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HIV Infection

Updated : December 19, 2022





Background

Epidemiology

Anatomy

Pathophysiology

Etiology

Genetics

Prognostic Factors

Clinical History

Physical Examination

Age group

Associated comorbidity

Associated activity

Acuity of presentation

Differential Diagnoses

Laboratory Studies

Imaging Studies

Procedures

Histologic Findings

Staging

Treatment Paradigm

by Stage

by Modality

Chemotherapy

Radiation Therapy

Surgical Interventions

Hormone Therapy

Immunotherapy

Hyperthermia

Photodynamic Therapy

Stem Cell Transplant

Targeted Therapy

Palliative Care

Medication

 

hydroxyurea

500

mg

Orally

twice a day



efavirenz

600

mg

Orally 

once a day

in combination with tenofovir and lamivudine
Discontinue therapy immediately, if moderate to severe hepatic impairment is noticed
Note: Not recommended to use in combination with abacavir and lamivudine, especially for patients receiving pre-antiretroviral therapy



didanosine

For <60 kg:

125

mg

Solution

oral

twice a day

or 250 mg oral solution once a day
>60 kg: 200 mg oral solution twice a day or 400 mg oral solution once a day
25 kg to 60 kg: 250 mg oral capsule once daily



tipranavir

500

mg

Capsule

Orally 

twice a day

in combination with ritonavir (200 mg)



nelfinavir

1250

mg

Orally 

every 12 hrs a day

or 750 mg orally every 8 hours a day



doravirine 

Indicated for the treatment of HIV-1 infection in patients in combination with other antiretrovirals
100mg orally every day



somatropin 

Indicated for HIV-associated Wasting or Cachexia:

Serostim: 0.1 mg/kg/day subcutaneously (SC) at bedtime increase up to 6 mg/day
Administer 0.1 mg/kg subcutaneously (SC) every other day if the patient is at risk of adverse effects
Alternatively:
Weight >55 kg: 6 mg/day subcutaneously (SC)
Weight 45-55 kg: 5 mg/day subcutaneously (SC)
Weight 35-45 kg: 4 mg/day subcutaneously (SC)
Weight <35 kg: 0.1 mg/kg/day subcutaneously (SC)
HIV Adipose Tissue Redistribution Syndrome
(Off-label)
Serostim: 4 mg/day subcutaneously (SC) at bedtime for 12 weeks; for maintenance following by 2-4 mg every other day for 12-24 weeks



lenacapavir 

2 recommended dosage regimens:



Dose option 1

Initiation:
Day 1: 927 mg Subcutaneous (SC) (2 x 1.5 mL) and 600 mg orally (2 x 300 mg) 
Day 2: 600 mg orally (2 x 300 mg) 

Maintenance:
Every six months (26 weeks), plus or minus two weeks: 927 mg Subcutaneous (SC) (2 x 1.5 mL) 

Dose option 2

Initiation:
Day 1-2: 600 mg orally (2 x 300 mg) daily 
Day 8: 300 mg orally (1 x 300 mg) 
Day 15: 927 mg Subcutaneous (SC)

Maintenance:
Every six months (26 weeks), plus or minus two weeks: 927 mg Subcutaneous (SC)
   



cabotegravir and rilpivirine 

(400/600) mg each drug once a month intramuscularly as two separate injections



fostemsavir 

Indicated in combination with other antiretroviral (ATV) medications for treating HIV-1 infection:


600mg orally twice a day



abacavir 

300 mg oral tablet 2 times a day or 600 mg tablet orally daily



elvitegravir/cobicistat/emtricitabine/tenofovir DF 

Take one tablet orally once daily with a meal



emtricitabine, rilpivirine, tenofovir DF 

one tablet (200mg emtricitabine /25mg rilpivirine /300mg tenofovir DF) orally daily with a meal



Dose Adjustments

Dose Modifications
rifabutin Coadministration

Add one tablet of 25mg rilpivirine with Complera for this duration of coadministration with rifabutin
Hepatic impairment
Mild-moderate (Child-Pugh score class A or B): dose adjustment is not required
Severe (Child-Pugh score class C): Not known
Renal impairment
Mild (CrCl above 50 mL/min): dose adjustment is not required
Moderate-severe (CrCl below 50 mL/min): usually not recommended

dapivirine intravaginal (FDA Approval Pending) 

Monthly once vaginal ring but FDA approval pending for prevention of human immune virus infection



lamivudine/raltegravir 

Take 1 tablet orally two times a day
Dosage Modifications
Renal impairment
Moderate-to-severe: avoid use
Hepatic impairment
Mild-to-moderate: dose modification not required
Decompensated liver disease: Safety and efficacy not determined
Severe: study not performed



darunavir and cobicistat 


Indicated for HIV-1 Infection
This medication is recommended to be used along with other antiretroviral drugs for both treatment-experienced and naive patients who do not have darunavir resistance-associated mutations.
1 tablet of 800mg darunavir /150mg cobicistat orally one time a day with food.



raltegravir 

If a patient has HIV RNA >100,000 copies/mL and a CD4 count <200 cells/mm3, they should not take raltegravir with darunavir and ritonavir. They should also avoid using raltegravir when used with abacavir and lamivudine.

Patients new to treatment:
Administer 400mg of Isentress tablets orally twice a day.
Note: Patients who first took raltegravir 400 mg twice a day and were virologically suppressed may change to taking Isentress HD once daily

Administer 1.2g daily once or 600mg Isentress HD twice daily
Note: Once-daily dose is not advised during pregnancy.

Patients with a prior medical history
Administer 400mg of Isentress tablets orally twice a day.

Non-occupational post-exposure prevention for HIV-1
Administer 400 mg twice daily for 28 days along with other antiretroviral medications. Begin treatment within 72 hours after exposure.

Occupational HIV-1 postexposure prophylaxis
Dosage modification for concurrent therapy: Serious medication interactions exist, necessitating dose/frequency modification or avoidance.



lopinavir and ritonavir 

400mg of lopinavir /100mg of ritonavir orally every 2 times a day, OR
800 mg of lopinavir /200 mg of ritonavir orally every day in patients with less than 3 lopinavir resistance-associated substitutions
Coadministration with nevirapine, efavirenz, nelfinavir or fosamprenavir
500 mg of lopinavir /125 mg of ritonavir orally every 2 times a day (i.e., 2 times of 200 mg of lopinavir /50 mg of ritonavir + 100 mg of lopinavir /25 mg of ritonavir), OR capsules/oral solution: 533 mg of lopinavir /133 mg of ritonavir orally every 2 times a day (i.e., approximately 6.5 mL every 2 times a day)



Dose Adjustments

Dose Modifications
Dose adjustments during pregnancy and postpartum period
In pregnant patients who have not taken substitutions of lopinavir-associated resistance, administer 400mg of lopinavir/100 mg of ritonavir twice daily; there is not enough data to recommend dosage for pregnant patients who have documented lopinavir-associated resistance substitutions; dosage adjustment is not required for patients during the postpartum period

saquinavir 

<16 years: Safety and efficacy are not established
>16 years: Administer 1000mg along with 100mg of ritonavir twice a day
There is no need for extra ritonavir in individuals receiving 100 mg twice daily of ritonavir as a component of their ART treatment.
Patients with no prior treatment
Initial dose-Administer 500mg orally twice a day along with 100mg of ritonavir twice a day for 7 days, then can increase the dose to 1000mg/100mg orally twice a day.
Investigation involving kids who have received therapy
≥2 years, ≥40 kg: Administer 50 mg/kg and 100mg of ritonavir orally twice daily.
≥2 years, 5 to <15 kg: Administer 50 mg/kg and 3mg of ritonavir orally twice daily.
≥2 years, 15 to 40 kg: Administer 50 mg/kg and 2.5mg of ritonavir orally twice daily.
<2 years: Safety and efficacy not established



abacavir and lamivudine 

1

Tablet (600 mg/300 mg lamivudine)

Orally 

every day



emtricitabine/tenofovir DF /efavirenz 


Indicated for HIV Infection
One tablet of 200 mg of emtricitabine/600 mg of efavirenz/300 mg of tenofovir DF orally every day on an empty stomach (recommended every night)



efavirenz/lamivudine/tenofovir DF 


Indicated for HIV Infection
One tablet of 400 mg of efavirenz/300 mg of tenofovir DF/300 mg of lamivudine orally every night
Or
One tablet of 600 mg of efavirenz/300 mg of tenofovir DF/300 mg of lamivudine orally every night



amprenavir 

1200

mg

Capsule

Orally 

two times a day


1400mg oral solution two times a day



Dose Adjustments

Renal dose adjustments
The oral solution is not recommended for use by people with renal insufficiency since it includes propylene glycol
Due to the increased risk of adverse effects linked to propylene glycol and the potential impact of its metabolites on acid-base balance, use with caution in individuals with renal impairment

Liver Dose Modifications
Propylene glycol is present in the oral solution, which is contraindicated in hepatic failing patients
Due to an increased risk of adverse effects related to propylene glycol, use with caution in patients with hepatic impairment
No study data is available about the use of amprenavir in children with hepatic complications
Child-Pugh scores of 5 to 8: 450 mg or 513 mg (oral solution in a volume of 34 mL) twice daily
Child-Pugh scores of nine to twelve: 300 mg (two 150 mg capsules) or 342 mg (23 mL oral solution) taken twice daily

lamivudine 

Patients with HIV-1 infection are recommended to take the dose of 300 mg once a day or 150 mg 2 times a day
The use of lamivudine to treat HIV-1 infection will be in combination with other nucleoside analog agents with antiretroviral properties



Dose Adjustments

Renal dose adjustments
In adult patients with HIV-1 infection, renal dose adjustment is done depending on the levels of CrCl
If CrCl is between 30 to 49 mL/min, then start the dose with 150 mg orally once a day
When it falls between 15 and 29 mL/min, the starting dose is 150 mg oral, followed by a 100 mg oral dose the next day
When the level is between 5 and 14 mL/min, the starting day dose is 150 mg oral, which is 50 mg oral from the next day
When the level is below 5 mL/min, the starting dose is 50 mg oral, which is made to 25 mg oral from the next day

tenofovir disoproxil fumarate or tenofovir DF 

The recommended dose is 300 mg orally once a day



Dose Adjustments

Renal dose adjustments
In Renal impairment patients, dosage adjustment should be considered when Crcl falls between 10 and 50
If Crcl is between 30 and 49 mL/min, an oral dose of 300 mg is once every two days
if Crcl is between 10 and 29 mL/min, an oral dose of 300 mg is once every 3 to 4 days
Dosage adjustment is not required in patients with CrCl below ten and above 50 mL/min, in which an oral dose of 300 mg once daily is recommended

bictegravir 

one tablet containing 50 mg bictegravir, 200 mg emtricitabine, and 25 mg tenofovir alafenamide administered once a day with or without food



atazanavir 

Treatment-Naive patients
300mg orally one time a day along with ritonavir 100mg
Note: administer atazanavir 400mg one time a day if ritonavir is not tolerable
Take 400mg once daily along with ritonavir 100mg if efavirenz is administered Treatment-experienced patients 300mg orally one time a day along with ritonavir 100mg
Note: Administer 400mg one time a day along with 100mg ritonavir if tenofovir disoproxil fumarate (DF) and H2- receptor antagonist is taken Pregnant patients
Treatment- naive and treatment-experienced 300mg orally one time a day along with ritonavir 100mg
Treatment- experienced during the second or third trimester
Administer 400mg one time a day along with 100mg ritonavir; either tenofovir disoproxil fumarate (DF) or H2- receptor antagonist is taken It is not recommended if both tenofovir disoproxil fumarate and H2-receptor antagonist are taken Indication: in the treatment of HIV-1 infection, this is used in combination with antiretroviral drugs Occupational exposure
Based on recommendations of the US Public Health Service Working Group: 300mg orally one time a day along with 100mg ritonavir for 28 days if tolerable Nonoccupational Exposure
Based on recommendations of the US CDC: 300mg orally along with 100mg ritonavir one time a day



lopinavir 

lopinavir is used in combination with ritonavir for treatment of HIV infection



 

efavirenz

Note: Not recommended to use in combination with abacavir and lamivudine, especially for patients receiving pre-antiretroviral therapy
Not recommended for <3 months infants Oral Dose instructions based on weight:
10 kg to <15 kg: 200 mg/day orally
15 kg to <20 kg: 250 mg/day orally
20 kg to <25 kg: 300 mg/day orally
25 kg to 32.5 kg: 350 mg/day orally
32.5 to <40 kg: 400 mg/day orally
>40 kg: 600 mg/day orally Discontinue therapy immediately, if moderate to severe hepatic impairment noticed



tipranavir

Children >2 years:

14

mg/kg

in combination with 6 mg/kg ritonavir twice a day (NMT 500 mg)



nelfinavir

Age: 2-13 years
45-55 mg/kg orally every 12 hours a day or 25-35 mg/kg orally every 8 hours a day
Adolescents:
1250 mg orally every 12 hours a day or 750 mg orally every 8 hours a day



cabotegravir and rilpivirine 

(400/600) mg each drug once a month intramuscularly as two separate injections



abacavir 

Infants >3 years to adolescents:
Dose instructions based on weight:
14 to <20kg: 150 mg orally twice daily
20 to <25 kg: 150 mg orally in the morning and 300 mg orally in the evening
>25 kg 300 mg orally every 12 hours



elvitegravir/cobicistat/emtricitabine/tenofovir DF 

Age 12 years or older, with a minimum weight of 35 kg: Take one tablet orally once daily with a meal



emtricitabine, rilpivirine, tenofovir DF 

Below 12 yrs: Safety & efficacy were not established
Above 12 yrs and above 35 kgs: 1 one tablet (200mg emtricitabine /25mg rilpivirine /300mg tenofovir DF) orally daily with a meal



Dose Adjustments

Dose Modifications
rifabutin Coadministration
Add one tablet of 25mg rilpivirine with Complera for this duration of coadministration with rifabutin
Hepatic impairment
Mild-moderate (Child-Pugh score class A or B): dose adjustment is not required
Severe (Child-Pugh score class C): Not known
Renal impairment
Mild (CrCl above 50 mL/min): dose adjustment is not required
Moderate-severe (CrCl below 50 mL/min): usually not recommended

emtricitabine, rilpivirine, tenofovir DF 

Below 12 yrs: Safety & efficacy were not established
Above 12 yrs and above 35 kgs: 1 one tablet (200mg emtricitabine /25mg rilpivirine /300mg tenofovir DF) orally daily with a meal



Dose Adjustments

Dose Modifications
rifabutin Coadministration
Add one tablet of 25mg rilpivirine with Complera for this duration of coadministration with rifabutin
Hepatic impairment
Mild-moderate (Child-Pugh score class A or B): dose adjustment is not required
Severe (Child-Pugh score class C): Not known
Renal impairment
Mild (CrCl above 50 mL/min): dose adjustment is not required
Moderate-severe (CrCl below 50 mL/min): usually not recommended

lamivudine/raltegravir 

<6 years: Safety and efficacy not determined
≥6 years and weight more than and equal to 30 kg: take 1 tablet orally two times a day
Dosage Modifications
Renal impairment
moderate-to-severe: avoid use
Hepatic impairment
Mild-to-moderate: dose modification not required
Decompensated liver disease: Safety and efficacy not determined
Severe: study not performed



darunavir and cobicistat 


Indicated for HIV-1 Infection
This medication is prescribed in combination with other antiretroviral drugs for HIV treatment in patients who weigh at least or more than 40 kg, are treatment-naive or experienced, and do not have darunavir resistance-associated substitutions.
1 tablet of 800mg darunavir /150mg cobicistat orally one time a day with food.



raltegravir 

Oral suspension (10 mg/mL):
Infants and Children weighing <20 kg:
Administer 6 mg/kg/dose orally twice a day. Do not exceed 100 mg/dose
Fixed dosing:
3 to <4 kg: Administer 25 mg orally twice a day.
4 to <6 kg: Administer 30 mg orally twice a day.
6 to <8 kg: Administer 40 mg orally twice a day.
8 to <11 kg: Administer 60 mg orally twice a day.
11 to <14 kg: Administer 80 mg orally twice a day.
14 to <20 kg: Administer 100 mg orally twice a day.

Chewable tablets
Children, Adolescents, and Infants weighing ≥3 kg:
Administer 6 mg/kg/dose orally twice a day. Do not exceed 300 mg/dose.
3 to <6 kg: Administer 25 mg orally twice a day.
6 to <10 kg: Administer 50 mg orally twice a day.
10 to <14 kg: Administer 75 mg orally twice a day.
14 to <20 kg: Administer 100 mg orally twice a day.
20 to <28 kg: Administer 150 mg orally twice a day.
28 to <40 kg: Administer 200 mg orally twice a day.
≥40 kg: Administer 300 mg orally twice a day.

Film-coated tablets
Isentress: Children and Adolescents ≥25 kg: Administer 400 mg orally twice daily.
Isentress HD: Children and Adolescents ≥40 kg:
Administer 1200 mg orally once a day.
Treatment-naive individuals should follow a different regimen than those who have been virologically suppressed by raltegravir 400 mg twice daily.

Non-occupational post-exposure prevention for HIV-1
Children <2 years and Infants:
Administer 6mg/kg/dose twice a day orally
Children >2 years:
11 to <14 kg: Administer 75 mg twice a day.
14 to <20 kg: Administer 100 mg twice a day.
20 to <28 kg: Administer 150 mg twice a day.
28 to <40 kg: Administer 200 mg twice a day.
≥40 kg: Administer 300 mg twice a day.

Film-coated tablets
Isentress: Children > 6 years weighing ≥25 kg: Administer 400 mg orally twice a day.



lopinavir and ritonavir 

In children and teenagers, do not use a once-daily dosage (administered every 12 hours)
less than 2 weeks: Safety and efficacy have not been established
2 weeks to 6 months
oral solution: 300 mg of lopinavir /75 mg of ritonavir (LPV/r) per m² or 16 mg of lopinavir /4 mg ritonavir LPV/r per kg orally every 2 times a day
In infants aged below 6 months, do not administer efavirenz, fosamprenavir, nevirapine, or nelfinavir
Use of 300 mg of lopinavir /75 mg of ritonavir (LPV/r) per m² in infants aged below 6 months LPV trough levels were lower in children than in adults; LPV dose was evaluated and adjusted for the growth at regular intervals
Oral solution: 6 months to 18 years (not receiving the concomitant nevirapine, efavirenz, nelfinavir, or fosamprenavir)
230 mg of lopinavir /57.5 mg of ritonavir /m² per dose orally every 2 times a day, should not exceed more than 400 mg/dose of lopinavir, OR weight-based on dosing listed below
7 to less than 15 kg: 12 mg/kg/dose orally every 2 times a day based on the lopinavir component
15 to 40 kg: 10 mg/kg/dose orally every 2 times a day based on the lopinavir component; should not exceed more than 400 mg of lopinavir /100 mg of ritonavir orally every 2 times a day
Above 40 kg: As adults; 400 mg of lopinavir /100 mg orally every 2 times a day
Oral tablets: 6 months to 18 years (not receiving the concomitant nevirapine, efavirenz, nelfinavir, or fosamprenavir)
Above 15 to 25 kg or above 0.6- below 0.9 m²: 200 mg of lopinavir /50 mg of ritonavir (two 100 mg of lopinavir /25 mg of ritonavir -tab) orally every 2 times a day
Above 25 to 35 kg or above 0.9- below 1.4 m²: 300 mg of lopinavir /75 mg of ritonavir (three 100 mg of lopinavir /25 mg of ritonavir -tab) orally every 2 times a day
Above 35 kg or above 1.4 m²: 400 mg of lopinavir /100 mg of ritonavir orally every 2 times a day
6 months to 18 years (coadministered with nevirapine, efavirenz, nelfinavir, or fosamprenavir)
300 mg of lopinavir /75 mg of ritonavir (LPV/r)/m²/dose orally 2 times a day, should not exceed more than 400 mg/dose of lopinavir
FDA-approved dosage: 500 mg of lopinavir /125 mg of ritonavir LPV/r orally 2 times a day, administer as the combination of 2 tablets of 200mg of lopinavir /50 mg of ritonavir LPV/r and 1 tablet of 100 mg of lopinavir /25 mg of ritonavir LPV/r
Most NIH Panel members recommend 600 mg of lopinavir /150 mg of ritonavir LPV/r orally 2 times a day (i.e., 3 tablets of 200 mg of lopinavir /50 mg of ritonavir for ease of administration)



abacavir and lamivudine 

Determine whether the child can take the pill whole

weight <25 kg: not safe

weight >25 kg: 1 tablet orally every day



abacavir and lamivudine 

Determine whether the child can take the pill whole

weight <25 kg: not safe

weight >25 kg: 1 tablet orally every day



emtricitabine/tenofovir DF /efavirenz 


Indicated for HIV Infection
Age >12 years and body weight >40 kg
One tablet of 200 mg of emtricitabine/600 mg of efavirenz/300 mg of tenofovir DF orally every day on an empty stomach
Age <12 years
Safety and efficacy not established



efavirenz/lamivudine/tenofovir DF 


Indicated for HIV Infection
Symfi:
Body weight >40 kg: One tablet of 600 mg of efavirenz /300 mg of lamivudine /300 mg of tenofovir DF orally every night
Body weight <40 kg: Safety and efficacy not established
Symfi Lo:
Body weight >40 kg: One tablet of 400 mg of efavirenz /300 mg of tenofovir DF/300 mg of lamivudine orally every night
Body weight <40 kg: Safety and efficacy not established



lamivudine 

In 3-month or older pediatric patients, treatment is started with 5 mg/kg oral solution two times a day or with 10 mg/kg oral solution once a day. The maximum recommended dose is 300 mg
In pediatric cases, dosage adjustments will be made depending on the child's weight. That is, if the weight is between 14 and 20 kg, an oral dose of 75 mg is taken twice a day, or 150 mg is taken once a day. When weight is between 20 and 25 kg, a 75 mg oral dose starts in the morning, followed by a 150 mg oral dose in the evening or a 225 mg oral dose once daily. When weight is 25 kg, an oral dose of 150 mg taken two times a day or 300 mg oral dose one time a day



tenofovir disoproxil fumarate or tenofovir DF 

Children below two years or older with HIV infection are treated with tenofovir DF and other anti-retroviral drugs
In children below two years of age who weigh more than 10 kg, the recommended dose is 8 mg/kg orally once a day, which should not exceed 300 mg once a day max



bictegravir 

Above 14 kg to below 25 kg: 1 tablet containing 30 mg bictegravir, 120 mg emtricitabine, and 15 mg tenofovir alafenamide administered once a day with or without food



atazanavir 

Oral powder
Treatment- naive and Treatment- Experienced Patients
Children aged 3 months and older
: Weight 5kg to <15kg: 200mg orally one time a day with ritonavir 80mg
Weight 15kg to <25kg: 250mg orally one time a day with ritonavir 80mg
Capsule
Treatment- naive and Treatment- Experienced Patients
Children of age from 6 years to <18 years: Weight 15kg to <35kg: 200mg orally one time a day with ritonavir 100mg
Weight of up to 35kg: 300mg orally one time a day with ritonavir 100mg Treatment-Naive patients intolerable to Ritonavir
Children of age from 13 years to < 18 years:
Minimum of 40kg weight: 400mg orally one time a day
Indication: in the treatment of HIV-1 infection along with antiretroviral agents



Dose Adjustments

Renal dose adjustments
Adjustments are not recommended in the absence of hemodialysis
Hepatic dose adjustments

Treatment-Naive adults
Child-Pugh A (Mild liver impairment): 400mg orally one time a day
Child-Pugh B (Moderate liver impairment): 300mg orally one time a day
Child-Pugh C (Severe liver impairment): not recommended

 

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References