Dried blood spots for viral load monitoring in malawi: Feasible and effective

PLoS ONE

Volumn 10, Issue 4, 2015, Pages

  Rutstein, Sarah E ^a,b   Hosseinipour, Mina C ^b,c   Kamwendo, Deborah ^c   Soko, Alice ^c   Mkandawire, Memory ^d   Biddle, Andrea K ^a   Miller, William C ^a,b   Weinberger, Morris ^a   Wheeler, Stephanie B ^a   Sarr, Abdoulaye ^e   Gupta, Sundeep ^e   Chimbwandira, Frank ^f   Mwenda, Reuben ^f   Kamiza, Steve ^g   Hoffman, Irving ^b   Mataya, Ronald ^d  

^a IL   (United States)

^b UNIVERSITY OF NORTH CAROLINA SCHOOL OF MEDICINE   (United States)

^c UNIVERSITY OF NORTH CAROLINA PROJECT   (Malawi)

^d LOMA LINDA UNIVERSITY   (United States)

^e CENTERS FOR DISEASE CONTROL AND PREVENTION   (United States)

^f MINISTRY OF HEALTH   (Malawi)

^g UNIVERSITY OF MALAWI   (Malawi)

Author keywords

[No Author keywords available]

Indexed keywords

EFAVIRENZ PLUS LAMIVUDINE PLUS TENOFOVIR DISOPROXIL; LAMIVUDINE PLUS NEVIRAPINE PLUS STAVUDINE; LAMIVUDINE PLUS NEVIRAPINE PLUS ZIDOVUDINE; ANTI HUMAN IMMUNODEFICIENCY VIRUS AGENT; VIRUS RNA;

ADULT; AFRICA SOUTH OF THE SAHARA; AGED; ARTICLE; CONTROLLED STUDY; DRIED BLOOD SPOT TESTING; DRUG TREATMENT FAILURE; FEMALE; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; MAJOR CLINICAL STUDY; MALAWI; MALE; OUTCOME ASSESSMENT; PUBLIC HOSPITAL; SYMPTOM; TREATMENT DURATION; VIRUS LOAD; ADOLESCENT; CD4 LYMPHOCYTE COUNT; DRUG EFFECTS; DRUG MONITORING; GENETICS; HIGHLY ACTIVE ANTIRETROVIRAL THERAPY; HIV INFECTIONS; HUMAN IMMUNODEFICIENCY VIRUS 1; ISOLATION AND PURIFICATION; MIDDLE AGED; PROSPECTIVE STUDY; TIME FACTOR; TREATMENT OUTCOME; VIROLOGY;

ADOLESCENT; ADULT; ANTI-HIV AGENTS; ANTIRETROVIRAL THERAPY, HIGHLY ACTIVE; CD4 LYMPHOCYTE COUNT; DRIED BLOOD SPOT TESTING; DRUG MONITORING; FEMALE; HIV INFECTIONS; HIV-1; HUMANS; MALAWI; MALE; MIDDLE AGED; PROSPECTIVE STUDIES; RNA, VIRAL; TIME FACTORS; TREATMENT OUTCOME; VIRAL LOAD;

EID: 84928782120     PISSN: None     EISSN: 19326203     Source Type: Journal    
DOI: 10.1371/journal.pone.0124748     Document Type: Article

References (53)

1. WHO. Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection. Geneva, Switzerland: WHO, 2013 2013.
2. Chaiwarith R, Wachirakaphan C, Kotarathititum W, Praparatanaphan J, Sirisanthana T, Supparatpinyo K. Sensitivity and specificity of using CD4+ measurement and clinical evaluation to determine antiretroviral treatment failure in Thailand. Int J Infect Dis. 2007; 11(5):413-6. PMID: 17331776
3. Mee P, Fielding KL, Charalambous S, Churchyard GJ, Grant AD. Evaluation of the WHO criteria for antiretroviral treatment failure among adults in South Africa. AIDS (London, England). 2008; 22(15): 1971-7. doi: 10.1097/QAD.0b013e32830e4cd8 PMID: 18784460
4. Reynolds SJ, Nakigozi G, Newell K, Ndyanabo A, Galiwongo R, Boaz I, et al. Failure of immunologic criteria to appropriately identify antiretroviral treatment failure in Uganda. AIDS (London, England). 2009; 23(6):697-700. doi: 10.1097/QAD.0b013e3283262a78 PMID: 19209067
5. Moore DM, Awor A, Downing R, Kaplan J, Montaner JS, Hancock J, et al. CD4+ T-cell count monitoring does not accurately identify HIV-infected adults with virologic failure receiving antiretroviral therapy. J Acquir Immune Defic Syndr. 2008; 49(5):477-84. doi: 10.1097/QAI.0b013e318186eb18 PMID: 18989232
6. van Oosterhout JJ, Brown L, Weigel R, Kumwenda JJ, Mzinganjira D, Saukila N, et al. Diagnosis of antiretroviral therapy failure in Malawi: poor performance of clinical and immunological WHO criteria. Tropical medicine & international health: TM & IH. 2009; 14(8):856-61.
7. Rawizza HE, Chaplin B, Meloni ST, Eisen G, Rao T, Sankale JL, et al. Immunologic criteria are poor predictors of virologic outcome: implications for HIV treatment monitoring in resource-limited settings. Clin Infect Dis. 2011; 53(12):1283-90. doi: 10.1093/cid/cir729 PMID: 22080121
8. Gsponer T, Petersen M, Egger M, Phiri S, Maathuis MH, Boulle A, et al. The causal effect of switching to second-line ART in programmes without access to routine viral load monitoring. AIDS. 2012; 26(1): 57-65. doi: 10.1097/QAD.0b013e32834e1b5f PMID: 22089376
9. Keiser O, Tweya H, Braitstein P, Dabis F, MacPhail P, Boulle A, et al. Mortality after failure of antiretroviral therapy in sub-Saharan Africa. Trop Med Int Health. 2010; 15(2):251-8. doi: 10.1111/j.1365-3156. 2009.02445.x PMID: 20003034
10. Hosseinipour MC, van Oosterhout JJ, Weigel R, Phiri S, Kamwendo D, Parkin N, et al. The public health approach to identify antiretroviral therapy failure: high-level nucleoside reverse transcriptase inhibitor resistance among Malawians failing first-line antiretroviral therapy. AIDS. 2009; 23(9):1127-34. doi: 10.1097/QAD.0b013e32832ac34e PMID: 19417582
11. Kumarasamy N, Madhavan V, Venkatesh KK, Saravanan S, Kantor R, Balakrishnan P, et al. High frequency of clinically significant mutations after first-line generic highly active antiretroviral therapy failure: implications for second-line options in resource-limited settings. Clin Infect Dis. 2009; 49(2):306-9. doi: 10.1086/600044 PMID: 19522657
12. Marconi VC, Sunpath H, Lu Z, Gordon M, Koranteng-Apeagyei K, Hampton J, et al. Prevalence of HIV-1 drug resistance after failure of a first highly active antiretroviral therapy regimen in KwaZulu Natal, South Africa. Clin Infect Dis. 2008; 46(10):1589-97. doi: 10.1086/587109 PMID: 18419495
13. Reynolds SJ, Kityo C, Mbamanya F, Dewar R, Ssali F, Quinn TC, et al. Evolution of drug resistance after virological failure of a first-line highly active antiretroviral therapy regimen in Uganda. Antivir Ther. 2009; 14(2):293-7. PMID: 19430104
14. Keiser O, Chi BH, Gsponer T, Boulle A, Orrell C, Phiri S, et al. Outcomes of antiretroviral treatment in programmes with and without routine viral load monitoring in Southern Africa. AIDS. 2011; 25(14): 1761-9. doi: 10.1097/QAD.0b013e328349822f PMID: 21681057
15. Estill J, Egger M, Johnson LF, Gsponer T, Wandeler G, Davies MA, et al. Monitoring of antiretroviral therapy and mortality in HIV programmes in Malawi, South Africa and Zambia: mathematical modelling study. PLoS One. 2013; 8(2):e57611. doi: 10.1371/journal.pone.0057611 PMID: 23469035
16. Gupta RK, Hill A, Sawyer AW, Cozzi-Lepri A, von Wyl V, Yerly S, et al. Virological monitoring and resistance to first-line highly active antiretroviral therapy in adults infected with HIV-1 treated under WHO guidelines: a systematic review and meta-analysis. Lancet Infect Dis. 2009; 9(7):409-17. doi: 10.1016/ S1473-3099(09)70136-7 PMID: 19555900
17. Mermin J, Ekwaru JP, Were W, Degerman R, Bunnell R, Kaharuza F, et al. Utility of routine viral load, CD4 cell count, and clinical monitoring among adults with HIV receiving antiretroviral therapy in Uganda: randomised trial. BMJ. 2011; 343:d6792. doi: 10.1136/bmj.d6792 PMID: 22074711
18. Sigaloff KC, Hamers RL, Wallis CL, Kityo C, Siwale M, Ive P, et al. Unnecessary antiretroviral treatment switches and accumulation of HIV resistance mutations; two arguments for viral load monitoring in Africa. J Acquir Immune Defic Syndr. 2011; 58(1):23-31. doi: 10.1097/QAI.0b013e318227fc34 PMID: 21694603
19. UNAIDS. Access to Antireretroviral Therapy in Africa: Status report on progress towards the 2015 targets. Geneva, Switzerland: UNAIDS, 2013.
20. WHO. HIV/AIDS Geneva: WHO; 2013 [cited 2013 Nov 18]. Available: http://www.who.int/ mediacentre/factsheets/fs360/en/.
21. Cohen MS, Chen YQ, McCauley M, Gamble T, Hosseinipour MC, Kumarasamy N, et al. Prevention of HIV-1 infection with early antiretroviral therapy. N Engl J Med. 2011; 365(6):493-505. doi: 10.1056/ NEJMoa1105243 PMID: 21767103
22. Bangsberg DR, Perry S, Charlebois ED, Clark RA, Roberston M, Zolopa AR, et al. Non-adherence to highly active antiretroviral therapy predicts progression to AIDS. AIDS. 2001; 15(9):1181-3. PMID: 11416722
23. Loutfy MR, Wu W, Letchumanan M, Bondy L, Antoniou T, Margolese S, et al. Systematic review of HIV transmission between heterosexual serodiscordant couples where the HIV-positive partner is fully suppressed on antiretroviral therapy. PLoS One. 2013; 8(2):e55747. PONE-D-12-17826 [pii]. PMID: 23418455; PubMed Central PMCID: PMC3572113. doi: 10.1371/journal.pone.0055747
24. Boulle A, Van Cutsem G, Hilderbrand K, Cragg C, Abrahams M, Mathee S, et al. Seven-year experience of a primary care antiretroviral treatment programme in Khayelitsha, South Africa. AIDS. 2010; 24(4):563-72. doi: 10.1097/QAD.0b013e328333bfb7 PMID: 20057311
25. Koyalta D, Charpentier C, Beassamda J, Rey E, Si-Mohamed A, Djemadji-Oudjeil N, et al. High frequency of antiretroviral drug resistance among HIV-infected adults receiving first-line highly active antiretroviral therapy in N'Djamena, Chad. Clin Infect Dis. 2009; 49(1):155-9. doi: 10.1086/599611 PMID: 19480574
26. Maldonado F, Biot M, Roman F, Masquelier C, Anapenge M, Bastos R, et al. Viraemia and HIV-1 drug resistance mutations among patients receiving antiretroviral treatment in Mozambique. Trans R Soc Trop Med Hyg. 2009; 103(6):607-12. doi: 10.1016/j.trstmh.2008.07.014 PMID: 18804251
27. Barth RE, van der Loeff MF, Schuurman R, Hoepelman AI, Wensing AM. Virological follow-up of adult patients in antiretroviral treatment programmes in sub-Saharan Africa: a systematic review. Lancet Infect Dis. 2010; 10(3):155-66. doi: 10.1016/S1473-3099(09)70328-7 PMID: 20185094
28. Coetzee D, Hildebrand K, Boulle A, Maartens G, Louis F, Labatala V, et al. Outcomes after two years of providing antiretroviral treatment in Khayelitsha, South Africa. AIDS. 2004; 18(6):887-95. PMID: 15060436
29. McMahon JH, Elliott JH, Bertagnolio S, Kubiak R, Jordan MR. Viral suppression after 12 months of antiretroviral therapy in low- and middle-income countries: a systematic review. Bull World Health Organ. 2013; 91(5):377-85E. doi: 10.2471/BLT.12.112946 PMID: 23678201
30. Fox MP, Cutsem GV, Giddy J, Maskew M, Keiser O, Prozesky H, et al. Rates and predictors of failure of first-line antiretroviral therapy and switch to second-line ART in South Africa. J Acquir Immune Defic Syndr. 2012; 60(4):428-37. doi: 10.1097/QAI.0b013e3182557785 PMID: 22433846
31. Pannus P, Fajardo E, Metcalf C, Coulborn RM, Duran LT, Bygrave H, et al. Pooled HIV-1 viral load testing using dried blood spots to reduce the cost of monitoring antiretroviral treatment in a resource-limited setting. J Acquir Immune Defic Syndr. 2013; 64(2):134-7. doi: 10.1097/QAI.0b013e3182a61e63 PMID: 23892241
32. HIV/AIDS Diagnostics Technology Landscape. Geneva, Switzerland: UNITAID/WHO, 2014 June 2014.
33. Rutstein SE, Kamwendo D, Lugali L, Thengolose I, Tegha G, Fiscus SA, et al. Measures of viral load using Abbott RealTime HIV-1 Assay on venous and fingerstick dried blood spots from provider-collected specimens in Malawian District Hospitals. J Clin Virol. 2014. Epub 2014/06/08.
34. Fajardo E, Metcalf CA, Chaillet P, Aleixo L, Pannus P, Panunzi I, et al. Prospective Evaluation of the Diagnostic Accuracy of Dried Blood Spots from Finger-Prick for the Determination of HIV-1 Viral Load with the NucliSENS Easy-Q HIV-1 v2.0 in Malawi. J Clin Microbiol. 2014; 52(5):1343. doi: 10.1128/ JCM.03519-13 PMID: 24501032
35. Arredondo M, Garrido C, Parkin N, Zahonero N, Bertagnolio S, Soriano V, et al. Comparison of HIV-1 RNA measurements obtained by using plasma and dried blood spots in the automated abbott real-time viral load assay. J Clin Microbiol. 2012; 50(3):569-72. JCM.00418-11 [pii]. PMID: 22170904; PubMed Central PMCID: PMC3295109. doi: 10.1128/JCM.00418-11
36. Johannessen A, Garrido C, Zahonero N, Sandvik L, Naman E, Kivuyo SL, et al. Dried blood spots perform well in viral load monitoring of patients who receive antiretroviral treatment in rural Tanzania. Clin Infect Dis. 2009; 49(6):976-81. doi: 10.1086/605502 PMID: 19663598
37. Brambilla D, Jennings C, Aldrovandi G, Bremer J, Comeau AM, Cassol SA, et al. Multicenter evaluation of use of dried blood and plasma spot specimens in quantitative assays for human immunodeficiency virus RNA: measurement, precision, and RNA stability. J Clin Microbiol. 2003; 41(5):1888-93. PMID: 12734222
38. Fiscus SA, Brambilla D, Grosso L, Schock J, Cronin M. Quantitation of human immunodeficiency virus type 1 RNA in plasma by using blood dried on filter paper. J Clin Microbiol. 1998; 36(1):258-60. PMID: 9431960
39. Smit PW, Sollis KA, Fiscus S, Ford N, Vitoria M, Essajee S, et al. Systematic review of the use of dried blood spots for monitoring HIV viral load and for early infant diagnosis. PLoS One. 2014; 9(3):e86461. doi: 10.1371/journal.pone.0086461 PMID: 24603442
40. O'Shea S, Mullen J, Corbett K, Chrystie I, Newell ML, Banatvala JE. Use of dried whole blood spots for quantification of HIV-1 RNA. AIDS. 1999; 13(5):630-1. PMID: 10203395
41. Global AIDS Response Progress Report: Malawi Progress Report for 2013. Lilongwe: Ministry of Health, 2014 31 March 2014.
42. Integrated HIV Program Report July-September 2013. Lilongwe: Government of Malawi Minsitry of Health, 2013.
43. Monleau M, Aghokeng AF, Eymard-Duvernay S, Dagnra A, Kania D, Ngo-Giang-Huong N, et al. Field evaluation of dried blood spots for routine HIV-1 viral load and drug resistance monitoring in patients receiving antiretroviral therapy in Africa and Asia. J Clin Microbiol. 2014; 52(2):578-86. doi: 10.1128/ JCM.02860-13 PMID: 24478491
44. Ouma KN, Basavaraju SV, Okonji JA, Williamson J, Thomas TK, Mills LA, et al. Evaluation of quantification of HIV-1 RNA viral load in plasma and dried blood spots by use of the semiautomated Cobas Amplicor assay and the fully automated Cobas Ampliprep/TaqMan assay, version 2.0, in Kisumu, Kenya. J Clin Microbiol. 2013; 51(4):1208-18. doi: 10.1128/JCM.03048-12 PMID: 23390278
45. Clinical Management of HIV in Children and Adults. Lilongwe: Ministry of Health, Malawi, 2011.
46. Pagano M, Gauvreau K. Principles of Biostatistics. 2nd edition ed: Cengage Learning; 2000.
47. Kamya MR, Mayanja-Kizza H, Kambugu A, Bakeera-Kitaka S, Semitala F, Mwebaze-Songa P, et al. Predictors of long-term viral failure among ugandan children and adults treated with antiretroviral therapy. J Acquir Immune Defic Syndr. 2007; 46(2):187-93. PMID: 17693883
48. El-Khatib Z, Delong AK, Katzenstein D, Ekstrom AM, Ledwaba J, Mohapi L, et al. Drug resistance patterns and virus re-suppression among HIV-1 subtype C infected patients receiving non-nucleoside reverse transcriptase inhibitors in South Africa. J AIDS Clin Res. 2011; 2(117). PMID: 21927716
49. Gupta RK, Goodall RL, Ranopa M, Kityo C, Munderi P, Lyagoba F, et al. High Rate of HIV Resuppression After Viral Failure on First-line Antiretroviral Therapy in the Absence of Switch to Second-line Therapy. Clin Infect Dis. 2014; 58(7):1023-6. doi: 10.1093/cid/cit933 PMID: 24352348
50. Orrell C, Harling G, Lawn SD, Kaplan R, McNally M, Bekker LG, et al. Conservation of first-line antiretroviral treatment regimen where therapeutic options are limited. Antivir Ther. 2007; 12(1):83-8. PMID: 17503751
51. Ford N, Darder M, Spelman T, Maclean E, Mills E, Boulle A. Early adherence to antiretroviral medication as a predictor of long-term HIV virological suppression: five-year follow up of an observational cohort. PLoS One. 2010; 5(5):e10460. doi: 10.1371/journal.pone.0010460 PMID: 20485480
52. Phan V, Thai S, Koole O,Menten J,Meheus F, van Griensven J, et al. Validation of a clinical prediction score to target viral load testing in adults with suspected first-line treatment failure in resource-constrained settings. J Acquir Immune Defic Syndr. 2013; 62(5):509-16. doi: 10.1097/QAI.0b013e318285d28c PMID: 23334504
53. van Zyl GU, van Mens TE, McIlleron H, Zeier M, Nachega JB, Decloedt E, et al. Low lopinavir plasma or hair concentrations explain second-line protease inhibitor failures in a resource-limited setting. J Acquir Immune Defic Syndr. 2011; 56(4):333-9. doi: 10.1097/QAI.0b013e31820dc0cc PMID: