Pediatric HIV Infection Medication
- Author: Delia M Rivera, MD; Chief Editor: Russell W Steele, MD more...
Antiretroviral drugs (ARDs) are used for the treatment of human immunodeficiency virus (HIV) infection and for postexposure prophylaxis (PEP). ARD monotherapy does not produce sustained clinical benefits, such as improved survival. This failure is partly due to the development of drug-resistant variants of HIV. Resistance develops rapidly during monotherapy, and cross-resistance among related drugs is common.
Combination therapy with ARDs (a strategy analogous to the treatment of TB and other infectious diseases) has improved efficacy, minimized toxicity, and delayed drug resistance.
Six classes of ARDs currently exist, as follows:
Nucleoside or nucleotide reverse transcriptase inhibitors (NRTIs)
Nonnucleoside reverse transcriptase inhibitors (NNRTIs)
Protease inhibitors (PIs)
Integrase inhibitors (IIs)
Fusion inhibitors (FIs)
Chemokine receptor antagonists (CRAs)
Initial therapy should be started with a combination of 3 ARDs, including a backbone of 2 NRTIs plus an NNRTI, or 2 NRTIs plus a protease inhibitor.
As of January 2016, more than 19 ARDs have been approved for pediatric usage and more than 15 are available as a pediatric formulation or capsule size.
Nucleoside or Nucleotide Reverse Transcriptase Inhibitors
NRTIs are nucleoside or nucleotide reverse transcriptase inhibitor analogs with antiretroviral activity. They are indicated for the treatment of HIV infection, and they delay the progression of the disease.
Patients and parents must be cautioned about the risk of serious hypersensitivity reaction. Provide a medication guide and warning card.
This agent is a purine nucleoside analog with antiviral activity.
Lamivudine is a dideoxynucleoside analog with antiretroviral activity. In combination with oral zidovudine, it produces substantial and sustained increases in CD4+ counts and decreases in viral load in HIV-infected patients. It is also approved by the US Food and Drug Administration (FDA) to treat hepatitis B.
Stavudine is a synthetic thymidine nucleoside analog active against HIV-1.
This agent is a thymidine analog that inhibits viral replication. It inhibits activity of HIV reverse transcriptase by competing with natural substrate for use by and incorporation into viral DNA.
A synthetic nucleoside cytosine analog, emtricitabine competes with deoxycytidine-5'-triphosphate and incorporates into viral DNA, causing chain termination.
This antiretroviral agent used in treatment of AIDS inhibits activity of HIV reverse transcriptase by competing with natural substrate deoxyadenosine 5'-triphosphate and, after incorporation into DNA, by causing DNA chain termination. It is administered as prodrug bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir, which is converted, in various enzymatic processes, to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5'-monophosphate.
Administration with a high-fat meal enhances bioavailability. Prolonged intracellular levels allows for once-daily dosing.
Indicated in combination with other antiretroviral agents (ART) for treatment of HIV-1 infection in ART-experienced patients with evidence of viral replication and HIV-1 strains resistant to a NNRTIs and other antiretroviral agents.
Nonnucleoside Reverse Transcriptase Inhibitors
NNRTIs inhibit both DNA-directed and RNA-directed polymerase functions of HIV-1 reverse transcriptase. The different sites of action of nonnucleoside and nucleoside inhibitors suggest potential synergistic effects of these agents and their potential activity against nucleoside-resistant HIV strains.
Delavirdine is a potent NNRTI used primarily in combination regimens.
Efavirenz is used only in combination regimens.
Nevirapine is indicated for use in combination with other ARDs for treatment of HIV-1 infection.
NNRTI indicated in combination with other ARTs for treatment of HIV-1 infection in treatment-naïve adolescents aged 12-17 y with HIV-1 RNA ≤100,000 copies/mL.
Protease inhibitors inhibit HIV protease, which is required for HIV replication and the formation of mature, infectious viral particles.
This agent prevents formation of protein precursors necessary for HIV infection of uninfected cells and viral replication.
Nelfinavir inhibits HIV-1 protease, resulting in the production of an immature and noninfectious virus.
Ritonavir is an HIV protease inhibitor used as part of double or triple therapy with nucleosides and other protease inhibitors.
Saquinavir (SQV, Invirase)
Saquinavir is an HIV protease inhibitor used as part of double or triple therapy with nucleosides and other protease inhibitors. It is available as a 200-mg hard gel cap or 500-mg film-coated tablet.
Lopinavir inhibits HIV protease and renders enzyme incapable of processing polyprotein precursors, leading to production of noninfectious, immature HIV particles. Ritonavir inhibits CYP3A metabolism of lopinavir, increasing plasma levels. This product is available in tablets (200 mg/50 mg LPV/r), pediatric tablets (100 mg/25 mg LPV/r), and PO solution (80 mg/20 mg LPV/r; 42.4% alcohol by volume).
Atazanavir is an azapeptide HIV-1 protease inhibitor. It prevents virion maturation by selectively inhibiting Gag and Gag-Pol polyproteins in HIV-1 infected cells.
An HIV-1 protease inhibitor, darunavir selectively inhibits HIV-encoded Gag-Pol polyprotein cleavage in infected cells, preventing formation of mature virus particles. It is indicated to treat HIV disease not responding to other ARDs. Coadminister with low-dose ritonavir (ritonavir-boosted therapy decreases elimination and increases darunavir serum concentration).
Darunavir is typically coadministered with other anti-HIV agents (eg, NRTIs). Food increases maximum concentration (Cmax) and area under the concentration-time curve (AUC). It is indicated to treat HIV infection in ART–experienced adults (eg, those with HIV-1 strains resistant to >1 protease inhibitor).
A prodrug of amprenavir (inhibitor of HIV protease), fosamprenavir is rapidly converted to amprenavir by cellular phosphatases in vivo. Amprenavir inhibits HIV-1 protease and binds its active site, preventing the processing of viral Gag and Gag-Pol polyprotein precursors and resulting in immature, noninfectious viral particles.
A nonpeptidic protease inhibitor, tipranavir inhibits HIV replication. It is indicated for combination ART of HIV-1 infection in adults with evidence of viral replication and who are highly treatment experienced or who have strains resistant to several protease inhibitors. This agent must be coadministered with ritonavir 200 mg to attain therapeutic levels. It is ineffective if used alone without ritonavir-boosted levels. Results of genotypic or phenotypic testing and/or treatment history should guide use. It is available as 250 mg caps or as PO solution of 100 mg/mL.
Entry and Fusion Inhibitors
These agents disrupt HIV binding and, ultimately, fusion with host cells. Entry inhibitors bind to CCR5 chemokines coreceptors. Fusion inhibitors bind to the HR1 region of gp41.
Enfuvirtide is the sole available fusion inhibitor. It blocks entry of HIV into human immune cells by inhibiting gp41 protein, disrupting viral structural rearrangement to fuse with healthy immune cells and preventing HIV replication. In clinical trials, selected patients with multidrug resistance were twice as likely to achieve undetectable HIV-1 plasma levels (< 40 copies/mL) when enfuvirtide was added to optimized antiretroviral regimens.
Maraviroc blocks viral entry via CCR5 co-receptor into host cells, reduces viral load, and increases T-cell counts in CCR5-tropic HIV-1 (ie, R5 virus). This agent is indicated for combination treatment with optimized background therapy in treatment-experienced adults infected with only R5 virus who have evidence of viral replication and have HIV-1 strains resistant to multiple antiretroviral agents.
HIV integrase is responsible for the transport and attachment of proviral DNA to host-cell chromosomes, allowing transcription of viral proteins.
Raltegravir is an HIV-1integrase strand transfer inhibitor (INSTI). It is indicated for use in combination therapy regimens for the treatment of HIV infection.
Dolutegravir is an integrase strand transfer inhibitor (INSTI) that inhibits catalytic activity of HIV-1 integrase, an HIV encoded enzyme required for viral replication. It is approved for use in children 12 years or older who weigh at least 40 kg.
HIV, ART Combos
Combination ARTs are helpful to promote compliance with complex medication regimens.
Contains emtricitabine and tenofovir (NRTIs), plus efavirenz (NNRTI).
Four-drug antiretroviral (ART) combination of elvitegravir (integrase strand transfer inhibitor [INSTI]), cobicistat (CYP3A inhibitor), and emtricitabine and tenofovir alafenamide (TAF), both nucleoside analog reverse transcriptase inhibitors (NRTIs). It is indicated as a complete treatment regimen for HIV-1 infection in adults and children aged ≥12 y (weight ≥35 kg) who are ART-naïve or to replace the current ART regimen in those who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable ART regimen for at least 6 months with no history of treatment failure and no known substitutions associated with resistance to the individual components.
Indicated as complete regimen for treatment of HIV-1 infection in treatment-naïve adults and adolescents aged 12 years or older (weight ≥35 kg) with HIV-1 RNA >100,000 copies/mL, and in certain virologically-suppressed (HIV-1 RNA <50 copies/mL) patients on a stable ART regimen at start of therapy in order to replace their current ART regimen. Combination consists of 2 NRTIs (ie, emtricitabine and tenofovir) and 1 NNRTI (ie, rilpivirine).
NRTI combination product. Indicated in combination with other ART agents (eg, NNRTIs, PIs) for the treatment of HIV-1 infection in adults and pediatric patients aged 12 y or older. Tenofovir alafenamide (AF) is a more targeted form of tenofovir that has demonstrated high antiviral efficacy at a dose that is 10 times lower than tenofovir DF, as well as an improved renal and bone safety profile.
Indicated, in combination with other antiretroviral agents (eg, NNRTIs, PIs), for the treatment of HIV-1 infection in adults and pediatric patients who weigh at least 17 kg and can swallow the tablet whole.
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- Table 1. CDC Immunologic Categories for HIV-Infection in Children Based on Absolute CD4+ Counts
- Table 2. Antibiotics for Primary and Secondary Prophylaxis of Opportunistic Infections
- Table 3. Drugs and Doses for Prophylaxis of Opportunistic Infections
- Table 4. CD4+ -Based Indications for Starting PCP Prophylaxis
- Table 5. CD4+ -Based Indications for MAC Prophylaxis
- Table 6. Risk Factors for Vertical Transmission
|< 1 y||1-5 y||6-12 y|
|1 - No suppression||≥1500 (>25)||≥1000 (>25)||≥500 (>25)|
|2 - Moderate suppression||750-1499 (15-24)||500-999 (15-24)||200-499 (15-24)|
|3 - Severe suppression||< 750 (< 15)||< 500 (< 15)||< 200 (< 15)|
|Infection||Indication||First-Line Regimen||Alternative Regimen|
|TB||PPD test result >5 mm||Isoniazid and pyridoxine qd for 9 mo||Rifampin for 4 mo|
|Exposure||Isoniazid and pyridoxine 3 times/wk for 9 mo, rifampin and pyrazinamide qd for 2 mo||Consult an infectious diseases specialist if the pathogen is multidrug resistant|
|PCP||CD4+ finding*||Trimethoprim-sulfamethoxazole qd||Trimethoprim-sulfamethoxazole 3 times/wk|
|Fever of unknown origin for 2 wk, history of infection||Dapsone, pyrimethamine, and leucovorin||Dapsone or aerosolized pentamidine in children >5 y|
|Toxoplasmosis||CD4+ count < 100 cells/mL||Trimethoprim-sulfamethoxazole qd||Dapsone, pyrimethamine, and leucovorin|
|Positive immunoglobulin G finding||None||Atovaquone|
|Previous infection||Sulfadiazine, pyrimethamine, and leucovorin||Clindamycin, pyrimethamine, and leucovorin|
|MAC infection||CD4+ finding**||Azithromycin qwk||Rifabutin qd or clarithromycin bid|
|Previous infection||Clarithromycin or azithromycin qd and ethambutol||Clarithromycin or azithromycin qd and ethambutol|
|Abbreviations: bid = twice daily; PPD = purified protein derivative; qd = every day; qwk = every week.
* See Table 4
**See Table 5
|Azithromycin||20 mg/kg/dose (1.2 g maximum) PO qwk or
5 mg/kg/dose (250 mg maximum) PO qd
|Clarithromycin||7.5 mg/kg/dose (500 mg maximum) PO bid|
|Clindamycin||20-30 mg/kg/d PO qid|
|Dapsone||1-2 mg/kg/d (100 mg maximum) PO qd|
|Ethambutol||15 mg/kg/dose (900 mg maximum) PO qd|
|Isoniazid||10-15 mg/kg/dose (300 mg maximum) PO/IM qd|
|Leucovorin||5 mg PO 3 times/wk|
|Pentamidine||4 mg/kg/dose monthly|
|Pyrimethamine||15 mg/m2/dose (25 mg maximum) PO qd|
|Rifabutin||5 mg/kg/dose (300 mg maximum) PO qd|
|Rifampin||10-20 mg/kg (600 mg maximum) PO/IV qd|
|Sulfadiazine||85-120 mg/kg/d PO bid|
|Trimethoprim-sulfamethoxazole||150/750 mg/m2/d PO bid|
|Abbreviations: bid = twice daily; PO = by mouth; qd = every day; qwk = every week.|
|Age or Status||CD4+ Count, cells/mL||CD4+ Percentage|
|6 wk to 1 y||Any||Any|
|1-2 y||< 750||< 15|
|2-5 y||< 500||< 15|
|>5 y||< 200||< 15|
|Previous PCP infection||Any||Any|
|Age or Status||CD4+ Count, Cells/mL|
|< 1y||< 750|
|1-2 y||< 500|
|2-6 y||< 75|
|> 6 y||< 50|
|Period||Factors That Increase Risk||Factors That Decrease Risk|
|Prenatal||Acute HIV infection
Viral load >10,000
Illicit IV drug use
|Viral load < 1000
|Perinatal||Rupture of membranes for >4 h
Emergency cesarean delivery
Use of scalp electrodes
|Elective cesarean delivery with zidovudine treatment|
Low birth weight