Maternal neutralizing antibodies against a CRF01_AE primary isolate are associated with a low rate of intrapartum HIV-1 transmission

Mother-to-child transmission (MTCT) of HIV-1 provides a model for studying the role of passively acquired antibodies in preventing HIV infection. We determined the titers of neutralizing antibodies (NAbs) against six primary isolates of clades B and CRF01_AE in sera from 45 transmitting and 45 nontransmitting mothers matched for the main independent factors associated with MTCT in Thailand. A lower risk of MTCT, particularly for intrapartum transmission, was associated only with higher NAb titers against the CRF01_AE strain, MBA. The envelope glycoprotein of this strain showed an unusually long V2 domain of 63 amino acids, encoding six potential N-linked glycosylation sites. We provided experimental data indicating that the extended V2 domain contributed to the higher level of resistance to neutralization by mothers' sera in this strain. Taken together the data suggest that some primary isolates with specific properties may be useful indicators for identifying protective antibodies.     

An Analytical Hierarchy Process (AHP) Approach to Risk Analysis: A Case Study of a New Generic Drug Development Process

Purpose

Risks that are associated with the new generic drug development process, which is the initial stage of the pharmaceutical supply chain, need to be considered and eliminated. The main purpose of this study was to prioritize the risks associated with the new generic drug development process in Thailand.

Methods

In this study, an in-depth interview, several rounds of expert discussion, and a focus group have been conducted to identify the risk factors. The final analysis was summarized based on the analytic hierarchy process (AHP) methodology.

Results

The risks were classified into the following seven categories: (1) regulatory, (2) technological, (3) operational, (4) intellectual property, (5) financial, (6) market, and (7) information. They were used as criteria for and developed a questionnaire according to the AHP structure. The results from the inputs of ten experts in the pharmaceutical supply chain who identified the priority criteria among these seven categories revealed that the most important criterion is regulatory risk, followed by information, operational, financial, intellectual property, market, and technology risks.

Conclusions

These major risks should be prioritized so that they can be appropriately managed.

     

Neonatal dengue infection: report of dengue fever in a 1-day-old infant

A male infant was admitted because of fever. He was born at 37-weeks' gestation. His mother had experienced acute febrile illness with headache and myalgia. Her illness persisted with onset of active labor pain on day 5, which prompted cesarean section; postoperatively, the hematocrit decreased, requiring transfusion. The infant was well until fever developed at 16 hours after birth. There were petichiae on his face and trunk and the liver was enlarged. Fever subsided on day 5 without evidence of plasma leakage or severe hemorrhage. He made an uneventful recovery after 8 days of illness. Leukopenia and thrombocytopenia were present in the mother and infant. Both were diagnosed as dengue fever. Dengue type 1 was recovered from the infant by polymerase chain reaction. The dengue enzyme-linked immunoassay showed secondary infection in the mother and primary infection in the infant. In dengue-endemic areas, clinicians should be alert to dengue fever/dengue hemorrhagic fever in pregnant women presenting with acute febrile illness, and be prepared for proper management.