Valacyclovir suppressive therapy reduces plasma and breast milk HIV-1 RNA levels during pregnancy and postpartum: A randomized trial

Journal of Infectious Diseases

Volumn 205, Issue 3, 2012, Pages 366-375

  Drake, Alison L ^a   Roxby, Alison C ^a   Ongecha Owuor, Francisca ^e   Kiarie, James ^f   John Stewart, Grace ^a,b   Wald, Anna ^a,c   Richardson, Barbra A ^a,c   Hitti, Jane ^a,b   Overbaugh, Julie ^d   Emery, Sandra ^d   Farquhar, Carey ^a  

^a UNIVERSITY OF WASHINGTON   (United States)

^b UNIVERSITY OF WASHINGTON SCHOOL OF MEDICINE   (United States)

^c Division of Vaccine and Infectious Disease   (United States)

^d Fred Hutchinson Cancer Research Center   (United States)

^e KENYATTA UNIVERSITY   (Kenya)

^f UNIVERSITY OF NAIROBI   (Kenya)

Author keywords

[No Author keywords available]

Indexed keywords

NEVIRAPINE; PLACEBO; VALACICLOVIR; VIRUS RNA; ZIDOVUDINE;

ADULT; ARTICLE; BREAST MILK; CD4 LYMPHOCYTE COUNT; CONTROLLED STUDY; DISEASE FREE SURVIVAL; DOUBLE BLIND PROCEDURE; DRUG EFFECT; FEMALE; FETUS RISK; GESTATION PERIOD; HERPES SIMPLEX; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS 1; HUMAN IMMUNODEFICIENCY VIRUS 1 INFECTION; INFANT MORTALITY; INFECTION PREVENTION; INFECTION RATE; INFECTION RISK; LIMIT OF DETECTION; MAJOR CLINICAL STUDY; MIXED INFECTION; NEWBORN INFECTION; PLACENTAL TRANSFER; PREGNANCY; PRIORITY JOURNAL; PUERPERIUM; RANDOMIZED CONTROLLED TRIAL; RISK ASSESSMENT; RNA ANALYSIS; SINGLE DRUG DOSE; VIRUS LOAD; VIRUS SHEDDING; VIRUS TRANSMISSION;

ACYCLOVIR; ADOLESCENT; ADULT; ANTI-HIV AGENTS; DOUBLE-BLIND METHOD; FEMALE; HIV INFECTIONS; HIV-1; HUMANS; INFECTIOUS DISEASE TRANSMISSION, VERTICAL; KENYA; MILK, HUMAN; NEVIRAPINE; PLACEBOS; PLASMA; POSTPARTUM PERIOD; PREGNANCY; PREGNANCY COMPLICATIONS, INFECTIOUS; RNA, VIRAL; TREATMENT OUTCOME; VALINE; VIRAL LOAD; YOUNG ADULT; ZIDOVUDINE;

EID: 84855870492     PISSN: 00221899     EISSN: None     Source Type: Journal    
DOI: 10.1093/infdis/jir766     Document Type: Article

References (45)

1. UNAIDS. UNAIDS report on the global HIV/AIDS epidemic, 2010. Available at: http://www.unaids.org/globalreport/Global-report.htm. Accessed 25 November 2011.
2. WHO. Antiretroviral drugs for treating pregnant women and preventing HIV infection in infants. Recommendations for a public health approach. 2010. Available at: http://www.who.int/hiv/pub/mtct/antiretroviral2010/en/index.html. Accessed 25 November 2011.
3. WHO. Towards universal access: scaling up priority HIV/AIDS interventions in the health sector. Progress report 2010. Available at: http://www.who.int/ hiv/pub/2010progressreport/en/. Accessed 25 November 2011.
4. Drake AL, John-Stewart GC, Wald A, et al. Herpes simplex virus type 2 and risk of intrapartum human immunodeficiency virus transmission. Obstet Gynecol 2007;109:403-9. (Pubitemid 46197434)
5. Mbopi-Keou FX, Gresenguet G, Mayaud P, et al. Interactions between herpes simplex virus type 2 and human immunodeficiency virus type 1 infection in African women: opportunities for intervention. J Infect Dis 2000;182:1090-6.
6. McClelland RS, Wang CC, Overbaugh J, et al. Association between cervical shedding of herpes simplex virus and HIV-1. AIDS 2002;16:2425-30. (Pubitemid 35471690)
7. Schacker T, Zeh J, Hu HL, Hill E, Corey L. Frequency of symptomatic and asymptomatic herpes simplex virus type 2 reactivations among human immunodeficiency virus-infected men. J Infect Dis 1998;178:1616-22. (Pubitemid 28558132)
8. Gray RH, Li X, Wawer MJ, et al. Determinants of HIV-1 load in subjects with early and later HIV infections, in a general-population cohort of Rakai, Uganda. J Infect Dis 2004;189:1209-15. (Pubitemid 38457245)
9. Schacker T, Zeh J, Hu H, Shaughnessy M, Corey L. Changes in plasma human immunodeficiency virus type 1 RNA associated with herpes simplex virus reactivation and suppression. J Infect Dis 2002;186:1718-25. (Pubitemid 35463503)
10. Mole L, Ripich S, Margolis D, Holodniy M. The impact of active herpes simplex virus infection on human immunodeficiency virus load. J Infect Dis 1997;176:766-70. (Pubitemid 27360547)
11. LeGoff J, Weiss HA, Gresenguet G, et al. Cervicovaginal HIV-1 and herpes simplex virus type 2 shedding during genital ulcer disease episodes. AIDS 2007;21:1569-78. (Pubitemid 47075478)
12. Nagot N, Ouedraogo A, Foulongne V, et al. Reduction of HIV-1 RNA levels with therapy to suppress herpes simplex virus. N Engl J Med 2007;356:790-9. (Pubitemid 46294611)
13. Baeten JM, Strick LB, Lucchetti A, et al. Herpes simplex virus (HSV)-suppressive therapy decreases plasma and genital HIV-1 levels in HSV-2/HIV-1 coinfected women: a randomized, placebo-controlled, cross-over trial. J Infect Dis 2008;198:1804-8.
14. Dunne EF, Whitehead S, Sternberg M, et al. Suppressive acyclovir therapy reduces HIV cervicovaginal shedding in HIV-and HSV-2-infected women, Chiang Rai, Thailand. J Acquir Immune Defic Syndr 2008;49:77-83.
15. Celum C, Wald A, Lingappa JR, et al. Acyclovir and transmission of HIV-1 from persons infected with HIV-1 and HSV-2. N Engl J Med 2010;362:427-39.
16. Zuckerman RA, Lucchetti A, Whittington WL, et al. Herpes simplex virus (HSV) suppression with valacyclovir reduces rectal and blood plasma HIV-1 levels in HIV-1/HSV-2-seropositive men: a randomized, double-blind, placebo-controlled crossover trial. J Infect Dis 2007;196:1500-8. (Pubitemid 351411987)
17. Delany S, Mlaba N, Clayton T, et al. Impact of aciclovir on genital and plasma HIV-1 RNA in HSV-2/HIV-1 coinfected women: a randomized placebo-controlled trial in South Africa. AIDS 2009;23:461-9.
18. Rousseau CM, Nduati RW, Richardson BA, et al. Association of levels of HIV-1-infected breast milk cells and risk of mother-to-child transmission. J Infect Dis 2004;190:1880-8. (Pubitemid 39487835)
19. John GC, Nduati RW, Mbori-Ngacha DA, et al. Correlates of motherto-child human immunodeficiency virus type 1 (HIV-1) transmission: association with maternal plasma HIV-1 RNA load, genital HIV-1 DNA shedding, and breast infections. J Infect Dis 2001;183:206-12. (Pubitemid 32066020)
20. Chen KT, Segu M, Lumey LH, et al. Genital herpes simplex virus infection and perinatal transmission of human immunodeficiency virus. Obstet Gynecol 2005;106:1341-8. (Pubitemid 41668955)
21. Bollen LJ, Whitehead SJ, Mock PA, et al. Maternal herpes simplex virus type 2 coinfection increases the risk of perinatal HIV transmission: possibility to further decrease transmission? AIDS 2008;22:1169-76.
22. Kenya Ministry of Health, National AIDS and STI Control Programme. Guidelines for prevention of mother to child transmission (PMTCT) of HIV/AIDS in Kenya. 3rd ed. 2009. Available at http://www.aidstar-one.com/focus-areas/pmtct/ resources/pmtct-country-guidelines. Accessed 25 November 2011.
23. John GC, Sheppard H, Mbori-Ngacha D, et al. Comparison of techniques for HIV-1 RNA detection and quantitation in cervicovaginal secretions. J Acquir Immune Defic Syndr 2001;26:170-5. (Pubitemid 32224189)
24. Wald A, Zeh J, Selke S, et al. Reactivation of genital herpes simplex virus type 2 infection in asymptomatic seropositive persons. N Engl J Med 2000;342:844-50. (Pubitemid 30165207)
25. Ashley RL, Militoni J, Lee F, Nahmias A, Corey L. Comparison of Western blot (immunoblot) and glycoprotein G-specific immunodot enzyme assay for detecting antibodies to herpes simplex virus types 1 and 2 in human sera. J Clin Microbiol 1988;26:662-7. (Pubitemid 18087189)
26. DeVange Panteleeff D, Emery S, Richardson BA, et al. Validation of performance of the gen-probe human immunodeficiency virus type 1 viral load assay with genital swabs and breast milk samples. J Clin Microbiol 2002;40:3929-37. (Pubitemid 35285770)
27. Emery S, Bodrug S, Richardson BA, et al. Evaluation of performance of the Gen-Probe human immunodeficiency virus type 1 viral load assay using primary subtype A, C, and D isolates from Kenya. J Clin Microbiol 2000;38:2688-95. (Pubitemid 30485151)
28. Magaret AS, Wald A, Huang ML, Selke S, Corey L. Optimizing PCR positivity criterion for detection of herpes simplex virus DNA on skin and mucosa. J Clin Microbiol 2007;45:1618-20. (Pubitemid 46762423)
29. Jerome KR, Huang ML, Wald A, Selke S, Corey L. Quantitative stability of DNA after extended storage of clinical specimens as determined by real-time PCR. J Clin Microbiol 2002;40:2609-11. (Pubitemid 34747371)
30. Panteleeff DD, John G, Nduati R, et al. Rapid method for screening dried blood samples on filter paper for human immunodeficiency virus type 1 DNA. J Clin Microbiol 1999;37:350-3. (Pubitemid 29056402)
31. Chohan BH, Emery S, Wamalwa D, et al. Evaluation of a single round polymerase chain reaction assay using dried blood spots for diagnosis of HIV-1 infection in infants in an African setting. BMC Pediatr 2011;11:18.
32. Kuhn L, Sinkala M, Kankasa C, et al. High uptake of exclusive breastfeeding and reduced early post-natal HIV transmission. PLoS One 2007;2:e1363.
33. Miotti PG, Taha TE, Kumwenda NI, et al. HIV transmission through breastfeeding: a study in Malawi. JAMA 1999;282:744-9. (Pubitemid 29404380)
34. Kumwenda NI, Hoover DR, Mofenson LM, et al. Extended antiretroviral prophylaxis to reduce breast-milk HIV-1 transmission. N Engl J Med 2008;359:119-29. (Pubitemid 351962035)
35. 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;11:171-80.
36. Taha TE, Kumwenda J, Cole SR, et al. Postnatal HIV-1 transmission after cessation of infant extended antiretroviral prophylaxis and effect of maternal highly active antiretroviral therapy. J Infect Dis 2009;200:1490-7.
37. Neveu D, Viljoen J, Bland RM, et al. Cumulative exposure to cell-free HIV in breast milk, rather than feeding pattern per se, identifies postnatally infected infants. Clin Infect Dis 2011;52:819-25.
38. Brown SD, Bartlett MG, White CA. Pharmacokinetics of intravenous acyclovir, zidovudine, and acyclovir-zidovudine in pregnant rats. Antimicrob Agents Chemother 2003;47:991-6. (Pubitemid 36254225)
39. Mitsuya H, Broder S. Strategies for antiviral therapy in AIDS. Nature 1987;325:773-8. (Pubitemid 17056472)
40. Collier AC, Bozzette S, Coombs RW, et al. A pilot study of low-dose zidovudine in human immunodeficiency virus infection. N Engl J Med 1990;323:1015-21. (Pubitemid 20336959)
41. Hollier L, Wendel G. Third trimester antiviral prophylaxis for preventing maternal genital herpes simplex virus (HSV) recurrences and neonatal infection. Cochrane Database Syst Rev 2008;1:CD004946.
42. Sheffield JS, Hill JB, Hollier LM, et al. Valacyclovir prophylaxis to prevent recurrent herpes at delivery: a randomized clinical trial. Obstet Gynecol 2006;108:141-7. (Pubitemid 44336857)
43. Ouedraogo A, Nagot N, Vergne L, et al. Impact of suppressive herpes therapy on genital HIV-1 RNA among women taking antiretroviral therapy: a randomized controlled trial. AIDS 2006;20:2305-13. (Pubitemid 44789532)
44. Mbori-Ngacha D, Richardson BA, Overbaugh J, et al. Short-term effect of zidovudine on plasma and genital human immunodeficiency virus type 1 and viral turnover in these compartments. J Virol 2003;77:7702-5. (Pubitemid 36734543)
45. Baeten JM, Lingappa J, Beck I, et al. Herpes simplex virus type 2 suppressive therapy with acyclovir or valacyclovir does not select for specific HIV-1 resistance in HIV-1/HSV-2 dually infected persons. J Infect Dis 2011;203:117-21.