Extended prophylaxis with nevirapine and cotrimoxazole among HIV-exposed uninfected infants is well tolerated

AIDS

Volumn 26, Issue 3, 2012, Pages 325-333

  Aizire, Jim ^a   Fowler, Mary Glenn ^a,b   Wang, Jing ^c   Shetty, Avinash K ^d   Stranix Chibanda, Lynda ^e   Kamateeka, Moreen ^a   Brown, Elizabeth R ^c   Bolton, Steve G ^b   Musoke, Philippa M ^a   Coovadia, Hoosen ^f,g  

^a MAKERERE UNIVERSITY   (Uganda)

^b JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c USA   (United States)

^d WAKE FOREST SCHOOL OF MEDICINE   (United States)

^e UNIVERSITY OF ZIMBABWE   (Zimbabwe)

^f UNIVERSITY OF THE WITWATERSRAND   (South Africa)

^g UNIVERSITY OF KWAZULU NATAL   (South Africa)

Author keywords

anemia; cotrimoxazole; HIV exposed uninfected infants; neutropenia; nevirapine; skin rash

Indexed keywords

COTRIMOXAZOLE; NEVIRAPINE; ZIDOVUDINE;

ANEMIA; ARTICLE; BREAST MILK; CONTROLLED STUDY; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; INFANT; INFECTION PREVENTION; MALE; NEUTROPENIA; PHASE 3 CLINICAL TRIAL; PRENATAL EXPOSURE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RASH; SINGLE DRUG DOSE; VIRUS TRANSMISSION;

ADULT; ANEMIA; ANTI-HIV AGENTS; BLOTTING, WESTERN; BREAST FEEDING; DRUG ADMINISTRATION SCHEDULE; DRUG ERUPTIONS; EXANTHEMA; FEMALE; HIV SEROPOSITIVITY; HIV-1; HUMANS; INFANT; INFANT, NEWBORN; INFECTIOUS DISEASE TRANSMISSION, VERTICAL; MALE; MILK, HUMAN; NEUTROPENIA; NEVIRAPINE; PREGNANCY; RISK FACTORS; TIME FACTORS; TREATMENT OUTCOME; TRIMETHOPRIM-SULFAMETHOXAZOLE COMBINATION; UGANDA;

EID: 84855348677     PISSN: 02699370     EISSN: 14735571     Source Type: Journal    
DOI: 10.1097/QAD.0b013e32834e892c     Document Type: Article

References (37)

1. World Health Organization. Rapid Advice: use of antiretroviral drugs for treating pregnant women and preventing HIV infection in infants. (2009). http://www.who.int/hiv/topics/mtct/. [Accessed June 2010].
2. World Health Organization. Antiretroviral drugs for treating pregnant women and preventing HIV infection in infants: towards universal access. Recommendations for a public health approach (2010). http://www.who.int/hiv/pub/ mtct/antiretroviral 2010/en/index.html. [Accessed November 2010].
3. Chasela CS, Hudgens MG, Jamieson DJ, Kayira D, Hosseinipour MC, Kourtis AP, et al. Maternal or infant antiretroviral drugs to reduce HIV-1 transmission. N Engl J Med 2010; 362:2271-2281.
4. The Kesho Bora Study Group. Triple antiretroviral compared with zidovudine and single-dose nevirapine prophylaxis during pregnancy and breastfeeding for prevention of mother-to-child transmission of HIV-1 (Kesho Bora study): a randomised controlled trial. Lancet Infect Dis 2011; [Epub ahead of print].
5. Six Week Extended-Dose Nevirapine (SWEN) Study Team. Extended-dose nevirapine to 6 weeks of age for infants to prevent HIV transmission via breastfeeding in Ethiopia, India, and Uganda: an analysis of three randomized controlled trials. Lancet 2008; 372:300-313.
6. Kumwenda NI, Hoover DR, Mofenson LM, Thigpen MC, Kafulafula G, Li Q, et al. Extended antiretroviral prophylaxis to reduce breast-milk HIV-1 transmission. N Engl J Med 2008; 359:119-129. (Pubitemid 351962035)
7. World Health Organization. Guidelines on co-trimoxazole prophylaxis for HIV-related infections among children, adolescents and adults: recommendations for a public health approach. WHO Library Cataloguing-in-Publication Data 2006, ISBN 92 4 159470 5 (NLM classification: WC 503.2) ISBN 978 92 4 159470 7. (2006) http://www.who.int/hiv/pub/guidelines/ctx/en/index.html. [Accessed July 2009].
8. Grimwade K, Swingler GH. Cotrimoxazole prophylaxis for opportunistic infections in children with HIV infection. Cochrane Database Syst Rev 2006:CD003508.
9. Chintu C, Bhat GJ, Walker AS, Mulenga V, Sinyinza F, Lishimpi K, et al. Co-trimoxazole as prophylaxis against opportunistic infections in HIV-infected Zambian children (CHAP): a doubleblind randomised placebo-controlled trial. Lancet 2004; 364: 1865-1871. (Pubitemid 39536090)
10. Mermin J, Lule J, Ekwaru JP, Malamba S, Downing R, Ransom R, et al. Effect of co-trimoxazole prophylaxis on morbidity, mortality, CD4-cell count, and viral load in HIV infection in rural Uganda. Lancet 2004; 364:1428-1434. (Pubitemid 39370718)
11. Jones JL, Hanson DL, Dworkin MS, Alderton DL, Fleming PL, Kaplan JE, et al. Surveillance for AIDS-defining opportunistic illnesses. MMWR CDC Surveill Summ 1999; 48:1-22.
12. May T, Beuscart C, Reynes J, Marchou B, Leclercq P, Borsa Lebas F, et al. Trimethoprim-sulfamethoxazole versus aerosolized pentamidine for primary prophylaxis of Pneumocystis carinii pneumonia: a prospective, randomized, controlled clinical trial. LFPMI Study Group. Ligue Francaise de Prevention des Maladies Infectieuses. J Acquir Immune Defic Syndr 1994; 7:457-462. (Pubitemid 24123706)
13. Martin MA, Cox PH, Beck K, Styer CM, Beall GN. A comparison of the effectiveness of three regimens in the prevention of Pneumocystis carinii pneumonia in human immunodeficiency virus-infected patients. Arch Intern Med 1992; 152:523-528.
14. Fisher RG, Nageswaran S, Valentine ME, McKinney RE Jr. Successful prophylaxis against Pneumocystis carinii pneumonia in HIV-infected children using smaller than recommended dosages of trimethoprim-sulfamethoxazole. AIDS Patient Care STDS 2001; 15:263-269. (Pubitemid 32429273)
15. Rieder MJ, King SM, Read S. Adverse reactions to trimethoprim- sulfamethoxazole among children with human immunodeficiency virus infection. Pediatr Infect Dis J 1997; 16:1028-1031. (Pubitemid 27494956)
16. Blum RN, Miller LA, Gaggini LC, Cohn DL. Comparative trial of dapsone versus trimethoprim/sulfamethoxazole for primary prophylaxis of Pneumocystis carinii pneumonia. J Acquir Immune Defic Syndr 1992; 5:341-347.
17. World Health Organization. Antiretroviral drugs for treating pregnant women and preventing HIV infection in infants in resource-limited settings. Geneva: WHO. (2006). www.who.int/hiv/pub/mtct/guidelines/en/. [Accessed November 2010].
18. National Institutes of Health. Division of AIDS (DAIDS) revised toxicity tables for grading severity of pediatric adverse experiences. US National Institutes of Health DAIDS HIV Vaccine and Research Program, version 1.0; Washington, DC. (2004) http://rcc.tech-res-intl.com. [Accessed June 2010].
19. Gill CJ, Sabin LL, Tham J, Hamer DH. Reconsidering empirical cotrimoxazole prophylaxis for infants exposed to HIV infection. Bull World Health Organ 2004; 82:290-297. (Pubitemid 38568466)
20. Coutsoudis A, Coovadia HM, Kindra G. Time for new recommendations on cotrimoxazole prophylaxis for HIV-exposed infants in developing countries? Bull World Health Organ 2010; 88:949-950.
21. Mirochnick M, Clarke DF, Dorenbaum A. Nevirapine: pharmacokinetic considerations in children and pregnant women. Clin Pharmacokinet 2000; 39:281-293.
22. Bardsley-Elliot A, Perry CM. Nevirapine: a review of its use in the prevention and treatment of paediatric HIV infection. Paediatr Drugs 2000; 2:373-407.
23. Boehringer-Ingelheim Viramune 1 Package Insert. Rev 2011. http://bidocs.boehringer-ingelheim.com/BIWebAccess/View Servlet.ser?docBase= renetnt&folderPath=/Prescribing+Information/PIs/Viramune/Viramune.pdf. [Accessed November 2011].
24. Krogstad P, Lee S, Johnson G, Stanley K, McNamara J, Moye J, et al. Nucleoside-analogue reverse-transcriptase inhibitors plus nevirapine, nelfinavir, or ritonavir for pretreated children infected with human immunodeficiency virus type 1. Clin Infect Dis 2002; 34:991-1001. (Pubitemid 34229769)
25. Verweel G, Sharland M, Lyall H, Novelli V, Gibb DM, Dumont G, et al. Nevirapine use in HIV-1-infected children. AIDS 2003; 17:1639-1647. (Pubitemid 36951685)
26. Burchett SK, Kovacs A, Khoury M, Yong F, Carey V, Smith E, et al. Preliminary toxicity and tolerability of 4-drug antiretroviral therapy with NRTIs, nevirapine, nelfinavir, and ritonavir in ARV-experienced children with advanced HIV disease [abstract 433]. In: 6th Conference on Retroviruses and Opportunistic Infections. 31 January-4 February 1999; Chicago, IL.
27. Guay LA, Musoke P, Fleming T, Bagenda D, Allen M, Nakabiito C, et al. Intrapartum and neonatal single-dose nevirapine compared with zidovudine for prevention of mother-tochild transmission of HIV-1 in Kampala, Uganda: HIVNET 012 randomised trial. Lancet 1999; 354:795-802. (Pubitemid 29415583)
28. Shetty AK, Coovadia HM, Mirochnick MM, Maldonado Y, Mofenson LM, Eshleman SH, et al. Safety and trough concentrations of nevirapine prophylaxis given daily, twice weekly, or weekly in breast-feeding infants from birth to 6 months. J Acquir Immune Defic Syndr 2003; 34:482-490. (Pubitemid 37500472)
29. Pollard RB, Robinson P, Dransfield K. Safety profile of nevirapine, a nonnucleoside reverse transcriptase inhibitor for the treatment of human immunodeficiency virus infection. Clin Ther 1998; 20:1071-1092. (Pubitemid 29058411)
30. Feola DJ, Garvy BA. Zidovudine plus sulfamethoxazoletrimethoprim adversely affects B lymphocyte maturation in bone marrow of normal mice. Int Immunopharmacol 2005; 5 (13-14):1881-1894. (Pubitemid 41586227)
31. Moore KH, Yuen GJ, Raasch RH, Eron JJ, Martin D, Mydlow PK, et al. Pharmacokinetics of lamivudine administered alone and with trimethoprim- sulfamethoxazole. Clin Pharmacol Ther 1996; 59:550-558.
32. Colebunders R, Hodossy B, Burger D, Daems T, Roelens K, Coppens M, et al. The effect of highly active antiretroviral treatment on viral load and antiretroviral drug levels in breast milk. AIDS 2005; 19:1912-1915. (Pubitemid 41546612)
33. Shapiro RL, Holland DT, Capparelli E, Lockman S, Thior I, Wester C, et al. Antiretroviral concentrations in breast-feeding infants of women in Botswana receiving antiretroviral treatment. J Infect Dis 2005; 192:720-727. (Pubitemid 41193069)
34. Wells J, Shetty AK, Stranix L, Falkovitz-Halpern MS, Chipato T, Nyoni N, et al. Range of normal neutrophil counts in healthy zimbabwean infants: implications for monitoring antiretroviral drug toxicity. J Acquir Immune Defic Syndr 2006; 42:460-463. (Pubitemid 44050894)
35. Kourtis AP, Bramson B, van der Horst C, Kazembe P, Ahmed Y, Chasela C, et al. Low absolute neutrophil counts in african infants. J Int Assoc Physicians AIDS Care (Chic) 2005; 4: 73-76.
36. Haddy TB, Rana SR, Castro O. Benign ethnic neutropenia: what is a normal absolute neutrophil count? J Lab Clin Med 1999; 133:15-22. (Pubitemid 29032412)
37. Fredlund VG, Nash J. How far should they walk? Increasing antiretroviral therapy access in a rural community in northern KwaZulu-Natal, South Africa. J Infect Dis 2007; 196 (Suppl 3): S469-S473. (Pubitemid 351417240)