1. 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

2. 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.

3. 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/mm 3

4. 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.

5. 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:

6. Adult: Treatment should be offered: CD4 + T cells <350/mm 3, or HIV RNA >30,000 copies/ml (bDNA), or HIV RNA >55,000copies/ml (RT-PCR). Treatment may be deferred: CD4 + T cells >350/mm 3, or HIV RNA <30,000 copies/ml (bDNA), or HIV RNA <55,000copies/ml (RT-PCR).

7. Pediatrics: Treatment should be offered to all newly diagnosed infected children, if universal early treatment not feasible, treatment should be offered if there is evidence of immune suppression as followings: CD4 + T cells Ages No./mm 3 % 1-5 yrs <1000 <25% 6-12 yrs <500 <25%

8. 2.When to change (1)Virologic failure: a. A reduction in plasma HIV RNA of less than 0.5 to 0.7 log 10 4 weeks following initiation of therapy; or less than 1 log 10 by week 8. b. Failure to suppress plasma HIV RNA to undetectable levels within 4 -6 months after initiation of therapy.

9. 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

10. B. Recommended regimens a 1.Acute HIV infection Drug of choice Alternative A B A B Indinavir Combivir b Abacavir AZT+3TC Saquinavir d4T+3TC AZT+ddI Ritonavir ddI+3TC AZT+ddc Nelfinavir d4T+ddI Efavirenz Nevirapine Saquinavir+Ritonavir Indinavir+Ritonavir Kaletra c

11. 2.Asymptomatic HIV infection Drug of choice Alternative A B A B Indinavir Combivir b Abacavir AZT+3TC Saquinavir d4T+3TC AZT+ddI Ritonavir ddI+3TC AZT+ddc Nelfinavir d4T+ddI Efavirenz Nevirapine Saquinavir+Ritonavir Indinavir+Ritonavir Kaletra c

12. 3.Advanced HIV infection Drug of choice Alternative A B A B Indinavir Combivir b Abacavir AZT+3TC Saquinavir d4T+3TC Nevirapine AZT+ddI Ritonavir ddI+3TC AZT+ddc Nelfinavir d4T+ddI Efavirenz Nevirapine Saquinavir+Ritonavir Indinavir+Ritonavir Kaletra c

13. 4.HIV-infected pediatric patients d Drug of choice Alternative A B A B Ritonavir e AZT g +3TC e Abacavir e AZT g +ddC e Nelfinavir f AZT g +ddI f Nevirapine f d4T e +3TC e d4T e +ddI f

14. 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

15. 6.Prophylaxis after occupational exposure h Drug of choice Alternative A B A B Indinavir Combivir Nelfinavir AZT+3TC Saquinavir d4T+3TC

16. Abbreviations: d4T : Stavudine 3TC: Lamivudine AZT: Zidovudine ddI: didanosine ddC: Zalcitabine a Antiretroviral drug regimens are comprised of one choice from column A and B. b Combivir: AZT+3TC. c Kaletra: lopinavir/ritonavir.

17. d All regimens used for adults are also recommended for pediatrics. e Oral solution formulation available. f Powder formulation for suspension available. g Syrup formulation available. h The 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.

18. 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

19. 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).

20. Antiretroviral therapy is recommended for all patients 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/mm 3. When to treat: Indication for antiretroviral therapy Panel ’ s Recommendations

21. Asymptomatic patients with CD4 + T cells counts of 201- 350/mm 3 should be offered treatment. Asymptomatic patients with CD4 + T cells counts of >350/mm 3 and plasma HIV RNA>100,000 copies/ml, most experienced clinicians defer therapy but some clinician consider initiating treatment.

22. Therapy should be deferred for patients with CD4 + T cells counts of >350/mm 3 and plasma HIV RNA<100,000 copies/ml.