New Long-Term Observational Study Shows Durable Viral Suppression of Boosted REYATAZ-Based Regimens

10-Nov-2010 - United Kingdom

Results from a European Observational Study, which included 1,294 antiretroviral (ARV)-experienced patients presented at the Tenth International Congress on Drug Therapy in HIV Infection (HIV10), demonstrated a low rate of discontinuation and sustained virologic suppression with REYATAZ® (atazanavir/ritonavir)-based regimens over a follow-up period of up to five years.

The aim of this study was to investigate the long-term outcomes of REYATAZ/ritonavir-containing regimens in ARV-experienced patients in a real-life clinical setting. The primary endpoint of the cohort study was the proportion of patients who remained on treatment over time by baseline HIV-1 RNA level (<500 copies/mL and >= 500 copies/mL). Secondary endpoints were reasons for discontinuation, time to virologic failure (defined as either two consecutive HIV-1 RNA >= 50 copies/mL or one HIV-1 RNA >= 50 copies/mL followed by discontinuation) and long-term safety profile.

The results of the study revealed that 56% of patients with baseline viral suppression (<500 copies/mL) (n= 722) and 53% of those with detectable viral load (>= 500 copies/mL) (n= 540) remained on treatment after 3 years with a median time to discontinuation of 4 versus 3.6 years, respectively. The overall discontinuation rate in the study was low (43%) with the reasons for discontinuation including adverse events (11%), withdrawn consent (6%) and lack of efficacy (6%). After three years on a REYATAZ/r-based regimen, 75% of patients with baseline HIV-1 RNA levels <50 copies/mL remained suppressed and 51% of patients with baseline HIV-1 RNA levels >=50 copies/mL achieved and maintained virological suppression.

Long-term safety outcomes from this real-life study were consistent with data observed in clinical trials: diarrhoea (4%), renal and urinary disorders (3%), nausea (<1%) and jaundice (<1%) were reported. Discontinuations due to hyperbilirubinemia were infrequent (<1%) and no new or unexpected adverse events were observed.

"Prior to this cohort study, less was known about long-term outcomes and the length of time on treatment in experienced patients after switching," said Professor Jan van Lunzen, M.D., Ph.D. of The University Medical Centre Hamburg-Eppendorf in Germany. "This cohort study shows in a real-life setting that a significant proportion of treatment-experienced patients stayed on an atazanavir/ritonavir-containing regimen for up to five years," he added.

https://www.bionity.com/en/news/125756/new-long-term-observational-study-shows-durable-viral-suppression-of-boosted-reyataz-based-regimens.html