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    • "EFV is a nonnucleoside reverse transcriptase inhibitor (NNRTI) indicated in combination with other antiretroviral agents for the treatment of HIV [3]. EFV is an FDA pregnancy category D drug based on animal studies and human case reports of fetal neural tube defects [3] [4] [5] [6]. Thus, preventing pregnancy is critical in HIV-infected women receiving EFV. "
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    ABSTRACT: Compare the Plan B levonorgestrel (LNG) area under the concentration- time curve (AUC(12)) prior to and with efavirenz (EFV). Design. Prospective, open-label, single-arm, equivalence study. Healthy HIV-negative subjects underwent 12 hr intensive pharmacokinetic (PK) sampling following single dose LNG alone and after 14 days of EFV. Geometric means, Geometric Mean Ratios, and 90% confidence intervals (CI) are reported for PK Parameters. T-tests were utilized. Clinical parameters and liver function tests (LFTs) were assessed. 24 women enrolled and 21 completed the study. With EFV, LNG AUC(12) was reduced 56% (95% CI: 49%, 62%) from 42.9 to 17.8 ng∗hr/mL, and maximum concentration (C(max)) was reduced 41% (95% CI: 33%, 50%) from 8.4 to 4.6 ng/mL. LNG was well tolerated with no grade 3 or 4 treatment-related toxicities. EFV significantly reduced LNG exposures. Higher LNG doses may be required with EFV. These results reinforce the importance of effective contraception in women taking EFV.
    Infectious Diseases in Obstetrics and Gynecology 02/2012; 2012:137192. DOI:10.1155/2012/137192
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    ABSTRACT: Medical issues faced by HIV-affected couples include transmission risks between partners and between mother and child, as well as the technologies and procedures available to reduce those risks. Assisted reproductive techniques discussed are artificial insemination, in vitro fertilization, intracytoplasmic sperm injection, self-insemination, and timed intercourse. It is important that physicians be aware of reproductive options available to couples affected by HIV and be prepared to engage in nonjudgmental dialogue with patients. This review is the result of a literature search performed to identify useful information to counsel HIV-serodiscordant and HIV-seroconcordant couples facing decisions on reproduction.
    Topics in HIV medicine: a publication of the International AIDS Society, USA 11/2003; 12(2):61-7.
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    ABSTRACT: Increasing rates of HIV infection in women worldwide, especially among those of childbearing age, reinforce the importance of understanding the management of HIV in pregnancy. Over the past decade, significant advances have been made in the prevention of vertical HIV transmission, including the use of single and combination antiretroviral therapy, elective caesarean section as the preferred mode of delivery and the elimination of breast feeding. Multiple clinical trials assessing antiretroviral therapy in pregnancy have been carried out worldwide. The first pivotal clinical trial, the AIDS Clinical Trials Group (ACTG) 076 study, was conducted in 1994 using a three-part zidovudine regimen. Despite the success of this regimen at decreasing rates of vertical transmission, it is not affordable in many developing countries. Consequently, many international clinical trials have concentrated on short-course antiretroviral regimens including zidovudine alone, zidovudine and lamivudine, and nevirapine alone. In the developed world, the management of nonpregnant HIV-infected individuals has also undergone significant advances and has implications for the management of HIV in pregnancy. A number of countries have participated in the development of guidelines for the management of HIV in pregnancy, which recommend that HIV-infected pregnant women should be offered combination antiretroviral therapy based on viral load and CD4+ cell count cut-offs used for individuals who are not pregnant, preferably with the inclusion of zidovudine. However, to maximise the benefits to their offspring, therapy is recommended at lower viral load thresholds than for nonpregnant adults. For antiretroviral-naive women, therapy is deferred until the second trimester because of the potential and uncertain risk of teratogenesis and the low risk of transmission during this period. Research has also found that maternal factors including viral load, immune status, chorioamnionitis, prematurely ruptured membranes and, to a lesser extent, intravenous drug use and smoking are associated with increased vertical transmission. These represent potentially modifiable risk factors that should be addressed before and throughout pregnancy. Despite the benefits of antiretroviral therapy to reduce HIV vertical transmission, its use can be complicated by known and unknown risks of toxicity to the mother, fetus or both as well as carrying the risk of developing drug-resistant virus. The latter can potentially compromise future treatment options for both the mother and child. Other important challenges include the use of antiretroviral drugs during pregnancy when the mother does not meet criteria for them for her own health, and balancing the relative risks and benefits of elective caesarean section at various degrees of viral load suppression. Clinicians managing HIV in pregnancy need to keep up to date with all the literature to provide optimal care, including counselling to allow mothers to balance the risks and benefits while deciding on treatment for both themselves and their children.
    Drugs 01/2004; 64(5). · 4.13 Impact Factor
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