Internal Medicine and Medical Investigation Journal

ISSN: 2474-7750

Highly Active Antiretroviral Therapy Induces Hematological and Dermatological Adverse Drug Reactions in HIV Patients in India


Author(s): Danturulu Muralidhar Varma , Radhakrishnan Rajesh *, Poornima Pulagam , Sudha Vidyasagar , Vasudeva Guddattu

In India, HIV patients are at a high risk of developing hematological and

dermatological adverse drug reactions (ADRs) leading to financial burden.

Materials and Methods:

A prospective observational study was conducted on hemato-

logical and dermatological ADRs in a South Indian teaching hospital from October

2011 to October 2012. The definition of ADRs established by the World Health Organi-

zation (WHO) was used to assess the causality. Predictability of ADRs was assessed by

Micromedex database. Preventability of ADRs was assessed using the Schumock and

Thornton criteria.


A total of 174 HIV patients were enrolled [133 (76.4%)

males and 41 (23.6%) females], who reported 99 ADRs to HAART. Of the total ADRs,

70 (70.7%) were reported in males and 29 (29.3%) in females, indicating significantly

higher reporting of ADRs in males. 67 of the 99 ADRs were hematological, while the

remaining 32 were dermatological. A high number of hematological [40 (59.6%)] and

dermatological [15 (46.8%)] ADRs were reported for zidovudine + lamivudine +

nevirapine-based HAART regimen. In most of the reported ADRs, the suspected drug

was withdrawn. The reported hematological ADRs were as follows: 1) anemia with

zidovudine [35 (52.2%)]; 2) pancytopenia with zidovudine [20 (29.9%)]; 3) neutrope-

nia with lamivudine; and 4) leucopenia, bicytopenia, and eosinophilia with zidovudine.

Dermatological ADRs were maculopapular rash [7 (21.8%)] with nevirapine-, tenofo-

vir + emtricitabine + efavirenz

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