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تعداد آیتم قابل مشاهده باقیمانده : 2 مورد

Fostemsavir: Drug information

Fostemsavir: Drug information
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For additional information see "Fostemsavir: Patient drug information"

For abbreviations, symbols, and age group definitions show table
Brand Names: US
  • Rukobia
Brand Names: Canada
  • Rukobia
Pharmacologic Category
  • Antiretroviral Agent, gp120 Attachment Inhibitor
Dosing: Adult
HIV-1 infection, treatment

HIV-1 infection, treatment: Oral: 600 mg twice daily, in combination with other antiretrovirals (Ref).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Liver Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Older Adult

Refer to adult dosing.

Adverse Reactions (Significant): Considerations
Liver enzyme elevations

Hepatoxicity has been associated with antiretroviral combination therapy, particularly among patients coinfected with hepatitis B virus (HBV) and/or hepatitis C virus (HCV). Increased serum alanine aminotransferase (ALT) and increased serum aspartate aminotransferase (AST) have been reported with fostemsavir, including severe (grade 3 or 4); some of these elevations were consistent with reactivation of HBV.

Mechanism: Liver enzyme elevations associated with antiretroviral combination therapy in the setting of chronic viral hepatitis may be part of an immune-restoration disease (Ref).

Onset: Varied; in a prospective cohort study of hepatotoxicity associated with antiretroviral therapy (not including fostemsavir), median onset to antiretroviral-induced severe hepatoxicity was 118 days (range: 63 to 156 days) (Ref). In general, the risk for developing liver enzyme elevations due to antiretroviral therapy is greatest during the first few months following therapy initiation (Ref).

Risk factors:

Antiretroviral combination therapy in general:

• Chronic HBV and/or HCV coinfection (Ref)

• Higher baseline ALT/AST levels (Ref)

• Females (Ref)

Immune reconstitution syndrome

Immune reconstitution syndrome has been reported with combination antiretroviral therapy, including fostemsavir. Immune reconstitution inflammatory syndrome (IRIS) typically results from an inflammatory response to an infectious agent, such as an indolent or residual opportunistic infection (OI) (eg, Mycobacterium avium infection, cytomegalovirus, Pneumocystis jirovecii pneumonia, tuberculosis). Immune reconstitution has also been associated with activation of certain autoimmune disorders (eg, Graves disease, polymyositis, Guillain-Barre syndrome, autoimmune hepatitis) and other noninfectious etiologies (Ref).

Mechanism: Non-dose-related; immunologic. Believed to result from an exaggerated activation of the immune system against persisting antigen (paradoxical) or viable pathogens (unmasking) in the setting of improved immunologic function (ie, a response to antiretroviral therapy); innate immunity has also been implicated (Ref).

Onset: Varied; in most cases, IRIS appears during the first 3 months after initiation of combination antiretroviral therapy (“early IRIS”); however, it can appear later, generally 3 to 12 months after therapy initiation (“late IRIS”). In a few cases, it may occur up to 4 years later (Ref). In the setting of immune reconstitution associated with autoimmune disorders, onset is more variable and can occur many months after therapy initiation.

Risk factors:

• Current or past history of OI

•· Very low CD4 cell count (<100 cells/mcL) at the time of antiretroviral treatment initiation (Ref)

QT prolongation

Prolonged QT interval on ECG has been reported with fostemsavir at supratherapeutic doses. Data suggest that clinically significant effects on the QTc interval are unlikely with therapeutic dosing of fostemsavir (Ref).

Mechanism: Dose-related (Ref)

Risk factors:

• Higher than recommended dosage (eg, 4 times the recommended daily dose [4,800 mg/day])

• History of prolonged QT interval or relevant preexisting cardiac disease (potential risk factor for QTcprolongation in general)

• Coadministration with drugs known to cause QT prolongation (potential risk factor for QTc prolongation in general)

• Older age (potential risk factor for QTc prolongation in general)

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Frequency of adverse events is as reported in adults receiving combination antiretroviral therapy.

>10%: Renal: Increased serum creatinine (grades 3/4: 19%)

1% to 10%:

Cardiovascular: Increased serum creatine kinase (grades 3/4: 2%), prolonged QT interval on ECG (asymptomatic, per manufacturer’s labeling)

Dermatologic: Pruritus, skin rash (3%)

Endocrine & metabolic: Hypercholesterolemia (grade 3: 5%), hyperglycemia (grades 3/4: 4%), increased LDL cholesterol (grades 3/4: 4%), increased serum triglycerides (grades 3/4: 5%), increased uric acid (grades 3/4: 3%)

Gastrointestinal: Abdominal pain (3%), diarrhea (4%), dysgeusia, dyspepsia (3%), increased serum lipase (grades 3/4: 5%), nausea (10%), vomiting (2%)

Hematologic & oncologic: Decreased hemoglobin (grades 3/4: 6%), decreased neutrophils (grades 3/4: 4%), leukocyte disorder (grades 3/4: 1%)

Hepatic: Increased direct serum bilirubin (grade 3: 7%), increased serum alanine aminotransferase (grades 3/4: 3% to 5%), increased serum aspartate aminotransferase (grades 3/4: 2% to 4%), increased serum bilirubin (grades 3/4: 3%)

Immunologic: Immune reconstitution syndrome (2%)

Nervous system: Dizziness, drowsiness (2%), fatigue (3%), headache (4%), peripheral neuropathy, peripheral sensory neuropathy, sleep disturbance (3%)

Neuromuscular & skeletal: Myalgia

Frequency not defined: Infection: Infection (Kozal 2020), reactivation of HBV

Contraindications

Hypersensitivity to fostemsavir or any component of the formulation; concomitant use of strong CYP3A inducers (eg, enzalutamide, carbamazepine, phenytoin, rifampin, mitotane, St John’s wort).

Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Warnings/Precautions

Disease-related concerns:

• Hepatitis B virus coinfection: Initiate and/or maintain effective anti–hepatitis B virus (HBV) therapy in patients coinfected with HBV.

Special populations:

• Older adult: Adverse effects may be increased in elderly patients.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet Extended Release 12 Hour, Oral, as tromethamine:

Rukobia: 600 mg

Generic Equivalent Available: US

No

Pricing: US

Tablet, 12-hour (Rukobia Oral)

600 mg (per each): $185.61

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet Extended Release 12 Hour, Oral, as tromethamine:

Rukobia: 600 mg

Administration: Adult

Oral: Administer with or without food. Swallow tablets whole; do not chew, crush, or split tablets.

Use: Labeled Indications

HIV-1 infection, treatment: Treatment of HIV-1 infection, in combination with other antiretrovirals, in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection failing their current antiretroviral regimen.

Medication Safety Issues
Sound-alike/look-alike issues:

Fostemsavir may be confused with fosamprenavir.

Metabolism/Transport Effects

Substrate of BCRP, CYP3A4 (Major with inducers), CYP3A4 (Minor with inhibitors), P-glycoprotein (Minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential; Inhibits BCRP, OATP1B1/1B3;

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.

Alpelisib: BCRP/ABCG2 Inhibitors may increase serum concentration of Alpelisib. Management: Avoid coadministration of BCRP/ABCG2 inhibitors and alpelisib due to the potential for increased alpelisib concentrations and toxicities. If coadministration cannot be avoided, closely monitor for increased alpelisib adverse reactions. Risk D: Consider Therapy Modification

Atogepant: OATP1B1/1B3 (SLCO1B1/1B3) Inhibitors may increase serum concentration of Atogepant. Management: For episodic migraine, the recommended atogepant dose is 10 mg or 30 mg once daily if given with OATP1B1/1B3 inhibitors. For chronic migraine, the recommended atogepant dose is 30 mg once daily with OATP1B1/1B3 inhibitors. Risk D: Consider Therapy Modification

Atrasentan: OATP1B1/1B3 (SLCO1B1/1B3) Inhibitors may increase serum concentration of Atrasentan. Risk X: Avoid

Brincidofovir: OATP1B1/1B3 (SLCO1B1/1B3) Inhibitors may increase serum concentration of Brincidofovir. Management: Consider alternatives to OATP1B/1B3 inhibitors in patients treated with brincidofovir. If coadministration is required, administer OATP1B1/1B3 inhibitors at least 3 hours after brincidofovir and increase monitoring for brincidofovir adverse reactions. Risk D: Consider Therapy Modification

Cladribine: BCRP/ABCG2 Inhibitors may increase serum concentration of Cladribine. Management: Avoid concomitant use of BCRP inhibitors during the 4 to 5 day oral cladribine treatment cycles whenever possible. If combined, consider dose reduction of the BCRP inhibitor and separation in the timing of administration. Risk D: Consider Therapy Modification

CYP3A4 Inducers (Strong): May decrease active metabolite exposure of Fostemsavir. Risk X: Avoid

Elagolix, Estradiol, and Norethindrone: OATP1B1/1B3 (SLCO1B1/1B3) Inhibitors may increase serum concentration of Elagolix, Estradiol, and Norethindrone. Specifically, concentrations of elagolix may be increased. Risk X: Avoid

Elagolix: OATP1B1/1B3 (SLCO1B1/1B3) Inhibitors may increase serum concentration of Elagolix. Risk X: Avoid

Elbasvir and Grazoprevir: OATP1B1/1B3 (SLCO1B1/1B3) Inhibitors may increase serum concentration of Elbasvir and Grazoprevir. Risk X: Avoid

Eluxadoline: OATP1B1/1B3 (SLCO1B1/1B3) Inhibitors may increase serum concentration of Eluxadoline. Management: Decrease the eluxadoline dose to 75 mg twice daily if combined with OATP1B1/1B3 inhibitors and monitor patients for increased eluxadoline effects/toxicities. Risk D: Consider Therapy Modification

Ethinyl Estradiol-Containing Products: Fostemsavir may increase serum concentration of Ethinyl Estradiol-Containing Products. Management: Ethinyl estradiol daily dose should not exceed 30 mcg during coadministration with fostemsavir. Monitor patients closely for any evidence of a thromboembolism. Risk D: Consider Therapy Modification

Haloperidol: QT-prolonging Agents (Indeterminate Risk - Caution) may increase QTc-prolonging effects of Haloperidol. Risk C: Monitor

HMG-CoA Reductase Inhibitors (Statins): Fostemsavir may increase serum concentration of HMG-CoA Reductase Inhibitors (Statins). Management: Use the lowest possible starting statin dose and monitor patients closely for statin-related adverse effects (eg, muscle aches and pains) during coadministration with fostemsavir. Risk D: Consider Therapy Modification

Methadone: Fostemsavir may increase QTc-prolonging effects of Methadone. Fostemsavir may increase serum concentration of Methadone. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor

Momelotinib: OATP1B1/1B3 (SLCO1B1/1B3) Inhibitors may increase serum concentration of Momelotinib. Risk C: Monitor

PAZOPanib: BCRP/ABCG2 Inhibitors may increase serum concentration of PAZOPanib. Risk X: Avoid

QT-prolonging Agents (Highest Risk): QT-prolonging Agents (Indeterminate Risk - Caution) may increase QTc-prolonging effects of QT-prolonging Agents (Highest Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor

Resmetirom: OATP1B1/1B3 (SLCO1B1/1B3) Inhibitors may increase serum concentration of Resmetirom. Risk X: Avoid

Revefenacin: OATP1B1/1B3 (SLCO1B1/1B3) Inhibitors may increase active metabolite exposure of Revefenacin. Risk X: Avoid

Seladelpar: BCRP/ABCG2 Inhibitors may increase serum concentration of Seladelpar. Risk C: Monitor

St John's Wort: May decrease active metabolite exposure of Fostemsavir. Risk X: Avoid

Talazoparib: BCRP/ABCG2 Inhibitors may increase serum concentration of Talazoparib. Risk C: Monitor

Taurursodiol: OATP1B1/1B3 (SLCO1B1/1B3) Inhibitors may increase serum concentration of Taurursodiol. Risk X: Avoid

Topotecan: BCRP/ABCG2 Inhibitors may increase serum concentration of Topotecan. Risk X: Avoid

Ubrogepant: BCRP/ABCG2 Inhibitors may increase serum concentration of Ubrogepant. Management: Use an initial ubrogepant dose of 50 mg and second dose (at least 2 hours later if needed) of 50 mg when used with a BCRP inhibitor. Risk D: Consider Therapy Modification

Voxilaprevir: OATP1B1/1B3 (SLCO1B1/1B3) Inhibitors may increase serum concentration of Voxilaprevir. Risk X: Avoid

Zavegepant: OATP1B1/1B3 (SLCO1B1/1B3) Inhibitors may increase serum concentration of Zavegepant. Risk X: Avoid

Reproductive Considerations

Contraception is not required to initiate or continue antiretroviral therapy.

Fostemsavir is not recommended (except in special circumstances) for patients with HIV infection who are not yet pregnant but are trying to conceive.

Maximum viral suppression sustained below the limits of detection prior to conception is recommended for all persons with HIV who are planning a pregnancy. Prior to pregnancy, select or make changes to a specific antiretroviral regimen as part of a shared decision-making process. In most cases, recommendations based on data obtained from cisgender women can be applied to transgender and gender diverse people assigned female sex at birth.

Health care providers caring for couples planning a pregnancy when one or both partners are diagnosed with HIV may contact the National Perinatal HIV Hotline (1-888-448-8765) for clinical consultation (HHS [perinatal] 2024).

Pregnancy Considerations

Data collected by the antiretroviral pregnancy registry are insufficient to evaluate human teratogenic risk.

Maternal antiretroviral therapy (ART) may be associated with adverse pregnancy outcomes including preterm birth, low birth weight, and small for gestational age infants. High viral loads are also associated with adverse outcomes, including preterm birth and pregnancy loss. Treatment improves the health of the pregnant patient and reduces the risk of perinatal transmission. Do not withhold appropriate maternal ART due to concerns for adverse neonatal outcomes. Closely monitor for pregnancy complications. Document in utero ART exposure in the long-term medical record of a child born without HIV; evaluate for potential metabolic dysfunction if significant organ system abnormalities of unknown etiology (particularly of the CNS or heart) develop.

Fostemsavir is not recommended as initial therapy for pregnant patients with HIV who are antiretroviral naïve; fostemsavir is not recommended (except in special circumstances) for pregnant patients with HIV who have had ART therapy in the past but are restarting, or who require a new ART regimen (due to poor tolerance or poor virologic response of current regimen). Fostemsavir may be continued if pregnancy occurs during therapy if viral suppression is effective and the regimen is well tolerated. Monitor viral load every 1 to 2 months in highly treatment experienced pregnant patients when alternatives to fostemsavir are not available. Data collected by the antiretroviral pregnancy registry are insufficient to make dosing recommendations.

ART is recommended for all pregnant people with HIV to maximize their health, maintain the viral load below the limit of an ultrasensitive assay detection, and reduce the risk of perinatal transmission. Start ART prior to conception or as soon as possible during pregnancy. During pregnancy, select or make changes to a specific antiretroviral regimen as part of a shared decision-making process. Patients on fully suppressive regimens prior to pregnancy generally may continue the same regimen considering known pregnancy outcomes and pharmacokinetic data. Monitor pregnant patients more frequently than non-pregnant patients. ART initiated during pregnancy can be modified after delivery. In most cases, recommendations based on data obtained from cisgender women can be applied to transgender and gender diverse people assigned female sex at birth.

Data collection to monitor pregnancy and infant outcomes following exposure to ART is ongoing. Enroll all patients exposed to antiretroviral medications as early in pregnancy as possible in the Antiretroviral Pregnancy Registry (1-800-258-4263).

Health care providers caring for pregnant patients with HIV infection and their infants may contact the National Perinatal HIV Hotline (1-888-448-8765) for clinical consultation (HHS [perinatal] 2024).

Breastfeeding Considerations

It is not known if fostemsavir is present in breast milk.

Provide patient-centered evidence-based counseling for infant feeding options as early as possible in pregnancy.

  • Using properly prepared formula or pasteurized banked donor milk eliminates the risk of postnatal HIV transmission via breastfeeding.

  • Counsel patients on antiretroviral therapy (ART) who achieve and maintain a consistently undetectable plasma viral load during pregnancy and postnatally about feeding options, including breastfeeding, formula feeding, or banked donor milk. Maintaining maximum viral suppression decreases but does not eliminate the risk of HIV transmission via breast milk. Temporary discontinuation of breastfeeding and use of replacement feeding may be required if maternal viral load becomes detectable or if mastitis or bleeding nipples develop. Permanent discontinuation of breastfeeding is recommended if the maternal HIV RNA is ≥200 copies/mL.

  • Formula feeding or banked donor milk is recommended for persons with HIV who are not on ART and/or do not have sustained viral suppression. Provide the infant presumptive antiretroviral therapy throughout breastfeeding and for up to 6 weeks after the last exposure to breast milk if the breastfeeding parent does not have sustained viral suppression but breastfeeding is continued; conduct infant virologic diagnostic testing at specified intervals.

  • When the HIV status at delivery is not known, breast milk may be expressed and stored until a negative test is available.

  • Discontinue breastfeeding immediately if HIV infection is diagnosed after breastfeeding has been initiated.

  • Evaluate and provide support for maternal conditions that would make adherence to postpartum ART difficult.

Information is available for counseling and managing patients with HIV who are considering breastfeeding (1-888-448-8765). In most cases, recommendations based on data obtained from cisgender women can be applied to transgender and gender diverse people assigned female sex at birth (HHS [perinatal] 2024).

Monitoring Parameters

CD4 count, HIV RNA plasma levels; hepatic transaminases in hepatitis B virus and/or hepatitis C virus coinfected patients.

Mechanism of Action

Fostemsavir is hydrolyzed to the active moiety, temsavir, which is a gp120 attachment inhibitor. Temsavir binds to the HIV-1 envelope protein gp120 subunit and selectively inhibits the interaction between the virus and cellular CD4 receptors, preventing host cell attachment. In addition, temsavir can inhibit gp120-dependent postattachment steps required for viral entry into host cells.

Pharmacokinetics (Adult Data Unless Noted)

Absorption: Administration with a high-fat meal (~985 calories, 60% fat) increases drug exposure compared to fasting (AUC ratio 1.8).

Distribution: Vd: 29.5 L.

Protein binding: 88.4%.

Metabolism: Hydrolysis (esterases) (36.1%); oxidation (CYP3A4) (21.2%); UGT (<1%).

Bioavailability: 26.9%.

Half-life elimination: 11 hours.

Time to peak: 2 hours.

Excretion: Urine: 51% (<2% as unchanged drug); feces: 33% (1.1% as unchanged drug).

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AR) Argentina: Rukobia;
  • (AT) Austria: Rukobia;
  • (AU) Australia: Rukobia;
  • (BE) Belgium: Rukobia;
  • (CH) Switzerland: Rukobia;
  • (CZ) Czech Republic: Rukobia;
  • (DE) Germany: Rukobia;
  • (ES) Spain: Rukobia;
  • (FI) Finland: Rukobia;
  • (FR) France: Rukobia;
  • (GB) United Kingdom: Rukobia;
  • (IT) Italy: Rukobia;
  • (LU) Luxembourg: Rukobia;
  • (NL) Netherlands: Rukobia;
  • (NO) Norway: Rukobia;
  • (PR) Puerto Rico: Rukobia;
  • (SE) Sweden: Rukobia;
  • (ZA) South Africa: Rukobia
  1. Kozal M, Aberg J, Pialoux G, et al. Fostemsavir in adults with multidrug-resistant HIV-1 infection. N Engl J Med. 2020;382(13):1232-1243. doi:10.1056/NEJMoa1902493 [PubMed 32212519]
  2. Lagishetty C, Moore K, Ackerman P, Llamoso C, Magee M. Effects of temsavir, active moiety of antiretroviral agent fostemsavir, on QT interval: results from a phase I study and an exposure-response analysis. Clin Transl Sci. 2020;13(4):769-776. doi:10.1111/cts.12763 [PubMed 32027457]
  3. Lexiva (fostemsavir) [prescribing information]. Research Triangle Park, NC: ViiV Healthcare; October 2020.
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  5. Müller M, Wandel S, Colebunders R, Attia S, Furrer H, Egger M; IeDEA Southern and Central Africa. Immune reconstitution inflammatory syndrome in patients starting antiretroviral therapy for HIV infection: a systematic review and meta-analysis. Lancet Infect Dis. 2010;10(4):251-261. doi:10.1016/S1473-3099(10)70026-8 [PubMed 20334848]
  6. Murdoch DM, Venter WD, Van Rie A, Feldman C. Immune reconstitution inflammatory syndrome (IRIS): review of common infectious manifestations and treatment options. AIDS Res Ther. 2007;4:9. doi:10.1186/1742-6405-4-9 [PubMed 17488505]
  7. Rukobia (fostemsavir) [prescribing information]. Durham, NC: ViiV Healthcare; February 2024.
  8. Sulkowski MS, Thomas DL, Chaisson RE, Moore RD. Hepatotoxicity associated with antiretroviral therapy in adults infected with human immunodeficiency virus and the role of hepatitis C or B virus infection. JAMA. 2000;283(1):74-80. doi:10.1001/jama.283.1.74 [PubMed 10632283]
  9. US Department of Health and Human Services (HHS) Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV. Department of Health and Human Services. Available http://aidsinfo.nih.gov/contentfiles/lvguidelines/AdultandAdolescentGL.pdf. Updated December 18, 2019. Accessed July 8, 2020.
  10. US Department of Health and Human Services (HHS) Panel on Treatment of HIV During Pregnancy and Prevention of Perinatal Transmission. Recommendations for the use of antiretroviral drugs during pregnancy and interventions to reduce perinatal HIV transmission in the United States. https://clinicalinfo.hiv.gov/en/guidelines/perinatal. Updated December 19, 2024. Accessed December 30, 2024.
  11. Wit FW, Weverling GJ, Weel J, Jurriaans S, Lange JM. Incidence of and risk factors for severe hepatotoxicity associated with antiretroviral combination therapy. J Infect Dis. 2002;186(1):23-31. doi:10.1086/341084 [PubMed 12089658]
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