MM Thorell PhD University of the Sciences in Philadelphia, 600 South 43rd Street, Philadelphia, Pennsylvania, , USA.

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1 Medical Journal of Therapeutics Africa 2007 Vol 1, No 2 Page 148 SUMMARY OF GUIDELINES FOR THE USE OF ANTIRETROVIRAL AGENTS IN HIV-INFECTED ADULTS AND ADOLESCENTS. MM Thorell PhD University of the Sciences in Philadelphia, 600 South 43rd Street, Philadelphia, Pennsylvania, , USA. Abstract The updated guidelines for the treatment of adults and adolescents living with HIV/AIDS were released on October 10, The Guidelines for the Use of Antiretroviral Agents in HIV-infected Adults and Adolescents were developed and are continually revised by the Department of Health and Human Services Panel on Antiretroviral Guidelines for Adolescents, a working group of the Office of AIDS Research Advisory Council, and provide information on the optimal time to initiate HIV treatment, use of resistance testing, preferred first-line regimens, adverse effects of ARV medications, management of the treatment-experienced patient, and examination of various considerations for special populations. This paper is a summary of these guidelines. Thorell MM. Summary of Guidelines for the Use of Antiretroviral Agents in HIV-infected Adults and Adolescents. Med J Therapeut Africa. 2007;2: Keywords: HIV/AIDS disease processes clinical changes anti-retroviral Introduction A score of antiretroviral (ARV) agents are available for the treatment of the human immunodeficiency virus (HIV), with more drugs recently approved and others in clinical trials. The updated guidelines for the treatment of adults and adolescents living with HIV/AIDS were released on October 10, The guidelines are developed by the Department of Health and Human Services Panel on Antiretroviral Guidelines for Adolescents, a working group of the Office of AIDS Research Advisory Council, and provide information on the optimal time to initiate HIV treatment, use of resistance testing, preferred first-line regimens, adverse effects of ARV medications, management of the treatment-experienced patient, and examination of various considerations for special populations.1 These apply specifically to adults and adolescents; recommendations for pregnant women, pediatric patients, and healthcare workers with occupational exposure to HIV are covered in other guidelines. Recommended treatment options FIRST AND SECOND-LINE TREATMENT Antiretroviral drugs restore immune function, allowing patients to stay healthier and to live longer. The Panel continues to recommend that regimens Table 1. Antiretroviral components recommended for treatment of HIV-1 infection in treatment-naive patients. Table 6a in Guidelines.(1)

2 Antiretroviral therapy guidelines Medical Journal of Therapeutics Africa 2007 Vol 1, No 2 Page 149 NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS (NRTIS) APPROVED IN THE UNITED STATES Abacavir Didanosine Emtricitabine Lamivudine Stavudine Tenofovir Zalcitabine Zidovudine (also known as AZT) with the best virologic and immunologic efficacy are those composed of 1 nonnucleoside reverse transcriptase inhibitor (NNRTI) plus 2 nucleoside reverse transcriptase inhibitors (NRTIs) or of a protease inhibitor (PI) (boosted with ritonavir, or unboosted) and 2 NRTIs (Tables 1, 2, and 3). These recommendations are based on results from randomized trials in treatment-naïve patients and on safety data. Treatment goals continue to be to reduce HIV-related morbidity and mortality, improve quality of life, restore and preserve immunologic function, and maximally and durably suppress viral load. Adoption of the treatment regimens recommended by the guidelines has substantially reduced HIVassociated morbidity and mortality. Because plasma viremia is a strong prognostic indicator of HIV/AIDS progression, antiretroviral therapy that reduces viral load has substantial clinical benefit. Achieving treatment goals requires considering NONNUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS (NNRTIS) APPROVED IN THE UNITED STATES Delavirdine Nevirapine Efavirenz -Selection of the proper combination regimen for the patient -Preservation of future treatment options (drugresistance and patient nonadherence rapidly exhaust treatment options) -Pretreatment drug resistance testing -Drug sequencing for initial and subsequent salvage therapy -Improved adherence PROTEASE INHIBITORS (PIS) APPROVED IN THE UNITED STATES Amprenavir Agenerase Atazanavir Fosamprenavir calcium Indinavir Lopinavir and ritonavir combination Nelfinavir Ritonavir Saquinavir Table 2. Panel s recommendations for preventing and treating antiretroviral resistance.

3 Antiretroviral therapy guidelines Medical Journal of Therapeutics Africa 2007 Vol 1, No 2 Page 150 Approved classes of drugs By 2006, the United States Food and Drug Administration had approved more than 20 antiretroviral drugs in 4 classes. NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS (NRTIS) By taking the place of essential viral parts during division, NRTIs prevent viral cells from copying properly. Thus they block the replication of viruses and slow the progression of viral infections such as HIV and hepatitis B. These drugs are also called nucleoside analogs. NONNUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS (NNRTIS) NNRTIs attach to reverse transcriptase to prevent conversion of RNA to DNA, thus preventing HIV's genetic material from being incorporated into the healthy genetic material of the cell. This class of drugs are also called nonnucleoside analogs. PROTEASE INHIBITORS (PIS) Protease inhibitors interrupt HIV from making copies of itself at a later step in its life cycle by blocking the enzyme protease. In this way they preventing protease from splicing the genetic material as required to correctly form new copies of the virus. FUSION INHIBITORS The FDA also has introduced a class of drugs known as fusion inhibitors. Enfuvirtide (T-20, Fuzeon), the first approved fusion inhibitor, works by interfering with the ability of HIV to enter and infect human immune cells by blocking the merging of the virus with the cell membranes. Enfuvirtide is designed for use in combination with other anti-hiv treatment. It reduces the level of HIV infection in the blood. COMBINATION THERAPY Because HIV can become resistant to any of these drugs, health care providers must use a combination treatment to effectively suppress the virus. When multiple drugs (3 or more) are used in combination, treatment is referred to as highly active antiretroviral therapy (HAART), which can be used by humans with HIV/AIDS who are either asymptomatic or symptomatic. HAART is a major factor in significantly reducing the number of deaths from HIV/AIDS in the United States and has greatly improved the health of many humans living with HIV/AIDS, Initiation of therapy Combination therapy (HAART) is the recommended treatment for the ARV-naïve patient. The decision of when to start treatment is complex for the asymptomatic patient and must be made in the setting of careful patient counseling and education. CD4+ T- cell count and baseline viral load are important indicators, as is the patient's readiness to begin therapy. The Panel's recommendations for antiretroviral therapy are given in Table 5 of the guidelines. These are: -For all patients who have had an AIDS-defining illness or severe symptoms of HIV infection regardless of CD4+ T-cell count Table 2. Antiretroviral components that are acceptable as initial antiretroviral components but are inferior to preferred or alternative components, Table 6b.(1)

4 Antiretroviral therapy guidelines Medical Journal of Therapeutics Africa 2007 Vol 1, No 2 Page 151 -For asymptomatic patients with a CD4+ T-cell count of 200 cells/mm3 -For asymptomatic patients with CD4+ T-cell counts of cells/mm3 -For asymptomatic patients with CD4+ T-cell of >350 cells/mm3 and plasma HIV RNA >100,000 copies/ml, although this is often deferred by experienced clinicians -Defer therapy for patients with CD4+ T cell counts of >350 cells/mm3 and plasma HIV RNA <100,000 copies/ml TREATMENT OF ADVERSE EFFECTS Adverse effects have been reported with virtually all antiretroviral drugs and are the most common reason for switching or discontinuing therapy. Some adverse effects have been identified during premarketing clinical trials; however, less frequent toxicities (lactic acidosis with hepatic steatosis and progressive ascending neuromuscular weakness syndrome) and long-term complications (dyslipidemia and fat maldistribution) were not recognized until after the drugs were in used by a larger number of patients for a longer period of time. Medication intolerance is perhaps the easiest adverse effect to counteract. The clinician needs to address and review the likely duration of the adverse effects, such as gastrointestinal symptoms, and treat the patient's symptoms with, for example, antiemetics or antidiarrheals. Changing to another drug within the same class or changing to a drug in another class can often eliminate adverse effects. For example, changing to tenofovir from zidovudine reduces gastrointestinal symptoms or anemia. Nevirapine can be substituted for efavirenz to reduce central nervous system symptoms. Each new patient during initial patient visits should have laboratory tests, to determine the adverse effects which may be arise for that patient. In addition to HIV antibody testing, CD4+ T-cell count, and plasma HIV RNA testing, a complete blood count should be done (including tuberculin skin test; Toxoplasma gondii immunoglobulin G antibody; hepatitis A, B, and C; and a Papanicolaou test in women). Fasting blood glucose and serum lipid tests should be considered for patients at risk for Table 3. Antiretroviral components not recommended for initial therapy. Table 7 in Guidelines. (1)

5 Antiretroviral therapy guidelines Medical Journal of Therapeutics Africa 2007 Vol 1, No 2 Page 152 cardiovascular disease. To manage cardiovascular effects: early diagnosis, prevention, and pharmacologic management of other risk factors, such as hyperlipidemia, hypertension, and insulin resistance/diabetes mellitus are important. The clinician should therefore assess cardiac risk factors and suggest appropriate lifestyle modifications (eg, diet, exercise, and smoking cessation). A switch to agents with less propensity for increasing cardiovascular risk factors, such as NNRTIs or an atazanavir-based regimen, can help manage metabolic syndrome and cardiovascular adverse effects. For hyperlipidemia, the AIDS Clinical Trials Group (ACTG) guidelines of recommended management should be followed, especially for the use of cholesterol-lowering agents, which is critical. Other serious adverse effects associated with ARV agents are shown in Table 4. ADHERENCE Adherence is perhaps one of the most important aspects of HIV clinical care in the United States and is responsible for suboptimal responses to treatment. Unfortunately, this issue has seen less rapid data evolution, and thus fewer changes. The Panel noted that the high degree of medication adherence with all ARV regimens is needed to prevent the selection of drug resistance. Nonadherence can rapidly exhaust treatment options. The reasons for variability in response to antiretroviral agents are complex but may include multiple social issues, such as substance abuse, depression, and lack of social support and should be addressed with patients before initiation of therapy. Predictors of inadequate adherence to medications include: -Lack of trust between clinician and patient -Active drug and alcohol use -Active mental illness (depression) -Lack of patient education and inability of patients to identify their medications -Lack of reliable access to primary medical care or medication Some suggestions by the Panel for improving adherence are to: -Establish readiness to start therapy -Provide education on medication dosing -Review potential adverse effects -Anticipate and treat adverse effects -Use educational aids, including pictures, pillboxes, and calendars -Engage family and friends -Simplify regimens, dosing, and food requirements -Use a team approach with nurses, pharmacists, and peer counselors -Provide an accessible, trusting health care team Conclusions HIV care is both evolving and complex; therefore guidelines can never been seen as fixed and must be individualized for each patient. The Panel carefully reviewed clinical trial results in HIV therapy and used these results to inform appropriate care guidelines. Recommendations are based on the best evidence from prospective trials with defined endpoints. When such evidence did not yet exist, the Panel attempted to reflect reasonable options in its conclusions. HIV care requires partnership and open communication between patients and all those involved with their care, such as clinicians, nurses, therapists, partners, family members, and friends. These guidelines are only the starting point for medical decisionmaking; as such, they identify boundaries of highquality care but cannot be substituted for sound judgment. These guidelines are modified as new drugs become available and increase choices in initial and secondary drug regimens. References 1.US Department of Health and Human Services Panel on Antiretroviral Guidelines for Adult and Adolescents-a Working Group of the Office of AIDS Research Advisory Council (OARAC). Guidelines for the Use of Antiretroviral Agents in HIV-infected Adults and Adolescents. Bethesda, MD: National Institutes of Health; 10 Oct 2006: At Accessed 02 May National Institute of Allergy and Infectious Diseases, US Department of Health and Human Services, National Institutes of health. HIV infection and AIDS: an overview. National Institute of Allergy and Infectious Diseases Web site. Mar At Accessed 05 May 2007.

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