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Safety and efficacy of maraviroc (MVC) combined with multiple different therapeutic agents in highly treatment-experienced (TE) patients in Brazil

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MVC is the first-in-class CCR5 antagonist approved for use in treatment of CCR5-tropic (R5) HIV-1 infection; however, there is limited experience with MVC in regimens containing newer PIs and other new agents... This open-label 96-week multi-center study evaluates MVC in a variety of regimens to obtain additional safety and efficacy data in TE patients with limited options due to intolerance or resistance in Brazil... Adult TE patients with R5 HIV-1 only (HIV-1 RNA >1000 cp/mL) received MVC 150-600mg (based on concomitant ARV) twice daily, combined with optimized background therapy (OBT)... OBT comprised PI+NRTI (67%), PI+NRTI+NNRTI (7.8%), PI+NRTI+other (14.6%), or other regimens (10.2%)... OBTs contained ≤1 drug (1% of patients), 2 drugs (7.3%), 3 drugs (24.3%), 4 drugs (35.4%), 5 drugs (23.8%), or ≥6 drugs (8.2%)... Sixty-five patients (31.6%) discontinued; reasons included death (6 patients), adverse events (5), insufficient clinical response (36), lost to follow-up (4), or other (14)... There were 238 treatment-related adverse events in 103 patients; 16 treatment-related serious adverse events in 9 subjects; 10 category C events, none treatment-related; and 2 of the 4 malignancies (Hodgkin's disease and intestinal T-cell lymphoma) were considered treatment-related... Median CD4 count increased persistently through week 48 (Figure), with similar responses comparing quartiles of baseline CD4; the median increase from baseline at week 48 was 164.5 cells/mm... HIV-1 RNA decreases were maintained regardless of baseline viral load; overall 41.1% of patients had HIV-1 RNA <400 copies/mL at week 48... In highly TE patients, regimens combining MVC with different agents from multiple classes were well tolerated and provided marked antiviral and immunologic responses.

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Safety and efficacy of maraviroc (MVC) combined with multiple different therapeutic agents in highly treatment-experienced (TE) patients in Brazil
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC3112879&req=5

View Article: PubMed Central - HTML

AUTOMATICALLY GENERATED EXCERPT
Please rate it.

MVC is the first-in-class CCR5 antagonist approved for use in treatment of CCR5-tropic (R5) HIV-1 infection; however, there is limited experience with MVC in regimens containing newer PIs and other new agents... This open-label 96-week multi-center study evaluates MVC in a variety of regimens to obtain additional safety and efficacy data in TE patients with limited options due to intolerance or resistance in Brazil... Adult TE patients with R5 HIV-1 only (HIV-1 RNA >1000 cp/mL) received MVC 150-600mg (based on concomitant ARV) twice daily, combined with optimized background therapy (OBT)... OBT comprised PI+NRTI (67%), PI+NRTI+NNRTI (7.8%), PI+NRTI+other (14.6%), or other regimens (10.2%)... OBTs contained ≤1 drug (1% of patients), 2 drugs (7.3%), 3 drugs (24.3%), 4 drugs (35.4%), 5 drugs (23.8%), or ≥6 drugs (8.2%)... Sixty-five patients (31.6%) discontinued; reasons included death (6 patients), adverse events (5), insufficient clinical response (36), lost to follow-up (4), or other (14)... There were 238 treatment-related adverse events in 103 patients; 16 treatment-related serious adverse events in 9 subjects; 10 category C events, none treatment-related; and 2 of the 4 malignancies (Hodgkin's disease and intestinal T-cell lymphoma) were considered treatment-related... Median CD4 count increased persistently through week 48 (Figure), with similar responses comparing quartiles of baseline CD4; the median increase from baseline at week 48 was 164.5 cells/mm... HIV-1 RNA decreases were maintained regardless of baseline viral load; overall 41.1% of patients had HIV-1 RNA <400 copies/mL at week 48... In highly TE patients, regimens combining MVC with different agents from multiple classes were well tolerated and provided marked antiviral and immunologic responses.

No MeSH data available.