PMID- 16340473 OWN - NLM STAT- MEDLINE DCOM- 20060302 LR - 20200930 IS - 1525-4135 (Print) IS - 1525-4135 (Linking) VI - 41 IP - 1 DP - 2006 Jan 1 TI - Reasons for modification of generic highly active antiretroviral therapeutic regimens among patients in southern India. PG - 53-8 AB - 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%). CONCLUSION: 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. FAU - Kumarasamy, Nagalingeswaran AU - Kumarasamy N AD - YRG Centre for AIDS Research and Education, Chennai, India. kumarasamy@yrgcare.org FAU - Vallabhaneni, Snigdha AU - Vallabhaneni S FAU - Cecelia, Anitha J AU - Cecelia AJ FAU - Yepthomi, Tokugha AU - Yepthomi T FAU - Balakrishnan, Pachamuthu AU - Balakrishnan P FAU - Saghayam, Suneeta AU - Saghayam S FAU - Flanigan, Timothy P AU - Flanigan TP FAU - Carpenter, Charles C J AU - Carpenter CC FAU - Solomon, Suniti AU - Solomon S FAU - Mayer, Kenneth H AU - Mayer KH LA - eng PT - Journal Article PT - Research Support, N.I.H., Extramural PT - Research Support, Non-U.S. Gov't PL - United States TA - J Acquir Immune Defic Syndr JT - Journal of acquired immune deficiency syndromes (1999) JID - 100892005 RN - 0 (Anti-HIV Agents) RN - 0 (Drugs, Generic) RN - 99DK7FVK1H (Nevirapine) SB - IM CIN - J Acquir Immune Defic Syndr. 2007 Sep 1;46(1):119-21. PMID: 17909318 MH - Acquired Immunodeficiency Syndrome/*drug therapy/physiopathology/transmission MH - Adult MH - Anti-HIV Agents/administration & dosage/*therapeutic use MH - Antiretroviral Therapy, Highly Active/*methods MH - CD4 Lymphocyte Count MH - *Drugs, Generic MH - Female MH - HIV Infections/*drug therapy/physiopathology/transmission MH - Heterosexuality MH - Humans MH - India MH - Male MH - Nevirapine/therapeutic use MH - Reproducibility of Results MH - Treatment Outcome EDAT- 2005/12/13 09:00 MHDA- 2006/03/03 09:00 CRDT- 2005/12/13 09:00 PHST- 2005/12/13 09:00 [pubmed] PHST- 2006/03/03 09:00 [medline] PHST- 2005/12/13 09:00 [entrez] AID - 00126334-200601010-00008 [pii] AID - 10.1097/01.qai.0000188123.15493.43 [doi] PST - ppublish SO - J Acquir Immune Defic Syndr. 2006 Jan 1;41(1):53-8. doi: 10.1097/01.qai.0000188123.15493.43.