Nevirapine versus efavirenz-based antiretroviral therapy regimens in antiretroviral-naive patients with HIV and tuberculosis infections in India: a pilot study

BMC Infectious Diseases

Ravindra Mohan Pandey³  Nawaid Hussain Khan⁴  Bharat Bhushan Rewari⁵  Srinivasaraghavan Venkatesh⁵  Jyotish Chandra Samantaray¹  Hafeez Ahmad¹  Sanjay Ranjan⁴  Thirumurthy Velpandian²  Meera Ekka⁴  Sahajal Dhooria⁴  Sanjiv Kumar⁴  Surendra K Sharma⁴  Rahul Chandrashekhar⁴  Puroshottam Raghunandan⁴  Sanjeev Sinha⁴ 

[1] Microbilogy, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, 110029 India;Ocular Pharmacology & Pharmacy, All India Institute of Medical Sciences, Ansari Nagar, New Delhi 110029, India;Biostatistics, All India Institute of Medical Sciences, Ansari Nagar, New Delhi 110029, India;Departments of Medicine, All India Institute of Medical Sciences, Ansari Nagar, New Delhi 110029, India;National AIDS Control Organisation, Ministry of Health & FW, Government of India, New Delhi 110001, India

关键词: Tuberculosis;    Nevirapine;    HIV;    Efavirenz;    Antiretroviral;   

Others  :  1145691
DOI  :  10.1186/1471-2334-13-482

 received in 2013-03-20, accepted in 2013-10-07,  发布年份 2013

【 摘 要 】

Background

Administration of rifampicin along with nevirapine reduces the plasma concentration of nevirapine in human immunodeficiency virus positive individuals with concomitant tuberculosis (HIV-TB patients). Nevirapine is a much cheaper drug than its alternative efavirenz, and might be beneficial in resource constrained settings.

Methods

A randomised open label trial was conducted at All India Institute of Medical Sciences, New Delhi, India. During the regimen of an antiretroviral therapy (ART), naive HIV-TB patients were randomly assigned to receive either nevirapine or efavirenz based ART with concomitant rifampicin based anti-tubercular therapy (ATT). Participants were followed for 24 months after starting ART. The end points were virological, immunological and clinical responses, and progression of HIV disease marked by failure of ART.

Results

Of the 135 HIV-TB patients, who were receiving rifampicin based ATT, 68 were selected randomly to receive efavirenz based ART and 67 to receive nevirapine based ART. The virological failure rates in the overall population, and the nevirapine and efavirenz groups were 14.1% (19/135); 14.9% (10/67) and 13.2% (9/68), respectively (p = 0.94). No significant difference was found between the groups in the rate of clinical, immunological or virological failures. The overall mortality was 17% with no significant difference between the two groups. Except for the lead in period on day 14, the mean nevirapine concentration remained above 3 mg/L. No association was found between plasma levels of nevirapine and incidence of unfavourable outcomes in this group.

Conclusions

Outcome of ART in HIV-TB patients on rifampicin based ATT showed no significant difference, irrespective of whether efavirenz or nevirapine was used. Therefore, nevirapine based ART could be an alternative in the resource limited settings in patients with HIV and tuberculosis co-infection.

Trial registration

NCT No. 01805258.

【 授权许可】

   
2013 Sinha et al.; licensee BioMed Central Ltd.

【 图 表 】

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