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Appendix - Recommended Treatment Options for Persons with Human Immunodeficiency Virus-Related Tuberculosis Infection and Disease

(Table_1A) Table 1A. Treatment regimens for human immunodeficiency

virus (HIV)-related tuberculosis (TB)

(Table_2A) Table 2A. Antituberculosis medcations: doses, toxicities,

and monitoring requirements.

(Table_3A) Table 3A. Tuberculosis (TB) preventive therapy regimens

for adults with human immunodeficiency virus (HIV) infection


Table_1A
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Table 1A. Treatment regimens for human immunodeficiency virus (HIV)-related tuberculosis (TB)
===================================================================================================================================================================

              Induction Phase               Continuation Phase
        -----------------------------   -----------------------------
Rating  Drugs   Interval and Duration   Drugs   Interval and Duration   Considerations for HIV Therapy  Comments
-------------------------------------------------------------------------------------------------------------------------------------------------------------------
Six-month RFB-based therapy (may be prolonged* to 9 months)
-------------------------------------------------------------------------------------------------------------------------------------------------------------------
 A.II   INH     Daily for 2 months      INH     Daily or 2 times/week   RFB should not be used          If the patient also is taking
        RFB     (8 weeks)               RBF     for 4 months (18 weeks) concurrently with ritonavir,    indinavir, nelfinavir, or
        PZA+                                                            hard-gel saquinavir (Invirase), amprenavir, the daily dose of RFB
                                                                        or delavirdine.                 is decreased from 300mg to
                                                                                                        150mg. The twice-weekly dose of
                                                                                                        RFB (300mg) remains unchanged
                                                                                                        if the patient is also taking these
                                                                                                        protease inhibitors.

                or                              or                      A 20%-25% increase in the dose
                                                                        of protease inhibitors or NNRTIs
                                                                        might be necessary.


        INH     Daily for 2 weeks and   INH     2 times/week for        The patient should be monitored If the patient also is taking
        RFB     then 2 times/week for   RFB     4 months (18 weeks)     carefully for RFB drug toxicity efavirenz, the daily or twice
                                                                        (arthalgia, uveitis,leukopenia) weekly dose of RFB is increased
                                                                        if RFB is used concurrently     from 300mg to 450 mg.
                                                                        with protease inhibitors or
                                                                        NNRTIs.

                                                                        Evidence of decreased           Three times a week
                                                                        antiretroviral drug activity    administration of RFB used in
                                                                        should be assessed              combination with antiretroviral
                                                                        periodically with HIV RNA       therapy has not been studied.
                                                                        levels.

                                                                        No contraindication exists for
                                                                        the use of RFB with NRTIs.

Nine-month SM-based therapy (may be prolonged* to 12 months)
-------------------------------------------------------------------------------------------------------------------------------------------------------------------
B.II    INH     Daily for 2 months      INH     2-3 times/week for      Can be used concurrently with   SM is contraindicated for
        SM      (8 weeks)               SM      7 months (30 weeks)     antiretroviral regimens that    pregnant women.
        PZA                             PZA                             include protease inhibitors,
                                                                        NRTIs, and NNRTIs.              Every effort should be made to
                                                                                                        continue administering SM for the
                                                                                                        total duration of treatment. When
                                                                                                        SM is not used for the recommended,
                                                                                                        9 months, EMB should be added to the
                                                                                                        regimen and the treatment duration
                                                                                                        should be prolonged from 9 months
                                                                                                        (38 weeks) to 12 months (52 weeks).

Six-month RIF-based therapy (may be prolonged* to 9 months)
-------------------------------------------------------------------------------------------------------------------------------------------------------------------
A.I     INH     Daily for 2 months      INH     Daily or 2-3 times/week Protease inhibitors or NNRTIs   SM is contraindicated for
        RIF     (8 weeks)               RIF     for 4 months (18 weeks) should not be administered      pregnant women.
        PZA&                                                            concurrently with RIF.
        EMB&
        (or SM) or                              or                      NRTIs can be administered
                                                                        concurrently with RIF.

        INH     Daily for 2 weeks and   INH     2-3 times/week for      If appropriate, patients should be
        RIF     then 2-3 times/week for RIF     4 months (18 weeks)     assessed every 3 months t
        PZA&    6 weeks                                                 evaluate the decision to initiate
        EMB&                                                            antiretroviral therapy.
        (or SM) or                      or
                                                                        A 2-week "P-450 induction
                                                                        washout" period may be
                                                                        necessary between the last dose
                                                                        of RIF and the first dose of
                                                                        protease inhibitors or NNRTIs.

        INH     3 times/week for        INH     3 times/week for
        RIF     2 months (8 weeks)      RIF     4 months (18 weeks)
        PZA                             PZA
        EMB                             EMB
        (or SM)                         (or SM)

-------------------------------------------------------------------------------------------------------------------------------------------------------------------
EMB=ethambutol; INH=isoniazid; PZA=pyrazinamide; RFB=rifabutin; RIF=rifampin; SM=streptomycin.
NNRTI=nonnucleoside reverse transcriptase inhibitor; NRTI=nucleoside reverse transcriptase inhibitor.

* Duration of therapy should be prolonged for patients with delayed response to therapy. Criteria for delayed response should be assessed at the end of the
  2-month induction phase and include a) lack of conversion of the Mycobacterium tuberculosis culture from positive to negative or b) lack or resolution or
  progression of signs or symptoms of TB.
+ Continue PZA and EMB for the total duration of the induction phase (8 weeks).
& Contimue PZA for the total duration of the induction phase (8 weeks). EMB can be stopped after susceptibility test retults indicate Mycobacterium tuberculosis
  susceptibility to INH and RIF.

===================================================================================================================================================================

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Table_2A
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TABLE 2A. Antituberculosis medications: doses, toxicities, and monitoring requirements.
========================================================================================================================================================================================================


                             Dose in mg/kg (maximum dose) Rout of Administration
        ------------------------------------------------------------------------------------------
                 Daily                     Two times/week *             Three times/week*
        -------------------------      ------------------------       ----------------------------
Drug    Children        Adults          Children        Adults          Children        Adults          Adverse Reactions               Monitoring                      Comments
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
INH     10-20           5               20-40           15              20-40           15              Rash                            Liver function tests            Hepatitis risk increases
        (300 mg)        (300 mg)        (900 mg)        (900 mg)        (900 mg)        (900 mg)        Hepatic enzyme elevation                                        with age and alcohol
        PO or IM        PO or IM        PO or IM        PO or IM        PO or IM        PO or IM        Hepatitis                       Repeat measurements if          consumption.
                                                                                                        Peripheral neuropathy           baseline results are
                                                                                                        Mild central nevous             abnormal                        Pyridoxine (Vitamin B6)
                                                                                                        system effects                  patient is pregnant or at       might prevent peripheral
                                                                                                        Drug interactions               high risk for adverse           neuropathy and central
                                                                                                        resulting in increased          reactions                       nervous system effects.
                                                                                                        phenytoin (Dilantin) or         patient has symptoms of
                                                                                                        disulfiram (Antabuse)           adverse reactions
                                                                                                        levels

RIF     10-20           10              10-20           10              10-20           10              Rash                            Complete blood count,           RIF use contraindicated
        (600 mg)        (600 mg)        (600 mg)        (600 mg)        (600 mg)        (600 mg)        Hepatitis                       platelets, and liver            for patients taking PIs or
        PO or IV        PO or IV        PO or IV        PO or IV        PO or IV        PO or IV        Fever                           function tests                  NNRTIs.
                                                                                                        Thrombocytopenia
                                                                                                        Flu-like symptoms               Repeat measurements if          Decreases levels of many
                                                                                                        associated with                 baseline results are            drugs (e.g., methadone,
                                                                                                        intermittent dosing             abnormal                        dapsone, ketoconazole,
                                                                                                        Orange-colored body             patient has symptoms            hormonal contraceptives
                                                                                                        fluids (secretions, urine,      of adverse reactions
                                                                                                        tears)                                                          Might permanently
                                                                                                                                                                        discolor soft contact lenses.

RFB+    10-20           5               10-20           5               Not             Not             Rash                            Complete blood count,           RFB is contraindicated for
        (300 mg)        (300 mg)        (300 mg)        (300 mg)        known           known           platelets, and liver            platelets, and liver            patients taking ritonavir,
        PO or IV        PO or IV        PO or IV        PO or IV                                        Fever                           function tests                  saquinavir (Invirase), or
                                                                                                        Thrombocytopenia                                                delavirdine.
        or              or              or              or                                              Orange-colored body             Repeat measurements if
                                                                                                        fluids (secretions, urine,      baseline results are            Reduces levels of many
        NA&             NA&             10-20&          5&              Not             Not             tears)                          abnormal                        drugs (e.g., PIs, NNRTIs,
        (150 mg)        (150 mg)        (300 mg)        (300 mg)        known           known                                           patient has symptoms            methadone, dapsone,
        PO or IV        PO or IV        PO or IV        PO or IV                                        With increased levels of        of adverse reactions            ketoconazole, hormonal
                                                                                                        RFB:                                                            contraceptives).
        or              or              or              or              Not             Not             Severe arthralgias              Use adjusted daily dose
                                                                        known           known           Uveitis                         of RFB&, and monitor for        Might permanently
        NA@             NA@             NA@             NA@                                             Leukopenia                      decreased antiretroviral        discolor soft contact
        (450 mg)        (450 mg)        (450 mg)        (450 mg)                                                                        activity and for RFB            lenses.
        PO or IV        PO or IV        PO or IV        PO or IV                                                                        toxicity if RFB taken
                                                                                                                                        concurrently with PIs or
                                                                                                                                        NNRTIs.

PZA     15-30           15-30           50-70           50-70           50-70           50-70           Gastrointestinal upset          Liver function tests and        Treat hyperuricemia only
        (2.0 g)         (2.0 g)         (3.5 g)         (3.5 g)         (2.5 g)         (2.5 g)         Hepatitis                       uric acid                       if patient has symptoms.
        PO              PO              PO              PO              PO              PO              Rash
                                                                                                        Arthralgias                     Repeat measurements if          Might make glucose
                                                                                                        Hyperuricemia                   baseline results are            control more difficult in
                                                                                                        Gout (rare)                     abnormal                        persons with diabetes.
                                                                                                                                        patient has symptoms of
                                                                                                                                        adverse reactions

EMB     15-25           15-25           50              50              25-30           25-30           Optic neuritis (decreased       Baseline and monthly            Optic neuritis might be
        (1600 mg)       (1600 mg)       (4000 mg)       (4000 mg)       (2000 mg)       (2000 mg)       red-green color                 tests of visual acuity and      unilateral; check each eye
        PO              PO              PO              PO              PO              PO              discrimination),                color vision                    separately.
                                                                                                        decreased visual acuity
                                                                                                        Rash

SM      20-40           15              25-30           25-30           25-30           25-30           Otoxicity (hearing loss         Baseline and repeat as          Ultrasound and warm
        (1 g)           (1 g)           (1.5 g)         (1.5 g)         (1.5 g)         (1.5 g)         or vestibular dysfunction)      needed audiometry and           compresses to injection
        IM or IV        IM or IV        IM or IV        IM or IV        IM or IV        IM or IV        Nephrotoxicity                  renal function tests            site might reduce pain.

                                                                                                                                                                        Maximum dose for
                                                                                                                                                                        patients >=60 years is 1.0 g.
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
EMB=ethambutol; INH=isoniazid; PZA=pyrazinamide; RFB=rifabutin; RIF=rifampin; SM=streptomycin.
NNRTIs=nonnucleoside reverse transcriptase inhibitors; PI=protease inhibitor.
IM=intramuscular; IV=intravenous; PO=by mouth

* All intermittent dosing should be administered with directly observed therapy.
+ The concurrent use of RFB is contraindicated with ritonavir, saquinavir (Invirase), and delavirdine. Information regarding the use of rifabutin with saquinavir
  (Fortovase), amprenavir, efavirenz, and nevirapine is limited.
& Not applicable. If nelfinavir, indinavir, or amprenavir is administered with RFB, blood concentrations of these protease inhibitors decrease. Thus, when RFB
  is used concurrently with any of these three drugs, the daily dose of RFB is reduced from 300mg to 150mg (the twice-weekly dose of RFB is unchanged,
  however).
@ NA=not applicable. If efavirenz is administered with RFB, blood concentrations of RFB decrease. Thus, when RFB is used concurrently with efavirenz, the
  dose of RFB for both daily and twice weekly administration should be increased from 300 mg to 450 mg.
========================================================================================================================================================================================================

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Table_3A
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TABLE 3A. Tuberculosis (TB) preventive therapy regimens for adults with human immunodeficiency virus (HIV) infection
========================================================================================================================================================
Rating  Drug            Interval and Duration           Comments                        Indications                     Conraindications
--------------------------------------------------------------------------------------------------------------------------------------------------------
A.II    INH             Daily for 9 months              INH can be administered         HIV-infected persons who are    History of an INH-induced
                                                        concurrently with NRTIs,        candidates for TB preventive    reaction, including hepatic,
                                                        protease inhibitors, or NNRTIs. therapy.                        skin, or other allergic
                                                                                                                        reactions or neuropathy.

B.I     INH             2 times/week for 9 months                                       DOPT must be used when          Known exposure to person
                                                                                        twice-weekly dosing is used.    who has INH-resistant TB.

                                                                                                                        Chronic severe liver disease.

A.I     RIF and PZA*    Daily for 2 months              Protease inhibitors or NNRTIs   HIV-inifected persons who are   History of rifamycin-
                                                        should not be administered      candidates for TB preventive    induced reaction, including
                                                        concurrently with RIF; in this  therapy.                        hepatic, skin, or other allergic
                                                        situation, an alternative is                                    reactions, or
                                                        the use of RFB+ and PZA.                                        thrombocytopenia.

                                                        If RFB is administered, patient HIV-infected persons known      Pregnancy.
                                                        should be monitored carefully   to be contacts of patient who
                                                        for potential RFB drug toxicity has INH-resistant,              Chronic severe hyperuricemia.
                                                        and potential decreased         rifamycin-susceptible TB.
                                                        antiretroviral drug activity.                                   Chronic severe liver disease.

                                                        Dose adjustments, alternative
                                                        therapies, or other
                                                        precautions might be needed
                                                        with rifamycins are used
                                                        (e.g., patients using hormonal
                                                        contraceptives must be
                                                        advised to use barrier
                                                        methods, and patients using
                                                        methodone require dose
                                                        adjustments).
--------------------------------------------------------------------------------------------------------------------------------------------------------
INH=isoniazid; PZA=pyrazinamide; RFB=rifabutin;RIF=rifampin.
DOPT=directly observed preventive therapy; NNRTI=nonnucleoside reverse transcriptase inhibitor; NRTO=nucleoside reverse transcriptase inhibitor.

* For patients with intolerance to PZA, some experts recommend the use of rifamycin (RIF or RFB) alone for preventive treatment. Most experts agree that
  available data support the recommendation that this treatment can be administered for as short a duration as 4 months, although some experts would treat
  for 6 months.
+ The concurrent use of RFB is contraindicated with ritonavir, hard-gel saquinavir (Invirase), and delavirdine. The information regarding the use of RFB
  with soft-gel saquinavir (Fortovase), amprenavir, efavirenz, and nevirapine is limited.

========================================================================================================================================================

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