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Two-Dose Intrapartum/Newborn Nevirapine and Standard Antiretroviral Therapy to Reduce Perinatal HIV Transmission

TL;DR: Risk of perinatal HIV transmission was low and no benefit from additional intrapartum/newborn nevirapine was demonstrated when women received prenatal care and antenatal ART, and elective cesarean section was made available.
About: The article was published on 2017-01-01 and is currently open access. It has received 368 citations till now. The article focuses on the topics: Nevirapine.
Citations
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Journal Article
TL;DR: The objectives of these recommendations are to increase HIV screening of patients, including pregnant women, in health-care settings; foster earlier detection of HIV infection; identify and counsel persons with unrecognized HIV infection and link them to clinical and prevention services; and further reduce perinatal transmission of HIV in the United States.
Abstract: These recommendations for human immunodeficiency virus (HIV) testing are intended for all health-care providers in the public and private sectors, including those working in hospital emergency departments, urgent care clinics, inpatient services, substance abuse treatment clinics, public health clinics, community clinics, correctional health-care facilities, and primary care settings. The recommendations address HIV testing in health-care settings only. They do not modify existing guidelines concerning HIV counseling, testing, and referral for persons at high risk for HIV who seek or receive HIV testing in nonclinical settings (e.g., community-based organizations, outreach settings, or mobile vans). The objectives of these recommendations are to increase HIV screening of patients, including pregnant women, in health-care settings; foster earlier detection of HIV infection; identify and counsel persons with unrecognized HIV infection and link them to clinical and prevention services; and further reduce perinatal transmission of HIV in the United States. These revised recommendations update previous recommendations for HIV testing in health-care settings and for screening of pregnant women (CDC. Recommendations for HIV testing services for inpatients and outpatients in acute-care hospital settings. MMWR 1993;42[No. RR-2]:1-10; CDC. Revised guidelines for HIV counseling, testing, and referral. MMWR 2001;50[No. RR-19]:1-62; and CDC. Revised recommendations for HIV screening of pregnant women. MMWR 2001;50[No. RR-19]:63-85). Major revisions from previously published guidelines are as follows: For patients in all health-care settings HIV screening is recommended for patients in all health-care settings after the patient is notified that testing will be performed unless the patient declines (opt-out screening). Persons at high risk for HIV infection should be screened for HIV at least annually. Separate written consent for HIV testing should not be required; general consent for medical care should be considered sufficient to encompass consent for HIV testing. Prevention counseling should not be required with HIV diagnostic testing or as part of HIV screening programs in health-care settings. For pregnant women HIV screening should be included in the routine panel of prenatal screening tests for all pregnant women. HIV screening is recommended after the patient is notified that testing will be performed unless the patient declines (opt-out screening). Separate written consent for HIV testing should not be required; general consent for medical care should be considered sufficient to encompass consent for HIV testing. Repeat screening in the third trimester is recommended in certain jurisdictions with elevated rates of HIV infection among pregnant women.

2,958 citations


Cites background from "Two-Dose Intrapartum/Newborn Nevira..."

  • ...Perinatal transmission rates can be reduced to <2% with universal screening of pregnant women in combination with prophylactic administration of antenatal antiretroviral drugs.(28)...

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Journal Article
TL;DR: These recommendations update the February 4,2002, guidelines for the use of zidovudine (ZDV) to reduce the risk for perinatal human immunodeficiency virus type 1 (HIV-1) transmission and include a recommendation that ZDV chemoprophylaxis should be incorporated into the antiretroviral regimen.
Abstract: These recommendations update the February 4,2002, guidelines developed by the Public Health Service for the use of zidovudine (ZDV) to reduce the risk for perinatal human immunodeficiency virus type 1 (HIV-1) transmission. This report provides healthcare providers with information for discussion with HIV-1-infected pregnant women to enable such women to make an informed decision regarding the use of antiretroviral drugs during pregnancy and use of elective cesarean delivery to reduce perinatal HIV-1 transmission. Various circumstances that commonly occur in clinical practice are presented, and the factors influencing treatment considerations are highlighted in this report. The Perinatal HIV Guidelines Working Group recognizes that strategies to prevent perinatal transmission and concepts related to management of HIV disease in pregnant women are rapidly evolving and will continually review new data and provide regular updates to the guidelines. The most recent information is available from the HIV/AIDS Treatment Information Service (available at http.//www.hivatis.org). In February 1994, the results of Pediatric AIDS Clinical Trials Group (PACTG) Protocol 076 documented that ZDV chemoprophylaxis could reduce perinatal HIV-1 transmission by nearly 70%. Epidemiologic data have since confirmed the efficacy of ZDV for reduction of perinatal transmission and have extended this efficacy to children of women with advanced disease, low CD4+ T-lymphocyte counts, and prior ZDV therapy. Additionally, substantial advances have been made in the understanding of the pathogenesis of HIV-1 infection and in the treatment and monitoring of persons with HIV-1 disease. These advances have resulted in changes in standard antiretroviral therapy for HIV-1-infected adults. More aggressive combination drug regimens that maximally suppress viral replication are now recommended. Although considerations associated with pregnancy may affect decisions regarding timing and choice of therapy pregnancy is not a reason to defer standard therapy. Use of antiretroviral drugs in pregnancy requires unique considerations, including the possible need to alter dosage as a result of physiologic changes associated with pregnancy the potential for adverse short- or long-term effects on the fetus and newborn, and the effectiveness of the drugs in reducing the risk for perinatal transmission. Data to address many of these considerations are not yet available. Therefore, offering antiretroviral therapy to HIV-1-infected women during pregnancy, whether primarily for HIV-1 infection, for reduction of perinatal transmission, or for both purposes, should be accompanied by a discussion of the known and unknown short- and long-term benefits and risks of such therapy to infected women and their infants. Standard antiretroviral therapy should be discussed with and offered to HIV-1-infected pregnant women. Additionally, to prevent perinatal transmission, ZDV chemoprophylaxis should be incorporated into the antiretroviral regimen.

642 citations


Cites background from "Two-Dose Intrapartum/Newborn Nevira..."

  • ...4% among women in the nevirapine group (69)....

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  • ...For women in the United States, Europe, Brazil, and the Bahamas receiving antenatal antiretroviral therapy, addition of the 2-dose nevirapine regimen did not result in lower transmission rates (69)....

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  • ...Given lack of further reduction of transmission with nevirapine added to an established regimen (69) and the potential development of resistance, addition of nevirapine during labor for women already receiving antiretroviral therapy is not recommended....

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  • ...Results of epidemiologic and clinical trials suggest that women receiving highly active antiretroviral regimens that effectively reduce HIV-1 RNA to <1,000 copies/mL or undetectable levels have very low rates of perinatal transmission (27,61,69,88)....

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Journal ArticleDOI
TL;DR: Tissue specimens showing more than 5 neutrophils/HPF show a sensitivity of 43% to 84% in specificity of 93% to 97% and the preferred culture sources are blood cultures or bone biopsy.
Abstract: 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).

536 citations


Cites background from "Two-Dose Intrapartum/Newborn Nevira..."

  • ...Given lack of further reduction of transmission with nevirapine added to an established regimen [83] and the potential development of resistance, addition of nevirapine during labor for women already receiving antiretroviral therapy is not recommended....

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  • ...For women in the United States, Europe, Brazil, and the Bahamas receiving antenatal antiretroviral therapy, addition of the 2–dose nevirapine regimen did not result in lower transmission rates [83]....

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  • ...Results of epidemiologic and clinical trials suggest that women receiving highly active antiretroviral regimens that effectively reduce HIV-1 RNA to <1,000 copies/mL or undetectable levels have very low rates of perinatal transmission [25, 66, 83, 102]....

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  • ...4% among women in the nevirapine group [83]....

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Journal ArticleDOI
TL;DR: All regimens of HAART from pregnancy through 6 months post partum resulted in high rates of virologic suppression, with an overall rate of mother-to-child transmission of 1.1%.
Abstract: Background The most effective highly active antiretroviral therapy (HAART) to prevent mother-to-child transmission of human immunodeficiency virus type 1 (HIV-1) in pregnancy and its efficacy during breast-feeding are unknown. Methods We randomly assigned 560 HIV-1−infected pregnant women (CD4+ count, ≥200 cells per cubic millimeter) to receive coformulated abacavir, zidovudine, and lamivudine (the nucleoside reverse-transcriptase inhibitor [NRTI] group) or lopinavir−ritonavir plus zidovudine−lamivudine (the protease-inhibitor group) from 26 to 34 weeks' gestation through planned weaning by 6 months post partum. A total of 170 women with CD4+ counts of less than 200 cells per cubic millimeter received nevirapine plus zidovudine−lamivudine (the observational group). Infants received single-dose nevirapine and 4 weeks of zidovudine. Results The rate of virologic suppression to less than 400 copies per milliliter was high and did not differ significantly among the three groups at delivery (96% in the NRTI gr...

496 citations


Additional excerpts

  • ...Village of Mochudi 42/170 (25) 50/285 (18) 44/275 (16)...

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  • ...Neutropenia 34/156 (22) 43/283 (15) 49/270 (18)...

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  • ...Town of Lobatse 31/170 (18) 53/285 (19) 52/275 (19)...

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  • ...$101–$200 31/170 (18) 34/285 (12) 38/275 (14)...

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References
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Journal ArticleDOI
16 Aug 2006-JAMA
TL;DR: The virologic target for patients with treatment failure is now a plasma HIV-1 RNA level below 50 copies/mL, making delivery of state-of-the-art care challenging.
Abstract: Context Guidelines for antiretroviral therapy are important for clinicians worldwide given the complexity of the field and the varied clinical situations in which these agents are used. The International AIDS Society–USA panel has updated its recommendations as warranted by new developments in the field. Objective To provide physicians and other human immunodeficiency virus (HIV) clinicians with current recommendations for the use of antiretroviral therapy in HIVinfected adults in circumstances for which there is relatively unrestricted access to drugs and monitoring tools. The recommendations are centered on 4 key issues: when to start antiretroviral therapy; what to start; when to change; and what to change. Antiretroviral therapy in special circumstances is also described. Data Sources and Study Selection A 16-member noncompensated panel was appointed, based on expertise in HIV research and patient care internationally. Data published or presented at selected scientific conferences from mid 2004 through May 2006 were identified and reviewed by all members of the panel. Data Extraction and Synthesis Data that might change previous guidelines were identified and reviewed. New guidelines were drafted by a writing committee and reviewed by the entire panel. Conclusions Antiretroviral therapy in adults continues to evolve rapidly, making delivery of state-of-the-art care challenging. Initiation of therapy continues to be recommended in all symptomatic persons and in asymptomatic persons after the CD4 cell count falls below 350/µL and before it declines to 200/µL. A nonnucleoside reverse transcriptase inhibitor or a protease inhibitor boosted with low-dose ritonavir each combined with 2 nucleoside (or nucleotide) reverse transcriptase inhibitors is recommended with choice being based on the individual patient profile. Therapy should be changed when toxicity or intolerance mandate it or when treatment failure is documented. The virologic target for patients with treatment failure is now a plasma HIV-1 RNA level below 50 copies/mL. Adherence to antiretroviral therapy in the short-term and the long-term is crucial for treatment success and must be continually reinforced.

1,050 citations

Journal ArticleDOI
19 Oct 2001-AIDS
TL;DR: NVPR was detected more frequently in infants than women following NVP prophylaxis, and different patterns of NVPR mutations were detected in women versus infants, and NVP-resistant HIV-1 faded from detection in women and infants over time.
Abstract: Objective To examine the emergence and fading of NVP resistance (NVP(R)) mutations in HIV-1-infected Ugandan women and infants who received single dose NVP to prevent HIV-1 vertical transmission. Design We examined NVP(R) in women and infants who received NVP in the HIVNET 012 clinical trial, including 41 out of 48 women with infected infants, 70 randomly-selected women with uninfected infants, and 33 out of 49 infected infants. Methods Plasma HIV-1 was analyzed using the Applied Biosystems ViroSeq HIV-1 Genotyping System. Results NVP(R) mutations were detected in 21 out of 111 (19%) women tested 6-8 weeks after delivery. The rate of NVP(R) was similar among women whose infants were or were not HIV-1 infected. K103N was the most common mutation detected. NVP(R) mutations faded from detection within 12-24 months in all 11 evaluable women. High baseline viral load and low baseline CD4 cell count were associated with development of NVP(R). NVP(R) mutations were detected in 11 out of 24 (46%) evaluable infants who were infected by 6-8 weeks of age. The most common NVP(R) mutation detected in infants was Y181C. Those mutations faded from detection by 12 months of age in all seven evaluable infants. Of nine evaluable infants with late HIV-1 infection, only one had evidence of NVP(R). Conclusions NVP(R) was detected more frequently in infants than women following NVP prophylaxis, and different patterns of NVP(R) mutations were detected in women versus infants. NVP(R) was detected infrequently in infants with late HIV-1 infection. NVP-resistant HIV-1 faded from detection in women and infants over time.

451 citations


"Two-Dose Intrapartum/Newborn Nevira..." refers background in this paper

  • ...In HIVNET 012, the resistance mutations detected during the early postpartum period were not apparent when the women were tested at later time points.(24) In a substudy of women participating in PACTG 316 who had active viral replication, new nevirapineresistance mutations were demonstrated in 15% (95% confidence interval, 8%-23%), suggesting that risk of new nevirapine-resistance mutations may occur even in women receiving other ART....

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Journal ArticleDOI
25 Apr 2001-JAMA
TL;DR: Lamivudine-zidovudine prophylaxis therapy may be effective in preventing maternal-infant HIV transmission, however, severe adverse effects and emergence of resistance to lamivUDine occurred.
Abstract: ContextZidovudine reduces maternal-infant transmission of human immunodeficiency virus 1 (HIV-1) infection by two thirds. Combination antiretroviral therapies are potentially more effective prevention.ObjectivesTo assess the safety of perinatal lamivudine-zidovudine therapy, especially in children, and its effects on viral load, acquisition of drug resistance, and maternal-infant transmission of HIV-1 in a nonbreastfeeding population.Design and SettingThe Agence Nationale de Recherches sur le SIDA (ANRS) 075 Study, an open-label, nonrandomized intervention trial conducted in the context of an ongoing observational cohort study in 48 sites in France.PatientsA total of 445 HIV-1–infected pregnant women were enrolled as the study cohort from February 1997 to September 1998; controls consisted of 899 pregnant women who had received zidovudine monotherapy in May 1994 to February 1997 as standard care.InterventionThe study cohort received lamivudine in addition to the standard Pediatric AIDS Clinical Trial Group 076 Study zidovudine prophylaxis regimen. Lamivudine was initiated in women at 32 weeks' gestation through delivery at 150 mg twice per day orally; children received lamivudine, 2 mg/kg twice per day for 6 weeks.Main Outcome MeasuresHIV-1 infection status and tolerance of therapy in children through age 18 months; maternal plasma HIV-1 RNA levels through 6 weeks after delivery.ResultsThe transmission rate in the study group was 1.6% (7/437; 95% confidence interval [CI], 0.7%-3.3%). In a multivariable analysis, transmission in the study group was 5-fold lower than in controls. In the study group, maternal plasma HIV-1 RNA level was less than 500 copies/mL at delivery in 74%; the median decrease was 1.24 (range, −1.63 to 3.40) log10 copies/mL. The M184V lamivudine resistance mutation was detected at 6 weeks after delivery in specimens from 52 of 132 women. The most frequent serious adverse events in children were neutropenia and anemia, requiring blood transfusion in 9 children and premature treatment discontinuation in 19. Two uninfected children died at age 1 year from neurologic complications related to mitochondrial dysfunction.ConclusionsLamivudine-zidovudine may be effective in preventing maternal-infant HIV transmission. However, severe adverse effects and emergence of resistance to lamivudine occurred. Thus, the role of this combination therapy in this setting is as yet unclear, and further research involving a variety of strategies is needed to definitively ascertain its utility for preventing maternal-infant HIV transmission.

388 citations

Journal ArticleDOI

381 citations


"Two-Dose Intrapartum/Newborn Nevira..." refers background or methods or result in this paper

  • ...The results of the Pediatric AIDS [acquired immunodeficiency syndrome] Clinical Trials Group (PACTG) 076, published in 1994, offered proof of the concept that a zidovudine regimen given antepartum, intrapartum, and to the newborn for 6 weeks could significantly reduce HIV transmission.(3) Implementation of this regimen in the developed world has reduced transmission rates of perinatal HIV to between 5% and 8%....

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  • ...natal HIV transmission is high ( 25%).(3) Two African trials have shown that the 2-dose nevirapine regimen is effective in reducing transmission in women who have not received antenatal ART....

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  • ...Women were encouraged to receive the PACTG 076 zidovudine regimen as a minimum therapy.(3)...

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