Rotavirus infection: Optimal treatment and prevention

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Applied Evidence

Rotavirus infection: Optimal treatment and prevention

J Fam Pract. 2011 May;60(5):E1-E6

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References

1. Parashar UD, Gibson CJ, Bresee JS, et al. Rotavirus and severe childhood diarrhea. Emerg Infect Dis. 2006;12:304-306.

2. Malek MA, Curns AT, Holman RC, et al. Diarrhea- and rotavirus-associated hospitalizations among children less than 5 years of age: United States, 1997 and 2000. Pediatrics. 2006;117:1887-1892.

3. Xu J, Dennehy P, Keyserling H, et al. Serum antibody responses in children with rotavirus diarrhea can serve as proxy for protection. Clin Diagn Lab Immunol. 2005;12:273-279.

4. World Health Organization. Rotavirus vaccines. Wkly Epidemiol Rec. 2007;82:285-295.

5. Ward RL, Bernstein DI, Staat MA. Rotaviruses. In: Feigin RD, Cherry JD, eds. Textbook of Pediatric Infectious Disease. Vol 2, 6th ed. New York, NY: Saunders; 2009:2245-2270.

6. Centers for Disease Control and Prevention. Prevention of rotavirus gastroenteritis among infants and children: recommendations of the Advisory Committee on Immunization Practices. MMWR Recomm Rep. 2009;58(RR-2):1-25.

7. Butz AM, Fosarelli P, Dick J, et al. Prevalence of rotavirus on high-risk fomites in day-care facilities. Pediatrics. 1993;92:202-205.

8. Fischer TK, Bresee JS, Glass RI. Rotavirus vaccines and the prevention of hospital-acquired diarrhea in children. Vaccine. 2004;22(suppl):S49-S54.

9. Kapikian AZ, Hoshino Y, Chanock RM. Rotaviruses. In: Knipe DM, Howley PM, Griffin DE, et al, eds. Fields Virology. 4th ed. Philadelphia, Pa: Lippincott Williams & Wilkins; 2001: 1787-1825.

10. Lorrot M, Vasseur M. How do the rotavirus NSP4 and bacterial enterotoxins lead differently to diarrhea? Virol J. 2007;4:31.-

11. Ramig RF. Pathogenesis of intestinal and systemic rotavirus infection. J Virol. 2004;78:10213-10220.

12. Robinson CG, Hernanz-Schulman M, Zhu Y, et al. Evaluation of anatomic changes in young children with natural rotavirus infection: is intussusception biologically plausible? J Infect Dis. 2004;189:1382-1387.

13. World Health Organization. Oral Rehydration Salts: Production of the New ORS. Geneva, Switzerland: WHO Document Production Services; 2006. Available at: http://whqlibdoc.who.int/hq/2006/WHO_FCH_CAH_06.1.pdf. Accessed April 11, 2011.

14. King CK, Glass R, Bresee JS, et al. Managing acute gastroenteritis among children: oral rehydration, maintenance, and nutritional therapy. MMWR Recomm Rep. 2003;52(RR-16):1-16.

15. DeCamp LR, Byerley JS, Doshi N, et al. Use of antiemetic agents in acute gastroenteritis: a systematic review and meta-analysis. Arch Pediatr Adolesc Med. 2008;162:858-865.

16. The Johns Hopkins Hospital, Custer JW, Rau RE. Harriet Lane Handbook: A Manual for Pediatric House Officers. 18th ed. St. Louis, Mo: Mosby/Elsevier; 2008.

17. Canani RB, Cirillo P, Terrin G, et al. Probiotics for treatment of acute diarrhoea in children: randomised clinical trial of five different preparations. BMJ. 2007;335:340.-

18. Van Niel CW, Feudtner C, Garrison MM, et al. Lactobacillus therapy for acute infectious diarrhea in children: a meta- analysis. Pediatrics. 2002;109:678-684.

19. Heaton PM, Goveia MG, Miller JM, et al. Development of a pentavalent rotavirus vaccine against prevalent serotypes of rotavirus gastroenteritis. J Infect Dis. 2005;192(suppl 1):S17-S21.

20. Centers for Disease Control and Prevention. Recommended immunization schedules for persons aged 0 through 18 years — United States, 2011. MMWR Morb Mortal Wkly Rep. 2011;60(5):1-4.

21. American Academy of Pediatrics (AAP) Committee on Infectious Diseases. Prevention of rotavirus disease: updated guidelines for use of rotavirus vaccine. Pediatrics. 2009;123:1412-1420.

22. Temte JL. Practice guidelines. ACIP releases 2009 child and adolescent immunization schedules. Am Fam Physician. 2009;79:56.-Available at: http://www.aafp.org/afp/2009/0101/p56.html. Accessed January 4, 2010.

23. Vesikari T, Matson DO, Dennehy P, et al. Safety and efficacy of a pentavalent human-bovine (WC3) reassortant rotavirus vaccine. N Engl J Med. 2006;354:23-33.

24. Centers for Disease Control and Prevention. Intussusception among recipients of rotavirus vaccine: United States, 1998– 1999. MMWR Morb Mortal Wkly Rep. 1999;48:577-581.

25. Centers for Disease Control and Prevention. Postmarketing monitoring of intussusception after RotaTeq vaccine: United States. February 1, 2006–February 15, 2007. MMWR Morb Mortal Wkly Rep. 2007;56:218-222.

26. Centers for Disease Control and Prevention. Reduction in rotavirus after vaccine introduction — United States, 2000-2009. MMWR Morb Mortal Wkly Rep. 2009;58:1146-1149.

27. Clark HF, Lawley D, Mallette LA, et al. Decline in cases of rotavirus gastroenteritis presenting to The Children’s Hospital of Philadelphia after introduction of a pentavalent rotavirus vaccine. Clin Vaccine Immunol. 2009;16:382-386.

28. Chang HG, Smith P, Tserenpuntsag B, et al. Reduction in New York hospitalizations for diarrhea and rotavirus. Presented at: 43rd National Immunization Conference; March 30-April 2, 2009; Dallas, Tex. Abstract 41. Available at: http://cdc.confex.com/cdc/nic2009/webprogram/Paper18073.html. Accessed April 15, 2011.

29. Boom JA, Tate JE, Sahni LC, et al. Effectiveness of pentavalent rotavirus vaccine in a large urban population in the United States. Pediatrics. 2010;125:e199-e207.

30. Yen C, Tate JE, Wenk JD, et al. Diarrhea-associated hospitalizations among US children over 2 rotavirus seasons after vaccine introduction. Pediatrics. 2011;127:e9-e15.

31. Correia JB, Patel MM, Nakagomi O, et al. Effectiveness of monovalent rotavirus vaccine (Rotarix) against severe diarrhea caused by serotypically unrelated G2P[4] strains in Brazil. J Infect Dis. 2010;201:363-369.

Regurgitation of a vaccine dose is uncommon. When it does occur, the RV5 vaccine should not be repeated; some of the vaccine dose is retained and the safety of the additional vaccine from a second dose is unknown. Readministration of a dose of RV1 is not recommended, although not contraindicated.

TABLE 2
Recommended rotavirus live virus vaccine dosing⁶

Patient age (mo)	RV5 (RotaTeq)	RV1 (Rotarix)
2	2 mL	1 mL
4	2 mL	1 mL*
6	2 mlL*	—
*The final dose of either vaccine must be given by no later than 8 months of age.

Vaccine efficacy
The safety and efficacy of live rotavirus vaccines were demonstrated in large studies that enrolled 71,725 children in RV5 vaccine trials²³ and 24,163 children in RV1 vaccine trials.²¹ The pivotal RV5 study included a nested substudy to evaluate efficacy against any G1–G4 rotavirus gastroenteritis.

RV5 (RotaTeq) vaccine. In double-blind, placebo-controlled clinical trials, for the first rotavirus season, live RV5 vaccine effectively prevented severe rotavirus infection in 98% of cases, and reduced hospitalization by 95%, emergency department visits by 94%, physician office visits by 86%, and all rotavirus cases by 74% for infants who received all 3 doses of vaccine according to protocol.²³ Hospitalization for any-cause gastroenteritis was reduced by 63%. Second-season data showed persistence of antibody protection. All 3 doses of vaccine are required for maximum protection.²³

Both preterm and term infants received their first dose of vaccine between 6 and 12 weeks of life. For preterm infants who are experiencing medical difficulties, the first dose of vaccine may be delayed until the patient is stable, if it can be given before 15 weeks of age.

FAST TRACK

ACIP, AAP, and AAFP recommend that all infants be vaccinated with the RV5 or RV1 vaccine.

RV1 (Rotarix) vaccine. In double-blind, placebo-controlled clinical trials, for the first rotavirus season, live RV1 vaccine was 85% (Latin America) to 96% (Europe) effective in preventing severe rotavirus infection. It reduced hospitalization due to rotavirus by 85% (Latin America) to 100% (Europe), and all rotavirus cases by 87% (Europe) for infants who received both doses of the vaccine according to protocol. For the second season, the vaccine reduced severe rotavirus disease by 70% to 96%, and any rotavirus disease by 73% to 89%, showing persistence of antibody protection.⁶

Adverse events
With both vaccines, common side effects include irritability, flatulence, fever, vomiting, diarrhea, cough, runny nose, and loss of appetite. The RV5 vaccine has been shown not to increase the risk of intussusception compared with placebo.^24,25 The RV1 vaccine should not be used in children with an uncorrected bowel malformation, due to unproven increased risk of intussusception. Risk of death from complications after administration of either vaccine did not differ from that among children receiving placebo.

Postmarketing surveillance of vaccination outcomes
Even though rotavirus vaccine coverage with RV5 RotaTeq in the 2007-2008 and 2008-2009 seasons was far less than that with other childhood immunizations, the number of rotavirus infections dropped by >60% in both 2008 and 2009.²⁶ The number of stool tests for rotavirus and the percentage of positive results also dropped dramatically.

Additionally, the rotavirus peak incidence was delayed 2 to 4 months until April 2008 and March 2009.²⁶ Incidence was reduced in all age groups, suggesting the possibility of herd immunity despite a low vaccine coverage rate (estimates are 57% for ≥1 dose) that would not be expected to provide herd immunity.²⁷ Hospitalizations in the United States for rotavirus gastroenteritis dropped by as much as 85%,²⁸ markedly reducing costs for gastroenteritis.

In a 2010 report from an emergency department in Houston, a complete RV5 vaccine series conferred 82% protection against acute gastroenteritis, 96% against severe rotavirus disease requiring IV rehydration, and 100% against hospitalization.²⁹ For more on the vaccine, see the report by Yen et al.³⁰

Reports of the effectiveness of Rotarix in postmarketing surveillance are limited, but the vaccine does seem to provide broad coverage.³¹

Costs of RV vaccines

As of April 11, 2011, RV5 costs $59.76/$69.59 per dose in the public/private sectors, respectively (3-dose series: $179.28/$208.77); RV1 costs $89.25/$102.50 per dose (2-dose series: $178.50/$205). routine vaccination costs about $138 per case averted and $3024 per serious case averted. neither vaccine contains thimerosal. Both vaccines are available in 10-dose packs.

Source: Centers for Disease Control and Prevention. CDC vaccine price list. Prices last reviewed/updated: April 8, 2011. Available at: http://www.cdc.gov/vaccines/programs/vfc/cdc-vac-price-list.htm. Accessed April 11, 2011.

Incorporating rotavirus vaccine into a family medicine practice
Given inadequately reimbursed costs including the cost of stocking RV vaccine (see “Costs of RV vaccines” above), family physicians who treat relatively few infants must determine whether offering RV vaccine fits within their practices.