Generic and low dose antiretroviral therapy in adults and children: implication for scaling up treatment in resource limited settings.

Reshmie Ramautarsing,Jintanat Ananworanich

doi:10.1186/1742-6405-7-18

Abstract

Although access to antiretroviral therapy (ART) for the treatment of HIV has increased during the last decade, many patients are still in need of treatment. With limited funds to provide ART to millions of patients worldwide, there is a need for alternative ways to scale up ART in resource limited settings. This review provides an overview of pharmacokinetic, safety and efficacy studies of generic and reduced dose ART. The production of generic ART has greatly influenced the decline in drug prices and the increased in ART access. Generic ART has good pharmacokinetic profile, safety and efficacy. Toxicity is however the main cause for ART discontinuation. Several dose reduction studies have shown adequate pharmacokinetic parameters and short term efficacy with reduced dose ART. Ethnicity may affect drug metabolism; several pharmacokinetic studies have confirmed higher plasma ART concentration in Asians. Randomized efficacy trial of reduced versus standard ART is warranted.

Highlights

In 2008, an estimated 33.4 million adults and children were living with HIV worldwide [1], most of whom were from low and middle income countries, and 9.6 million people were in need of antiretroviral treatment (ART) [2]
The data summarized in this review underscores the need to explore alternative options to scale up ART for resource limited settings, safe and effective generic ART, and dose reduction of ART
Current evidence support the bioequivalence, safety and efficacy of generic ART compared to branded products

Summary

Introduction

In 2008, an estimated 33.4 million adults and children were living with HIV worldwide [1], most of whom were from low and middle income countries, and 9.6 million people were in need of antiretroviral treatment (ART) [2]. Due to its high cost, the access to PIs is still limited for pediatric treatment To address this issue, Puthanakit et al assessed the LPV plasma concentrations in Thai HIV-infected children being treated with the adult tablet formulation of the Matrix generic LPV/r, and compared these to the LPV plasma concentrations during treatment with the branded soft gel capsule (SGC) formulation in the same patients [29]. At GA 33, 95% of the women had sufficient LPV plasma concentration above 1.0 mg/l and at 12PP all women had LPV plasma concentration above 1.0 mg/l, indicating that Thai HIV-infected pregnant women do not require a LPV/r dose increase during the third trimester of pregnancy This highlights the needs to conduct studies in different ethnic groups as guidelines developed based on Caucasian PK data cannot be extrapolated to other ethnicities

Conclusions

UNAIDS

Findings

56. Frederiksen MC