Article

Reasons for modification of generic highly active antiretroviral therapeutic regimens among patients in southern India

Brown University, Providence, Rhode Island, United States
JAIDS Journal of Acquired Immune Deficiency Syndromes (Impact Factor: 4.39). 02/2006; 41(1):53-8. DOI: 10.1097/01.qai.0000188123.15493.43
Source: PubMed

ABSTRACT 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.
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.
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%).
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.

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    • "In comparison with patients from low-income countries, those from high-income countries were more likely to change two or more drugs of the failing regimen and to change to a PI-containing regimen (Zhou et al., 2009). For India in particular, previous studies have shown the majority of switches were treatment substitutions within the same class of drugs, driven primarily by concomitant tuberculosis (TB) infection and adverse reactions to antiretroviral agents (Kumarasamy et al., 2006). "
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    ABSTRACT: Early identification and management of treatment failure on highly active antiretroviral therapy (HAART) is crucial in maintaining a sustained response to therapy in HIV infection. However, HIV viral load (VL) and resistance testing, and second-line HAART regimens, are unaffordable to many patients in India, leaving them with limited treatment options. Predictors and reasons for antiretroviral switching, therefore, are likely to differ in settings of varying resources. A one-year, observational study of patients receiving antiretroviral therapy was conducted in a private, non-profit hospital in Bangalore. This paper examines the predictors and consequences of antiretroviral treatment switching in this setting and explores reasons for switching in a subset of patients. Data on demographics, drug regimens, adherence, and physical and psychosocial outcomes were collected quarterly. Tests of VL and CD4 cell counts were performed every six months. One-third of the patients switched therapy during the study period. Baseline predictors of switching included lower CD4 cell counts and more physical symptoms. Contrary to studies in other settings, a high VL did not predict treatment switching, and only a minority of those experiencing drug failure were switched to second-line regimens. Both groups (switchers and non-switchers) improved significantly over time with respect to CD4 counts and psychological well-being, and showed a reduction in physical and depressive symptoms. Any differences between the groups were no longer significant at the end of the study, once we controlled for baseline levels. Clinical, policy, and research implications of these findings are discussed within the context of resource-limited settings.
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    • "More commonly studies have looked at the direct costs. There is evidence from Uganda, Nigeria, Cameroon, Tanzania, Malawi, Botswana, Senegal and India to say that financial constraints and/or user fees are associated with lower rates of adherence (Laniece et al. 2003; Weiser et al. 2003; Byakika- Tusiime et al. 2005; Iliyasu et al. 2005; Laurent et al. 2005; van Oosterhout et al. 2005; Crane et al. 2006; Kumarasamy et al. 2006; Kiguba et al. 2007; Oyugi et al. 2007; Ramadhani et al. 2007). This is supplemented with similar data from 15 programmes in Africa, Asia and South America (Brinkhof et al. 2008). "
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    • "More commonly studies have looked at the direct costs. There is evidence from Uganda, Nigeria, Cameroon, Tanzania, Malawi, Botswana, Senegal and India to say that financial constraints and/or user fees are associated with lower rates of adherence (Laniece et al. 2003; Weiser et al. 2003; Byakika-Tusiime et al. 2005; Iliyasu et al. 2005; Laurent et al. 2005; van Oosterhout et al. 2005; Crane et al. 2006; Kumarasamy et al. 2006; Kiguba et al. 2007; Oyugi et al. 2007; Ramadhani et al. 2007). This is supplemented with similar data from 15 programmes in Africa, Asia and South America (Brinkhof et al. 2008). "
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