Data from two 24-week analyses of the RESIST-1 and RESIST-2 studies, which evaluated Aptivus? (tipranavir) in treatment-experienced HIV-1 infected patients, were published in the 15 November issue of Clinical Infectious Diseases. Data demonstrate that at 24-weeks Aptivus, used with ritonavir (Aptivus/r) as part of combination antiretroviral therapy, achieved superior antiviral and immunological activity in treatment-experienced patients with multidrug-resistant HIV-1 infection.
These 24-week results are supported by long-term data from RESIST combined analyses, which show that Aptivus/r provides a durable treatment response through nearly two years (96 weeks) of therapy.
?Findings from the RESIST studies, which are comprised of more than 1,400 patients, are important because once patients experience triple-class virological failure, their treatment options are extremely limited. Data show Aptivus provides these patients with an effective therapeutic option and the potential for long term treatment success.? said Pedro Cahn, M.D., director, Fundaci?n Huesped, Buenos Aires, Argentina.
At 24 weeks, Aptivus/r outperformed a group of ritonavir-boosted comparator protease inhibitors that include lopinavir/r (Kaletra?), amprenavir/r (Agenerase?), saquinavir/r (Invirase?), and indinavir/r (Crixivan?). In the RESIST studies, treatment response was defined as a confirmed 1 log10 or greater decrease in viral load from baseline. When compared to these protease inhibitors:
More than twice the percentage of patients in the Aptivus/r arm reduced the amount of HIV present in their blood (viral load) to undetectable levels (less than 50 copies/mL), p<0.0001.1
The virologic benefits of an Aptivus-based regimen were enhanced by co-administration with other active antiretroviral agents (e.g., the fusion inhibitor enfuvirtide), p<0.0001.1
Treatment with Aptivus/r more than doubled the amount of patients? immune (CD4+) cells, p<0.001.1
With regard to safety, gastrointestinal symptom disorders and elevated transaminase, cholesterol and triglycerides were more frequent in the Aptivus arms than in the comparator-ritonavir arms but necessitated discontinuation of treatment in a minority of cases. The majority of Grade 3 or 4 ALT elevations were clinically asymptomatic and more that three quarters of the patients developing a Grade 3 or 4 ALT elevation continued treatment with Aptivus/r.1 Rates of leucopoenia and increased lipase concentrations were more frequent in the comparator-ritonavir arms.