Analysis of Six Clinical Trials Finds EPZICOM(R) Effective in Treatment-Naive HIV Patients With Both High and Low Baseline V...(5202 to assess the impact of screening v...),Health

The six clinical trials included in the analysis were CNA30024, CNA30021, ESS30009, SHARE, KLEAN and HEAT. The analysis examined EPZICOM-containing regimens in each study and the Truvada-containing regimens in HEAT. Among all patients receiving EPZICOM in the six clinical trial analysis, 87-95% did not experience virologic failure by 48 weeks of treatment. In the HEAT study 87-90% of patients in both the EPZICOM and Truvada arms did not experience virologic failure by 48 weeks, regardless of baseline viral load (<100,000 and greater than or equal to 100,000c/mL).

A safety analysis was also conducted in the HEAT study using the ACTG 5202 safety endpoint criteria. The safety endpoint was defined as time to onset of first grade 3 or 4 sign, symptom, or lab toxicity at least 1 grade higher than baseline, as used in ACTG 5202. In both treatment arms of the HEAT trial, 15% of patients had drug-related Grade 3-4 adverse events. Safety data from the HEAT analysis also found that both EPZICOM- and Truvada-containing regimens were generally well-tolerated with few treatment discontinuations due to adverse events, (19% with Epzicom and 24% with Truvada).

Important Information about EPZICOM

EPZICOM, in combination with other antiretroviral agents, is indicated for the treatment of HIV-1 infection in adults.

EPZICOM is one of 3 medicines containing abacavir. Before starting EPZICOM, your healthcare professional will review your medical history in order to avoid the use of abacavir if you have experienced an allergic reaction to abacavir in the past.

In one study, more patients had a severe hypersensitivity reaction in the abacavir once-daily group than in the abacavir twice-daily group.
EPZICOM should not be used as part of a triple-nucleoside regimen.

EPZICOM does not cure HIV infection/AIDS or prevent passing HIV to others.

Important Safety
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