The
´´95% Adherence Rule´´ May Not Apply to Lopinavir/Ritonavir (Kaletra)- based HAART
Regimens There
is widespread agreement that virologic failure is likely when adherence to HAART
falls below 95%, although this belief has not been tested using newer agents with
superior pharmacokinetic profiles.
To evaluate this accepted notion, patients
who were receiving LPV/r BID as part of their HAART regimens were enrolled into
a 24-week MEMS cap study of adherence and virologic outcomes.
Adherence
rate was defined as the number of bottle openings/number of doses prescribed.
Results 
An interim analysis is presented for the first 53 study completers of 85 patients
enrolled.
The mean and median durations of MEMS monitoring were 160 and 164 days, respectively.
Mean
age was 45 years, 57% were male, 41% female and 2% transgender.
53% were Hispanic and 40% Black non-Hispanic. Risk factors for HIV acquisition
were heterosexual contact 53%, IDU 32%, and MSM 15%.
83% of patients had CDC-defined AIDS at enrollment, and two-thirds had more than
5 years of ART experience. 1/53 was ART naïve.
The mean maximum documented VL was 262,725 copies/ml. At enrollment all patients
were receiving LPV/r, and 94% of patients combined this with two or more NRTIs.
At enrollment
36% of patients had VL<75 and 49% had VL<400, and at 24 weeks 53% of patients
had VL<75 and 78% had VL<400.
The mean overall adherence rate was 73%.
No association was found between 24 week VL and adherence rate (P=0.44; Spearman's
rho).
|
Adherence rate |
>95% |
90-94.9% |
80-89.9% |
70-79.9% |
50-69.9% |
<50% |
| % of pts. with VL<400 (n) at 24 weeks |
70%
(10) |
88%
(8) |
100%
(9) |
100%
(4) |
55%
(11) |
73%
(11) | "In
this inner-city, treatment-experienced cohort with high baseline HIV-1 VL,"
conclude the authors, "rates of virologic failure with LPV/r based therapy
were surprisingly low across the range of adherence levels studied." "These
results challenge the view that very high levels of adherence to all HAART regimens
are necessary to avoid virologic failure." Montefiore
Medical Center(MMC)/Albert Einstein College of Medicine(AECOM), Medicine/Infectious
Diseases, Bronx, NY, United States, Montefiore Medical Center, AIDS Center, Bronx,
NY, United States, Abbott Laboratories, Abbott Park, IL, United States, Montefiore
Medical Center (MMC)/Albert Einstein College of Medicine (AECOM), AECOM/MMC Center.
08/25/06 Reference
 J
Shuter, J A Sarlo, T J Kanmaz, and others. The
"95% adherence rule" may not apply to lopinavir/ritonavir (LPV/r) based
HAART regimens. 16th International AIDS Conference. August 13-18, 2006. Toronto,
Canada. Abstract TUPE0110. 
|
