Effectiveness

Nevirapine (Viramune) is able to reduce HIV-1 viral load and increase CD4 cell counts in the majority of people when taken in combination with at least two other antiretroviral drugs. Nevirapine is not active against HIV-2.

Nevirapine was licensed after three clinical trials found that the combination of nevirapine, AZT (zidovudine, Retrovir) and ddI (didanosine, Videx) brought about greater decreases in viral load and increases in CD4 cell counts than AZT and ddI taken without nevirapine in patients who had not taken antiretroviral therapy before. The triple combination also led to fewer cases of HIV disease progression.1 2 3

Several studies have reported that triple regimens including nevirapine are as effective as protease inhibitor-containing regimens.4 5 6 Concerns about the potency of nevirapine in people who begin treatment with high viral load have been dispelled by these studies.7 A recent study has also demonstrated that nevirapine is a safe and effective option for patients beginning therapy with a CD4 cell count below 200 cells/mm3.8

The latest research suggests that nevirapine-based regimens are not inferior to efavirenz (Sustiva)-based regimens in patients who have not taken HIV therapy before. The 2NN study found no significant difference between efavirenz and once and twice daily nevirapine when taken with d4T (stavudine, Zerit) and 3TC (lamivudine, Epivir) in terms of the percentage of patients with undetectable viral load at week 48, CD4 cell count increases and quality of life. Nevirapine-treated individuals were more likely to develop liver toxicity in this study, although Boehringer Ingelheim has claimed that this difference was driven by unusual findings from one of the study’s 65 centres, which contributed 17% of the study’s patients.9 10 11

Switching from a protease inhibitor to either nevirapine or efavirenz also appears to be equivalent in terms of virological response, although lipid levels may improve more after a switch to nevirapine.12 13 Patients who have switched from a protease inhibitor to nevirapine have been shown to have a high chance of virological suppression for over three years.14

Nevirapine can penetrate into the brain and spinal fluids, where it may have anti-HIV activity.15

In 2001, the United States Food and Drug Administration (FDA) recommended avoiding the use of nevirapine as post-exposure prophylaxis after reports of life-threatening side-effects, which may be more severe in HIV-negative people.16

References

  1. d'Aquila R et al. Nevirapine, zidovudine, and didanosine compared with zidovudine and didanosine in patients with HIV-1 infection. Ann Intern Med 124: 1019-1030, 1996
  2. Montaner JSG et al. A randomized, double-blind trial comparing combinations of nevirapine, didanosine, and zidovudine for HIV-infected patients. JAMA 279: 930-937, 1998
  3. Floridia M et al. A randomized, double-blind trial on the use of a triple combination including nevirapine, a nonnucleoside reverse transcriptase inhibitor, in antiretroviral-naive patients with advanced disease. J Acquir Immune Defic Syndr Hum Retrovirol 20: 11-19, 1999
  4. Squires K et al. The Atlantic Study: a randomized, open-labeled trial comparing two protease inhibitor (PI)-sparing anti-retroviral strategies versus a standard pi-containing regimen, final 48 week data. 13th International AIDS Conference, Durban, abstract LbPeB7046, 2000
  5. Guardiola J et al. A open-label, randomized, comparative study of stavudine (d4T) + didanosine (ddI) + indinavir (IDV) versus d4T + ddI + nevirapine (NVP) in treatment of HIV-infected naive patients. 40th Interscience Conference on Antimicrobial Agents and Chemotherapy, Toronto, abstract 539, 2000
  6. Chen SY et al. Which antiretroviral regimens yield the best odds of survival in San Francisco? 15th International AIDS Conference, Bangkok, abstract MoOrC1082, 2004
  7. Podzamczer D et al. A randomized clinical trial comparing nelfinavir or nevirapine associated to zidovudine/lamivudine in HIV-infected naive patients (the Combine Study). Antivir Ther 7: 81-90, 2002
  8. Ferrer E et al. Nevirapine-containing regimens in HIV-infected naïve patients with CD4 cell counts of 200 cells/mm3 or less. AIDS 18: 1727-1740, 2004
  9. van Leth F et al. 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: 1253-1263, 2004
  10. van Leth F et al. Quality of life in patients treated with first-line antiretroviral therapy containing nevirapine and / or efavirenz. Antivir Ther 9: 721-728, 2004
  11. Storfer S et al. Analysis of hepatic events within the 2NN study: controlling for geographic region and CD4+ cell count at initiation of nevirapine therapy. 45th Interscience Conference on Antimicrobial Agents and Chemotherapy, Washington, abstract LB-13, 2005
  12. Negredo E et al. Virological, immunological and clinical impact of switching from protease inhibitors to nevirapine or to efavirenz in patients with human immunodeficiency virus infection and long-lasting viral suppression. Clin Infect Dis 34: 540-510, 2002b
  13. Negredo E et al. Reversal of atherogenic lipoprotein profile in HIV-1 infected patients with lipodystrophy after replacing protease inhibitors by nevirapine. AIDS 16: 1383-1389, 2002
  14. Gil P et al. Long-term efficacy and safety of protease inhibitor switching to nevirapine in HIV-infected patients with undetectable virus load. Clin Infect Dis 39: 1024-1029, 2004
  15. Gibbs JE et al. Nevirapine uptake into the central nervous system of the guinea pig: an in situ brain perfusion study. J Pharmacol Exp Ther 317: 746-751, 2006
  16. Patel SM et al. Serious adverse cutaneous and hepatic toxicities associated with nevirapine use by non-HIV-infected individuals. J Acquir Immune Defic Syndr 35: 120-125, 2004
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