SUMMARY The availability of an increasing number of antiretroviral agents and the rapid evolution of new information has introduced extraordinary complexity into the treatment of HIV-infected persons. In 1996, the Department of Health and Human Services and the Henry J. Kaiser Family Foundation convened the Panel on Clinical Practices for the Treatment of HIV to develop guidelines for the clinical management of HIV-infected adults and adolescents. This report recommends that care should be supervised by an expert, and makes recommendations for laboratory monitoring including plasma HIV RNA, CD4 cell counts and HIV drug resistance testing. The report also provides guidelines for antiretroviral therapy, including when to start treatment, what drugs to initiate, when to change therapy, and therapeutic options when changing therapy. Special considerations are provided for adolescents and pregnant women. As with treatment of other chronic conditions, therapeutic decisions require a mutual understanding between the patient and the health care provider regarding the benefits and risks of treatment. Antiretroviral regimens are complex, have major side effects, pose difficulty with adherence, and carry serious potential consequences from the development of viral resistance due to non-adherence to the drug regimen or suboptimal levels of antiretroviral agents. Patient education and involvement in therapeutic

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Guidelines for the use of antiretroviral agents in HIV-infected adults and adolescents

https://www.thelancet.com/pdfs/journals/lancet/PIIS0140-6736(99)80008-7.pdf

Intrapartum and neonatal single-dose nevirapine compared with zidovudine for prevention of mother-to-child transmission of HIV-1 in Kampala, Uganda: HIVNET 012 randomised trial

This publication is intended to serve as a reference tool for countries with limited resources as they develop or revise national guidelines for the use of ART in adults and postpubertal adolescents (see Annex 9 for pubertal Tanner staging; prepubertal adolescents should follow the WHO paediatric guidelines). The material presented takes updated evidence into account including new ART treatment options and draws on the experience of established ART scale-up programmes. The simplified approach with evidence-based standards continues to be the basis of WHO recommendations for the initiation and monitoring of ART. The guidelines are primarily intended for use by national and regional HIV programme managers managers of nongovernmental organizations delivering HIV care services and other policy-makers who are involved in the scaling up of comprehensive HIV care and ART in resource-limited countries. The comprehensive up-to-date technical and clinical information on the use of ART however also makes these guidelines useful for clinicians in resource-limited settings. The recommendations contained in these guidelines are made on the basis of different levels of evidence from randomized clinical trials high-quality scientific studies observational cohort data and where insufficient evidence is available expert opinion. The strengths of the recommendations in Table 1 are intended to indicate the degrees to which the recommendations should be considered by regional and country programmes. Cost-effectiveness is not explicitly considered as part of the recommendations although the realities of human resources health system infrastructures and socioeconomic issues should be taken into account when the recommendations are being adapted to regional and country programmes. (excerpt)

Antiretroviral therapy for HIV infection in adults and adolescents: recommendations for a public health approach. 2006 revision.

Each year, an estimated 590,000 infants acquire human immunodeficiency virus type 1 (HIV) infection from their mothers, mostly in developing countries that are unable to implement interventions now standard in the industrialized world. In resource-poor settings, the HIV pandemic has eroded hard-won gains in infant and child survival. Recent clinical trial results from international settings suggest that short-course antiretroviral regimens could significantly reduce perinatal HIV transmission worldwide if research findings could be translated into practice. This article reviews current knowledge of mother-to-child HIV transmission in developing countries, summarizes key findings from the trials, outlines future research requirements, and describes public health challenges of implementing perinatal HIV prevention interventions in resource-poor settings. Public health efforts must also emphasize primary prevention strategies to reduce incident HIV infections among adolescents and women of childbearing age. Successful implementation of available perinatal HIV interventions could substantially improve global child survival.

http://www.engenderhealth.org/files/pubs/acquire-digital-archive/6.0_integrate_fp-lapms/6.2_resources/6.2.4_tools/fhi-contraception-cd/resources/decockarticle.pdf

Prevention of mother-to-child HIV transmission in resource-poor countries: translating research into policy and practice.

Adverse effects of antiretroviral therapy

The transmission of HIV-1 infection from an infected mother to her infant is estimated to be 15-40% with more than half of transmission probably occurring late in pregnancy or during labor and delivery. Nevirapine a non-nucleoside reverse transcriptase inhibitor is an excellent candidate for a single-dose antiretroviral intervention administered during labor. Findings are presented from a study assessing the safety pharmacokinetics tolerance antiretroviral activity and infant HIV infection status following the administration of 1 dose of nevirapine to HIV-1-infected pregnant women during labor and their newborns during the first week of life. 200 mg of nevirapine were given as a single dose during labor to 21 HIV-1-infected pregnant women in Kampala Uganda. 8 of their infants did not receive the drug while 13 infants received 1 dose of nevirapine at 2 mg/kg at 72 hours of age. Nevirapine was well tolerated by both the women and infants with no serious adverse events related to the drug observed. Median nevirapine concentration in breast milk 1 week after delivery was 103 ng/ml. Plasma nevirapine concentrations remained above 100 ng/ml in all infants from both cohorts tested at age 7 days. Maternal HIV-1 RNA levels decreased by a median of 1.3 logs at 1 week postpartum and returned to baseline by 6 weeks postpartum. Detectable plasma HIV-1 RNA was observed in 1 of 22 (4.5%) infants at birth 3/21 (14%) at 6 weeks and 4/21 (19%) at 6 months of age. This regimen has promise as a prophylaxis against intrapartum and early breast milk HIV transmission in a breast-feeding population.

Kevin Dransfield

Papers

Intrapartum and neonatal single-dose nevirapine compared with zidovudine for prevention of mother-to-child transmission of HIV-1 in Kampala, Uganda: HIVNET 012 randomised trial

A phase I / II study of the safety and pharmacokinetics of nevirapine in HIV-1-infected pregnant Ugandan women and their neonates (HIVNET 006).

Safety profile of nevirapine, a nonnucleoside reverse transcriptase inhibitor for the treatment of human immunodeficiency virus infection