High Rates of Regimen Change due to Drug Toxicity Among South Indian Adults

[Guest guest]

[A pdf version of the article is avaiable from the editor, AIDS INDIA e FORUM]

Dear FORUM,

I am enclosing an abstract of the article titled " High Rates of Regimen Change

due to Drug Toxicity Among a Cohort of South Indian Adults with HIV Infection

Initiated on Generic, First-Line Antiretroviral Treatment " published in the May

2009 issue of the Journal of Association of Physicians of India (Sivadasan A,

Abraham OC, Rupali P, et al. High rates of regimen change due to drug toxicity

among a cohort of south Indian adults with HIV infection initiated on generic,

first-line antiretroviral treatment. J Assoc Physicians India 2009;57:15-19.)

for posting in the AIDS-India e-forum.

_____________

High Rates of Regimen Change due to Drug Toxicity Among a Cohort of South Indian

Adults with HIV Infection Initiated on Generic, First-Line Antiretroviral

Treatment

Ajith Sivadasan1, OC Abraham1, Priscilla Rupali1, ne A Pulimood2, Joyce

Rajan1, S Rajkumar1, Anand Zachariah1, Rajesh Kannangai3, Abraham ph

Kandathil3, G Sridharan3, Dilip Mathai1

Departments of Medicine Unit 1 & Infectious Diseases, 2Dermatology and 3Clinical

Virology, Christian Medical College, Vellore. Received : 28.05.2008; Accepted :

02.03.2009

Abstract

Objectives: To determine the rates, reasons and predictors of treatment change

of the initial antiretroviral treatment (ART) regimen in HIV-infected south

Indian adults.

Methods: In this prospective cohort study, ART-naïve adults initiated on

generic, fixed dose combination ART as per the National AIDS Control

Organization guidelines were followed up at an academic medical center.

Treatment change was defined as any event which necessitated a change in or

discontinuation of the initial ART regimen.

Results: Two hundred and thirty persons with HIV infection (males 74.8% and

median age 37 years) were followed up for median duration of 48 weeks. The

majority (98.7%) had acquired HIV infection through the heterosexual route. Most

(70.4%) had advanced HIV infection (WHO clinical stage 3 or 4) and 78% had CD4+

T-lymphocyte counts below 200 cells/µL. The initial ART regimens used were:

Lamivudine (3TC) with Stavudine (d4T) (in 76%) or Azidothymidine (AZT) and

Nevirapine (NVP) (in 86%) or Efavirenz (EFV). The cumulative incidence of

treatment change was 39.6% (91 patients). Drug toxicity (WHO grade 3 or 4) was

the reason for treatment change among 62 (27%) (incidence rate 35.9/100

person-years). The most common toxicities were attributable to the thymidine

analogue nucleoside reverse transcriptase inhibitors (NRTIs), d4T and AZT

[lactic acidosis (8.7%), anemia (7%) and peripheral neuropathy (5.2%)]. The

other toxicities were rash (3.9%) and hepatitis (1.3%) due to NVP. The mortality

(4.6/100 person-years) and disease progression rates (4.1/100 person-years) were

low.

Conclusions: The ART regimens used in this study were effective in decreasing

disease progression and death. However, they were associated with high rates of

drug toxicities, particularly those attributable to thymidine analogue NRTI. As

efforts are made to improve access to ART, treatment regimens chosen should not

only be potent, but also safe.

________________

Dr. O.C. Abraham,

Department of Medicine Unit 1 & Infectious Diseases,

Christian Medical College,

Vellore

E-MAIL: <ocabraham@...>