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Outcomes of Adults Receiving Second-line ART in Médecins Sans Frontières-supported Projects in Resources-limited Countries
M Pujades1, Alexandra Calmy*2, D O'Brien3, P Humblet4, and MSF HIV/AIDS working group
1Epicentre, Paris, France; 2St Vincent's Hosp, Sydney, Australia; 3Médecins Sans Frontières, Amsterdam, The Netherlands; and 4Médecins sans Frontières, Brussels, Belgium
Background: With increasing access to, and time on, ART in
resource-limited countries, more people will develop failure to first-line ART.
However, the lack of
virological monitoring may delay detection of failure, and, in addition, the
lack of alternative drugs means that second-line ART regimens are often
suboptimal. Thus, outcomes on second-line ART may be adversely affected, but
data on this are limited.
Methods: We used routinely collected patient data
(FUCHIA software) from 50 Médecins Sans Frontières (MSF) -supported ART
projects in 22 resource-limited countries in Africa, Asia, and Central America. All adults started on second-line ART
regimens were included in the analysis.
Results: Globally, 253 (0.4%) of 57,147 adults who
commenced ART in MSF-supported programs since 2001 have had to switch to
second-line ART because of treatment failure. Of these, at first-line ART
initiation, 220 (87%) were WHO clinical stage 3 or 4, and the median CD4 count
was 63 cells/mL (IQR 20 to 132; n =
199); 70 (28%) were ART-experienced and 231 (91%) started standard WHO
first-line therapy (55% stavudine [d4T] + lamivudine [3TC] + nevirapine [NVP]).
Median time from ART initiation to switch was 15.6 months (IQR 11.7 to 22.3);
177 (70%) switched after >24 months. Median CD4 cell count at switch was 84
cells/mL (IQR 33 to 172; n = 165)
with 36% < 50 and 56% < 100 cells/mL. Second-line ART regimens were
nelfinavir (NFV) -based for 130 (51%) and lopinavir/ritonavir (LPV/r) -based
for 99 (39%). Median follow-up on second-line ART was 11 months (IQR 5 to 18
months). Median CD4 count and CD4 gain were 169 cells/mL (IQR 100 to 301; n = 64) and 91 (47 to 151; n = 43) at 6 months, and 214 (133 to
300; n = 53) and 113 (33 to 227; n = 35) at 12 months. After a median
time of 6.4 months (IQR 3.2 to 11.9), 19 (8%) patients died; and after a median
time of 5.0 months (IQR 3.1 to 12.4), 16 (6%) were lost to follow-up.
Probabilities of survival (endpoint deaths + lost to follow-up) at 6 and 12
months were 0.92 (IQR 0.88 to 0.95) and 0.87 (0.82 to 0.91), respectively.
Conclusions: Adult patients on ART in MSF-supported programs
in resource-limited countries have infrequently required change to second-line
regimens. Early outcomes for adults on protease inhibitor (PI) -based
second-line ART regimens appear to be satisfactory.
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