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Response to Kaletra-based Second-line Drug Regimen in HIV-1 Patients in Nigeria
Gerald Onwuegbuzie*1, J Idoko1, O Agbaji1, P Agaba1, L Akintunde1, M Muazu1, G Imade1, J L Sankale2, R Murphy2, and P Kanki2
1APIN Plus/Harvard PEPFAR, Jos Univ Teaching Hosp, Nigeria and 2Harvard Sch of Publ Hlth, Boston, MA, US
Background: The use of HAART has proven remarkably
effective in controlling the progression of HIV and prolonging survival, and in
Nigeria,
HAART has been subsidized since 2002. But these benefits can be compromised by
the development of drug resistance. HIV-1 drug resistance is likely to increase
with widespread use of HAART. Therefore, determining optimal management of
virologic failure is critical in resource-limited setting. The objective of
this study is to evaluate the drug response to Kaletra-based regimen among
patients with virologic failure at the Jos University Teaching Hospital, Nigeria.
Methods: We identified 120 patients with virologic or
immunologic failure from June 2005 to August 2006. They had initially been on
stavudine (d4T), lamivudine (3TC), and nevirapine (NVP) and then subsequently
switched to a Kaletra-based regimen plus 2 new nucleoside reverse transcriptase
inhibitors (NRTI). Patients’ blood samples were collected at the time of
switch, and again at 12 and 24 weeks; and analyzed for CD4 count, viral load,
hematologic, biochemical, and hepatitis B and C analyses. Statistical analysis was performed using SPSS
12.0.
Results: Of the 120 patients identified, 41 completed
24 weeks on second line Kaletra-based regimens (24 male, 17 female). The mean
age was 42.8±1.5 years. Genotype resistance testing was performed for 19
patients. The median viral load at time of switch, 12 weeks, and 24 weeks was
6655±9380.5, 200±1472.6, and 415±2649.9 copies/mL, respectively. At 12 weeks
65.0% had a viral load <400 copies/mL (p
= 0.001) and at 24 weeks 51.2% had a viral load <400 copies/mL (p = 0.002). The median CD4 count at
switch, week 12, and week 24 were 143±21.2, 153±20.8 (p = 0.44) and 206±23.9 (p
= 0.001) cells/mm3, respectively. The most common mutation was the
M184V (13%). Others were M36I (13%), Y181C (9%), K70R (7%), and T215F (6%).
Conclusions: This preliminary report suggests good
clinical responses to second line Kaletra-based regimens in patients who fail
first-line therapy in a resource-limited setting. Continued evaluation of
mutational patterns in patients failing first-line treatment will contribute to
improved management in resource-limited settings.
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