCLUSIONS: The restoration of health and longevity in many HAART-treated women is often accompanied by childbearing, as evidenced by the large fraction of women in our cohort who became pregnant despite their initial statements of intent to avoid pregnancy. Of 22 first-trimester EFV-exposed live births, 1 neonate was found to have a major congenital abnormality; however, this defect was unrelated to EFV exposure. The small sample size is insufficient to estimate accurately the underlying risk of congenital malformation after exposure to EFV in early pregnancy, underscoring the importance of reporting to the existing international Antiretroviral Pregnancy Registry. In addition to accessing safe and effective HAART regimens, HIV-infected women require access to comprehensive family planning services, including contraception and procreation counseling.     

Preliminary outcomes of a pilot physical therapy program for HIV-infected patients with chronic pain

Chronic pain in HIV-infected individuals is common and often undertreated. Physical therapy (PT) is an evidence-based nonpharmacologic treatment for chronic pain. Our objective is to present the results of a pilot PT program in an HIV pain/palliative care clinic, which is embedded within a Ryan White-funded multidisciplinary HIV primary care clinic. Medical records of HIV-infected patients participating in a PT program between November 2012 and July 2013 were retrospectively reviewed. Pain scores on a 0–10 scale and cost data were collected and analyzed. Among 43 patients referred, 27 collectively attended 86 sessions. Median age of enrolled patients was 54 (IQR 49–58). Sixteen (59%) were African-American and 20 (77%) had an undetectable HIV viral load. Mean pain score at initial visit was 6.5 (SD = 1.1). The average session-level decrease was 2.6 (SD = 1.7) and patient-level decrease was 2.5 (SD = 1.2). The largest payors were Medicare managed care (28%), Medicaid (21%), and Ryan White grant-related funds (18%). When the first four months of the program are excluded to account for slow start-up, the program's monthly net revenue during the remaining five months was $163. We present preliminary data from a low-cost pilot PT program integrated into an HIV clinic in a primary care setting associated with clinically significant improvements in pain. Further investigation into the implementation of such programs is essential.     

Exclusive breastfeeding frequency during the first seven days of life in term neonates

SUMMARY The study evaluated the effect of frequent suckling on neonatal serum bilirubin level, weight gain and passage of meconium in exclusively breastfed (Ebfed) neonates in the first week of lactation. These variables were investigated for 358 healthy full-term, EBfed Nigerian newborn, delivered vaginally without complications at the Jos University Teaching Hospital (JUTH) in their first week of life. Their maternal breast problems and time of achievement of let-down reflex were also evaluated. Mothers nursed their newborns on the average of 13.3 + 1.6 times in the first 24 hours. This non-significantly decreased to 13.1 + 1.2 by the 7th day. Significant positive correlations were found between the frequency of EBfing and passage of meconium in the first 24 hours of life ( r = 0.41, p < 0.05), and weight gain by day 7 ( r = 0.34, p<0.001). Inverse relationship was observed between frequency of suckling and neonatal serum bilirubin level on days 3 and 7 (r = -.13 and -.15), time of achievement of maternal let-down reflex ( r = -.43) and their breast problems (r = -.38), P values < 0.05. We therefore concluded that frequent suckling during EBfing has beneficial health effect on both the mother and her newborn in the first week of lactation. BG.     

Phospholipon 90H (P90H)-based PEGylated microscopic lipospheres delivery system for gentamicin: an antibiotic evaluation

Objective

To formulate gentamicin liposphere by solvent-melting method using lipids and polyethylene glycol 4 000 (PEG-4 000) for oral administration.

Methods

Gentamicin lipospheres were prepared by melt-emulsification using 30% w/w Phospholipon® 90H in Beeswax as the lipid matrix containing PEG-4 000. These lipospheres were characterized by evaluating on encapsulation efficiency, loading capacity, change in pH and the release profile. Antimicrobial activities were evaluated against Escherichia coli, Pseudomonas aeruginosa, Salmonella paratyphii and Staphylococcus aureus using the agar diffusion method.

Results

Photomicrographs revealed spherical particles within a micrometer range with minimal growth after 1 month. The release of gentamicin in vitro varied widely with the PEG-4 000 contents. Moreover, significant (P>0.05) amount of gentamicin was released in vivo from the formulation. The encapsulation and loading capacity were all high, indicating the ability of the lipids to take up the drug. The antimicrobial activities were very high especially against Pseudomonas compare to other test organisms. This strongly suggested that the formulation retain its bioactive characteristics.

Conclusions

This study strongly suggest that the issue of gentamicin stability and poor absorption in oral formulation could be adequately addressed by tactical engineering of lipid drug delivery systems such as lipospheres.     

Exploring the boundary between health protective and hazardous drinking in a community cohort

We sought to identify a level of alcohol consumption representing the boundary between health protective and hazardous drinking. The Winnipeg Health and Drinking Survey began in 1990–91 (n = 1257). Seven years later, a third wave of interviews (n = 785) expanded questions on heavy episodic drinking (HED) and assessed the consumption of ≥ 3, ≥ 5, ≥ 8, and ≥ 12 drinks at a sitting for each of wine, beer and liquor (equivalent to about 40 g, 65 g, 105 g and 155 g of ethanol). Cox proportional hazards models were based on seven years of illness and mortality data following the Wave 3 interview, and were stratified by gender and HED definition. For HED of ≥ 40 g, ≥ 65 g, ≥ 105 g, or ≥ 155 g per occasion, the hazard ratios for morbidity and mortality from all causes were 1.06, 1.09, 1.17, and 1.16 respectively in women, and 1.00, 0.98, 1.02, and 1.02 in men. Most of these hazard ratios were significant in women, whereas none was significant in men. This study did not provide support for a definition of HED that could divide protective from hazardous alcohol consumption.