Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2017 Dec 11;17(1):761.
doi: 10.1186/s12879-017-2864-0.

Nevirapine- versus Efavirenz-based antiretroviral therapy regimens in antiretroviral-naive patients with HIV and Tuberculosis infections in India: a multi-centre study

Sanjeev Sinha  1 , Kartik Gupta  2 , Srikanth Tripathy  3 , Sahajal Dhooria  2 , Sanjay Ranjan  2 , R M Pandey  4
Affiliations
Randomized Controlled Trial

Nevirapine- versus Efavirenz-based antiretroviral therapy regimens in antiretroviral-naive patients with HIV and Tuberculosis infections in India: a multi-centre study

Sanjeev Sinha et al. BMC Infect Dis. .

Abstract

Background: According to World Health Organization (WHO) guidelines, which have also been adopted by the National AIDS Control Organization (NACO), India, Efavirenz-based Anti-Retroviral Therapy (ART) is better in Human-Immunodeficiency-Virus (HIV)-infected patients who are also being treated with Rifampicin-based Anti-Tuberculous Therapy (ATT). However, Efavirenz is much more expensive. We hypothesize that Nevirapine is a cheaper alternative that possesses equal efficacy as Efavirenz in HIV-Tuberculosis (TB) co-infected patients.

Methods: A parallel open-label randomized clinical trial was conducted at All India Institute of Medical Sciences (AIIMS), New Delhi and National AIDS Research Institute (NARI), Pune. Those who were ART-naïve and co-infected with TB were randomized to receive either Nevirapine (Group 1)- or Efavirenz (Group 2)-based ART along with Rifampicin-based ATT. ATT was begun first in ART-naïve patients according to the NACO guidelines, with a median of 27 days between ATT and ART in both groups. The primary endpoint was a composite unfavourable outcome (death and/or ART failure) at 96 weeks, and the secondary outcome was successful TB treatment at 48 weeks.

Results: A total of 284 patients (mean age 36.7 ± 8.1 years) were randomized in a 1:1 ratio to receive either Nevirapine (n = 144)- or Efavirenz (n = 140)-based ART after a median ATT-ART gap of 27 days. The median CD4 count was 105 cells/μl, with a median viral load of 820,200 copies/μl and no significant difference between the groups. Composite unfavourable outcomes were reported in 49 patients in the Nevirapine group and 51 patients in the Efavirenz group (35.3% vs. 36.9%; hazard ratio, 0.95, 95% confidence interval (CI), 0.63,1.43, adjusted). There was no difference in successful TB treatment outcome between the groups (71.5% vs. 65.6%, 95% CI -3.8,17.9, adjusted). The results were similar, showing no difference between the groups in the two centres of the study after adjusting for disease stage.

Conclusions: Composite unfavourable outcome in HIV-TB co-infected patients who were ART-naïve showed no statistically significant difference in the Nevirapine or Efavirenz groups.. Therefore, Nevirapine-based ART is a reasonable alternative to Efavirenz in resource-limited settings. However, multi-centric studies with larger sample sizes are required to confirm these findings.

Trial registration: NCT01805258 (Retrospectively registered on March 6, 2013) Date of registration: March 2013.

Keywords: ART naïve; ATT; Antiretroviral; Efavirenz; Nevirapine; Tuberculosis.

PubMed Disclaimer

Conflict of interest statement

Ethics approval and consent to participate

This study has been approved by the Institute Ethics Committee, All-India Institute of Medical Sciences, New Delhi, India. Before the start of the study, all participants provided written informed consent. Participants were informed that they had the right to discontinue their participation or withdraw from the study at any time.

Consent for publication

Consent was taken from both the ethics committee and the subjects at the time of enrolment.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Study Flow chart
Fig. 2
Fig. 2
Kaplan-Meier survival curve with cumulative probability of composite unfavorable outcome (death and or ART failure at 24 months)
Fig. 3
Fig. 3
CD4 cell count at follow-up intervals of 6 months in Nevirapine (NVP) and Efavirenz (EFV) group
Fig. 4
Fig. 4
Viral load at follow-up intervals of 6 months in log scale in Nevirapine (NVP) and Efavirenz (EFV) group
See this image and copyright information in PMC

References

    1. Low A, Gavriilidis G, Larke N, B-Lajoie MR, Drouin O, Stover J, Muhe L, Easterbrook P. Incidence of opportunistic infections and the impact of antiretroviral therapy among HIV-infected adults in low- and middle-income countries: a systematic review and meta-analysis. Clin Infect Dis. 2016;62(12):1595–1603. doi: 10.1093/cid/ciw125. - DOI - PMC - PubMed
    1. World Health Organization: Global tuberculosis report 2016. Geneva: WHO; 2016. Available: http://www.who.int/tb/publications/global_report/gtbr2016_executive_summ...
    1. National AIDS Control Organisation India . Department of AIDSControl, Ministry of Health & Family Welfare: Annual Report 2015–16. New Delhi: National AIDS control organization; 2015.
    1. De Cock KM, Soro B, Coulibaly I, Lucas SB. Tuberculosis and HIV infection in sub-Saharan Africa. JAMA. 1992;268(12):1581–1587. doi: 10.1001/jama.1992.03490120095035. - DOI - PubMed
    1. Niemi M, Backman JT, Fromm MF, Neuvonen PJ, Kivistö KT. Pharmacokinetic interactions with Rifampicin. Clin Pharmacokinet. 2003;42(9):819–850. doi: 10.2165/00003088-200342090-00003. - DOI - PubMed

Publication types

MeSH terms

Associated data