Gene/Protein Disease Symptom Drug Enzyme Compound
Pivot Concepts:   Target Concepts:
Query: EC:2.7.7.49 (reverse transcriptase)
 31,746 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

DuPont Merck and Gilead Sciences are finalizing a program to make their new, experimental anti-HIV drugs available free to people who are not benefiting from other treatments. Enrollment information is included. The program includes the drugs DMP-266 and adefovir dipivoxil, and is a model for how drug companies can work together effectively to make experimental treatments available through expanded access programs. Initially, DMP-266 enrollment will be limited to 2,000 people with CD4 counts below 50 who are failing their current regimen. Adefovir will be available to 1,000 patients with CD4 counts below 50 and viral loads above 30,000. DMP-266 is a non-nucleoside reverse transcriptase inhibitor that is only taken once a day and shows great promise when used in combination with indinavir. Adefovir belongs to the nucleotide analog reverse transcriptase inhibitor class, and shows a unique resistance profile. It is also taken only once a day.
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PMID:DMP-266 and adefovir dipivoxil: 2 new AIDS drugs available to patients without treatment options. 1136 9

DuPont Merck's non-nucleoside reverse transcriptase inhibitor DMP 266 (called Sustiva or efavirenz) will be available through an expanded access program starting in October 1997. A filing for Food and Drug Administration (FDA) marketing approval is expected in March 1998. Volunteers must have CD4 counts lower than 50 in the last 3 months and be failing current treatment regimens. DMP 266 has shown effectiveness in viral suppression when combined with indinavir. Two new trials are currently enrolling for combination therapy using DMP 266 with AZT/3TC. Contact information is provided for further details.
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PMID:DMP 266 now available. 1136 51

DuPont Merck is opening an expanded access program for efavirenz (Sustiva), a non-nucleoside reverse transcriptase inhibitor (NNRTI). Efavirenz (formerly called DMP-266), the most potent NNRTI to date, is taken only once a day. To participate, patients must be failing therapy or be intolerant of current therapy. The patients are required to take the drug with another anti-HIV drug that they have never taken. Contact information for efavirenz studies, including a pediatric trial, is provided.
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PMID:DMP 266 (Sustiva) expanded access. 1136 50

Sustiva (DMP 266 or efavirenz) has been available on an expanded access program since October 1. Sustiva is a non-nucleoside reverse transcriptase inhibitor, has fewer side effects than other drugs of its class, and is taken once a day at bedtime. Criteria for the program are T4 counts under 50 in patients whose current therapy is not working. Adefovir dipivoxil (bis-POM PMEA or Preveon) is a nucleotide analog that is also available through an expanded access program. Adefovir's properties make it less vulnerable to resistance. It is not as potent as other drugs of the same class; however, its effect seems to last longer. It is also effective against some herpesviruses and hepatitis B. Contact information is provided for both programs.
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PMID:Expanded access programs. 1136 31

Merck Pharmaceuticals has relaxed the criteria for expanded access for efavirenz (Sustiva or DMP-266). Under the new guidelines, patients who have ever had a CD4 count below 400 can now participate; earlier guidelines limited the program to those with counts below 50 within the last 90 days. European entry criteria will change shortly. Efavirenz must be used in conjunction with another antiretroviral that the patient has not taken previously. The drug is not recommended for use as monotherapy, and patients who have failed on non-nucleoside reverse transcriptase inhibitors are less likely to benefit from Sustiva because of a common mutation. Contact information is given for enrolling in the program.
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PMID:Efavirenz (Sustiva) expanded access now to 400 CD4. 1136 52

Dupont Merck announced an expanded access program for Efavirenz (Sustiva, DMP 266). The non-nucleoside reverse transcriptase inhibitor is taken just once a day, and 88 percent of people taking it in combination with indinavir achieved undetectable viral load. The program is open to people with CD4 counts below 400 who have no other viable treatment options. A contact telephone number is provided for further information.
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PMID:Efavirenz expanded access. 1136 75

As many as 25 to 45 percent of patients using triple therapy with protease inhibitors will develop resistance due to a change in the genetic HIV code. However, patients who develop resistance may still benefit clinically when protease inhibitors are used in combination with other antiretrovirals. These patients may not have undetectable viral loads although they may have stable T4-cell counts. Resistance does not always lead to disease progression. Newer drugs under development or available through compassionate track programs may benefit people with resistance. DMP-266 (Sustiva) is a non-nucleoside reverse transcriptase inhibitor that shows promise for these patients. Other drugs in development include Compound 141, 1592, and adefovir.
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PMID:Understanding and managing resistance. 1136 97

Studies of efavirenz (Sustiva, formerly DMP-266) in monkeys have shown newborn monkeys with abnormalities. Dupont Merck, the manufacturer of the non-nucleoside reverse transcriptase inhibitor, presented the information to the Food and Drug Administration (FDA). Although it is unknown if the risk exists in humans, the FDA warns that pregnant women should not use DMP-266.
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PMID:Safety alert issued on efavirenz (Sustiva). 1136 72

Phase III data show that efavirenz (Sustiva, formerly DMP-266) is effective in suppressing viral load when used in combination with other treatments. A head-to-head comparison trial in volunteers with little or no previous antiretroviral experience shows that efavirenz may suppress viral load as well as Indinavir (Crixivan). Efavirenz is an experimental non-nucleoside reverse transcriptase inhibitor (NNRTI), and widespread consensus seems to accept it as a valid treatment for AIDS. The most noteworthy trial result showed that using it in combination with AZT plus 3TC suppressed viral load to below 400 copies in a significant number of volunteers, with few patients dropping out. Viral load remains low at 72 weeks, but not much information is available on those patients who were more heavily pre-treated. Other combinations also appear effective. DuPont Pharmaceuticals, the manufacturer, says common side effects include rash, nausea, diarrhea, headache, and insomnia, and cautions against widespread use in pregnant women. Efavirenz is unlikely to work in patients who have developed resistance to either Nevirapine or Delavirdine, two other NNRTI drugs.
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PMID:Efavirenz (Sustiva) may equal or exceed protease inhibitor in initial antiretroviral combination. 1136 99

The Food and Drug Administration (FDA) approved DuPont Pharma's new non-nucleoside reverse transcriptase inhibitor (NNRTI) efavirenz (Sustiva, DMP-266). Efavirenz has shown promise in trials with over 2000 participants for up to 24 weeks, and early data suggests it may be as effective as protease inhibitors when used in a combination regimen. It is the first anti-HIV drug approved for once-daily dosing. Efavirenz is well tolerated, and the main side effects reported are dizziness, insomnia, abnormal dreams, and skin rash. Efavirenz has been approved for adults and children, but should not be used by pregnant women. Contact information is provided.
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PMID:FDA approves efavirenz. Food and Drug Administration. 1136 87


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