INtrODUCTION
Antiretroviral therapy (ART) has dramatically reduced morbidity and mortality rates in advanced human immunodeficiency virus (
HIV
) disease in both the developed and developing world.1-3 Generic manufacturers of antiretrovirals(ARVs)have made ART more affordable and accessible. In order to provide optimal quality care, physicians need to have 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
. Of the twenty-one antiretrovirals approved by US FDA, currently fourteen are 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 for prevention of Drug resistant HIV epidemic in India in future.
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The objectives of these guidelines are:
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To develop evidence-based, state-of-the- art guidelines for use of ART in India
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To develop guidelines which are simple to implement in clinical practice
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To balance science with feasibility to provide quality care to
HIV
infected persons
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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 speciality necessitating periodic updating. Most issues relating to use of ART in the Indian context will be addressed by the guidelines andupdated 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 currently available therapeutic options, eradication of
HIV
cannot be achieved [4]. However, with the advent of potent antiretroviral therapy, HIV infection has now been transformed into a chronic, manageable illness.
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The goals of ART are:
-
To ensure maximal and durable suppression of the virus
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To reconstitute and preserve immunologic quantity and function
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To improve quality of life
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To reduce morbidity and mortality due to
HIV
infection
-
Additionally, antiretroviral Drugs can be used to reduce 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 reduction in the risk of sexual transmission of HIV.
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Since use of ART is life-long, 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 and affordability and patient’s readiness for therapy. An algorithm summarizing when to initiate ART is illustrated in Fig. 1.
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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 CD4counts 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.5,6 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 illness 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/mm3.7,8.
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Adequate control of opportunistic infections (OIs) with appropriate antimicrobial therapy and stabilizing patients is crucial before initiating ART. This helps reduce risk of development of IRIS, reduces pill burden, prevents additive toxicities and makes it easier to identify the offending Drug in case of overlapping toxicities. Finally, certain
AIDS
defining illness like cryptosporidiosis, progressive multifocal leucoencephalopathy(PML) may be most effectively treated with ART induced immunereconstitution.9,10
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There is a limited HIV natural history data from India, especially the risk of progression to HIV infection need to be started on treatment. The decision to initiate ART is made after weighing the risk of progression to AIDS at various CD4 counts and viral load levels. A retrospective analysis demonstrated that Indian HIV infected patients with CD4 counts <200/mm3 were 19 times more likely to die than were those with CD4 counts>350/mm3.11 Since the risk of developing OIs is significant whenCD4 counts drop to less than 200/mm3, HIV infection need to be started on treatment. The decision to initiate ART is made after weighing the risk of progression to therapy is indicated for these patients.5 At the same time it should be remembered that
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