Guidelines for the use of antiretroviral agents in HIV

infections in Taiwan, revised in 2002

by Infectious Diseases Society of the ROC and Taiwan AIDS

Society

Guidelines for the use of antiretroviral agents in HIV infections

Significant progress in the field of antiretroviral therapy over the past year .

New drugs approved for clinical use and new insights gained in many aspect of therapy.

An update of the first “Guidelines for the use of antiretroviral agents in HIV infections in Taiwan” established in March 11, 2001, and organized a meeting on November 24, 2001.

Guidelines for the use of antiretroviral agents in HIV infections

The new guidelines: more conservative in the initiation of treatment in asymptomatic patients, and offered an option for treatment in patients with CD4+ T cells >350/mm3

Guidelines for the use of antiretroviral agents in HIV infections

Other important issues not included in this guidelines:the side effects, drug resistance, patients compliance, prevention of opportunistic infections, Immunotherapy, and vaccine.

Guidelines for the use of antiretroviral agents in HIV-

infected patients

A. General consideration 1.When to start (1) Acute HIV infection: treatment should be offered. (2) Symptomatic: treatment should be offered. (3) Asymptomatic:

Adult:Treatment should be offered: CD4+ T cells <350/mm3, or HIV RNA >30,000 copies/ml (bDNA), or HIV RNA >55,000copies/ml (RT-PCR). Treatment may be deferred: CD4+ T cells >350/mm3, or HIV RNA <30,000 copies/ml (bDNA), or HIV RNA <55,000copies/ml (RT-PCR).

Pediatrics:Treatment should be offered to all newlydiagnosed infected children, if universal earlytreatment not feasible, treatment should beoffered if there is evidence of immune suppression as followings:

CD4+ T cells

Ages No./mm3 %

1-5 yrs <1000 <25% 6-12 yrs <500 <25%

2.When to change (1)Virologic failure: a. A reduction in plasma HIV RNA of less than 0.5 to 0.7 log10 4 weeks following initiation of

therapy; or less than 1 log10 by week 8.

b. Failure to suppress plasma HIV RNA to undetectable levels within 4 -6 months after initiation of therapy.

c. Repeated detection of virus in plasma after initial suppression to undetectable level, suggesting the development of resistance. d. Any reproducible significant increase, defined as 3-fold or greater, from the nadir of plasma HIV RNA not attributable to intercurrent infection, vaccination, or test methodology.(2) Toxicity(3) Intolerance

B. Recommended regimensa

1.Acute HIV infection

Drug of choice Alternative A B A B Indinavir Combivirb Abacavir AZT+3TC Saquinavir d4T+3TC AZT+ddI Ritonavir ddI+3TC AZT+ddc Nelfinavir d4T+ddI Efavirenz Nevirapine Saquinavir+Ritonavir Indinavir+Ritonavir Kaletrac

2.Asymptomatic HIV infection

Drug of choice Alternative A B A B Indinavir Combivirb Abacavir AZT+3TC Saquinavir d4T+3TC AZT+ddI

Ritonavir ddI+3TC AZT+ddc

Nelfinavir d4T+ddI Efavirenz Nevirapine Saquinavir+Ritonavir Indinavir+Ritonavir Kaletrac

3.Advanced HIV infection

Drug of choice Alternative A B A B Indinavir Combivirb Abacavir AZT+3TC Saquinavir d4T+3TC Nevirapine AZT+ddI Ritonavir ddI+3TC AZT+ddc

Nelfinavir d4T+ddI Efavirenz Nevirapine Saquinavir+Ritonavir Indinavir+Ritonavir Kaletrac

4.HIV-infected pediatric patientsd

Drug of choice Alternative A B A B Ritonavire AZTg+3TCe Abacavire AZTg+ddCe

Nelfinavirf AZTg+ddIf Nevirapinef d4Te+3TCe

d4Te+ddIf

5.HIV infection in pregnant women Drug of choice Alternative A B A B Nevirapine Combivir Nelfinavir AZT+3TC Saquinavir AZT+ddI Indinavir d4T+3TC Ritonavir

6.Prophylaxis after occupational exposureh

Drug of choice Alternative A B A B Indinavir Combivir Nelfinavir AZT+3TC Saquinavir d4T+3TC

Abbreviations:

d4T : Stavudine3TC: LamivudineAZT: ZidovudineddI: didanosineddC: ZalcitabineaAntiretroviral drug regimens are comprised ofone choice from column A and B.bCombivir: AZT+3TC.cKaletra: lopinavir/ritonavir.

dAll regimens used for adults are also recommended for pediatrics.eOral solution formulation available.fPowder formulation for suspension available.gSyrup formulation available.hThe previous treatment regimens of source patient

should be taken into consideration; the duration of treatment is 4 weeks; the risk group should be considered, if contact with body fluid except blood, dual therapy is recommended.

Developed by the Panel on Clinical Practices for Treatment of HIV infection convened by the Department of Health and Human Services (DHHS)

Guidelines for the Use of Antiretroviral Agents in

HIV-1 infected in Adults and Adolescents October 29, 2004

It is emphasized that concepts relevant to HIV management evolve rapidly. The panel has a mechanism to update recommendations on a regular basis, and the most recent information is available on the AIDSinfo Web site. (http:/AIDSinfo.nih.gov).

Antiretroviral therapy is recommended for allpatients with history of an AIDS-defining illness or severe symptoms of HIV infection regardless of CD4+ T cells count.

Antiretroviral therapy is also recommended for asymptomatic patients with CD4+ T cells < 200/mm3.

When to treat: Indication for antiretroviral therapyPanel’s Recommendations

Asymptomatic patients with CD4+ T cells counts of 201- 350/mm3 should be offered treatment. Asymptomatic patients with CD4+ T cells counts of >350/mm3 and plasma HIV RNA>100,000 copies/ml, most experienced clinicians defer therapy but some clinician consider initiating treatment.

Therapy should be deferred for patients with CD4+ T cells counts of >350/mm3 and plasma HIV RNA<100,000 copies/ml.