Download file (Advanced Pharmaceutical Care: HIV)

Facts
Hypothesis
Learning Questions
Patient presented to ER 24 days
ago with symptoms of shortness of
breath, dry cough, and 20 lb
weight loss leading to diagnosis of
PCP (PJP)
PCP disease is
secondary to HIV
diagnosis
1. What are the 1st and 2nd line
treatment guidelines for PCP,
and what symptoms and
diagnostic tests confirm
eradication of PCP?
Patient is HIV positive
and at childbearing
age
2. How are CD4+ cell count, viral
load, and genotype analyzed
with respect to HIV and AIDS?
Patient given discharge regimen of
21 day course of bactrim and
prednisone and oxygen (not used)
Patient has unprotected sex with
multiple partners
Duplicate ELISAS and
confirmatory Western Blot were
positive for HIV (CD4, viral load,
and genotype are pending)
3. What are the treatment
guidelines for HIV/AIDS in
regards to age, sex, pregnancy,
and lab values?
4. What lifestyle changes must
an HIV patient take regarding
sexual behavior, STD testing,
and emotional changes?
Patient has 20 lb weight loss,
depression episodes, consumes
excessive alcohol, and
experiments with “ecstasy”
Patient has a mood
disorder related to
these behaviors
5. What are the long term effects
of alcohol and illicit drugs
(“ecstasy”) in HIV patients?
6. What are the treatment
parameters and guidelines for
depression in HIV patients?
Patient has symptoms of GERD
and takes omeprazole twice daily
Patient is self treating
her GERD and
symptoms are possibly
worsening
7. What are the treatment
guidelines of GERD and how do
they limit treatment to HIV
patients?
Patient has unstable social
environment and does not
currently live at home
Patient may have
compliance and
access issues with
HIV/AIDS medications
8. What are methods to lower
medication costs and decrease
dosing to increase patient
compliance?
Patient has no health insurance
1. From CDC.gov website
● Histopathologic demonstration of organisms in tissue, bronchoalveolar lavage fluid, or
induced sputum samples is required for a definitive diagnosis.
● Trimethoprim-sulfamethoxazole (TMP-SMX) is the treatment of choice. The dose must
be adjusted for abnormal renal function
●
●
●
●
●
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Patients with documented PCP and moderate-to-severe disease, as defined by room air
pO2 <70 mm/Hg or arterial-alveolar O2 gradient >35 mm/Hg, should receive
corticosteroids as early as possible, and certainly within 72 hours after starting specific
PCP therapy.
Alternative therapeutic regimens include
○ 1) dapsone and TMP for mild-to-moderate disease
■Regimen may have similar efficacy and fewer side effects than TMPSMX but
is less convenient because of the number of pills);
○ 2) primaquine plus clindamycin (77--79) (BI)
■This regimen is also effective in mild-to-moderate disease, and the
clindamycin component can be administered intravenously for more
severe cases; however, primaquine is only available orally
○ 3) intravenous pentamidine (80--82)
■Generally the drug of second choice for severe disease
○ 4) atovaquone suspension (67,83) (BI)
■This is less effective than TMP-SMX for mild-to-moderate disease but has
fewer side effects
○ 5) trimetrexate with leucovorin (84) (BI)
■This is less effective than TMP-SMX but can be used if the latter is not
tolerated and an intravenous regimen is needed
The recommended duration of therapy for PCP is 21 days.
Certain patients with AIDS and severe PCP should be offered ICU admission or
mechanical ventilation when appropriate (e.g., when they have reasonable functional
status)
Follow-up after therapy includes assessment for early relapse, especially when therapy
has been with an agent other than TMP-SMX or was shortened for toxicity.
PCP prophylaxis should be initiated promptly and maintained until the CD4+ T
lymphocyte count is >200 cells/µL.
○ If PCP occurred at a CD4+ T lymphocyte count >200 cells/µL, maintaining PCP
prophylaxis for life regardless of the CD4+ T cell response might be prudent
Indications for therapy IN PREGNANCY are the SAME AS FOR NONPREGNANT. The
preferred initial therapy during pregnancy is TMP-SMX, although alternate therapies can
be used if patients are unable to tolerate or are unresponsive to TMP-SMX
2.
●
●
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Genotype
○ Screen for HLA-B*5701 before starting patients on an abacavir (ABC) containing regimen to reduce the risk of hypersensitivity reaction
○ HLA-B*5701 should not be prescribed ABC
○ Positive status should be recorded as ABC allergy
○ When testing not available, reasonable to initiate ABC with monitoring for HSR
Viral Load
CD4+
○
○
A CD4:CD8 ratio is calculated by dividing the number of CD4+ T cells by the
number of CD8+ T cells; this ratio is usually greater than 1 in
immunocompetent individuals [5]. However, in HIV infection, the CD4:CD8
ratio is less than 1.
HIV-infected patients with a CD4 count <200 cells/mm3 are classified as
having AIDS
5.
●
Alcohol
○ Alcohol has been demonstrated to depress levels of CD4 counts [111,112].
One prospective study evaluated the effect of alcohol use on CD4 T-cell
counts in 595 HIV-infected patients [111]. In patients not on ART, heavy
alcohol consumption was associated with a lower CD4 cell count compared to
patients who had a history of abstinence.
●
MDMA (Ecstasy) (from 2006 oxford journal article, too old???)
○ Evidence suggests that there are clinically significant neurological consequences of
○
○
MDMA use [29]. Some, but not all, studies report high rates of depression, anxiety,
insomnia, and impaired cognitive performance among MDMA users
No studies have demonstrated conclusively that club drugs directly influence the
progression of HIV disease
Club drugs and interactions with ARTs. The combination of club drugs with ART
may produce serious and even fatal interactions. Patients starting retroviral therapy
should be advised that their “normal” doses of club drugs may produce untoward effects
when coadministered with ART. MDMA, GHB, ketamine, and methamphetamine are all at
least partially cleared through the cytochrome P-450 system, as are a variety of retroviral
medications [1]. Thus, concomitant use of club drugs and antiretrovirals can delay
clearance of club drugs, dramatically increasing blood levels and leading to adverse
events. In case reports, ritonavir has been implicated in increasing both MDMA and GHB
levels, with at least 1 death attributed to the effect of ritonavir on delaying MDMA
clearance [84, 85]. The interactive effects of nucleoside reverse-transcriptase inhibitors
and nonnucleoside reverse-transcriptase inhibitors on club drug levels remain less
understood, although ketamine levels may increase when individuals are taking
nonnucleoside reverse-transcriptase inhibitors [86].
6.
●
Depression guidelines
○ HIV-infected patients with major depression respond to antidepressant
○
○
○
medication similarly to other patients with major depression.
Antidepressants are the most commonly prescribed psychotropic drugs for HIV-infected
patients.
Interactions with antiretrovirals are possible with all selective serotonin reuptake
inhibitors by means of their potential to inhibit cytochrome P450 enzymes
Fluoxetine and paroxetine, potent inhibitors of CYP2D6, may cause toxicity by increasing
levels of protease inhibitors. Fluvoxamine, a potent inhibitor of CYP1A2, may also create
toxicity through increased levels of protease inhibitors. Sertraline, citalopram, and
escitalopram, however, appear to have little effect on the major CYP isoforms.
○
Through randomized clinical trials, fluoxetine has been shown to be the most effective of
the selective serotonin reuptake inhibitors in the treatment of major depression in HIVinfected patients. Paroxetine, sertraline, and citalopram have also demonstrated efficacy
○
This link lists interactions between HIV drugs and antidepressants
■http://www.hivguidelines.org/clinical-guidelines/hiv-and-mentalhealth/appendix-ii-interactions-between-hiv-related-medications-andpsychotropic-medications/
7. http://www.hiv.va.gov/provider/manual-primary-care/gerd.asp - pretty much go along with
normal GERD therapy but make sure not an opportunistic infection first
weight loss potential explanation: talking about acute infection of HIV
During this period (usually 2–4 weeks post-exposure) many individuals develop an influenza or
mononucleosis-like illness calledacute HIV infection, the most common symptoms of which may include
fever, lymphadenopathy, pharyngitis, rash, myalgia,malaise, mouth and esophageal sores, and may also
include, but less commonly, headache, nausea and vomiting, enlarged liver/spleen, weight loss,
thrush, and neurological symptoms. Infected individuals may experience all, some, or none of these
symptoms. The duration of symptoms varies, averaging 28 days and usually lasting at least a week
stages of HIV infection include; 1. acute infection → 2. chronic infection → 3. AIDS (CD4 <200)
Guidelines: http://www.aidsinfo.nih.gov/guidelines
If she turns out to be pregnant: http://www.aidsinfo.nih.gov/guidelines/html/3/perinatalguidelines/156/hiv-infected-women-who-have-never-received-antiretroviral-drugs--naive-
HIV
Things to do, if not already done:
HIV testing (ELISA + Western Blot) - X
Drug resistance testing, genotype - pending
CD4+ T-cell count - pending
● recheck every 3-4 weeks
● goal: Adequate response is an increase of 50-150 cells/mm3 per year until steady state
level is reached
Plasma HIV RNA (viral load) - pending
● Measured 2-8 weeks after initiation or modification of therapy
● goal: UNDETECTABLE VIRAL LOAD (<50 copies/mL)
AIDS?
● CD4 T-cell count < 200 cells/mm3 or
● AIDS defining illness - PCP
Check renal function - adjust NRTIs accordingly (except abacavir)
Screening for STDs
Tuberculin skin test
Routine chemistries (CBC, liver enzymes)
Fasting blood glucose and serum lipids
Hepatitis A, B, and C serologies
Treatment:
Darunavir + Ritonavir (QD) + Tenofovir + Emtricitabine
or
Raltegravir (BID) + Tenofovir + Emtricitabine
NRTI:
● monitoring
○ Peripheral neuropathy and pancreatitis (stavudine, didanosine)
○ nephrotoxicity (tenofovir)
○ HLA-B*5701 - abacavir HSR
PLAN for NON PREGNANCY
PCP
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If considered treatment failure (NOT SURE IF IT IS TX FAILURE OR NOT)
Dapsone 100 mg PO once-daily + trimethoprim 5 mg/kg q8h x 21 days.
o Dapsone & trimethoprim are both Pregnancy Category C
o http://www.hopkinsguides.com/hopkins/ub/view/Johns_Hopkins_HIV_Guide/545049/all/D
apsone?q=dapsone%20PCP
o PPx after eradication of current PCP infection due to patient history of PCP
Bactrim (DS) tablet PO daily
o Adverse reaction rates among patients with AIDS are high for TMP-SMX (20%–85%)
(135,136,147,149,153,161–165).
o Common adverse effects are rash (30%–55%) (including Stevens-Johnson syndrome),
fever (30%–40%), leukopenia (30%–40%), thrombocytopenia (15%), azotemia (1%–5%),
hepatitis (20%), and hyperkalemia.
o Supportive care for com-mon adverse effects should be attempted before discontinuing
TMP-SMX (AIII).
o Rashes can often be “treated through” with antihistamines, nausea can be controlled with
antiemetics, and fever can be managed with antipyretics.
LIFELONG OR
o Secondary prophylaxis should be discontinued for adult and adolescent patients whose
CD4+ T lymphocyte cell count has increased from <200 cells/µL to >200 cells/µL for at
least 3 months as a result of ART (94--97) (AI). Secondary prophylaxis should be reintroduced if the CD4+ T lymphocyte count decreases to <200 cells/µL (AIII) or if PCP
recurs at a CD4+ T lymphocyte count of >200 cells/µL (CIII).
o HIV/AIDS
Panel’s Recommendations:
o Antiretroviral therapy (ART) should be initiated in all patients with a history of an AIDS-defining
illness or with a CD4 count <350 cells/mm3 (AI).
 PCP is an AIDS –defining illness
o ART is also recommended for patients with CD4 counts between 350 and 500 cells/mm3 (A/B*II).
o ART should be initiated, regardless of CD4 count, in patients with the following conditions: HIVassociated nephropathy (HIVAN) (AII) and hepatitis B virus (HBV) coinfection when treatment of HBV is
indicated (AIII).
o A combination antiretroviral (ARV) drug regimen is also recommended for pregnant women who do
not meet criteria for treatment with the goal to prevent perinatal transmission (AI).
o For patients with CD4 counts >500 cells/mm3, Panel members are evenly divided: 50% favor starting
ART at this stage of HIV disease (B); 50% view initiating therapy at this stage as optional (C) (B/C-III).
· Genetic testing:
o HIV drug-resistance testing is recommended for persons with HIV infection when they enter
into care regardless of whether antiretroviral therapy (ART) will be initiated immediately or
deferred (AIII). If therapy is deferred, repeat testing at the time of ART initiation should be
considered (CIII).
o Genotypic testing is recommended as the preferred resistance testing to guide therapy in
antiretroviral (ARV)-naïve patients (AIII).
o Standard genotypic drug-resistance testing in ARV-naïve persons involves testing for
mutations in the reverse transcriptase (RT) and protease (PR) genes. If transmitted integrase
strand transfer inhibitor (INSTI) resistance is a concern, providers may wish to supplement
standard genotypic resistance testing with genotypic testing for resistance to this class of drug
(CIII).
·
Combination Therapy
o Protease Inhibitor Option
§ Ritonavir (100mg)-boosted darunavir (800) PO QD with food
· Monitor: hyperlidemia, pre-diabetes, lipodystrophy, elevated liver function tests,
gastrointestinal intolerances
· ADR: diarrhea. Rash
· Caution with: Hormonal contraceptives***
o Use a barrier method
o NRTI Option
§ Tenofovir (300mg qd)/emtricitabine (200qd) (DRV/r + TDF/FTC) (AI) PO QD [Truvada]
· Monitor for lactic acidosis, hepatic steatosis, lipodystrophy, peripheral neuropathy and
pancreatitis
· Nephrotoxicity
·
Lab Schedule
o CD4+T cell count should be determined every 3-6 months.
§ Adequate response to therapy is an increase of 50-150 cells/mm3 per year until steady state
level is reached.
§ IF STABLE FOR 2-3 YEARS, MONITORING MAY BE EXTENDED TO EVERY 6 MONTHS.
o CD4 Count: entry into care, at initiation of tx, and then every 3-6 mos thereafter
o Viral load
§ Plasma viral load should be measured before initiation of therapy and preferably within 2–4 weeks, and
not more than 8 weeks, after treatment initiation or after treatment modification (BI).
§ Repeat viral load measurement should be performed at 4–8-week intervals until the level falls below
the assay’s limit of detection (BIII).
§ Measured every 3-4 months for stable patients.
§ TREATMENT GOAL= UNDETECTABLE VIRAL LOAD (<50copies/ml)
§ Complete viral suppression should occur in 12-24 weeks in compliant patients.
§ Treatment is considered a failure if:
· HIV-RNA level >400 copies/ml after 24 weeks
· HIV-RNA level >50 copies/ml after 48 weeks
o Perform physical, history, and complete work up including
§ Complete blood count, chemistry profile, transaminase levels, blood urea nitrogen (BUN) and
creatinine, urinalysis, and serologies for hepatitis A, B, and C viruses (AIII); Fasting blood glucose
and serum lipids (AIII);
o In addition, other tests, including screening tests for sexually transmitted infections and tests
for determining risk for opportunistic infections and need for prophylaxis, should be performed as
recommended by HIV primary care and opportunistic infections guidelines
·
PPx based on CD4 count
o PCP
<200
TMP/SMX DS 3x/week
o Toxoplasma gondi
<100
TMP/SMX DS 3x/week
o Mycobacterium avium
<50
Azithromycin 1200 mg/week
o TB
+ test or close contacts
Isoiazid 300 mg PO for 9 mos
o Cytomegalovirus
<50
None (maybe valganciclovir)
PREVENTION TRANSMISSION OF HIV
·
Emerging evidence supports the concept of "treatment as prevention" of sexual
transmission of HIV. Lower plasma HIV RNA levels are associated with decreases in the
concentration of the virus in genital secretions [83-84]. Studies of HIV serodiscordant
heterosexual couples have demonstrated a relationship between the level of plasma viremia and
HIV transmission risk: when plasma HIV RNA levels are lower, transmission events are less
common [85-89]. These investigations, as well as other observational studies and modeling
analyses demonstrating a decreased rate of HIV transmission among serodiscordant
heterosexual couples following the introduction of ART, suggest that suppression of viremia in
ART-adherent patients with no concomitant sexually transmitted infections (STIs) substantially
reduces the risk of HIV transmission [88-93]. Based on these studies, the use of effective ART
regardless of CD4 count is likely to reduce transmission to the uninfected sexual partner (BII).
don’t have to notify, counseling is not required
·
CHOICES Intervention
http://www.cdc.gov/hiv/topics/research/prs/resources/factsheets/CHOICES.htm
o Target Population
§ Low-income heterosexually active women
§ Goals of Intervention
·
Prevent new sexually transmitted diseases (STDs)
·
Increase use of safer sex strategies such as abstinence, monogamy, and/or condom use
·
Safe sex education and Group therapy (include telling previous partners to get tested and
child)
o Ryan white http://www.careacttarget.org/community.asp
SOCIAL SUPPORT/ HOMELESSNESS
·
Housing and financial aid
o Ryan White http://www.careacttarget.org/community.asp
o HOPWA http://www.hudhre.info/hopwa/index.cfm?do=viewLocalHopwaPrgm
o PMAPS www.needymeds.org
·
Counseling
PATIENT EDUCATION ON COMPLIANCE AND ADHERENCE
·
Patients initiating ART should be willing and able to commit to lifelong treatment and should
understand the benefits and risks of therapy and the importance of adherence (AIII). Patients may choose
to postpone therapy, and providers, on a case-by-case basis, may elect to defer therapy based on clinical
and/or psychosocial factors.
·
Use a mulitdicipilinary team
·
Assess adherence at every clinic visit
·
Identify reasons for noncompliance: pill burden, failure to understand directions, forgetfulness,
active substance abuse
Table 12. Strategies to Improve
Adherence to Antiretroviral Therapy
Strategies
Use a multidisciplinary team approach
Provide an accessible, trusting health
care team
Examples
• Nurses, social workers, pharmacists, and medication managers
Establish a trusting relationship with the
patient
Establish readiness to start ART
Identify potential barriers to adherence
prior to starting ART
• Psychosocial issues
• Active substance abuse or at high risk of relapse
• Low literacy level
• Busy daily schedule and/or travel away from home
• Lack of disclosure of HIV diagnosis
• Skepticism about ART
• Lack of prescription drug coverage
Provide resources for the patient
• Referrals for mental health and/or substance abuse treatment
• Resources to obtain prescription drug coverage
• Pillboxes
Involve the patient in antiretroviral (ARV)
regimen selection
• For each option, review potential side effects, dosing frequency,
pill burden, storage requirements, food requirements, and
consequences of nonadherence
Assess adherence at every clinic visit
• Use a simple checklist the patient can complete in the waiting
room
• Have other members of the health care team also assess
adherance
• Ask the patient open-ended questions (e.g., In the last 3 days,
please tell me how you took your medicines.)
Identify the type of nonadherence
• Failure to fill the prescription(s)
• Failure to take the right dose(s) at the right time(s)
• Nonadherence to food requirements
Identify reasons for nonadherence
• Adverse effects from medications
• Complexity of regimen (pill burden, dosing frequency, etc.)
• Difficulty swallowing large pills
• Forgetfulness
• Failure to understand dosing instructions
• Inadequate understanding of drug resistance and its relationship
to adherence
• Pill fatigue
• Other potential barriers (see list above)
Assess and simplify regimen, if possible
DEPRESSION
· NONPHARM as primary treatment:
o Meditation, massage, yoga, breathing, and relaxation exercises are all alternative therapies that may
help you feel better. Acupuncture and acupressure therapies may help reduce stress and improve your
mood. Good nutrition and exercise are beneficial, no matter which treatments you choose. Also have your
testosterone level checked. Low testosterone can cause depression.
· Generally, the safest class of antidepressants for use with HIV medications is selective serotonin reuptake inhibitors (SSRI’s) such as Prozac, Zoloft, and Paxil. Popular herbal preparations used for
depression that include St. Johns wort should not be taken with some HIV medications.
citalopram (little effect with cyp)
o
http://www.thewellproject.org/en_US/Diseases_and_Conditions/Other_Diseases_and_Conditions/Wome
n_and_Depression.jsp
o Fluoxetine 20 mg PO QD in the morning
§ Avoid activities requiring mental alertness, sweating, weight loss, dyspepsia, insomnia
§ Symptomatic improvement may not be seen for a few weeks
§ Report any skin rash with or w/o systemic symptoms
§ Avoid NSAIDS or ASA
§ Don’t abruptly stop medication
CHILDBEARING AGE
·
Birth Control:
http://www.thewellproject.org/en_US/Womens_Center/Birth_Control_Options.jsp
·
IUD + Condom use
·
An IUD is a small, T-shaped device put into the uterus (womb) by a health care provider.
There are two types of IUDs currently available. The first is called ParaGard. It contains copper
and lasts for up to 10 years. The second is called Mirena. It releases small amounts of the
hormone progestin and lasts 5 years.
o Drawbacks:
§ Does not offer protection against STDs (including HIV)
§ Some cramping and pain may occur when the IUD is first put into the uterus
§ For the first 3 to 6 months you may have:
·
spotting between periods
·
irregular periods with Mirena
·
worse menstrual cramps or heavier periods with ParaGard
§ You need to check occasionally to make sure it is still in place
§ Some risk of ectopic pregnancy (when a fertilized egg grows outside the uterus) and pelvic
inflammatory disease; in very rare cases, the IUD pushes through the wall of the uterus (uterine
perforation)
WORSENING GERD
·
Famotidine (Can be used in pregnancy, as well)
o 20 mg PO BID for 6-12 weeks (can be increased to 40 mg BID for 12 weeks if non-responsive
to therapy)
o OK to use with DRV
·
Antacid use
·
Blocks under bed legs
VACCINATIONS
·
Hepatitis B
·
Influenza
·
Tetanus
ABOUT DISCLOSURE TO OTHERS ONCE RECEIVE HIV+ DIAGNOSIS
PA: http://www.nccc.ucsf.edu/docs/Pennsylvania.pdf
TN: http://www.nccc.ucsf.edu/docs/Tennessee.pdf
HIV/AIDS
Darunavir - 800 mg
Ritonavir (QD) - 100 mg (80 mg/ml solution)
● with food
Truvada
●
PCP
●
●
emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg (1 tablet) ORALLY once daily, with or
without food
keep therapy
Oral thrush
fluconazole rather than topical therapy in patients who are at risk of developing esophageal
candidiasis (CD4 count <100 cells/microL)
200 mg loading dose, followed by 100 to 200 mg daily for 7 to 14 days
GERD
○ testing
Depression
Vaccines