Nevirapine-Based Regimens in HIV-Infected Antiretroviral-Naive Patients: Systematic Review and Meta-Analysis of Randomized Controlled Trials

PLoS ONE

Volumn 8, Issue 10, 2013, Pages

  Kawalec, Paweł ^a,b   Kryst, Joanna ^b   Mikrut, Alicja ^b   Pilc, Andrzej ^a,c  

^a JAGIELLONIAN UNIVERSITY   (Poland)

^b Techmo sp z oo   (Poland)

^c INSTITUTE OF PHARMACOLOGY   (Poland)

Author keywords

[No Author keywords available]

Indexed keywords

ABACAVIR PLUS DIDANOSINE PLUS LAMIVUDINE; ABACAVIR PLUS LAMIVUDINE PLUS STAVUDINE; ANTIRETROVIRUS AGENT; ATAZANAVIR PLUS EMTRICITABINE PLUS RITONAVIR PLUS TENOFOVIR; DIDANOSINE PLUS LAMIVUDINE; DIDANOSINE PLUS LAMIVUDINE PLUS NEVIRAPINE; DIDANOSINE PLUS LAMIVUDINE PLUS RITONAVIR PLUS SAQUINAVIR; DIDANOSINE PLUS NEVIRAPINE PLUS STAVUDINE; DIDANOSINE PLUS ZIDOVUDINE; EFAVIRENZ; EMTRICITABINE PLUS LOPINAVIR PLUS NEVIRAPINE PLUS TENOFOVIR; EMTRICITABINE PLUS NEVIRAPINE PLUS TENOFOVIR; LAMIVUDINE PLUS NEVIRAPINE PLUS STAVUDINE; LAMIVUDINE PLUS NEVIRAPINE PLUS ZIDOVUDINE; LAMIVUDINE PLUS STAVUDINE PLUS ZIDOVUDINE; LAMIVUDINE PLUS ZIDOVUDINE; NEVIRAPINE; NONNUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITOR; PROMECO; PROTEINASE INHIBITOR; RITONAVIR; UNCLASSIFIED DRUG; VIRUS RNA;

ARTICLE; COMBINATION CHEMOTHERAPY; DISEASE COURSE; DRUG EFFICACY; DRUG SAFETY; HIGH RISK PATIENT; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; INFECTION RISK; META ANALYSIS (TOPIC); MONOTHERAPY; MORTALITY; RANDOMIZED CONTROLLED TRIAL (TOPIC); SYSTEMATIC REVIEW; TREATMENT DURATION; UNSPECIFIED SIDE EFFECT; VIRUS LOAD;

ANTI-HIV AGENTS; BENZOXAZINES; DRUG THERAPY, COMBINATION; HIV INFECTIONS; HIV PROTEASE INHIBITORS; HUMANS; NEVIRAPINE; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RITONAVIR; TREATMENT OUTCOME;

EID: 84885073514     PISSN: None     EISSN: 19326203     Source Type: Journal    
DOI: 10.1371/journal.pone.0076587     Document Type: Article

References (44)

1. Reynolds C, de Koning CB, Pelly SC, van Otterlo WA, Bode ML, (2012) In search of a treatment for HIV-current therapies and the role of non-nucleoside reverse transcriptase inhibitors (NNRTIs). Chem Soc Rev 41(13):: 4657-4670. doi:10.1039/c2cs35058k. PubMed: 22618809.
2. Thompson MA, Aberg JA, Hoy JF, Telenti A, Benson C, et al. (2012) Antiretroviral treatment of adult HIV infection: 2012 recommendations of the International Antiviral Society-USA panel. JAMA 308(4):: 387-402. doi:10.1001/jama.2012.7961. PubMed: 22820792.
3. Panel on Antiretroviral Guidelines for Adults and Adolescents Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents Department of Health and Human Services. Available: http://aidsinfo.nih.gov/ContentFiles/. AdultandAdolescentGL pdf Accessed March 17 (2013).
4. Parienti JJ, Peytavin G, (2011) Nevirapine once daily: pharmacology, metabolic profile and efficacy data of the new extended-release formulation. Expert Opin Drug Metab Toxicol 7(4):: 495-503. doi:10.1517/17425255.2011.565331. PubMed: 21417819.
5. FDA resources page; Food and Drug Administration Web site. Available: http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/HIVandAIDSActivities/ucm248800.htm. Accessed January 25, 2013.
6. Wester CW, Kim S, Bussmann H, Avalos A, Ndwapi N, et al. (2005) Initial response to highly active antiretroviral therapy in HIV-1C-infected adults in a public sector treatment program in Botswana. J Acquir Immune Defic Syndr 40: 336-343. doi:10.1097/01.qai.0000159668.80207.5b. PubMed: 16249709.
7. Stringer JS, Zulu I, Levy J, Stringer EM, Mwango A, et al. (2006) Rapid scale-up of antiretroviral therapy at primary care sites in Zambia: feasibility and early outcomes. JAMA 296: 782-793. doi:10.1001/jama.296.7.782. PubMed: 16905784.
8. Moher D, Liberati A, Tetzlaff J, Altman DG, the Prisma Group (2010) Preferred reporting items for systematic reviews and meta-analyses: The PRISMA statement. Int J Surg 8(5):: 336-341. doi:10.1016/j.ijsu.2010.02.007. PubMed: 20171303.
9. Higgins JPT, Green S, (2011) Cochrane handbook for systematic reviews of interventions, version 5.1.0 [updated March 2011]. Cochrane Collaboration and John Wiley. Available: www.cochrane-handbook.org.
10. Jadad AR, Moore RA, Carroll D, Jenkinson C, Reynolds JM, et al. (1996) Assessing the quality of reports of randomized clinical trials: is blinding necessary? Control Clin Trials 17(1):: 1-12. doi:10.1016/0197-2456(95)00134-4. PubMed: 8721797.
11. Centers for Disease Control (1992) 1993 revised classification system for HIV infection and expanded surveillance case definition for AIDS among adolescents and adults. MMWR Recomm Rep 41Volumes RR-17: 1-19. PubMed: 1361652.
12. Albert JM, Conway B, Ioannidis JP, Reichelderfer P, (1998) Statistical issues for HIV surrogate endpoints: point/counterpoint. An NIAID Workshop. Stat Med 17(21):: 2435-2462. doi:10.1002/(SICI)1097-0258(19981115)17:21. PubMed: 9819838.
13. Raboud JM, Montaner JS, Conway B, Rae S, Reiss P, et al. (1998) Suppression of plasma viral load below 20 copies/ml is required to achieve a long-term response to therapy. AIDS 12(13):: 1619-1624. doi:10.1097/00002030-199813000-00008. PubMed: 9764780.
14. Raboud JM, Rae S, Montaner JS, The Incas Avanti Study Groups (2000) Predicting HIV RNA virologic outcome at 52-weeks follow-up in antiretroviral clinical trials. J Acquir Immune Defic Syndr 24(5):: 433-439. doi:10.1097/00042560-200008150-00006. PubMed: 11035613.
15. Gaytán JJA, Garza ERZ, Garcia MC, Chavez SBV, (2004) Nevirapine or efavirenz in combination with two nucleoside analogues in HIV-infected antiretroviral-naive patients. Med Int Mex 20(1):: 29-33.
16. Núñez M, Soriano V, Martín-Carbonero L, Barrios AA, Barreiro PP, et al. (2002) SENC (Spanish efavirenz vs. nevirapine comparison) trial: a randomized, open-label study in HIV-infected naive individuals. HIV. Clin Trials 3(3):: 186-194. doi:10.1310/0CJ5-2ABQ-CB00-6MR6.
17. van den Berg-Wolf M, Hullsiek KH, Peng G, Kozal MJ, Novak RM, et al. (2008) Virologic, immunologic, clinical, safety, and resistance outcomes from a long-term comparison of efavirenz-based versus nevirapine-based antiretroviral regimens as initial therapy in HIV-1-infected persons. HIV. Clin Trials 9(5):: 324-336. doi:10.1310/hct0905-324.
18. MacArthur RD, Novak RM, Peng G, Chen L, Xiang Y, et al. (2006) A comparison of three highly active antiretroviral treatment strategies consisting of non-nucleoside reverse transcriptase inhibitors, protease inhibitors, or both in the presence of nucleoside reverse transcriptase inhibitors as initial therapy (CPCRA 058 FIRST Study): a long-term randomised trial. Lancet 368(9553):: 2125-2135. doi:10.1016/S0140-6736(06)69861-9. PubMed: 17174704.
19. van Leth F, Phanuphak P, Ruxrungtham K, Baraldi E, Miller S, et al. (2004) Comparison of first-line antiretroviral therapy with regimens including nevirapine, efavirenz, or both drugs, plus stavudine and lamivudine: a randomised open-label trial, The 2NN Study. Lancet 363(9417):: 1253-1263. doi:10.1016/S0140-6736(04)15997-7. PubMed: 15094269.
20. Wester CW, Thomas AM, Bussmann H, Moyo S, Makhema JM, et al. (2010) Non-nucleoside reverse transcriptase inhibitor outcomes among combination antiretroviral therapy-treated adults in Botswana. AIDS 24 (Suppl 1)():: S27-S36. doi:10.1097/01.aids.0000390705.73759.2c. PubMed: 20023437.
21. Dejesus E, Mills A, Bhatti L, Conner C, Storfer S, (2011) A randomised comparison of safety and efficacy of nevirapine vs. atazanavir/ritonavir combined with tenofovir/emtricitabine in treatment-naïve patients. Int J Clin Pract 65(12):: 1240-1249. doi:10.1111/j.1742-1241.2011.02807.x. PubMed: 21999631.
22. Harris M, Côté H, Ochoa C, Allavena C, Negredo E, et al. (2009) A randomized, open-label study of a nucleoside analogue reverse transcriptase inhibitor sparing regimen in antiretroviral-naive HIV-infected patients. J Acquir Immune Defic Syndr 50(3):: 335-337. doi:10.1097/QAI.0b013e3181938fc9. PubMed: 19242263.
23. Lapadula G, Costarelli S, Quiros-Roldan E, Calabresi A, Izzo I, et al. (2008) Risk of early virological failure of once-daily tenofovir-emtricitabine plus twice-daily nevirapine in antiretroviral therapy-naive HIV-infected patients. Clin Infect Dis 46(7):: 1127-1129. doi:10.1086/529394. PubMed: 18444839.
24. Lockman S, Hughes MD, McIntyre J, Zheng Y, Chipato T, et al. (2010) Antiretroviral therapies in women after single-dose nevirapine exposure. N Engl J Med 363(16):: 1499-1509. doi:10.1056/NEJMoa0906626. PubMed: 20942666.
25. Lockman S, Hughes M, Sawe F, Zheng Y, McIntyre J, et al. (2012) Nevirapine- versus lopinavir/ritonavir-based initial therapy for HIV-1 infection among women in Africa: a randomized trial. PLOS Med 9(6):: e1001236. PubMed: 22719231.
26. Lowe SH, Wensing AM, Hassink EA, ten Kate RW, Richter C, et al. (2005) Comparison of two once-daily regimens with a regimen consisting of nelfinavir, didanosine, and stavudine in antiretroviral therapy-naïve adults: 48-week results from the Antiretroviral Regimen Evaluation Study (ARES). HIV. Clin Trials 6(5):: 235-245. doi:10.1310/A686-M37Y-J2PT-E9GJ.
27. Soriano V, Arastéh K, Migrone H, Lutz T, Opravil M, et al. (2011) Nevirapine versus atazanavir/ritonavir, each combined with tenofovir disoproxil fumarate/emtricitabine, in antiretroviral-naive HIV-1 patients: the ARTEN Trial. Antivir Ther 16(3):: 339-348. doi:10.3851/IMP1745. PubMed: 21555816.
28. Mbuagbaw LC, Irlam JH, Spaulding A, Rutherford GW, Siegfried N, (2010) Efavirenz or nevirapine in three-drug combination therapy with two nucleoside-reverse transcriptase inhibitors for initial treatment of HIV infection in antiretroviral-naïve individuals. Cochrane Database Syst Rev 12CD004246: CD004246 PubMed: 21154355.
29. World Health Organization (2010) Antiretroviral therapy for HIV infection in adults and adolescents: recommendations for a public health approach-2010 rev. WHO Guidelines.
30. Siegfried NL, Van Deventer PJ, Mahomed FA, Rutherford GW, (2006) Stavudine, lamivudine and nevirapine combination therapy for treatment of HIV infection and AIDS in adults. Cochrane Database Syst Rev 2CD004535: CD004535 PubMed: 16625606.
31. Raboud JM, Rae S, Vella S, Harrigan PR, Bucciardini R, et al. (1999) Meta-analysis of two randomized controlled trials comparing combined zidovidine and didanosine therapy with combined zidovidine, didanosine, and nevirapine therapy in patients with HIV. J Acquir Immune Defic Syndr 22(3):: 260-266. doi:10.1097/00126334-199911010-00007. PubMed: 10770346.
32. Bartlett JA, Chen SS, Quinn JB, (2007) Comparative Efficacy of Nucleoside/Nicleotide Reverse Transcriptase Inhibitors in Combination with Efavirenz: Results of Systematic Overview. HIV. Clin Trials 8(4):: 221-226. doi:10.1310/hct0804-221.
33. Bucher HC, Guyatt GH, Griffith LE, Walter SD, (1997) The results of direct and indirect treatment comparisons in meta-analysis of randomized controlled trials. J Clin Epidemiol 50(6):: 683-691. doi:10.1016/S0895-4356(97)00049-8. PubMed: 9250266.
34. Song F, Altman DG, Glenny AM, Deeks JJ, (2003) Validity of indirect comparison for estimating efficacy of competing interventions: empirical evidence from published meta-analyses. BMJ 326(7387):: 472. doi:10.1136/bmj.326.7387.472. PubMed: 12609941.
35. Ioannidis JP, (2006) Indirect comparisons: the mesh and mess of clinical trials. Lancet 368: 1470-1472. doi:10.1016/S0140-6736(06)69615-3. PubMed: 17071265.
36. Chou R, Fu R, Huffman LH, Korthuis PT, (2006) Initial highly-active antiretroviral therapy with a protease inhibitor versus a non-nucleoside reverse transcriptase inhibitor: discrepancies between direct and indirect meta-analyses. Lancet 368(9546):: 1503-1515. doi:10.1016/S0140-6736(06)69638-4. PubMed: 17071284.
37. de Beaudrap P, Etard JF, Guèye FN, Guèye M, Landman R, et al. (2008) Long-term efficacy and tolerance of efavirenz- and nevirapine-containing regimens in adult HIV type 1 Senegalese patients. AIDS Res Hum Retrovir 24(6):: 753-760. doi:10.1089/aid.2007.0295. PubMed: 18507521.
38. Patel AK, Pujari S, Patel K, Patel J, Shah N, et al. (2006) Nevirapine versus efavirenz based antiretroviral treatment in naive Indian patients: comparison of effectiveness in clinical cohort. J Assoc Physicians India 54: 915-918. PubMed: 17334006.
39. HIV-CAUSAL Collaboration (2012) The effect of efavirenz versus nevirapine-containing regimens on immunologic, virologic and clinical outcomes in a prospective observational study. AIDS 26(13) (1691-1705).
40. Reekie J, Reiss P, Ledergerber B, Sedlacek D, Parczewski M, et al. (2011) A comparison of the long-term durability of nevirapine, efavirenz and lopinavir in routine clinical practice in Europe: a EuroSIDA study. HIV Med 12(5):: 259-268. doi:10.1111/j.1468-1293.2010.00877.x. PubMed: 20812948.
41. Sanne I, (2000) Severe liver toxicity in patients receiving two nucleoside analogues and a non-nucleoside reverse transcriptase inhibitor [abstract PL 9.3]. AIDS 14 (Suppl 4)():: S12.
42. Zhou J, Phanupak P, Kiertiburanakul S, Ditangco R, Kamarulzaman A, et al. (2006) Highly active antiretroviral treatment containing efavirenz or nevirapine and related toxicity in the TREAT Asia HIV Observational Database. J Acquir Immune Defic Syndr 43(4):: 501-503. doi:10.1097/01.qai.0000243109.33759.81. PubMed: 17099317.
43. Nevirapine Teva (2013) Summary of Product; Characteristic,. Available: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/001119/WC500041898.pdf. Accessed January 25, 2013.
44. Coster LO, Kumar PN, (2012) Contemporary role of nevirapine in HIV treatment. AIDS Res 14(2):: 132-144. PubMed: 22627609.