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Determinants of First Line Antiretroviral Treatment Failure in
Public Hospitals of Addis Ababa, Ethiopia: Unmatched Case
Control tud!

,ale-wor. /etnet BSc, 0#H

1ecturer in Addis A2a2a Science and 3echnology 4ni5ersity, Addis A2a2a- 6thio$ia
yale-wor.getnet7g-ail.co-

Abstract
"ac#$round: 3he identification and -anage-ent of first-line antiretro5iral thera$y failure is a .ey challenge for
hu-an i--une deficiency 5irus $rogra-s in resource-li-ited settings. 6thio$ia 2eing one of the resource-
li-ited countries has li-ited resources a5aila2le for diagnosing treat-ent failure and -onitoring $atient res$onse
with 5iral load, which is the gold standard, is not feasi2le in this li-ited setting. #atients initiate treat-ent with
5ery ad5anced disease. Howe5er, factors lead to treat-ent failure is not well understood and well-studied.
%b&ective: 3o identify deter-inants of first line antiretro5iral treat-ent failure in $u2lic hos$itals of Addis
A2a2a 'ethods: An un-atched case control study was conducted at Addis A2a2a $u2lic hos$itals using record
re5iew. 3otal sa-$le si8e was 3' "+3 cases and 29 controls%. Bi5ariate analysis was done and all e:$lanatory
5aria2les associated with first line treat-ent failure with P;.& were entered in to -ulti5aria2le logistic
regression analysis using 2ac. ward ste$wise li.ely hood ratio -ethod to identify inde$endent $redictors. (esult:
)ne hundred three cases and two hundred si: controls were included in the study. 3reat-ent interru$tion
"Ad<usted odds ratio &.4, '&= confidence inter5al 2.33 to +2.+3%, 2ase line clusters of differentiation cell count
;& cells>?l "Ad<usted odds ratio 2.@, '&= confidence inter5al +.24 to &.94%, $ul-onary 3u2erculosis treat-ent
"Ad<usted odds ratio 2.', '&= confidence inter5al +.&& to &.34% and history of gastric $ro2le- "Ad<usted odds
ratio 9.9, '&= confidence inter5al 2.33 to +!.!@% were all inde$endently associated with first line antiretro5iral
treat-ent failure. Conclusion and (ecommendation: Base line lower clusters of differentiation cell count ;&
cell>?l, treat-ent interru$tion, history of $ul-onary 3u2erculosis treat-ent during follow u$ ti-e and chronic
gastric $ro2le- were the inde$endent $redictors of first line antiretro5iral treat-ent failure. 3here for Health
$rofessionals should $ay s$ecial attention for the ris. grou$ identified.
)e!*ords: antiretro5iral thera$y, case control study, treat-ent failure, highly acti5e

+, -.T(%DUCT-%.
A2out 34 -illion $eo$le were li5ing with hu-an i--une deficiency 5irus>acAuired i--une deficiency
syndro-e "HI*>AIBS% in 2+ "esti-ates range fro- 3.' to 39.' -illion, .&= of the world $o$ulation%.
Annually &!.& -illion healthy life-years lost, +.! -illion Beaths $er year, 4SC &2.3 2illion, or .!9= of glo2al
gross do-estic $roduct "/B#% in da-ages $er year and -ost of these "9!=% li5es in su2-Saharan African
countries. Hu-an i--une deficiency 5irus affects -ostly $eo$le in the econo-ically $roducti5e age range,
reducing the wor.-force and, in doing so, constraining de5elo$-ent D+, 2E.
3he o5erall growth of the glo2al AIBS e$ide-ic a$$ears to ha5e sta2ili8ed. 3he annual nu-2er of new HI*
infections has 2een steadily declining since the late +''s and there are fewer AIBS-related deaths due to the
significant scale u$ of antiretro5iral thera$y o5er the $ast few years D4E. But significant challenges re-ain and
treat-ent outco-es continue to 2e su2stantially worse. 3reat-ent failure, whether attri2uta2le to any ty$e of
failure, discontinuing AF3, or loss to follow-u$, has 2een shown to increase -or2idity and -ortality D+'E.
Howe5er, the identification and -anage-ent of first-line antiretro5iral thera$y "AF3% failure is a .ey challenge
for HI* $rogra-s in resource-li-ited settings D9E. Staying on a failing first-line thera$y is associated with an
increased -ortality ris. G conseAuences of early treat-ent failure can 2e significant "de5elo$-ent of drug
resistance li-its the a2ility to construct new, $otent and tolera2le regi-ens in the future% D@E.
6thio$ia has the fifth largest $o$ulation of HI* infected indi5iduals li5ing in Africa, which accounts to
a$$ro:i-ately 4= of the worldHs HI*>AIBS cases D'E. Adult HI* $re5alence in 2+ was 2.4= "@.@= ur2an and
.'= rural% with -ale fe-ale ratio of +.'= and 2.'= res$ecti5ely. According to federal -inistry of health of
6thio$ia "I0)H% re$ort, there were +.2 -illion $eo$le li5e with HI*, and 3'@,!+! are esti-ated to 2e in need of
antiretro5iral treat-ent in 2+ D+E. According to 2++ Addis A2a2a health 2ureau, esti-ated HI* $re5alence
in Addis A2a2a was !.&= and 2&!,23! $eo$le li5ing with HI*>AIBS "#1JHA%, e5er started 2&,2!&, @9,42+
AF3 ser5ice users and &&,+39 currently on AF3 D++E.
3he current status of antiretro5iral thera$y is therefore encouraging, 2ut significant $ro2le-s re-ainK it is not
de5oid of unwanted secondary effects, $oor a2sor$tion of anti-HI* -edications, $ro2le-s due to other illnesses
or conditions, $ro2le-s due to $oor health 2efore starting treat-ent, side effects of -edications or interactions
with other -edications and su2stance a2use leading to $oor treat-ent adherence and treat-ent failure D+2,E.
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#atients failed for first line drug are 49= -ore li.ely to fail again for 2nd line drug G attri2uted to the higher
nu-2er of side effects, ha5e greater li.elihood of e:$eriencing drug resistance and treat-ent fatigue as a result
of 2eing on treat-ent longer D+3E. 0oreo5er, $atients need -ore attention and ad5anced -onitoring syste- due
to uncertainty if 5iral load "*1% -onitoring co-$ared to clinical or i--unological -onitoring affects critical
outco-es D+4E 2ecause of the association with earlier and -ore freAuent switching to second-line regi-ens than
the use of clinical>i--unological -onitoring strategies D+&E.
Howe5er, data fro- AF3 $rogra- and glo2al $rocure-ent syste-s also suggests that treat-ent switching has
occurred at lower than e:$ected rates in resource-li-ited settings due to low access to second-line drugs "due to
e:$ensi5eness%, difficulties in defining treat-ent failure in an adherent $atient with no other reasons for an
ele5ated *1 G the de5elo$-ent of drug resistance li-its the a2ility to construct new, $otent and tolera2le
regi-ens in the future. 3husK the identification and -anage-ent of first-line antiretro5iral thera$y failure is a .ey
challenge for HI* $rogra-s in resource-li-ited settings D3, &, +9E.
In resource li-iting setting since there is li-ited a5aila2ility of second line AF3, switching is often not done G
inco-$lete for-ularies li-it o$tions. )ften there is no LB4 or 5iral load -onitoring. Lurrent 2nd line regi-ens
are co-$le:, and ha5e difficult drug interaction es$ecially with rifa-$icin i-$acting on the -anage-ent of
tu2erculosis "3B% co-infection. Iurther-ore cost is an i-$ortant 2arrierK the cost for 2nd line in 29 was 2= of
total cost. 3his condition -a.es difficulty in HI* treat-ent $rogra- es$ecially in resource li-iting countries
li.e 6thio$ia D@, +@, and +!E.
6thio$ia 2eing one of the resource-li-ited countries, has li-ited resources a5aila2le for diagnosing treat-ent
failure and -onitoring $atient res$onse with 5iral load which is the gold standard, is not feasi2le, $atients initiate
treat-ent with 5ery ad5anced disease D3E. Howe5er, factors lead to treat-ent failure is not well understood and
well-studied es$ecially in 6thio$ia.
3herefore the rationale of the study is identifying those ris. factors for first line AF3 failure "that will hel$ to
define early $redictors of treat-ent efficacy that $er-it 2etter use of these $otent drugs, a5oid unnecessary side
effects of second line drug, $re5ent drug resistance G decrease econo-ic 2urden es$ecially in resource li-iting
setting li.e 6thio$ia due to the e:$ensi5eness of second line drug%. It will also hel$ as a guide for health
$rofessionals and higher officials to alle5iate the $ro2le- G will hel$ to #atients to de5elo$ strategies allowing
the- to ta.e their treat-ent correctly.

/, 'ATE(-AL A.D 'ETH%D
3he study was conducted in Addis A2a2a $u2lic hos$itals at chronic HI* care. Addis A2a2a has an area of &4
sAuare .ilo-eter with an esti-ated $o$ulation of 3,3!,'9 $eo$le "&2.39= fe-ale, 4@.9@= -ale%. 3he
structures of organ $ower of the city consists of city go5ern-ent,+ su2 cities and ++9 districts with 3! hos$itals
"+ $u2lic hos$itals, 2 nongo5ern-ental "N/)%, 3 defense and $olice ,23 $ri5ate% and 2@ health centers.
AF3 ser5ice is 2eing gi5en at && sites "+ $u2lic hos$itals, +& $ri5ate hos$itals, 2& health centers G & N/)
clinics% D++E. )f these sites, ' $u2lic hos$itals treating a2out 44,3' adult HI* infected $atients were included in
the study. 3he study was conducted fro- Ie2ruary 9 to 0arch 9, 2+2.
4n-atched case control study was conducted 2ased on -edical records of $atients getting AF3 ser5ice at
HAAF3 clinics in Addis A2a2a $u2lic hos$itals. #atients greater than or eAual to +& year old who are on second
line drug due to treat-ent failure and first line drug users fro- Se$ 2& to Se$ 2++ for cases and controls
res$ecti5ely were the study $o$ulation for the study. All $atients started AF3 in other AF3 site "lac.s full
infor-ation in their records%, and $atients with inco-$lete 2ase line records were e:cluded in the study.
ample si0e determination and amplin$ techni1ue
Sa-$le si8e was calculated using e$i info 5ersion 3.&.+ software using $ro$ortion of ne5ira$ine 2ased first line
regi-en a-ong cases and controls 4!.+!= and 3+.+= res$ecti5ely D2'E using != $ower with '&= LI and case
to control ratio of +M2. 3otal sa-$le si8e was 3' "29 control and +3 cases%. All $u2lic hos$itals in Addis
A2a2a e:ce$t A16F3 hos$ital were included for the study "2ecause $ri5ate hos$itals started AF3 ser5ice
recently%. 1ist of $atients fro- each hos$ital on AF3 for the $ast si: years "Se$ 2& to Se$ 2++% were
generated fro- the AF3 dis$ensing tool G -erged. 3hen sa-$le fra-e for cases G controls se$arately was
$re$ared 2y the $rinci$al in5estigator. Sa-$led cases G controls were selected 2y si-$le rando- sa-$ling
techniAue G the selected cases and controls were distri2uted to each hos$ital 2ased on their uniAue AF3
registration nu-2er.
A, election of cases
1ist of $atients for cases 2ased on their uniAue AF3 registration nu-2er fro- nine hos$itals were generated for
the $ast si: years fro- the AF3 dis$ensing tool which is electronic software used for dis$ensing AF*s 2ut is
a2le to generate re$orts. 3hen sa-$led cases were ta.en using si-$le rando- sa-$ling techniAue.
", election of controls
1ist of $atients for controls fro- nine hos$itals were generated for the $ast si: years fro- the AF3 dis$ensing
tool which is electronic software used for dis$ensing AF*s 2ut is a2le to generate re$orts. Iinally Si-$le
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rando- sa-$ling techniAue was used to select controls.
Data collection instruments and techni1ues
3he $atient infor-ation collecting sheet was $re$ared in 6nglish. It was ada$ted fro- federal -inistry of health
of 6thio$ia AF3 guide line and AF3 follow u$ for- and data were collected 2y record re5iew. 3he collected
data were chec.ed 2y su$er5isors and $rinci$al in5estigator. Bata collectors and su$er5isors were trained for two
days a2out the o2<ecti5es of the study, contents of tools and how to collect the data 2efore the data collection.
Bata were collected 2y ' trained data collectors "AF3 trained nurse%. 3he $rinci$al in5estigator and three other
AF3 trained health officers "H)s% su$er5ised the data collection $rocess.
Data processin$, anal!sis and presentation
Bata were first chec.ed -anually for co-$leteness and consistency 2y su$er5isors G $rinci$al in5estigator
during the ti-e of data collection and rechec.ed again at office 2efore data entry. Bata were entered and cleaned
using e$i info 5ersion 3.&.3. 3hen e:$orted to S#SS 5ersion +9. for analysis G descri$ti5e statistics were done
to su--ari8e the data. 3hen 2i5ariate analysis was done to see the association 2etween outco-e 5aria2le G
inde$endent 5aria2le. All e:$lanatory 5aria2les associated with first line antiretro5iral treat-ent failure with
P;.& were entered in to -ulti5aria2le logistic regression analysis. Howe5er scientifically intuiti5e and clinically
i-$ortant 5aria2les were included in -ulti5aria2le analyses though PN.&. Bac.ward ste$wise li.ely hood ratio
logistic regression was used in -ulti5aria2le analysis.
0ulti-collinearity test was done to chec. whether there are correlated inde$endent 5aria2les or not 2y e:a-ining
the 5alues of 5ariance inflation factor "*II%K there were no seriously correlated 5aria2les. P;.& in -ulti5aria2le
analysis was used to declare association 2etween inde$endent $redictors and the outco-e 5aria2le. Iinally
conclusion and reco--endation were -ade 2ased on the findings of the study.
Data 2ualit! control
3o .ee$ the Auality of the study, infor-ation collecting sheet was $re$ared 2ased on federal -inistry of health of
6thio$ia standard AF3 guide line and AF3 follow u$ for-. Bata collectors and su$er5isors were AF3 trained.
0oreo5er, data Auality also ensured during collection, entry G analysis. 3raining was gi5en for data collectors
and su$er5isors 2efore data collection and there was close follow u$ of data collectors 2y su$er5isors and the
$rinci$al in5estigator including o2ser5ation of how they were collecting the recorded data.
tren$th
3he study was conducted in a conte:t where HAAF3 had 2een started for the last 9 years "Se$ 2& to Se$ 2++%
to -ini-i8e $oorly record data and to include all $u2lic hos$itals in the study "AF3 ser5ice was started in all
$u2lic hos$ital le5el 9 years 2ac. in 6thio$ia%.
Being case control study is the strength of this study. Since antiretro5iral treat-ent failure is a rare occurrence
2ut had a serious i-$act glo2ally and challenge HI* $re5ention and control $rogra-, case control study is a 2est
study design for this situation and the design ena2led to see -ulti$le e:$osure unli.e other study designs.
Limitation
3his study has li-itation due to the -ethod of data collection techniAue usedK using secondary data li.e relaying
on $ast infor-ation which can 2e changed su2seAuently. 3his study didnHt assess those $redictors of treat-ent
failure fro- the $atient directly which li-it to see whether the $atients were ta.ing the drug $ro$erly or not, had
got shortage of drug or not and had got adeAuate infor-ation a2out the treat-ent fro- the ser5ice $ro5ider.
Although there is a standard treat-ent guide line which wor.s for all health institutions gi5ing AF3 ser5ice,
there -ight 2e a difference in Auality of care G Auality of ser5ice in each hos$ital. Howe5er, this study didnHt
assess it.

3, (EULT A.D D-CU-%.
3,+, ocio4demo$raphic characteristics of stud! population
A total of +3 cases and 29 controls were included in the study. Iro- these '3 "'.3=% of cases G +' "'2.2=%
of controls were ali5e, ! "@.!=% of cases G ' "4.4=% of controls were died and 2 "+.'=% of cases G@ "3.4=% of
controls were defaulters. 3he -ean age at starting treat-ent was 3@ and 39 with a standard de5iation of ' year
for cases G controls res$ecti5ely. 0a<orities, && "&3.4=% of cases and +23 "&'.@=% of controls were fe-ales.
0ost, @& "@2.!=% of cases and +9& "!.+=% of controls were orthodo: Lhristian followers. Fegarding to -arital
status, 44 "42.@=% of cases and '! "4@.9=% controls were -arried and 2@ "39=% of cases and 3' "29=% of
controls had HI* $ositi5e $artnerK 22 of 2@ "!+.2=% and 2+ of 3' "&3.!=% were on AF3 while 3 "2'.+=% of
cases and 9& "3+.9=% of controls had un.nown HI* status. A2out 32 "32=% of cases and ++4 "&3=% of controls
were full ti-e e-$loyed while 3' "3@.' =% of cases and 32 "+&.&=% of controls were not wor.ing>due to ill
health G -a<orities, 4 "3!.!=% of cases and @' "3!.3=% of controls had finished their secondary education at the
ti-e of HAAF3 initiation "3a2le +%.
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3,/, "ase line laborator! measures
A-ong cases and controls res$ecti5elyK the -edian "interAuartile range% 2aseline "at HAAF3 initiation% LB4
count was @4 cells>?l "+O439% and +4 cells>?l "+-99@%. 3he -ean "SB% white 2lood cell "JBL% count a-ong
cases was &+&@ "2332% cells>--3, while in controls was &92' "29'!% cells>--3. 3he -ean ly-$hocyte count in
cases and controls was 2&= and 3+= while the -ean neutro$hil count a-ong cases and controls was 3!= and
42= with -ean he-oglo2in le5el +2.3g>dl and +3.+g>dl res$ecti5ely "3a2le 2%.

3,3, A(5 dru$ related variables
3he -ost freAuent starting regi-ens for cases were AP3 33L N*# "32=%, d4t 33L N*# "29.2=%, AP3 33L
6I* "+@.&=%, and d4t 33L 6I* "+2.9=%. Si-ilarly d4t 33L N*# "2!.2=%, AP3 33L 6I* "2@.@=%, AP3 33L
N*# "2.4=% and d4t 33L 6I* "+3.+=% were the -ost freAuent starting regi-ens a-ong controls. Ior the &&
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fe-ale cases and +23 fe-ale controls for who- #03L3 e:$osure could 2e deter-ined, ! of && "+4.&=% and 4
"3.3=% had recei5ed #03L3 inter5entions res$ecti5ely "3a2le 3%.

3,6, Adherence related variables
0a<ority of cases, &! "&9.3=% and 99 "32=% controls were not consistently adhered during HAAF3 follow u$.
)n the other hand, 3@ "3&.'=% of cases G ' "4.4=% of controls interru$ted "defaulted% HAFF3. 0ost of the cases,
@3 "@.'=% and +&! "@9.@=% controls disclosed their HI* sero-$ositi5e status during HAAF3 initiation. 3he
-edian "interAuartile range% duration of treat-ent for case G controls with first line drug was 4+ and &3 -onths
res$ecti5elyK !2 "@'.9 =% of cases and +!& "!'.! =% of controls were treated for -ore than 24 -onths. 0a<ority
of cases, 9& "93.+=% and +&4 "@4.!=% of controls were not using any of the su2stance. Howe5er ! "@.!=% of
cases and +& "@.3=% of controls used alcohol, & "4.'=% of cases G + ".&=% of controls were s-o.ers, 3 "2.'=%
of cases and @ "3.4=% of controls used soft and hard drugs, while 22 "2+.4=% of cases and 2' "+4.+=% of controls
used two or -ore su2stances during the ti-e of HAAF3 initiation "3a2le 4%.

3,7, "ase line nutritional status 8"'-9
A2out 4! "49.9=% of casesH and +43 "9'.4=% of controlsH 2ody -ass inde: "B0I% laid in the category NQ+!.&
.g>-2 while 32 "3+.+=% of casesH and 4& "2+.!=% of controlsH B0I laid 2etween +9-+!.4 .g>-2. 3he re-ained
23 "22.3=% of casesH and +! "!.@=% of controlsH B0I laid under the category of ;+9.g>-2 "3a2le &%.
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3,:, %ther health problems and clinical disease mechanism related variables
Fegarding to history of o$$ortunistic infection and other -edical health $ro2le-s a2out 3' "3@.'=% of cases and
3 "+4.9=% of controls had history of o$$ortunistic infection. A2out &! "&9.4=% of cases G 4@ "22.!=% of
controls had history of 3B treat-entK $ul-onary 3B treat-ent accounted for '+.4= and @9.&= a-ong cases and
controls res$ecti5ely. 0a<ority of cases, 9+ "&'.2=% G 99 "32=% of controls too. additional -edication other
than HAAF3. A2out )ne fourth of the cases, 29 "2&.2=% G @ "3.4=% of controls had history of chronic diarrhea
while 3 "2'.+=% of cases G 9 "2.'=% of controls had history of chronic gastric $ro2le-.
0ore than half of the cases, &@ "&&.3=% G +9+ "@!.2=% of controls were wor.a2le in their functional status
during the ti-e of HAAF3 initiation. Jhile only ! "3.'=% of cases G +9 "+&.&=% of controls were 2edridden at
the ti-e of HAAF3 initiation. A2out 3' "3@.'=% of cases G '& "49.+=% of controls were clinically JH) stage
III while 3& "34=% of cases G 3@ "+!=% of controls were JH) stage I* "3a2le 9%.

3, ;, "ivariate anal!ses
3,;,+, "ivariate anal!sis of ocio demo$raphic characteristics
In a 2i5ariate analysis of socio-de-ogra$hic characteristics, none of the- were associated with first line
antiretro5iral treat-ent failure e:ce$t 2eing 0usli- in religion "3a2le @%.
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3,;,/, "ivariate anal!ses of base line laborator! measures
A-ong 5aria2les related to 2ase line la2oratory -easures that are clinically i-$ortant in HI* treat-ent $rogra-,
2ase line LB4 count ;& cell>?l and 2ase line he-oglo2in le5el were significantly associated with treat-ent
failure in a 2i5ariate analysis ""L)F &.2, '&= LI 2.@4 to '.!! "L)F .4!, '&= LI .2! to .!3%% res$ecti5ely
"3a2le !%.

3,;,3, "ivariate anal!sis of A(5 dru$ related 5ariables
A-ong 5aria2les related to anti-retro5iral drug, duration on HAAF3 "L)F 2.2&, '&= LI +.+9 to 4.39%, 2ase line
first line drug regi-en "L)F +.@', '&= LI +.+ to 2.'3% and $re5ious AF3 e:$osure "L)F4.2&, '&= LI +.2& to
+4.4@% were significantly associated with first line antiretro5iral treat-ent failure in a 2i5ariate analysis "3a2le '%.
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3,;,6, "ivariate anal!sis of adherence related 5ariables
In a 2i5ariate analysis of adherence related 5aria2les and su2stance useK su2stance use "L)F +.@3, '&= LI +.4
to 2.!!%, consistency of adherence "L)F 2.@3, '&= LI +.9! to 4.4&% and treat-ent interru$tion "L)F '.'3, '&=
LI 4.@' to 2.&'% were significantly associated with first line treat-ent failure "3a2le +%.

3,;,7 "ivariate anal!ses of base line "'-
Fegarding to 2ase line B0I, 2ase line B0I ;+9.g>-2 G +9-+!.4 .g>-2 were significantly associated with first
line antiretro5iral treat-ent failure in a 2i5ariate analysis ""L)F 3.!, '&= LI +.!' to @.9&% G "L)F 2.++, '&=
LI +.2+ to 3.@%% res$ecti5ely "3a2le ++%.

3,;,:, "ivariate anal!ses of clinical disease mechanism and other health problems related variables
Iro- all 5aria2les related to clinical disease -echanis- G other health $ro2le-s, JH) stage I* "L)F 2.@3,
'&= LI +.+2 to 9.94%, 2ed ridden in functional status "L)F &.9&, '&= LI 2.2' to +3.'%, a-2ulatory in
functional status "L)F 2.2', '&= LI +.2' to 4.4%, history of )I "L)F 3.&@, '&= LI 2.& to 9.23%, history of
$ul-onary 3B treat-ent "L)F 4.39, '&= LI 2.92 to @.24%, history of chronic gastric $ro2le- "L)F +3.99,LI
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&.4@ to 34.2&%, history of chronic diarrhea "L)F '.&', '&= LI 4. to 23.2% G ta.ing other -edication "L)F
3.!, '&= LI +.!! to &.2% were significantly associated with first line antiretro5iral treat-ent failure in a
2i5ariate analysis "3a2le +2%.

7,<, 'ultivariable anal!ses
All 5aria2les associated with first line treat-ent failure in the 2i5ariate analysis with P 5alue ;.& were entered
in a -ulti5aria2le logistic regression analysis. Iinally, 2aseline LB4 count ;& cell>?l, treat-ent interru$tion,
history of $ul-onary 3B treat-ent during HAAF3 follow u$ ti-e, and history of chronic gastric $ro2le- were
inde$endently associated with first line antiretro5iral treat-ent failure.
#atients with 2ase line LB4 count 2elow &cell>?l failed for first line antiretro5iral drug 2.@ ti-es than that of
with N+& cell>-icroliter with '&= LI +.24 to &.94.
#atients who interru$ted treat-ent through defaulting or other reason were failed for first line antiretro5iral drug
&.4 ti-es than that of not interru$ted $atients with '&= LI 2.33 to +2.+3. Jhile $atients ha5ing history of
$ul-onary 3B treat-ent during HAAF3 follow u$ were failed al-ost 3 ti-es than that of without history with
'&= LI +.&& to &.34. Si-ilarly, those $atients ha5ing history of gastric $ro2le- during HAAF3 follow u$ ti-e
were failed 9.9 ti-es than that of with no history of gastric $ro2le- with '&= LI 2.33 to +!.!@ "3a2le +3%.
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+

Discussion
3he study has $ro5ided an o$$ortunity to find out deter-inants of first line antiretro5iral treat-ent failure in
what is glo2ally a 5ery serious challenge for antiretro5iral treat-ent $rogra-. In the study, se5eral ris. factors of
first line antiretro5iral treat-ent failure were in5estigated in adult HI*-infected $o$ulation in Addis A2a2a
$u2lic hos$itals. A-ong 2ase line la2oratory -easures, 2ase line LB4 count ;& cell>?l was significantly
associated with first line antiretro5iral treat-ent failure. #atients with 2ase line LB4 count 2elow &cell>?l failed
2.@ ti-es than that of with N+& cell>?l with '&= LI +.24 to &.94. 3he result is consistent with other study done
in South AfricaK a 2aseline LB4 count less than & cells $er -icroliter increased the odds of failure -ore than &
folds D2'E. Si-ilarly, a study done 2y 6uro SIBA study grou$ had re$orted the association 2etween lower 2ase
line LB4 count and treat-ent outco-e or disease $rogressionK des$ite i--unological failure, $atients with
higher $re-HAAF3 LB4R cell counts would 2e at less i--ediate ris. of disease $rogression D&E.
#atients who interru$ted treat-ent through defaulting or other reason were failed &.4 ti-es than not interru$ted
with '&= LI 2.33 to +2.+3. 3he result is co-$ara2le with a study done in South AfricaK the odds of treat-ent
failure were -ore than ! folds for #atients who interru$ted treat-ent through defaulting or non-adherence D3E.
3he 5ery high ris. of first line antiretro5iral treat-ent failure in the study in $atients with un$lanned
interru$tions to thera$y raises a concern that the failure to stagger AF3 cessation -ay 2e contri2uting to
su2seAuent treat-ent failure which is consistent with se5eral $re5ious re$orts D2', 32E.
Howe5er the finding of this study is inconsistent with a study done in Sa-$ala, 4gandaK history of un$lanned
treat-ent interru$tion was negati5ely associated with 5irologic treat-ent failure "odds ratio, .2K '&=
confidence inter5al, .+O.9% D3&E. 3his 5ariation -ight 2e due to the difference in study design. )ther reason
-ight 2e the difference of the stages of failure seen in this study and a study in 4gandaK this study includes all
stages of treat-ent failure while the 4gandan study was s$ecific to 5irulogic failure. 3he effect could 2e
$otential use of treat-ent interru$tions as a strategy in hea5ily $retreated $atients "e.g., to $er-it ree-ergence of
drug-susce$ti2le 5irus as a do-inant strain%, which is not ad5isa2le to 2e considered as a 5ia2le o$tion in $atients
with ad5anced i--une su$$ression at the ti-e of 5irologic failure D34E.
Lhronic gastric $ro2le- and $ul-onary 3B treat-ent during HAAF3 follow u$ were significantly associated
with first line antiretro5iral treat-ent failure in this study. Se5eral studies ha5e shown that other health $ro2le-s
other than HI*>AIBS are a strong ris. factor for occurrence of first line antiretro5iral treat-ent failure or $oor
treat-ent success. A co-$arati5e study done 2etween low and high inco-e countries showed that those $atients
with co-or2idities are at a higher ris. of -ortality and $oor treat-ent outco-eK 6ligi2ility for antiretro5iral
treat-ent and the need for treat-ent of tu2erculosis should 2e deter-ined earlier and HAAF3 should 2e started
2efore serious co-or2idities de5elo$ D42E.
#atients ha5ing history of $ul-onary 3B treat-ent during HAAF3 follow u$ failed al-ost 3 ti-es than that of
without history with '&= LI +.&& to &.34. 3his finding is inconsistent with a study done in South AfricaK
$ul-onary 3B treat-ent was not associated with first line antiretro5iral treat-ent failure D3E. 3he discre$ancy
-ight 2e due to the lower i--une status related to $oor nutritional status G low socio econo-ic 2ac. ground of
$atients in 6thio$ia as co-$ared to South Africa. 3he other reason to 2e inconsistent 2etween this study and a
study done in South Africa -ight 2e due to the initiation of HAAF3 after serious co-or2idities and ad5anced
stage of disease had occurred a-ong $atients in 6thio$ia 2ecause of late HI* test and late initiation of HAAF3.
3here -ight 2e also a difference due to sa-$le si8e 5ariation in this study and South African study. In addition
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++
to these, the study done in South Africa is s$ecific to 5irulogic failure "early stage of treat-ent failure% though
this study includes all stages "i--unological, clinical or 5irulogical% failure in defining cases. 4
Si-ilarly, those $atients ha5ing history of chronic gastric $ro2le- failed 9.9 ti-es than that of with no history of
gastric $ro2le- with '&= LI 2.33 to +!.!@. 3he result is consistent with a study done on gastro intestinal
$ro2le-s G HI* on treat-ent success which showed that gastro intestinal $ro2le- was a strong $redictor for a
2etter treat-ent outco-eK a healthy /I tract is necessary for $ro$er a2sor$tion of -edications. And controlling
sy-$to-s li.e nausea and diarrhea will i-$ro5e your Auality of life and hel$ you adhere to your -edications,
causing 2etter long-ter- treat-ent outco-es D42E.

6, C%.CLU-%.
0a<orities, && "&3.4=% of cases and +23 "&'.@=% of controls were fe-ales. 0ost, @& "@2.!=% of cases and +9&
"!.+=% of controls were orthodo: Lhristian followers. regarding to -arital status, 44 "42.@=% of cases and '!
"4@.9=% controls were -arried. A-ong cases and controls res$ecti5elyK the -edian "interAuartile range% 2aseline
"at HAAF3 initiation% cd4 count was @4 cells>?l "+O439% and +4 cells>?l "+-99@%.the inde$endent $redictors for
first line antiretro5iral treat-ent failure wereK2ase line cd4 count lower than & cell>?l, un$lanned anti-retro5iral
treat-ent interru$tion, history of $ul-onary treat-ent during HAAF3 follow u$ and, history of chronic gastric
$ro2le- were the inde$endent $redictors for first line antiretro5iral treat-ent failure. Based on the findings of
the study the following reco--endation is forwarded. health $rofessionals should $ay attention not to delay to
start art for $atients ha5ing lower cd4 count, close follow u$ to all $atients on art to a5oid un$lanned treat-ent
interru$tion G conseAuent $ro2le-s, $atients on $ul-onary 3B treat-ent and>or history of 3B treat-ent during
HAAF3 follow u$ need further in5estigation and all HI* infected $atients on HAAF3 should 2e e:a-ined for
all gastro intestinal $ro2le-s G should 2e treated su2seAuently. Iinally, further study with regards to Auality of
care gi5en in health institutionswhich are su$$osed to gi5e AF3 ser5ice, care $ro5ider as$ect G directly fro-
$atientsH side should 2e done in the future.

AC).%=LED>E'E.T
I would li.e to e:$ress -y sincere than.s and a$$reciation to -y ad5isors Br.Sahilu Asegid and 0r.Heno.
Assefa for $ro5iding -e indis$ensi2le guidance, encourage-ent and su$$ort fro- the scratch of the $ro$osal
de5elo$-ent. I also e:tend -y sincere a$$reciation to 0r. ,i2eltal Sifle, 0r. Belete 3e-iti-, 0r.A2dulhali.
3or.icho and all J4 e$ide-iology de$art-ent staffs for their constructi5e ad5ice. 0y s$ecial than.s also go to
Ji--a 4ni5ersity for gi5ing the o$$ortunity G financing, 6thio$ian federal -inistry of health, Addis A2a2a
health 2ureau and all $u2lic hos$italsH ad-inistrati5e and other staffs for their coo$eration and gi5ing all
necessary infor-ation. 1ast 2ut not least I would li.e to than. all -y friends and -y fa-ilies who had su$$orted
-e in different as$ects.

AUTH%(? C%.T(-"UT-%.
Author A designed the study, $erfor-ed the statistical analysis, wrote the $rotocol, and wrote the draft of the
-anuscri$t. TAuthor BH and TAuthor LH ga5e co--ents. All authors read and a$$ro5ed the final -anuscri$t.


ETH-CAL APP(%5AL
6thical a$$ro5al to carry out the study was sought fro- Ji--a 4ni5ersity health research G $ost graduate
coordinating office of college of $u2lic health and -edical science. Ior-al letter was ta.en fro- J4 and
#er-ission was o2tained fro- I0)H and AAHB. Ior-al letter was ta.en to each hos$ital and #er-ission
o2tained fro- each hos$ital. 3he study was done with a care not to interfere with the nor-al -anage-ent of the
$atients. Since the data were collected using only $atientsH uniAue AF3 registration nu-2er confidentiality of
the data were fully guaranteed and the collected data were used only for research $ur$ose.

(EFE(E.CE
+. 3a--y 1. Sorndoerfer et al. 2++.
2. JH), et al. "2++%
3. Iederal HI*>AIBS $re5ention and control office.2+
4. 4NAIBS. 2+
&. 4lri. Ba. B, et al.24
9. Fewari BB, et al.2++
@. )li5ia S, et al. 2+
!. JosU A. 6.2'
'. Belay 3, 2+
+. Iederal Be-ocratic Fe$u2lic of 6thio$ia, 0inistry of Health. 2+
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*ol.4, No.+&, 2+4

+2
++. Addis A2a2a regional health 2ureau disease $re5ention and control.2++
+2. Jose A. 6, 3o-as L2'
+3. 0ar #u<ades-F.2+
+4. )li5ia S, et al. 2'
+&. Andrew N #, et al.2!
+9. 0a: 5on S.2++
+@. Besta S.2++
+!. 0ar #u<ades-F, et al 2+
+'. JH).2+ re5
2. Ioru- for colla2orati5e HI* research.+''!
2+. Nicastri 6, et al.2&
22. IranVoise F, et al. 2++
23. #eter 1. A, et al.23
24. Igho5werha ), et al.2@
2&. 0ichael 0. 1, et al. 2++
29. Llaudia H, et al.2++
2@. Foos 6. B, et al.2++
2!. #ro<ect of the New 0e:ico AIBS 6ducation and 3raining Lenter.LB4 cell tests "www.aidsinfonet.org%.
2'. 0oha--ed IshaaA B, et al. 2+
3. JH). 29.
3+. Stringer JSA, et al.2+
32. Braitstein #, et al.29
33. Fio B. 29
34. 1isa A. S, et al.29
3&. Ia2ris #aolo, et al.2
39. 0aria Jose 0, /ail S, et al 23
3@. )-ar B, et al.+''9
3!. Begu J, et al.29
3'. 0arianne A. B. 5an der Sande, et al.24
4. NI #aton, et al.29
4+. 1aurence A, et al. 2'
42. Anne 0onroe. 2&
43. Andrew H, Andrew B. 2'
44. /erd I, et al. +''@


Definition for the term
5irulo$ic failure4Jhen #las-a 5iral load is a2o5e & co$ies>-l it is 5irulogical failure D+'E.
-mmunolo$ical failure- Jhen LB4 count falls to the 2ase line "2elow or &=% fro- on treat-ent $ea. 5alue or
$ersistent LB4 le5el 2elow+ cell>--3 without conco-itant infection to cause transient LB4 cell
decrease-ent D+'E.
Clinical failure4 New or recurrent JH) stage 4 conditions occurred and certain JH) stage 3 conditions
"$ul-onary 3B and recurrent 2acterial infections% D+'E.

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