A cross-sectional study to evaluate second line virological failure and elevated bilirubin as a surrogate for adherence to atazanavir/ritonavir in ... View Full Text


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Article Info

DATE

2017-07-03

AUTHORS

Dennis Miyoge Ongubo, Robertino Lim, Hannock Tweya, Christopher Chikhosi Stanley, Petros Tembo, Richard Broadhurst, Salem Gugsa, McNeil Ngongondo, Colin Speight, Tom Heller, Sam Phiri, Mina C. Hosseinipour

ABSTRACT

BackgroundMalawi’s national antiretroviral therapy program provides atazanavir/ritonavir–based second line regimens which cause concentration-dependent rise in indirect bilirubin. We sought to determine if elevated bilirubin, as a surrogate of atazanavir/ritonavir adherence, can aid in the evaluation of second line virological failure in Malawi.MethodsWe conducted a cross-sectional study of HIV-infected patients ≥15 years who were on boosted protease inhibitor-based second line antiretroviral therapy for at least 6 months in two urban HIV clinics in Lilongwe, Malawi. Antiretroviral therapy history and adherence data were extracted from the electronic medical records and blood was drawn for viral load, complete blood count, total bilirubin, and CD4 cell count at a clinic visit. Factors associated with virological failure were assessed using multivariate logistic regression model.ResultsOut of 376 patients on second line antiretroviral therapy evaluated, 372 (98.9%) were on atazanavir/ritonavir-based therapy and 142 (37.8%) were male. Mean age was 40.9 years (SD ± 10.1), mean duration on second line antiretroviral therapy was 41.9 months (SD ± 27.6) and 256 patients (68.1%) had elevated bilirubin >1.3 mg/dL. Overall, 35 (9.3%) patients had viral load >1000 copies/ml (virological failure). Among the virologically failing vs. non-failing patients, bilirubin was elevated in 34.3% vs. 72.0% respectively (p < 0.001), although adherence by pill count was similar (62.9% vs. 60.7%, p = 0.804). The odds of virological failure were higher for adults aged 25–40 years (adjusted odds ratio (aOR) 2.5, p = 0.048), those with CD4 cell count <100 (aOR 17.5, p < 0.001), and those with normal bilirubin levels (aOR 5.4, p < 0.001); but were lower for the overweight/obese patients (aOR 0.3, p = 0.026). Poor pill count adherence (aOR 0.7, p = 0.4) and male gender (aOR 1.2, p = 0.698) were not associated with second line virological failure.ConclusionsAmong patients receiving atazanavir/ritonavir-based second line antiretroviral therapy, bilirubin levels better predicted virological failure than pill count adherence. Therefore, strategic use of bilirubin and viral load testing to target adherence counseling and support may be cost-effective in monitoring second line antiretroviral therapy adherence and virological failure. Drug resistance testing targeted for patients with virological failure despite elevated bilirubin levels would facilitate timely switch to third line antiretroviral regimens whenever available. More... »

PAGES

461

Identifiers

URI

http://scigraph.springernature.com/pub.10.1186/s12879-017-2528-0

DOI

http://dx.doi.org/10.1186/s12879-017-2528-0

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1090274734

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/28673254


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27 schema:description BackgroundMalawi’s national antiretroviral therapy program provides atazanavir/ritonavir–based second line regimens which cause concentration-dependent rise in indirect bilirubin. We sought to determine if elevated bilirubin, as a surrogate of atazanavir/ritonavir adherence, can aid in the evaluation of second line virological failure in Malawi.MethodsWe conducted a cross-sectional study of HIV-infected patients ≥15 years who were on boosted protease inhibitor-based second line antiretroviral therapy for at least 6 months in two urban HIV clinics in Lilongwe, Malawi. Antiretroviral therapy history and adherence data were extracted from the electronic medical records and blood was drawn for viral load, complete blood count, total bilirubin, and CD4 cell count at a clinic visit. Factors associated with virological failure were assessed using multivariate logistic regression model.ResultsOut of 376 patients on second line antiretroviral therapy evaluated, 372 (98.9%) were on atazanavir/ritonavir-based therapy and 142 (37.8%) were male. Mean age was 40.9 years (SD ± 10.1), mean duration on second line antiretroviral therapy was 41.9 months (SD ± 27.6) and 256 patients (68.1%) had elevated bilirubin >1.3 mg/dL. Overall, 35 (9.3%) patients had viral load >1000 copies/ml (virological failure). Among the virologically failing vs. non-failing patients, bilirubin was elevated in 34.3% vs. 72.0% respectively (p < 0.001), although adherence by pill count was similar (62.9% vs. 60.7%, p = 0.804). The odds of virological failure were higher for adults aged 25–40 years (adjusted odds ratio (aOR) 2.5, p = 0.048), those with CD4 cell count <100 (aOR 17.5, p < 0.001), and those with normal bilirubin levels (aOR 5.4, p < 0.001); but were lower for the overweight/obese patients (aOR 0.3, p = 0.026). Poor pill count adherence (aOR 0.7, p = 0.4) and male gender (aOR 1.2, p = 0.698) were not associated with second line virological failure.ConclusionsAmong patients receiving atazanavir/ritonavir-based second line antiretroviral therapy, bilirubin levels better predicted virological failure than pill count adherence. Therefore, strategic use of bilirubin and viral load testing to target adherence counseling and support may be cost-effective in monitoring second line antiretroviral therapy adherence and virological failure. Drug resistance testing targeted for patients with virological failure despite elevated bilirubin levels would facilitate timely switch to third line antiretroviral regimens whenever available.
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33 schema:keywords CD4 cell count
34 ConclusionsAmong patients
35 HIV
36 HIV clinic
37 Lilongwe
38 Line Antiretroviral Therapy
39 Malawi
40 MethodsWe
41 National Antiretroviral Therapy Program
42 ResultsOut
43 adherence
44 adherence counseling
45 adherence data
46 adults
47 age
48 antiretroviral regimens
49 antiretroviral therapy
50 antiretroviral therapy adherence
51 antiretroviral therapy history
52 antiretroviral therapy programs
53 atazanavir/ritonavir
54 bilirubin
55 bilirubin levels
56 blood
57 blood count
58 cell count
59 clinic
60 clinic visits
61 complete blood count
62 concentration-dependent rise
63 copies/
64 counseling
65 count
66 cross-sectional study
67 data
68 drug resistance testing
69 duration
70 electronic medical records
71 elevated bilirubin
72 elevated bilirubin levels
73 evaluation
74 factors
75 failure
76 gender
77 history
78 indirect bilirubin
79 levels
80 line regimens
81 load
82 logistic regression models
83 male gender
84 mean age
85 medical records
86 model
87 months
88 multivariate logistic regression model
89 non-failing patients
90 normal bilirubin levels
91 obese patients
92 odds
93 patients
94 pill count
95 pill count adherence
96 pills
97 program
98 records
99 regimens
100 regression models
101 resistance testing
102 rise
103 ritonavir
104 second-line antiretroviral therapy
105 second-line regimens
106 strategic use
107 study
108 support
109 surrogate
110 testing
111 therapy
112 therapy adherence
113 therapy history
114 therapy program
115 total bilirubin
116 urban HIV clinic
117 use
118 viral load
119 virological failure
120 visits
121 years
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