Management of the Treatment Naïve Patient

Jason M. Leider, MD, PhDNBHN Adult HIV Director

Associate Professor of Internal Medicine @ AECOMAugust 5, 2009

ST, a 56-year-old white man, presents to your clinic for initial management of HIV infection. He was diagnosed 4 months ago at the local health department where he underwent testing after learning of exposure from a previous sexual partner. He has no signs or symptoms of an opportunistic infection. His past medical history includes a myocardial infarction, hypertension, and dyslipidemia. His CD4 count is 420 cells/µL and his viral load is 83,000 copies/mL. Prior to his appointment, you review the lab results and determine that it may be prudent to recommend initiation of antiretroviral therapy (ART).

This recommendation is based on which of the following factors that mirrors the recommendations of the US Department of Health and Human Services Panel on Antiretroviral Guidelines for Adults and Adolescents, issued November 3, 2008?

1) A plasma HIV-1 RNA level > 75,000 copies/mL

2) Emerging data showing no difference in all-cause mortality when ART is initiated at CD4 counts between 351 cells/µL and 500 cells/µL compared with lower CD4 counts

3) Earlier initiation of ART may reduce cardiovascular or other non-AIDS-related disease risks

4) The risk for opportunistic infection decreases when treatment is initiated at CD4 counts > 500 cells/µL compared with CD4 counts between 351 cells/µL and 500 cells/µL

Which of these laboratory values or conditions would not influence the choice of an initial regimen for ST?

1) A plasma HIV-1 RNA level > 75,000 copies/mL

2) History of myocardial infarction

3) History of hypertension

4) History of dyslipidemia

After assessing his readiness to take medication and addressing factors that might limit adherence, you negotiate a treatment plan. He commits to beginning an antiretroviral regimen. Given his current medical problems and treatment-naive HIV status, is there any class of drugs that should be avoided as initial therapy?

1) Nonnucleoside reverse transcriptase inhibitors

2) Nucleoside reverse transcriptase inhibitors

3) Protease inhibitors

4) CCR5 antagonists

5) None of these classes need to be excluded as a group

A 35-year-old black woman who was screened in your office tests positive for HIV on rapid testing. A Western blot test confirms the initial positive screening result. Her only risk factor is 3 male sexual partners in the past 6 years. She reports that she is not currently sexually active. She has no current medical problems and takes no prescription medications. Her initial CD4 count is 387 cells/µL and her initial HIV-1 RNA serum level is 46,000 copies/mL. She is very nervous about having an infection in her body and wants to start treatment as soon as possible.

Which of the following would not be an indication to start ART in this patient at this time?

1) Hepatitis B virus coinfection that needs treatment

2) Pregnancy

3) History of atypical squamous cells of undetermined significance on a routine Pap smear

4) HIV-associated nephropathy

5) Opportunistic infection

RW, a 57-year-old Hispanic man, presents to your clinic for initial management of HIV infection. He was diagnosed 4 months ago at the local health department where he underwent testing after learning of exposure from a previous sexual partner. He has no signs or symptoms of an opportunistic infection. His past medical history includes a previous myocardial infarction, hypertension, and dyslipidemia. His CD4 count is 410 cells/µL and his viral load is 78,000 copies/mL. Prior to his appointment, you review the lab results and determine that it may be prudent to recommend initiation of antiretroviral therapy (ART).

This recommendation is based on which of the following factors that mirrors the recommendations of the US Department of Health and Human Services Panel on Antiretroviral Guidelines for Adults and Adolescents, issued November 3, 2008?

1) A plasma HIV-1 RNA level > 75,000 copies/mL2) Emerging data showing no difference in all-cause

mortality when ART is initiated at CD4 counts between 351 cells/µL and 500 cells/µL compared with lower CD4 counts

3) Earlier initiation of ART may reduce cardiovascular or other non-AIDS-related disease risks

4) The risk for opportunistic infection decreases when treatment is initiated at CD4 counts > 500 cells/µL compared with CD4 counts between 351 cells/µL and 500 cells/µL

This recommendation is based on which of the following factors that mirrors the recommendations of the US Department of Health and Human Services Panel on Antiretroviral Guidelines for Adults and Adolescents, issued November 3, 2008?

Answer 3: Earlier initiation of ART may reduce cardiovascular or other

non-AIDS-related disease risksCD4 counts and clinical conditions, including consideration of a possible benefit in terms of non-HIV-related diseases, are generally considered to be more important than the viral load. Although some experts would start treatment when the viral load is > 100,000 copies/mL, a viral load > 75,000 copies/mL would not generally be an indication for treatment.

Which of these laboratory values or conditions would not influence the choice of an initial regimen for RW?

1) A plasma HIV-1 RNA level > 75,000 copies/mL

2) History of myocardial infarction

3) History of hypertension

4) History of dyslipidemia

Which of these laboratory values or conditions would not influence the choice of an initial regimen for RW?

Answer 1: A plasma HIV-1 RNA level > 75,000 copies/mL:

A viral load > 100,000, but not 75,000 copies/mL, would argue against the use of abacavir. The clinical conditions listed would, appropriately, be used to select a regimen, choosing one that is less likely to cause dyslipidemia.

After assessing his readiness to take medication and addressing factors that might limit adherence, you negotiate a treatment plan. He commits to beginning an antiretroviral regimen. Given his current medical problems and treatment-naive HIV status, is there any class of drugs that should be avoided as initial therapy?

1) Nonnucleoside reverse transcriptase inhibitors

2) Nucleoside reverse transcriptase inhibitors

3) Protease inhibitors4) CCR5 antagonists

After assessing his readiness to take medication and addressing factors that might limit adherence, you negotiate a treatment plan. He commits to beginning an antiretroviral regimen. Given his current medical problems and treatment-naive HIV status, is there any class of drugs that should be avoided as initial therapy?

Answer 4: CCR5 antagonistsThe currently approved CCR5 antagonist is approved for treatment-experienced -- not treatment-naive -- patients, and the DHHS guidelines indicate that there is insufficient evidence for it to be used as initial therapy. It is also important to note that there is substantial heterogeneity within the current classes of antiretroviral agents and that an entire class need not be avoided in a patient with cardiovascular risk factors.

A 27-year-old black woman who was screened in your office tests positive for HIV on rapid testing. A Western blot test confirms the initial positive screening result. Her only risk factor is 4 male sexual partners in the past 5 years. She reports that she is not currently sexually active. She has smoked a pack of cigarettes per day since age 14 but otherwise has no current medical problems and takes no prescription medications. Her initial CD4 count is 378 cells/µL and her initial HIV-1 RNA serum level is 34,000 copies/mL. She wants to start treatment as soon as possible.

Which of the following would not be an indication to start ART in this patient at this time?

1) Hepatitis B virus coinfection that needs treatment

2) Pregnancy3) History of atypical squamous cells of

undetermined significance on a routine Pap smear

4) HIV-associated nephropathy5) Opportunistic infection

Which of the following would not be an indication to start ART in this patient at this time?

Answer 3: History of atypical squamous cells of undetermined

significance on a routine Pap smearThere are several instances in which an underlying clinical condition takes precedence over the recommendation to wait until the CD4 count has dropped to 350 cells/µL. If the patient has a history of an AIDS-defining illness, is pregnant, has hepatitis B coinfection that is in need of treatment, or has HIV-associated nephropathy, treatment should be initiated regardless of CD4 count. Note that the presence of these conditions may affect the choice of treatment.