Study: Durability and potency of Kaletra
The 43rd Interscience Conference on Antimicrobial Agents and Chemotherapy (ICCAC) held September 13-17, 2003 featured a poster (#-H-844) by Abbott on a five-year follow-up of Kaletra (Lopinavir/ritonavir) in antiretroviral-naïve HIV-infected patients. This was the first trial of LPV/r in HIV-infected patients, therefore providing the longest duration of follow-up for patients treated with LPV/r. This poster presents data on antiviral activity, immunologic parameters and safety through five years of follow-up. Antiretroviral-naïve patients receiving Kaletra exhibited sustained virologic response, with 67% of patients demonstrating HIV RNA <400 copies/mL and 64% demonstrating HIV RNA <50 copies/mL by intent-to-treat (NC=F) analysis. Through 252 weeks of follow-up, no protease inhibitor resistance mutations have been observed in subjects with sustained viral load rebound. Discontinuations due to LPV/r-related adverse events were 10/100, 10%.
www.natap.org, 9/27/03

Study: The Use of T-1249 (second generation fusion inhibitor) on Patients with T-20 Resistance
Final results were reported at ICCAC on the use of T-1249 on 51 patients with T-20 resistance. After 11 days, HIV viral load was decreased by a median of -1.26 log (ITT). Seventy-three percent of patients after 11 days had at least a one log reduction in viral load. Patients did not respond as well if they had remained on T-20 for a long period of time with dectectable HIV. Twenty-one out of 25 patients who remained on T-20 for less than 65 weeks with detectable viral load of >5000 copies/ml achieved at least a one log reduction in viral load. Sixteen out of 26 patients who remained on T-20 for greater than 65 weeks with detectable viral load of >5000 copies/ml achieved a one log reduction or greater in viral load. T-1249 was well-tolerated and exhibited potent short-term antiviral activity. Sixty-four percent of patients experienced injection site reactions. The study authors reported that baseline T-1249 susceptibility does not appear to predict short-term responses to T-1249.
www.natap.org, 9/27/03

Study: Effect of Short-Term Monotherapy with UK-427,857 (first HIV attachment inhibitor) on Viral Load in HIV-Infected Patients
Fatkentheuer and colleagues reported for the first time results from a one-day study of monotherapy of the first HIV attachment inhibitor to be studied in HIV-infected patients. After HIV binds to the CD4 receptor on the CD4 cell, HIV binds to a co-receptor. CCR5 or CXCR4 are the two co-receptors that HIV uses to attach itself to the CD4 cell for entry into the CD4 cell, where HIV replication takes place. "427" is the first attachment inhibitor targeting inhibition of the CCR5 co-receptor to be studied in HIV-infected patients. The drug is active against HIV resistant to current HIV drugs. Efficacy against HIV with T-20 resistance has yet to be tested, but future studies are planned.
www.natap.org, 9/27/03

Drug Warning from the AETC National Resource Center: Early Virologic Failure in Patients treated with Didanosine + Lamivudine + Tenofovir
Susa Coffey, M.D.
Gilead Sciences has issued a "Dear Health Care Professional" letter to warn of high rates of early virologic failure in patients treated with a once-daily triple nucleoside reverse transcriptase inhibitor (NRTI) regimen consisting of didanosine + lamivudine + tenofovir. The letter describes interim results of a pilot study of didanosine (enteric-coated formulation, 250 mg) + lamivudine (300 mg) + tenofovir (300 mg), all dosed once daily in 24 treatment-naïve patients. At week 12, virologic failure (<2 log10 reduction in HIV RNA) was seen in 91% of study subjects. Resistance testing performed on 21 patients revealed the M184I/V mutation in 95%, and K65R + M184I/V mutations in 50%. Study enrollment was terminated upon discovery of this high rate of early regimen failure. This announcement reinforces data on high rates of early virologic failure and early emergence of NRTI-associated resistance mutations that were previously reported in several studies of other triple-NRTI regimens. These include reports on the combinations abacavir + lamivudine + tenofovir, abacavir + lamivudine + zidovudine, and abacavir + didanosine + stavudine. The combination of didanosine + lamivudine + tenofovir, like the other triple-NRTI regimens with demonstrated high failure rates, are not recommended for the treatment of patients with HIV infection. The letter is available on the U.S. Food and Drug Administration website.
http://www.fda.gov/oashi/aids/new.html,10/14/03

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