The Centre for the AIDS Program of Research in South Africa (CAPRISA) 004 trial assessed the effectiveness and safety of a 1% vaginal gel formulation of tenofovir, a nucleotide reverse transcriptase inhibitor, for the prevention of HIV acquisition in women. A double-blind, randomized controlled trial was conducted comparing tenofovir gel (n = 445 women) with placebo gel (n = 444 women) in sexually active, HIV-uninfected 18- to 40-year-old women in urban and rural KwaZulu-Natal, South Africa. HIV serostatus, safety, sexual behavior, and gel and condom use were assessed at monthly follow-up visits for 30 months. HIV incidence in the tenofovir gel arm was 5.6 per 100 women-years (person time of study observation) (38 out of 680.6 women-years) compared with 9.1 per 100 women-years (60 out of 660.7 women-years) in the placebo gel arm (incidence rate ratio = 0.61; P = 0.017). In high adherers (gel adherence > 80%), HIV incidence was 54% lower (P = 0.025) in the tenofovir gel arm. In intermediate adherers (gel adherence 50 to 80%) and low adherers (gel adherence < 50%), the HIV incidence reduction was 38 and 28%, respectively. Tenofovir gel reduced HIV acquisition by an estimated 39% overall, and by 54% in women with high gel adherence. No increase in the overall adverse event rates was observed. There were no changes in viral load and no tenofovir resistance in HIV seroconverters. Tenofovir gel could potentially fill an important HIV prevention gap, especially for women unable to successfully negotiate mutual monogamy or condom use.

/pdf/effectiveness-and-safety-of-tenofovir-gel-an-antiretroviral-2ccoqcdrry.pdf

Effectiveness and Safety of Tenofovir Gel, an Antiretroviral Microbicide, for the Prevention of HIV Infection in Women

https://www.thelancet.com/pdfs/journals/lancet/PIIS0140-6736(04)17140-7.pdf

Mortality of infected and uninfected infants born to HIV-infected mothers in Africa: a pooled analysis

Associations: Most common: S. aureus Foreign body: Coagulase-negative Staphylococcus or P. acnes Nosocomial: Enterobacteraceae, P. aeruginosa, Candida Bites, diabetic foot lesions, and decubitus ulcers: Streptococci and anaerobes Sickle cell disease: Salmonella or S. pneumonia HIV: Bartonella Bites, human or animal: P. multocida, E. corrodens Immunosuppressed: Aspergillis, C. albicans, Mycobacteria Populations where these organisms are prevalent: Brucella, TB, Coxiella burnetti, endemic fungi Microbiology and histology. The preferred culture sources are blood cultures (which are usually positive only with hematogenous osteomyelitis) or bone biopsy. Cultures from sinus tracts are often misleading. Tissue specimens showing more than 5 neutrophils/HPF show a sensitivity of 43% to 84% in specificity of 93% to 97% (AbdulKarim FW. Mod Pathol. 1998;11:427).

Recommendations for use of antiretroviral drugs in pregnant hiv-1-infected women for maternal health and interventions to reduce perinatal hiv-1 transmission in the United States

Background We analyzed individual patient data to determine the contribution of late postnatal transmission to the overall risk of mother-to-child transmission of human immunodeficiency virus type 1 (HIV-1) and the timing and determinants of late postnatal transmission. Methods Eligible trials were conducted where breast-feeding was common; included >/=2 HIV-1 tests by 3 months, and, if follow-up continued, >/=2 tests at 3-12 months; and regularly assessed infant-feeding modality. Data on children born before January 2000 were analyzed. Results Of 4085 children from 9 trials (breast-fed singletons for whom HIV-1 testing was performed), 993 (24%) were definitively infected (placebo arms, 25.9%; treatment arms, 23.4%; P=.08). Of 539 children with known timing of infection, 225 (42%) had late postnatal transmission. Late postnatal transmission occurred throughout breast-feeding. The estimated hazard function for time to late postnatal transmission was roughly constant. The cumulative probability of late postnatal transmission at 18 months was 9.3%. The overall risk of late postnatal transmission was 8.9 transmissions/100 child-years of breast-feeding and was significantly higher with lower maternal CD4(+) cell counts and male sex. Conclusions Late postnatal transmission contributes substantially to overall mother-to-child transmission of HIV-1. The risk of late postnatal transmission is generally constant throughout breast-feeding, and late postnatal transmission is associated with a lower maternal CD4(+) cell count and male sex. Biological and cultural mechanisms underlying the association between sex and late postnatal transmission should be further investigated. Interventions to decrease transmission of HIV-1 through breast-feeding are urgently needed.

/pdf/late-postnatal-transmission-of-hiv-1-in-breast-fed-children-52ew2efkte.pdf

Late Postnatal Transmission of HIV-1 in Breast-Fed Children: An Individual Patient Data Meta-Analysis

BACKGROUND: At the end of 2000 it was estimated that over 36 million people were living with the human immunodeficiency virus (HIV). This includes 1.4 million children less than 15 years of age. This is one of several reviews assessing the available evidence for preventing mother-to-child transmission of HIV infection. The other reviews will address other interventions, including Caesarean section, breast feeding, vaginal lavage and vitamin A supplementation. OBJECTIVES: To assess which antiretroviral therapies may be effective in decreasing the risk of mother-to-child transmission of HIV infection as well as their effect on neonatal and maternal mortality and morbidity. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group trials register and the Cochrane Controlled Trials Register. We also searched conference abstracts from the International AIDS Conferences and Conference on Retroviruses and Opportunistic Infections. SELECTION CRITERIA: Randomised trials comparing any antiretroviral therapy aimed at decreasing the risk of mother-to-child transmission of HIV infection with placebo or no treatment, or any two or more antiretroviral therapies or regimens aimed at decreasing the risk of mother-to-child transmission of HIV infection. DATA COLLECTION AND ANALYSIS: Two reviewers independently extracted data and assessed trial quality. MAIN RESULTS: Zidovudine monotherapy Any zidovudine regimen versus placebo significantly reduces the risk of mother-to-child transmission (Peto odds ratio (OR) 0.46, 95% confidence interval (CI) 0.35 to 0.60). Zidovudine also appears to decrease the risk of infant death within the first year of birth (OR 0.57, 95% CI 0.38 to 0.85) and the risk of maternal death (OR 0.32, 95% CI 0.16 to 0.66). There is no evidence that zidovudine influences the incidence of premature delivery (OR 0.86, 95% CI 0.57 to 1.29) or low birth weight (OR 0.74, 95% CI 0.53 to 1.04). The risk of transmission using a 'short-short' course of zidovudine (from 35 weeks in pregnancy for the mother and for the baby until 3 days old) was higher than the risk using a 'long-long' course (from 28 weeks in pregnancy for the mother and for the baby until 6 weeks old), (OR 2.55, 95% CI 1.26 to 5.18). However, the effectiveness of the 'long-short' course (from 28 weeks in pregnancy for the mother and for the baby until 3 days old) and the 'short-long' course (from 35 weeks in pregnancy for the mother and for the baby until 6 weeks old) did not differ from that of the 'long-long' course. Nevirapine One large randomised controlled trial demonstrates that nevirapine given to mothers as a single dose at the onset of labour and to babies as a single dose within 72 hours of birth is more effective than an intrapartum and post-partum regimen of zidovudine (OR 0.51, 95% CI 0.33 to 0.79). When nevirapine is given to mothers already receiving standard antiretroviral therapy, however, there appears to be no additional advantage (OR 1.10, 95% CI 0.42 to 2.86). Combination Therapy Preliminary findings of the effect of combination therapy using zidovudine and lamivudine (3TC) suggest a decrease in the risk of transmission when the combination is given during the antenatal and intrapartum period or during the intrapartum and postpartum period compared with placebo. There is no evidence that intrapartum zidovudine and lamivudine alone are sufficient to decrease the risk of transmission compared with placebo. REVIEWER'S CONCLUSIONS: Implications for practice The randomised trials included in this review provide evidence that short course zidovudine and single-dose nevirapine are effective therapies for reducing mother-to-child transmission of HIV. The challenge for low and middle income countries will be to institute this therapy in practice. In industrialised countries practice has already moved on from the current evidence and combination antiretroviral therapy aimed primarily at preventing disease progression in the mother is the standard of care. Implications for research The potential value of nevirapine used for longer durations in breastfeeding populations should be considered as it may further reduce the risk of mother-to-child transmission, particularly if combined with early weaning. On-going evaluation of combination antiretroviral therapy is essential and will have an immediate benefit for countries with the resources to adopt such treatment. The search for effective, affordable, safe and acceptable alternatives to antiretroviral therapy for reducing mother-to-child transmission in resource poor countries should remain on the research agenda.

Antiretrovirals for reducing the risk of mother-to-child transmission of HIV infection

Providing antiretroviral therapy to human immunodeficiency virus type 1 (HIV-1)-infected women at the onset of labor could offer a relatively simple and affordable means of preventing vertical transmission. The HIVNET 012 study team reported, in 1999, that a single-dose intrapartum/neonatal regimen of nevirapine significantly lowered the risk of mother-child transmission by 47% compared with a brief regimen of zidovudine. The 496 infants had been followed up for 14 to 16 weeks. Data now are available for these infants up to age 18 months. Participating mothers had been assigned to receive either 200 mg nevirapine at the onset of labor, with 2 mg/kg for the infant within 72 hours after birth (regimen A), or 600 mg zidovudine at the onset of labor, followed by 300 mg every 3 hours until delivery and then 4 mg/kg orally twice a day for 7 days for the infant (regimen B). Testing for HIV-1 estimated HIV-1 RNA up to age 1 year and HIV-1 antibody at age 18 months. The estimated risk of HIV-1 transmission was 10.3% with zidovudine and 8.1% in the nevirapine group at birth; 20% and 11.8%, respectively, by age 6 to 8 weeks; 22.1% and 13.5% by age 14 to 16 weeks; and 25.8% and 15.7% by age 18 months. In all, nevirapine was associated with a 41% reduction in the relative risk of HIV-1 transmission at last follow up (95% confidence interval, 16-59%). Multivariate analysis showed that highly significant factors, besides the treatment effect, included the baseline maternal viral load and CD4 cell count. Adjusting for breastfeeding status did not alter the treatment effect. Serious adverse infant events in the first 2 months after birth occurred in approximately 10% of both treatment groups, and events also were comparably frequent at age 18 months. Intrapartum/neonatal nevirapine appears to be a simple, inexpensive, and well-tolerated regimen for significantly reducing perinatal transmission of HIV-1 in less developed countries.

Intrapartum and neonatal single-dose nevirapine compared with zidovudine for prevention of mother-to-child transmission of HIV-1 in Kampala, Uganda: 18-month follow up of the HIVNET 012 randomized trial

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Intrapartum and neonatal single-dose nevirapine compared with zidovudine for prevention of mother-to-child transmission of HIV-1 in Kampala, Uganda: 18-month follow up of the HIVNET 012 randomized trial