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INTRODUCTION
Antiretroviral therapy (ART) has significantly reduced morbidity and mortality rates in advanced human immunodeficiency virus (HIV) disease in both the developed and developing world. Generic manufacturers of antiretrovirals (ARVs) have made ART more affordable and accessible. Physicians need knowledge about ART, including indications for its use, which drugs to choose and how to choose them, complications of therapy, and managing special situations like HIV and tuberculosis (TB), HIV and pregnancy. Fourteen of the twenty-one antiretrovirals approved by the US FDA are currently available in India (Zidovudine (ZDV), Stavudine (d4T), Lamivudine (3TC), Didanosine (ddI), Zalcitabine (ddC), Abacavir (ABC), Tenofovir (TDF), (Nucleotide RTI), Nevirapine (NVP), Efavirenz (EFV), Nelfinavir (NFV), Lopinavir (LPV/r), Saquinavir (SQV), Indinavir (IDV), Ritonavir (RTV)). Rational use of ART is critical to prevent a drug-resistant HIV epidemic in India in the future.
The objectives of these guidelines are:
- To develop evidence-based, state-of-the-art guidelines for the use of ART in India
- To develop guidelines that are simple to implement in clinical practice
- To balance science with feasibility to provide quality care to HIV infected persons
- The guidelines are designed to assist physicians in extending care to HIV infected individuals and establish a standard of clinical practice across India. HIV medicine is a rapidly changing specialty necessitating periodic updates. Most issues relating to the use of ART in the Indian context will be addressed by the guidelines and updated every three months on the Web. The Web Version is available on www.japi.org. These guidelines will be reviewed on an annual basis.
WHEN TO INITIATE ART?
With the currently available therapeutic options, the eradication of HIV cannot be achieved. However, with the advent of potent antiretroviral therapy, HIV infection has now been transformed into a chronic, manageable illness.
The goals of ART are:
- To ensure maximal and durable suppression of the virus
- To reconstitute and preserve immunologic quantity and function
- To improve the quality of life
- To reduce morbidity and mortality due to HIV infection
- Additionally, antiretroviral drugs can be used to reduce the transmission of HIV in various situations, e.g., transmission of HIV from infected mother-to-child (MTCT), after occupational post-exposure prophylaxis (PEP), and non-occupational exposures. Theoretically, a reduction in plasma viral load is likely to lead to a reduction in the risk of sexual transmission of HIV.
- Since the use of ART is lifelong and associated with long-term adverse events, not all patients diagnosed with HIV infection need to be started on treatment. The decision to initiate ART is made after weighing the risk of progression to AIDS and other important determinants such as the incidence of short and long-term adverse events, commitment to high levels of adherence, development of resistance to ARVs, affordability, and the patient's readiness for therapy. An algorithm summarizing when to initiate ART is illustrated in Fig. 1.
- Antiretroviral treatment is indicated for all patients who are symptomatic with an HIV infection need to be started on treatment. The decision to initiate ART is made after weighing the risk of progression to AIDS-defining illness, irrespective of CD4 counts or viral load levels. Patients with HIV infection need to be started on treatment. The decision to initiate ART is made after weighing the risk of progression to AIDS have higher rates of mortality unless treated with ART. In addition, patients with non-HIV infection need to be started on treatment. The decision to initiate ART is made after weighing the risk of progression to AIDS-defining illnesses like recurrent oral candidiasis, oral hairy leukoplakia may have a risk of rapid progression, and therapy is indicated in these patients if CD4 count is <350/mm3.
- Adequate control of opportunistic infections (OIs) with appropriate antimicrobial therapy and stabilizing patients is crucial before initiating ART. This helps reduce the risk of the development of IRIS, reduces pill burden, prevents additive toxicities, and makes it easier to identify the