Med Monitor

Patients on lopinavir/ritonavir-based anti-HIV regimens who simultaneously take medications to reduce gastric acid do not appear to have a reduction in blood concentrations of lopinavir or ritonavir, according to a study reported in the April edition of AIDS Patient Care and STDs. ---------- A Food and Drug Administration advisory panel has recommended accelerated approval of the CCR5 inhibitor maraviroc, to be marketed as Celsentri. Pfizer's maraviroc is the first in this new class of antiretrovirals to be considered for approval for patient use. ---------- Progenics Pharmaceuticals has announced promising data from a Phase Ib clinical trial of CCR5 inhibitor PRO 140. The FDA granted fast-track status for PRO 140 in May, and further clinical trials are scheduled to start this year. ---------- The FDA has approved two tests that help gauge patients' virologic responses to anti-HIV treatment: Abbott Laboratories' RealTime HIV-1 test and Roche's Cobas AmpliPrep/Cobas TagMan HIV-1 Test. ---------- Protease inhibitor darunavir has shown positive results in attacking drug-resistant HIV, according to a study published in the April 7 issue of The Lancet. Darunavir, marketed as Prezista, received accelerated approval last year that required developer Tibotec Pharmaceuticals to continue safety and efficacy testing. Participating in the new study, conducted by the AIDS Healthcare Foundation, were 230 patients who had failed to respond to at least three kinds of anti-HIV meds. All were given a standard drug regimen prescribed by their doctors. In addition, 110 patients received twice-daily doses of darunavir boosted with ritonavir. At 48 weeks 61% of the darunavir group had achieved a 10-fold reduction in viral levels. In the control group about 15% achieved such a reduction. Forty-five percent of the darunavir patients achieved an undetectable viral load, compared to 10% of the control patients. ---------- Ritonavir-boosted atazanavir as maintenance monotherapy was determined to be not as potent as conventional antiretroviral therapy when a study was halted after the threshold number of cases reached virologic failure, according to a report in the April 1 edition of the Journal of Acquired Immune Deficiency Syndromes.