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Query: UMLS:C0019693 (HIV)
 170,526 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

Vertical transmission of HIV infection can take place in utero, during delivery and postnatally through breastfeeding, with about three-quarters of infections occurring around the time of delivery in non-breastfeeding populations. In Europe, in the absence of specific interventions, the vertical transmission rate was 15-20%. High maternal load is the major risk factor for both intra-uterine and intra-partum mother-to-child transmission. Prematurity is the most common adverse neonatal outcome associated with maternal HIV infection. Earlier diagnosis of paediatric HIV infection than previously available is now possible with virological tests, particularly HIV DNA polymerase chain reaction. An estimated one fifth of infected children will have been diagnosed with AIDS or have died by 12 months of age, rising to a third by 6 years of age. Surgical and therapeutic interventions are effective in reducing vertical transmission risk, in addition to the avoidance of breastfeeding. Caesarean section delivery before labour and before rupture of membranes approximately halves the risk of transmission, while prophylactic zidovudine therapy according to the ACTG076 regimen reduces transmission by up to two-thirds, transmission is reduced even further with both interventions. Trials of short-course zidovudine regimens show their effectiveness in reducing vertical transmission, in breastfeeding and non-breastfeeding populations. Nevirapine has been shown to be significantly more effective than short course zidovudine regimens in breastfeeding populations, but is still under evaluation in non-breastfeeding populations additionally receiving routine anti-retroviral prophylaxis. Reports of a small number of serious adverse events in uninfected children exposed in utero or neonatally to antiretroviral therapy need further investigation. Trials of vitamin A supplementation to reduce vertical transmission have had negative results, while the effectiveness of vaginal lavage and passive immune therapy in reducing vertical transmission remains uncertain.
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PMID:Epidemiology of HIV infection in the newborn. 1078 32

The aetiology of hepatic dysfunction in patients with HIV infection is multifactorial. Re-activation of hepatitis C infection, drug toxicity, and opportunistic infections are all potential causes. Nevirapine (NVP) is a non-nucleoside reverse transcriptase inhibitor used as part of combination antiretroviral therapy for the treatment of HIV infection. It is associated with a significant incidence of hepatotoxicity, usually occurring in the initial month of therapy. We report the case of a 49-year-old man who developed NVP-induced prolonged hepatotoxicity 5 months after commencing antiretroviral therapy.
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PMID:Late onset hepatitis and prolonged deterioration in hepatic function associated with nevirapine therapy. 1082 44

Nevirapine (Viramune), a dipyridiodiazepinone, is a potent and highly specific nonnucleoside inhibitor of HIV-1 reverse transcriptase. This paper describes the validation of a specific, sensitive, and stability-indicating high-performance liquid chromatography method for the assay and determination of related organic impurities in nevirapine drug substance. This method uses a Supelcosil LC-ABZ column, a mobile phase of 20:80 (v/v) acetonitrile-25mM NH4H2PO4 (pH 5.0), and ultraviolet detection at a wavelength of 220 nm. This method was validated for specificity, linearity, accuracy, repeatability, detection limit, quantitation limit, stability of analyte solutions, robustness, and intermediate precision. Nevirapine is completely separated from all impurities. The method is shown to be linear with coefficients of determination r2 greater than 0.999. Average accuracy is 100.4% with a relative standard deviation of 0.7% for the assay. Accuracy ranges from 100.1 to 102.6% for related organic impurities. Repeatability is good, with relative standard deviations not more than 1.4%. The detection limit and the quantitation limit are determined to be 0.001 and 0.003%, respectively. Relative response factors of known organic impurities are determined, permitting the use of nevirapine at the 0.1% level as an external standard for the quantitation of these impurities. Analyte solutions are shown to be stable for at least 2 days at ambient temperature. The method is validated as robust, and intermediate precision is high. A system suitability test is developed and validated, and requirements are set.
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PMID:Validation of a high-performance liquid chromatography method for the assay of and determination of related organic impurities in nevirapine drug substance. 1089 Jul 48

(1) Nevirapine is the first non nucleoside inhibitor of HIV-1 reverse transcriptase to be marketed in France. (2) The clinical file comprises three comparative double-blind trials. One showed a better clinical benefit (in terms of disease progression or death) of a three-drug regimen comprising zidovudine, didanosine and nevirapine than with zidovudine + didanosine bitherapy. Two trials focusing on laboratory criteria (viral load and the CD4+ cell count) showed that a three-drug regimen of zidovudine + didanosine + nevirapine was more effective, after 12 months of treatment, than bitherapy with zidovudine + nevirapine or zidovudine + didanosine. (3) Occasionally severe cutaneous reactions are the main adverse effects of nevirapine. (4) Nevirapine is a liver enzyme inducer, hence the possibility of drug interactions, especially with protease inhibitors of HIV; the clinical consequences are poorly known.
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PMID:Nevirapine: new preparation. In second-line triple-drug anti-HIV regimens. 1091 17

Nevirapine is a potent non-nucleoside inhibitor of HIV-1 reverse transcriptase. It is effective when used as part of combination therapy to treat HIV-1-infected individuals and as monotherapy for prevention of mother-to-child HIV-1 transmission. Nevirapine pharmacokinetics are characterised by rapid absorption and distribution, followed by prolonged elimination. Nevirapine is generally well tolerated. The most common toxicity is rash, which is usually mild and self-limiting. The primary route of nevirapine elimination is through metabolism by the cytochrome P450 enzyme system. Nevirapine elimination accelerates during long term administration because of autoinduction of the enzymes involved in its elimination pathway. The recommended regimen for adults is nevirapine 200mg once daily for 2 weeks, followed by 200mg twice daily. Nevirapine elimination is prolonged in pregnant women during labour and in newborns. A regimen of a single 200mg oral dose administered to the mother during labour and a single 2 mg/kg dose administered to the newborn at 48 to 72 hours after birth maintains serum nevirapine concentrations above 100 microg/L (10 times the in vitro 50% inhibitory concentration against wild-type HIV-1) throughout the first week of life. This limited regimen has been shown to be extremely well tolerated and to reduce mother-to-child transmission by nearly 50% in mothers and infants receiving no other antiretrovirals. There are few data describing the safety and pharmacokinetics of nevirapine during long term use in pregnancy. In children, nevirapine elimination accelerates during the first years of life, reaching a maximum at around 2 years of age, followed by a gradual decline during the rest of childhood. Children should receive 4 mg/kg once daily for the first 2 weeks of therapy, followed by 7 mg/kg doses twice daily if below the age of 8 years or 4 mg/kg twice daily if older than 8 years. Alternatively, children may receive 150 mg/m2 across all ages, once daily for the first 2 weeks of therapy followed by the same dose twice daily.
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PMID:Nevirapine: pharmacokinetic considerations in children and pregnant women. 1106 14

During the 13th International AIDS Conference in Durban, South Africa, investigators of trials in several countries reported success with simple, cheap regimens of nevirapine given to mothers and newborn infants. Results from the South African Intrapartum Nevirapine Trial confirmed that nevirapine is safe and effective in reducing mother-to-child transmission of HIV. In addition, preliminary findings of long-term follow-up of a trial in Uganda indicated that the benefits of this drug are maintained at 18 months. However, the investigators also recorded a seven-fold increase in HIV infection at 4-8 weeks in breast-fed infants. Loss of efficacy may be explained through a high number of infection in breast-fed children, with breast-feeding doubling the risk at 18 months. Moreover, Anna Coutsoudis of the University of Natal, South Africa, suggested that the culture of breast-feeding in this region contribute to this loss of efficacy. She explained that adding foods into the child's diet at an early stage introduces allergens or contaminants to the gut, which in turn led to an inflammatory response. The resulting damage to the gut might allow the virus to enter the baby's system.
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PMID:Hope for prevention of mother-to-child transmission of HIV. 1107 Nov 95

Nevirapine is a non-nucleoside reverse transcriptase inhibitor widely used in combination with other antiretroviral agents for the treatment of HIV infection. Severe rash, including the Stevens-Johnson syndrome (SJS), is the major toxicity of nevirapine and is described in the package labeling with a prominent, boxed warning. Though physicians treating large populations of patients with HIV are well aware of this complication, only one other report of nevirapine-associated SJS has been documented in the dermatology literature. We describe 2 cases of SJS related to nevirapine use and review the literature on this newly recognized association.
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PMID:Stevens-Johnson syndrome caused by the antiretroviral drug nevirapine. 1117 14

The results of the AIDS Clinical Trials Group (ACTG) 076 protocol have proved that antiviral medications, specifically zidovudine (ZDV; AZT), can reduce HIV transmission from mother to fetus. However, AZT therapy is not a viable option for many women--women who are at a late stage in disease progression, have had ZDV therapy prior to pregnancy, are unable to tolerate ZDV, or cannot afford ZDV. In response, the Pediatric AIDS Clinical Trials Group is developing other trials that might offer evidence of reduction of perinatal transmission. Nevirapine is a non-nucleoside HIV reverse transcriptase inhibitor. In studies of adults and children older than three months, nevirapine has demonstrated an ability to reduce HIV viral burden although it is an unlikely candidate for long-term therapy because HIV develops resistance to it in four weeks. Nevirapine may be useful in preventing perinatal transmission since fifty to seventy percent of vertical transmission is believed to occur during labor and delivery. The ACTG has established nine ACTG 250 (nevirapine) sites in the United States and Puerto Rico. It is imperative for clinicians to provide a thorough, non-directive, and culturally appropriate presentation of information about the complex research studies. The discussions should cover data about perinatal transmission, with and without ZDV use; possible benefits of the trial; unknown long-term adverse outcomes for the woman and her infant; information about study protocol, including the existence of placebo arms; and notice of the rights of the woman to withdraw without compromising her or her infant's health care at the clinic. Clinicians must negotiate a balance between providing appropriate clinical care and enrolling the number of participants that will secure not only the current trial but also future trials.
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PMID:Nevirapine: ethical dilemmas and care for HIV-infected mothers. 1136 87

An antiviral drugs advisory committee unanimously recommended accelerated approval for nevirapine (Viramune) for combination therapy with other anti-HIV drugs. Nevirapine, produced by Boehringer Ingelheim Parmaceuticals, is the first non-nucleoside reverse transcriptase inhibitor (NNRTI) to be approved by the Food and Drug Administration (FDA). Studies have shown that best results were seen when patients started using the drug at the same time they began using previously untried nucleoside analogs. In April, an expanded access program was initiated to make Viramune available to adult and pediatric patients with progressive, symptomatic disease.
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PMID:Nevirapine recommended for approval. 1136 50

The Food and Drug Administration (FDA) Antiviral Drugs Advisory Committee recommended the accelerated approval of nevirapine, a nonnucleoside reverse transcriptase inhibitor. The recommendation was based on immunologic and virologic data obtained in several trials. Nevirapine must be given in combination with nucleoside analogs. Combining protease inhibitors with nevirapine is being considered, but more data on its safety is necessary. HIV becomes resistant to nevirapine, but curiously, some patients sustain their reduction in HIV RNA. Several adult nevirapine trials are summarized. Pediatric studies have shown interesting results, such as effective entry of the drug into both plasma and cerebrospinal fluid, decreased viral load, and antibody seroreversion. The primary side effect of nevirapine is rash, which may be fatal in some patients.
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PMID:Nevirapine: new drug, new class, new questions. 1136 50


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