Gene/Protein Disease Symptom Drug Enzyme Compound
Pivot Concepts: Gene/Protein Disease Symptom Drug Enzyme Compound   Target Concepts: Gene/Protein Disease Symptom Drug Enzyme Compound

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Query: EC:2.7.7.49 (reverse transcriptase)
31,746 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

Voluntary HIV testing of pregnant women and perinatal treatment with AZT have caused a decline in the rate of transmission of HIV to infants during delivery. Researchers are now looking at whether AZT in combination with other antiretrovirals will be even more effective in reducing infection rates. At the 37th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) held in Toronto, researchers from the Centers for Disease Control and Prevention (CDC) reported that up to 80 percent of mothers whose HIV-positive children were identified by HIV/AIDS surveillance knew their health status before giving birth. A total of 77 percent of women received perinatal prophylaxis in 1996, compared to 36 percent in 1994. The CDC also reported a 12 percent infection rate in children who received perinatal treatment from September 1994 to December 1995, compared to 30 percent in those who received no treatment. The CDC is using this surveillance data to help States to determine how close they are to meeting the new guidelines of the Ryan White CARE Act. One requirement is to inform 95 percent of all pregnant women about their HIV status, thereby reducing perinatal infections by half. Of the new treatments being tested to reduce transmission rates, a Phase III study of nevirapine (Viramune) is the farthest along. The ACTG 316 study has begun enrolling women at 18 centers in the United States to test the non-nucleoside reverse transcriptase inhibitor. When combined with European sites, the study population should be large enough to guarantee statistical significance.
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PMID:Perinatal HIV down as treatment increases. 1136 70

Efavirenz (Sustiva), a non-nucleoside reverse transcriptase inhibitor (NNRTI) developed by DuPont Pharmaceuticals, was approved by the Food and Drug Administration. DuPont has promoted the once-daily efavirenz as being as equally effective as a protease inhibitor, and has priced it accordingly. The results from Study 006, the central trial for efavirenz, reported high antiviral activity, but had a significant dropout rate. This made it difficult to extrapolate the findings for those individuals remaining. The results of other key studies, such as Study 020 and ACTG 364, are discussed. Efavirenz is most effective when combined with protease inhibitors or nucleoside analogs. Some of the side effects of efavirenz are higher cholesterol levels, dizziness, and skin rashes. The possibility of birth defects has prompted DuPont to advise patients to use two types of birth control while taking efavirenz. A contact number is provided for physicians to register pregnant patients for follow-up if they have been exposed to efavirenz. Other protease-sparing options besides efavirenz are discussed, such as Nevirapine and Delavirdine.
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PMID:Another expensive drug for your cocktail. 1136 6

Treating Hepatitis C among HIV patients under antiretroviral drug therapy requires a high degree of vigilance and continuous monitoring because of frequent problems with intolerance and/or drug interactions. Recent studies, including three therapeutic trials, on Ribavic, APRICOT, and ACTG A5671, have given some insights on following these patients up. The adverse effects are relatively similar in HCV-HIV-co-infected patients and patients infected by HCV only. Their frequency is, on the other hand, higher among HCV-HIV-Co-infected patients. The adverse-effects are consistent, in a non-exhaustive way, with pseudo influenza-like symptoms, fever, myalgia, cephalgia, with psychiatric disorders (irritability, depression, etc.); endocrine disorders (thyroid dysfunction, diabetes...); and with hematological anomalies especially anemia and leucopenia. But the percentage of lymphocyte T CD4 is not modified, therefore there is no risk of opportunistic infection. Pharmacokinetic interactions between antiretroviral drugs and treatment for HCV infection including ribavirin plus interferon alpha (IFN-alpha) or pegylated IFN are described. They are almost exclusively due to the combination of ribavirin and of nucleoside analogue reverse transcriptase inhibitors. One of the principal consequences is the emergence of mitochondrial toxicity defined by the occurrence of hyperlactatemia, or acute pancreatitis). Thus, some combinations should be avoided such as ddI+ribavirin and ddI+d4T+ribavirin. The d4T+ribavirin combination must also be used with caution.
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PMID:[Intolerance to and/or drug interactions of anti-HIV and anti-HVC therapy]. 1591 Nov 83

ACTG (AIDS Clinical Trials Group) A5095 was a double-blinded Phase III clinical trial designed to compare three simple strategies for the initial treatment of HIV-1 infection: a non-nucleoside reverse transcriptase inhibitor (NNRTI) combined with two nucleosides, a triple-nucleoside regimen, and an NNRTI combined with three nucleosides. The study was designed to provide a rigorous evaluation of the relative effectiveness of the three different treatment strategies in achieving and maintaining durable HIV-1 RNA suppression using both superiority and non-inferiority designs. At the same time, we sought to provide study participants with flexible treatment management options that closely reflected clinical care approaches available outside the setting of a clinical trial in this rapidly changing field of medicine. Fulfilling both of these goals required making decisions about the primary endpoint definition, blinding, treatment changes, and stopping guidelines for the primary efficacy hypotheses. In this paper we describe the study design decisions that were made, in the context of randomized HIV treatment trials in general. We hope that the discussion will inform the design of treatment strategy trials, both for HIV and for other diseases where clinical standards change rapidly. We also hope to inform the field regarding issues in choosing composite versus virological endpoints as well as other key considerations in trial design and monitoring.
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PMID:Design issues in initial HIV-treatment trials: focus on ACTG A5095. 1731 Aug 19

Emtricitabine, a nucleoside reverse transcriptase inhibitor (RTI), and tenofovir disoproxil fumarate (tenofovir DF), a nucleotide RTI, as a fixed-dose combination tablet (emtricitabine/tenofovir DF) for once-daily oral administration, are used as the nucleoside/nucleotide RTI backbone in combination with other antiretroviral agents, including ritonavir-boosted protease inhibitors (PIs), in the treatment of adults with HIV-1 infection. Emtricitabine and tenofovir DF show good activity against laboratory strains and clinical isolates of HIV-1 in vitro, although strains with resistance to emtricitabine or tenofovir have also been reported. Regimens consisting of once-daily emtricitabine/tenofovir DF 200 mg/300 mg plus lopinavir/ritonavir (in the randomized, double-blind, placebo-matched, multicentre HEAT study) or boosted atazanavir or efavirenz (in the randomized, partially-blind, multicentre ACTG 5202 trial) were effective in the initial treatment of patients with HIV-1 infection (with screening plasma HIV-1 RNA levels of >or=100,000 copies/mL in ACTG 5202). In other randomized studies, emtricitabine/tenofovir DF 200 mg/300 mg once daily was an effective backbone for boosted PI-based regimens in the initial treatment of HIV-1 infection. Treatment-experienced patients with HIV-1 infection also experienced beneficial virological effects when treated with similar regimens. Emtricitabine/tenofovir DF in combination with various boosted PIs was generally well tolerated by adults with HIV-1 infection.
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PMID:Emtricitabine/tenofovir disoproxil fumarate: in combination with a protease inhibitor in HIV-1 infection. 1944 71

Efavirenz, a non-nucleoside reverse transcriptase inhibitor, has been an important component of the treatment of HIV infection for 10 years and has contributed significantly to the evolution of highly active antiretroviral therapy (HAART). The efficacy of efavirenz has been established in numerous randomized trials and observational studies in HAART-naive patients, including those with advanced infection. In the ACTG A5142 study, efavirenz showed greater virological efficacy than the boosted protease inhibitor (PI), lopinavir. Efavirenz is more effective as a third agent than unboosted PIs or the nucleoside analogue abacavir. Some, but not all, studies have suggested that efavirenz (added to two nucleoside reverse transcriptase inhibitors) is more effective than nevirapine. Virological and immunological responses achieved with efavirenz-based HAART have been maintained for 7 years. Dosing convenience predicts adherence, and studies have demonstrated that patients can be switched from PI-based therapy to simplified, once-daily efavirenz-based regimens without losing virological control. The one-pill, once-daily formulation of efavirenz plus tenofovir and emtricitabine offers a particular advantage in this regard. Efavirenz also retains a role after failure of a first PI-based regimen. Efavirenz is generally well tolerated: rash and neuropsychiatric disturbances are the most notable adverse events. Neuropsychiatric disturbances generally develop early in treatment and they tend to resolve with continued administration, but they are persistent and troubling in a minority of patients. Efavirenz has less effect on plasma lipid profiles than some boosted PIs. Lipodystrophy can occur under treatment with efavirenz but it may be reduced if the concurrent use of thymidine analogues is avoided. Efavirenz resistance mutations (especially K103N) can be selected during long-term treatment, underscoring the importance of good adherence. Recent data have confirmed that efavirenz is a cost-effective option for first-line HAART. In light of these features, efavirenz retains a key role in HIV treatment strategies and is the first-line agent recommended in some guidelines.
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PMID:Efavirenz: a decade of clinical experience in the treatment of HIV. 1976 18

The current standard of care for treating HIV infection is the use of three antiretroviral drugs: a combination of two nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) and a third agent from either the integrase strand transfer inhibitor (INSTI), boosted protease inhibitor (PI) or non-nucleoside reverse transcriptase inhibitor (NNRTI) classes. In an effort to minimize the long-term adverse effects and cost of antiretroviral therapy, the use of regimens with fewer drugs in the combination has been under active investigation. To this end, the combination of dolutegravir (DTG) plus lamivudine (3TC), two antiretroviral drugs with a long track record of efficacy and safety in the treatment of HIV infection, is undergoing clinical evaluation in treatment-naive HIV-infected participants. The promising results of the PADDLE study, with 90% of study participants achieving the primary endpoint of HIV-1 RNA lower than 50 copies/mL, were confirmed by the results of ACTG A5353, a phase II, single-arm, open-label study. Subsequently, GEMINI-1 and -2, two phase III, double-blind, noninferiority studies, compared DTG + 3TC to a three-drug regimen of DTG, tenofovir disoproxil fumarate and emtricitabine in 1,433 antiretroviral treatment-naive adults, and demonstrated noninferior efficacy at 48 weeks with no emergence of NRTI or INSTI mutations and a more favorable safety profile. This dual regimen should be avoided in those patients with existing mutations and chronic hepatitis B virus infection. In addition, data in patients with CD4 counts less than 200/mm3 is limited.
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PMID:Dolutegravir plus lamivudine dual therapy - a new option for initial antiretroviral therapy. 3113 40


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