Guidelines for the use of antiretroviral agents in HIV infections

1. Guidelines for the use of antiretroviral agents in HIV infections in Taiwan, revised in 2002by 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/mm3

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. A. General consideration 1.When to start (1) Acute HIV infection: treatment should be offered. (2) Symptomatic: treatment should be offered. (3) Asymptomatic: Guidelines for the use of antiretroviral agents in HIV-infected patients

6. 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).

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:

8. 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.

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 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

11. 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

12. 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

13. 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

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 exposureh 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 aAntiretroviral drug regimens are comprised of one choice from column A and B. bCombivir: AZT+3TC. cKaletra: lopinavir/ritonavir.

17. 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.

18. Guidelines for the Use of Antiretroviral Agents in HIV-1 infected in Adults and AdolescentsOctober 29, 2004 Developed by the Panel on Clinical Practices for Treatment of HIV infection convened by the Department of Health and Human Services (DHHS)

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. When to treat: Indication for antiretroviral therapyPanel’s Recommendations 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 asymptomaticpatients with CD4+ T cells < 200/mm3.

21. Asymptomatic patients with CD4+ T cells counts of 201- 350/mm3 should be offered treatment. Asymptomaticpatients 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.

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