Antiretroviral drugs for prevention of mother-to-child transmission: Pharmacologic considerations for a public health approach

AIDS

Volumn 28, Issue 17, 2014, Pages 2551-2563

  Lamorde, Mohammed ^a   Schapiro, Jonathan M ^b   Burger, David ^c   Back, David J ^d  

^a MAKERERE UNIVERSITY COLLEGE OF HEALTH SCIENCES   (Uganda)

^b National Hemophilia Center   (Israel)

^c RADBOUD UNIVERSITY MEDICAL CENTER   (Netherlands)

^d UNIVERSITY OF LIVERPOOL   (United Kingdom)

Author keywords

Efavirenz; Infectious disease transmission; Vertical

Indexed keywords

ANTIRETROVIRUS AGENT; EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL; ZIDOVUDINE; ADENINE; BENZOXAZINE DERIVATIVE; PHOSPHONIC ACID DERIVATIVE;

ANTIVIRAL RESISTANCE; ANTIVIRAL THERAPY; ARTICLE; BREAST FEEDING; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; INFECTION RISK; PRIORITY JOURNAL; TREATMENT OUTCOME; VERTICAL TRANSMISSION; ADULT; ANALOGS AND DERIVATIVES; CHILD; DRUG EFFECTS; DRUG THERAPY; HIV INFECTIONS; HUMAN IMMUNODEFICIENCY VIRUS; ISOLATION AND PURIFICATION; PREVENTION AND CONTROL; PROCEDURES; PUBLIC HEALTH; TRANSMISSION; VIROLOGY;

ADENINE; ADULT; ANTI-RETROVIRAL AGENTS; BENZOXAZINES; CHILD; DRUG RESISTANCE, VIRAL; DRUG THERAPY; HIV; HIV INFECTIONS; HUMANS; INFECTIOUS DISEASE TRANSMISSION, VERTICAL; LAMIVUDINE; ORGANOPHOSPHONATES; PUBLIC HEALTH;

EID: 84927744186     PISSN: 02699370     EISSN: 14735571     Source Type: Journal    
DOI: 10.1097/QAD.0000000000000439     Document Type: Article

References (66)

1. WHO. Towards universal access scaling up priority HIV/AIDS interventions in the health sector: progress report 2010. Geneva: World Health Organization; 2010.
2. WHO. Antiretroviral drugs for treating pregnant women and preventing HIV infection in infants: towards universal access. Recommendations for a public health approach (2010 version). Geneva: World Health Organization; 2010.
3. WHO. Technical update on treatment optimization. Use of efavirenz during pregnancy: a public health perspective. Geneva: World Health Organization; 2012.
4. WHO. Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection recommendations for a public health approach. Geneva: World Health Organization; 2013.
5. Arrive E. Newell ML. Ekouevi DK. Chaix ML. Thiebaut R. Masquelier B. et al. Prevalence of resistance to nevirapine in mothers and children after single-dose exposure to prevent vertical transmission of HIV-1: a meta-analysis. Int J Epidemiol 2007; 36: 1009-1021.
6. 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-to-child transmission of HIV-1 in Kampala. Uganda: HIVNET 012 randomised trial. Lancet 1999; 354: 795-802.
7. de Bethune MP. Nonnucleoside reverse transcriptase inhibitors (NNRTIs). their discovery. development. and use in the treatment of HIV-1 infection: a review of the last 20 years (1989-2009). Antiviral Res 2010; 85: 75-90.
8. 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: 493-505.
9. Shah M. Johns B. Abimiku A. Walker DG. Cost-effectiveness of new WHO recommendations for prevention of mother-tochild transmission of HIV in a resource-limited setting. AIDS 2011; 25: 1093-1102.
10. Kuznik A. Lamorde M. Hermans S. Castelnuovo B. Auerbach B. Semeere A. et al. Evaluating the cost-effectiveness of combination antiretroviral therapy for the prevention of mother-tochild transmission of HIV in Uganda. Bull World Health Organ 2012; 90: 595-603.
11. Taylor S. Boffito M. Khoo S. Smit E. Back D. Stopping antiretroviral therapy. AIDS 2007; 21: 1673-1682.
12. Mackie NE. Fidler S. Tamm N. Clarke JR. Back D. Weber JN. Taylor GP. Clinical implications of stopping nevirapine-based antiretroviral therapy: relative pharmacokinetics and avoidance of drug resistance. HIV Med 2004; 5: 180-184.
13. Hsiou Y. Ding J. Das K. Clark AD Jr. Hughes SH. Arnold E. Structure of unliganded HIV-1 reverse transcriptase at 2.7 A resolution: implications of conformational changes for polymerization and inhibition mechanisms. Structure 1996; 4: 853-860.
14. Sluis-Cremer N. Temiz NA. Bahar I. Conformational changes in HIV-1 reverse transcriptase induced by nonnucleoside reverse transcriptase inhibitor binding. Curr HIV Res 2004; 2: 323-332.
15. Ribaudo HJ. Haas DW. Tierney C. Kim RB. Wilkinson GR. Gulick RM. et al. Pharmacogenetics of plasma efavirenz exposure after treatment discontinuation: an Adult AIDS Clinical Trials Group Study. Clin Infect Dis 2006; 42: 401-407.
16. Taylor S. Jayasuriya A. Fisher M. Allan S. Wilkins E. Gilleran G. et al. Lopinavir/ritonavir single agent therapy as a universal combination antiretroviral therapy stopping strategy: results from the STOP 1 and STOP 2 studies. J Antimicrob Chemother 2012; 67: 675-680.
17. Marzolini C. Telenti A. Decosterd LA. Greub G. Biollaz J. Buclin T. Efavirenz plasma levels can predict treatment failure and central nervous system side effects in HIV-1-infected patients. AIDS 2001; 15: 71-75.
18. Bristol-Myers Squibb. Sustiva (efavirenz) capsules and tablets. Full prescribing information. Princeton. NJ: Bristol-Myers Squibb Company; 2010.
19. Venkatakrishnan K. Von Moltke LL. Greenblatt DJ. Human drug metabolism and the cytochromes P450: application and relevance of in vitro models. J Clin Pharmacol 2001; 41: 1149-1179.
20. Haas DW. Ribaudo HJ. Kim RB. Tierney C. Wilkinson GR. Gulick RM. et al. Pharmacogenetics of efavirenz and central nervous system side effects: an Adult AIDS Clinical Trials Group study. AIDS 2004; 18: 2391-2400.
21. Ribaudo HJ. Liu H. Schwab M. Schaeffeler E. Eichelbaum M. Motsinger-Reif AA. et al. Effect of CYP2B6. ABCB1. and CYP3A5 polymorphisms on efavirenz pharmacokinetics and treatment response: an AIDS Clinical Trials Group study. J Infect Dis 2010; 202: 717-722.
22. Jackson A. Moyle G. Watson V. Tjia J. Ammara A. Back D. et al. (2012) Tenofovir (TFV). emtricitabine (FTC) intracellular (IC) and plasma. and efavirenz (EFV) plasma concentration decay following drug intake cessation: implications for HIV treatment and prevention. 19th CROI; Seattle. WA. March 5-8. 2012.
23. Pruvost A. Negredo E. Theodoro F. Puig J. Levi M. Ayen R. et al. Pilot pharmacokinetic study of human immunodeficiency virus-infected patients receiving tenofovir disoproxil fumarate (TDF): investigation of systemic and intracellular interactions between TDF and abacavir. lamivudine. or lopinavir-ritonavir. Antimicrob Agents Chemother 2009; 53: 1937-1943.
24. Anderson PL. Kiser JJ. Gardner EM. Rower JE. Meditz A. Grant RM. Pharmacological considerations for tenofovir and emtricitabine to prevent HIV infection. J Antimicrob Chemother 2011; 66: 240-250.
25. Theys K. Vercauteren J. Snoeck J. Zazzi M. Camacho RJ. Torti C. et al. HIV-1 subtype is an independent predictor of reverse transcriptase mutation K65R in HIV-1 patients treated with combination antiretroviral therapy including tenofovir. Antimicrob Agents Chemother 2013; 57: 1053-1056.
26. Anderson PL. Rower JE. Zidovudine and lamivudine for HIV infection. Clin Med Rev Ther 2010; 2: a2004.
27. Anderson PL. Kakuda TN. Kawle S. Fletcher CV. Antiviral dynamics and sex differences of zidovudine and lamivudine triphosphate concentrations in HIV-infected individuals. AIDS 2003; 17: 2159-2168.
28. Aweeka FT. Rosenkranz SL. Segal Y. Coombs RW. Bardeguez A. Thevanayagam L. et al. The impact of sex and contraceptive therapy on the plasma and intracellular pharmacokinetics of zidovudine. AIDS 2006; 20: 1833-1841.
29. Rower JE. Meditz A. Gardner EM. Lichtenstein K. Predhomme J. Bushman LR. et al. Effect of HIV-1 infection and sex on the cellular pharmacology of the antiretroviral drugs zidovudine and lamivudine. Antimicrob Agents Chemother 2012; 56: 3011-3019.
30. Maserati R. De Silvestri A. Uglietti A. Colao G. Di Biagio A. Bruzzone B. et al. Emerging mutations at virological failure of HAART combinations containing tenofovir and lamivudine or emtricitabine. AIDS 2010; 24: 1013-1018.
31. Marcelin AG. Charpentier C. Wirden M. Landman R. Valantin MA. Simon A. et al. Resistance profiles of emtricitabine and lamivudine in tenofovir-containing regimens. J Antimicrob Chemother 2012; 67: 1475-1478.
32. McColl DJ. Margot N. Chen SS. Harris J. Borroto-Esoda K. Miller MD. Reduced emergence of the M184V/I resistance mutation when antiretroviral-naive subjects use emtricitabine versus lamivudine in regimens composed of two NRTIs plus the NNRTI efavirenz. HIV Clin Trials 2011; 12: 61-70.
33. Borroto-Esoda K. Vela JE. Myrick F. Ray AS. Miller MD. In vitro evaluation of the anti-HIV activity and metabolic interactions of tenofovir and emtricitabine. Antivir Ther 2006; 11: 377-384.
34. Delobel P. Saliou A. Nicot F. Dubois M. Trancart S. Tangre P. et al. Minor HIV-1 variants with the K103N resistance mutation during intermittent efavirenz-containing antiretroviral therapy and virological failure. PLoS One 2011; 6: e21655.
35. Trancart S. Charreau I. Marchou B. Bocquentin M. Molina JM. Izopet J. et al. Presence of lamivudine or emtricitabine is associated with reduced emergence of nonnucleoside reverse transcriptase inhibitor mutations in an efavirenz-based intermittent antiretroviral treatment regimen. Antimicrob Agents Chemother 2012; 56: 1655-1657.
36. Fox Z. Phillips A. Cohen C. Neuhaus J. Baxter J. Emery S. et al. Viral resuppression and detection of drug resistance following interruption of a suppressive nonnucleoside reverse transcriptase inhibitor-based regimen. AIDS 2008; 22: 2279-2289.
37. Geretti AM. Fox Z. Johnson JA. Booth C. Lipscomb J. Stuyver LJ. et al. Sensitive assessment of the virologic outcomes of stopping and restarting nonnucleoside reverse transcriptase inhibitorbased antiretroviral therapy. PLoS One 2013; 8: e69266.
38. Danel C. Moh R. Chaix ML. Gabillard D. Gnokoro J. Diby CJ. et al. Two-months-off. four-months-on antiretroviral regimen increases the risk of resistance. compared with continuous therapy: a randomized trial involving West African adults. J Infect Dis 2009; 199: 66-76.
39. Darwich L. Esteve A. Ruiz L. Bellido R. Clotet B. Martinez-Picado J. Variability in the plasma concentration of efavirenz and nevirapine is associated with genotypic resistance after treatment interruption. Antivir Ther 2008; 13: 945-951.
40. 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: 293-297.
41. Ananworanich J. Nuesch R. Le Braz M. Chetchotisakd P. Vibhagool A. Wicharuk S. et al. Failures of 1 week on. 1 week off antiretroviral therapies in a randomized trial. AIDS 2003; 17: F33-F37.
42. Cressey TR. Green H. Khoo S. Treluyer JM. Compagnucci A. Saidi Y. et al. Plasma drug concentrations and virologic evaluations after stopping treatment with nonnucleoside reversetranscriptase inhibitors in HIV type 1-infected children. Clin Infect Dis 2008; 46: 1601-1608.
43. Pirillo M. Palmisano L. Pellegrini M. Galluzzo C. Weimer L. Bucciardini R. et al. Nonnucleoside reverse transcriptase inhibitor concentrations during treatment interruptions and the emergence of resistance: a substudy of the ISS-PART Trial. AIDS Res Hum Retroviruses 2010; 26: 541-545.
44. Imaz A. Olmo M. Penaranda M. Gutierrez F. Romeu J. Larrousse M. et al. Evolution of HIV-1 genotype in plasma RNA and peripheral blood mononuclear cells proviral DNA after interruption and resumption of antiretroviral therapy. Antivir Ther 2012; 17: 577-583.
45. Sadiq ST. Fredericks S. Khoo SH. Rice P. Holt DW. Efavirenz detectable in plasma 8 weeks after stopping therapy and subsequent development of nonnucleoside reverse transcriptase inhibitor-associated resistance. AIDS 2005; 19: 1716-1717.
46. Mukonzo JK. Nanzigu S. Rekic D. Waako P. Roshammar D. Ashton M. et al. HIV/AIDS patients display lower relative bioavailability of efavirenz than healthy subjects. Clin Pharmacokinet 2011; 50: 531-540.
47. Pennings PS. Standing genetic variation and the evolution of drug resistance in HIV. PLoS Comput Biol 2012; 8: e1002527.
48. Hebert MF. Easterling TR. Kirby B. Carr DB. Buchanan ML. Rutherford T. et al. Effects of pregnancy on CYP3A and P-glycoprotein activities as measured by disposition of midazolam and digoxin: a University of Washington specialized center of research study. Clin Pharmacol Ther 2008; 84: 248-253.
49. Mirochnick M. Capparelli E. Pharmacokinetics of antiretrovirals in pregnant women. Clin Pharmacokinet 2004; 43: 1071-1087.
50. Acosta EP. Zorrilla C. Van Dyke R. Bardeguez A. Smith E. Hughes M. et al. Pharmacokinetics of saquinavir-SGC in HIV-infected pregnant women. HIV Clin Trials 2001; 2: 460-465.
51. Syme MR. Paxton JW. Keelan JA. Drug transfer and metabolism by the human placenta. Clin Pharmacokinet 2004; 43: 487-514.
52. Cressey TR. Stek A. Capparelli E. Bowonwatanuwong C. Prommas S. Sirivatanapa P. et al. Efavirenz pharmacokinetics during the third trimester of pregnancy and postpartum. J Acquir Immune Defic Syndr 2012; 59: 245-252.
53. Wind-Rotolo M. Durand C. Cranmer L. Reid A. Martinson N. Doherty M. et al. Identification of nevirapine-resistant HIV-1 in the latent reservoir after single-dose nevirapine to prevent mother-to-child transmission of HIV-1. J Infect Dis 2009; 199: 1301-1309.
54. Goodman DD. Zhou Y. Margot NA. McColl DJ. Zhong L. Borroto-Esoda K. et al. Low level of the K103N HIV-1 above a threshold is associated with virological failure in treatmentnaive individuals undergoing efavirenz-containing therapy. AIDS 2011; 25: 325-333.
55. Fasawe O. Avila C. Shaffer N. Schouten E. Chimbwandira F. Hoos D. et al. Cost-effectiveness analysis of Option BR for HIV prevention and treatment of mothers and children in Malawi. PLoS One 2013; 8: e57778.
56. Gopalappa C. Stover J. Shaffer N. Mahy M. The costs and benefits of Option BR for the prevention of mother-to-child transmission of HIV. AIDS 2014; 28 (Suppl 1): S5-S14.
57. O'Brien L. Shaffer N. Sangrujee N. Abimbola TO. The incremental cost of switching from Option B to Option BR for the prevention of mother-to-child transmission of HIV. Bull World Health Organ 2014; 92: 162-170.
58. Garcia-Diaz A. Lok CB. Madge S. Booth C. Tyrer M. Bonora S. et al. Detection of low-frequency K103N mutants after unstructured discontinuation of efavirenz in the presence of the CYP2B6 516 TT polymorphism. J Antimicrob Chemother 2008; 62: 1188-1190.
59. Dybul M. Nies-Kraske E. Dewar R. Maldarelli F. Hallahan CW. Daucher M. et al. A proof-of-concept study of short-cycle intermittent antiretroviral therapy with a once-daily regimen of didanosine. lamivudine. and efavirenz for the treatment of chronic HIV infection. J Infect Dis 2004; 189: 1974-1982.
60. Paredes R. Cheng I. Kuritzkes DR. Tuomala RE. Postpartum antiretroviral drug resistance in HIV-1-infected women receiving pregnancy-limited antiretroviral therapy. AIDS 2010; 24: 45-53.
61. Perez H. Vignoles M. Laufer N. Gomez A. Coll P. Lottner J. et al. Low rate of emergence of nevirapine and lamivudine resistance after postpartum interruption of a triple-drug regimen. Antivir Ther 2008; 13: 135-139.
62. Lehman DA. Chung MH. Mabuka JM. John-Stewart GC. Kiarie J. Kinuthia J. Overbaugh J. Lower risk of resistance after shortcourse HAART compared with zidovudine/single-dose nevirapine used for prevention of HIV-1 mother-to-child transmission. J Acquir Immune Defic Syndr 2009; 51: 522-529.
63. Lyons FE. Coughlan S. Byrne CM. Hopkins SM. Hall WW. Mulcahy FM. Emergence of antiretroviral resistance in HIVpositive women receiving combination antiretroviral therapy in pregnancy. AIDS 2005; 19: 63-67.
64. Chi BH. Sinkala M. Mbewe F. Cantrell RA. Kruse G. Chintu N. et al. Single-dose tenofovir and emtricitabine for reduction of viral resistance to nonnucleoside reverse transcriptase inhibitor drugs in women given intrapartum nevirapine for perinatal HIV prevention: an open-label randomised trial. Lancet 2007; 370: 1698-1705.
65. Chi BH. Ellis GM. Chintu N. Cantrell RA. Sinkala M. Aldrovandi GM. et al. Intrapartum tenofovir and emtricitabine reduces low-concentration drug resistance selected by singledose nevirapine for perinatal HIV prevention. AIDS Res Hum Retroviruses 2009; 25: 1099-1106.
66. Arrive E. Chaix ML. Nerrienet E. Blanche S. Rouzioux C. Avit D. et al. Maternal and nenonatal tenofovir and emtricitabine to prevent vertical transmission of HIV-1: tolerance and resistance. AIDS 2010; 24: 2481-2488.