title: Reasons for modification of generic highly active antiretroviral therapeutic regimens among patients in southern India.
abstract: OBJECTIVE
  To describe reasons for modification and discontinuation of antiretroviral regimens in association with adverse events (AEs), treatment failure, and cost among patients in southern India.
  
  
  METHODS
  Secular trends of patients initiating highly active antiretroviral therapy (HAART) between January 1996 and October 2004 at a tertiary HIV referral center in India were analyzed using a previously validated natural history database.
  
  
  RESULTS
  All previously antiretroviral therapy-naive patients who initiated HAART (N = 1443) and had at least 1 follow-up visit were evaluated. The median CD4 count at the time of initiating HAART was 108 cells/microL. The most common first-line regimens were stavudine (d4T) plus lamivudine (3TC) plus nevirapine (NVP) (63%), zidovudine (AZT) plus 3TC plus NVP (19%), d4T plus 3TC plus efavirenz (EFV) (9%), and AZT plus 3TC plus EFV (4%). Twenty percent of patients modified their first-line regimen. The most common reason for modifying therapy was the development of an AE (64%), followed by cost (19%) and treatment failure (14%), with median times to modify therapy being 40, 151, and 406 days, respectively. Common AEs were itching and/or skin rash (66%), hepatotoxicity (27%), and anemia (23%). Nine percent of patients discontinued therapy entirely after a median duration of 124 days, primarily because of cost (64%).
  
  
  CONCLUSIONS
  The most common reason for modifying therapy was the occurrence of AEs, whereas cost was the most common reason for discontinuing therapy. Despite increasing access to lower cost generic HAART in India, even less expensive and more tolerable first-line regimens and cost-effective treatment monitoring tools need to be introduced to achieve better treatment outcomes and access in resource-constrained settings.
authors.affiliation: YRG Centre for AIDS Research and Education, Chennai, India. kumarasamy@yrgcare.org
authors.forename: Nagalingeswaran
authors.initials: N
authors.lastname: Kumarasamy
authors.forename: Snigdha
authors.initials: S
authors.lastname: Vallabhaneni
authors.forename: Anitha J
authors.initials: AJ
authors.lastname: Cecelia
authors.forename: Tokugha
authors.initials: T
authors.lastname: Yepthomi
authors.forename: Pachamuthu
authors.initials: P
authors.lastname: Balakrishnan
authors.forename: Suneeta
authors.initials: S
authors.lastname: Saghayam
authors.forename: Timothy P
authors.initials: TP
authors.lastname: Flanigan
authors.forename: Charles C J
authors.initials: CC
authors.lastname: Carpenter
authors.forename: Suniti
authors.initials: S
authors.lastname: Solomon
authors.forename: Kenneth H
authors.initials: KH
authors.lastname: Mayer
mesh_terms: D000163:Acquired Immunodeficiency Syndrome / Q000188:drug therapy* / Q000503:physiopathology / Q000635:transmission; D000328:Adult; D019380:Anti-HIV Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D023241:Antiretroviral Therapy, Highly Active / Q000379:methods*; D018791:CD4 Lymphocyte Count; D016568:Drugs, Generic; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000503:physiopathology / Q000635:transmission; D020010:Heterosexuality; D006801:Humans; D007194:India; D008297:Male; D019829:Nevirapine / Q000627:therapeutic use; D015203:Reproducibility of Results; D016896:Treatment Outcome
chemical_list: D019380:Anti-HIV Agents; D016568:Drugs, Generic; D019829:Nevirapine