Miriam E. Tucker

Medtronic Diabetes is recalling its Quick-set infusion sets that have lot numbers starting with the number 8 and reference numbers MMT-396 through MMT-399.

The “Lot 8” Quick-set infusion sets, used with MiniMed Paradigm insulin pumps, are being recalled because they were manufactured with an added lubricant that was clogging the vents in approximately 2% of the sets from that lot, preventing the insulin pump from venting properly. This could potentially result in too much or too little insulin being delivered and may lead to serious injury or death.

Customers should stop using Lot 8 Quick-set infusion sets right away. Medtronic is providing replacement infusion sets to customers at no additional charge.

Limited quantities of Lot 8 infusion sets have been distributed in the Bahamas, Bermuda, Brazil, Canada, Ecuador, El Salvador, Germany, Kuwait, Mexico, Paraguay, Turkey, and the United Kingdom. In Canada, customers who have received the sets from Medtronic Diabetes will be contacted. Canadian customers who have questions or concerns should call Canada's customer service line at 1-800-284-4416 for more information.

No other Medtronic infusion sets are affected by this recall. Customers may use any other Paradigm infusion sets they have available and have been trained on (including Quick-sets other than Lot 8, and Silhouette, Sure-T, Sof-set, or Polyfin infusion sets), the company said online.

Medtronic Diabetes is recalling its Quick-set infusion sets that have lot numbers starting with the number 8 and reference numbers MMT-396 through MMT-399.

The “Lot 8” Quick-set infusion sets, used with MiniMed Paradigm insulin pumps, are being recalled because they were manufactured with an added lubricant that was clogging the vents in approximately 2% of the sets from that lot, preventing the insulin pump from venting properly. This could potentially result in too much or too little insulin being delivered and may lead to serious injury or death.

Customers should stop using Lot 8 Quick-set infusion sets right away. Medtronic is providing replacement infusion sets to customers at no additional charge.

Limited quantities of Lot 8 infusion sets have been distributed in the Bahamas, Bermuda, Brazil, Canada, Ecuador, El Salvador, Germany, Kuwait, Mexico, Paraguay, Turkey, and the United Kingdom. In Canada, customers who have received the sets from Medtronic Diabetes will be contacted. Canadian customers who have questions or concerns should call Canada's customer service line at 1-800-284-4416 for more information.

No other Medtronic infusion sets are affected by this recall. Customers may use any other Paradigm infusion sets they have available and have been trained on (including Quick-sets other than Lot 8, and Silhouette, Sure-T, Sof-set, or Polyfin infusion sets), the company said online.

Medtronic Diabetes is recalling its Quick-set infusion sets that have lot numbers starting with the number 8 and reference numbers MMT-396 through MMT-399.

The “Lot 8” Quick-set infusion sets, used with MiniMed Paradigm insulin pumps, are being recalled because they were manufactured with an added lubricant that was clogging the vents in approximately 2% of the sets from that lot, preventing the insulin pump from venting properly. This could potentially result in too much or too little insulin being delivered and may lead to serious injury or death.

Customers should stop using Lot 8 Quick-set infusion sets right away. Medtronic is providing replacement infusion sets to customers at no additional charge.

Limited quantities of Lot 8 infusion sets have been distributed in the Bahamas, Bermuda, Brazil, Canada, Ecuador, El Salvador, Germany, Kuwait, Mexico, Paraguay, Turkey, and the United Kingdom. In Canada, customers who have received the sets from Medtronic Diabetes will be contacted. Canadian customers who have questions or concerns should call Canada's customer service line at 1-800-284-4416 for more information.

No other Medtronic infusion sets are affected by this recall. Customers may use any other Paradigm infusion sets they have available and have been trained on (including Quick-sets other than Lot 8, and Silhouette, Sure-T, Sof-set, or Polyfin infusion sets), the company said online.

ATLANTA — Merck & Co.'s human papillomavirus vaccine Gardasil was efficacious against persistent infections and genital warts caused by the vaccine strains in a randomized, double-blind, placebo-controlled study of more than 4,000 adolescent and young adult males.

The study, funded by Merck, was planned as a 36-month follow-up but was stopped early based on efficacy and safety data at a mean of 29 months, according to Dr. Richard M. Haupt, executive director of clinical research, Merck Research Laboratories, Whitehouse Station, N.J.

The company submitted a biologics licensing application to the Food and Drug Administration in December 2008 for the use of Gardasil in males aged 9-26 years.

“Gardasil is highly efficacious against HPV-6/11/16/18-related persistent infections and genital warts in men. This efficacy may also translate to reduced transmission of vaccine type strains between sexual partners,” Dr. Haupt said at a meeting of the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices.

The study involved 3,463 heterosexual men aged 16-23 years and 602 men aged 16-26 years who have sex with men. At baseline, just 17% of the total group was positive to at least one of the vaccine HPV strains (6, 11, 16, and/or 18) by either serology or polymerase chain reaction testing.

“This gives an idea of the great opportunity to prevent infections of all four types,” Dr. Haupt said.

The primary end point was vaccine efficacy against all external genital lesions, including condyloma and penile/perineal/perianal intraepithelial neoplasia (PIN) of any grade.

In the per-protocol population, overall efficacy was 90%, driven primarily by the prevention of genital warts: 28 of 1,408 placebo subjects developed condyloma, compared with 3 of 1,397 who received Gardasil, for an efficacy of 89%. Efficacy against PIN 1/2/3 was 100%, but the numbers were small (3 vs. 0 cases).

Efficacy against persistent infection—defined as two or more consecutive positive samples with the same HPV strain 6 months apart—was 86% (101 placebo subjects vs. 15 who got Gardasil). The vaccine was highly immunogenic, with seroconversion rates at 7 months ranging from 97% for anti-HPV-18 antibodies to 99% for anti-HPV-6. At 24 months, seroconversion rates remained high for all strains except anti-HPV-18, which dropped to 62%. Efficacy remained high against all strains, he noted.

ATLANTA — Merck & Co.'s human papillomavirus vaccine Gardasil was efficacious against persistent infections and genital warts caused by the vaccine strains in a randomized, double-blind, placebo-controlled study of more than 4,000 adolescent and young adult males.

The study, funded by Merck, was planned as a 36-month follow-up but was stopped early based on efficacy and safety data at a mean of 29 months, according to Dr. Richard M. Haupt, executive director of clinical research, Merck Research Laboratories, Whitehouse Station, N.J.

The company submitted a biologics licensing application to the Food and Drug Administration in December 2008 for the use of Gardasil in males aged 9-26 years.

“Gardasil is highly efficacious against HPV-6/11/16/18-related persistent infections and genital warts in men. This efficacy may also translate to reduced transmission of vaccine type strains between sexual partners,” Dr. Haupt said at a meeting of the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices.

The study involved 3,463 heterosexual men aged 16-23 years and 602 men aged 16-26 years who have sex with men. At baseline, just 17% of the total group was positive to at least one of the vaccine HPV strains (6, 11, 16, and/or 18) by either serology or polymerase chain reaction testing.

“This gives an idea of the great opportunity to prevent infections of all four types,” Dr. Haupt said.

The primary end point was vaccine efficacy against all external genital lesions, including condyloma and penile/perineal/perianal intraepithelial neoplasia (PIN) of any grade.

In the per-protocol population, overall efficacy was 90%, driven primarily by the prevention of genital warts: 28 of 1,408 placebo subjects developed condyloma, compared with 3 of 1,397 who received Gardasil, for an efficacy of 89%. Efficacy against PIN 1/2/3 was 100%, but the numbers were small (3 vs. 0 cases).

Efficacy against persistent infection—defined as two or more consecutive positive samples with the same HPV strain 6 months apart—was 86% (101 placebo subjects vs. 15 who got Gardasil). The vaccine was highly immunogenic, with seroconversion rates at 7 months ranging from 97% for anti-HPV-18 antibodies to 99% for anti-HPV-6. At 24 months, seroconversion rates remained high for all strains except anti-HPV-18, which dropped to 62%. Efficacy remained high against all strains, he noted.

ATLANTA — Merck & Co.'s human papillomavirus vaccine Gardasil was efficacious against persistent infections and genital warts caused by the vaccine strains in a randomized, double-blind, placebo-controlled study of more than 4,000 adolescent and young adult males.

The study, funded by Merck, was planned as a 36-month follow-up but was stopped early based on efficacy and safety data at a mean of 29 months, according to Dr. Richard M. Haupt, executive director of clinical research, Merck Research Laboratories, Whitehouse Station, N.J.

The company submitted a biologics licensing application to the Food and Drug Administration in December 2008 for the use of Gardasil in males aged 9-26 years.

“Gardasil is highly efficacious against HPV-6/11/16/18-related persistent infections and genital warts in men. This efficacy may also translate to reduced transmission of vaccine type strains between sexual partners,” Dr. Haupt said at a meeting of the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices.

The study involved 3,463 heterosexual men aged 16-23 years and 602 men aged 16-26 years who have sex with men. At baseline, just 17% of the total group was positive to at least one of the vaccine HPV strains (6, 11, 16, and/or 18) by either serology or polymerase chain reaction testing.

“This gives an idea of the great opportunity to prevent infections of all four types,” Dr. Haupt said.

The primary end point was vaccine efficacy against all external genital lesions, including condyloma and penile/perineal/perianal intraepithelial neoplasia (PIN) of any grade.

In the per-protocol population, overall efficacy was 90%, driven primarily by the prevention of genital warts: 28 of 1,408 placebo subjects developed condyloma, compared with 3 of 1,397 who received Gardasil, for an efficacy of 89%. Efficacy against PIN 1/2/3 was 100%, but the numbers were small (3 vs. 0 cases).

Efficacy against persistent infection—defined as two or more consecutive positive samples with the same HPV strain 6 months apart—was 86% (101 placebo subjects vs. 15 who got Gardasil). The vaccine was highly immunogenic, with seroconversion rates at 7 months ranging from 97% for anti-HPV-18 antibodies to 99% for anti-HPV-6. At 24 months, seroconversion rates remained high for all strains except anti-HPV-18, which dropped to 62%. Efficacy remained high against all strains, he noted.

ATLANTA — The Centers for Disease Control and Prevention's vaccine advisory panel voted to update its guidelines on antiviral treatment of influenza to include new information about antiviral resistance of seasonal influenza and address influenza caused by the newly-emerging pandemic strain of H1N1.

At the time of the Advisory Committee on Immunization Practice's June meeting, all pandemic H1N1 viruses tested were sensitive to oseltamivir and zanamivir and resistant to adamantadines. In contrast, seasonal H1N1 influenza is resistant to oseltamivir but susceptible to the other two antivirals. As of now, all circulating seasonal influenza H3N2 and B strains are susceptible to zanamivir, Dr. Anthony J. Fiore of the CDC's Influenza Division said at the meeting.

Subsequent to the meeting, a patient with oseltamivir-resistant novel H1N1 was identified in Denmark. This does not change the recommendations the committee voted on, CDC spokesman Tom Skinner said in a interview.

Antiviral treatment should be started as soon as possible after illness onset. Persons for whom antiviral treatment should be considered include those with influenza viral pneumonia or influenza and complicating bacterial pneumonia. The treatment also should be considered for patients hospitalized with influenza and those at higher risk for influenza complications, regardless of illness severity.

Zanamivir is recommended if laboratory testing is not done or is negative but there is clinical suspicion of influenza. The antiviral also is recommended if a patient tests positive for influenza A, influenza A and B, or seasonal A (H1N1).

Combined treatment with oseltamivir plus rimantadine is an acceptable alternative if zanamivir is unavailable or can't be tolerated. Either oseltamivir or zanamivir is recommended for positive A (H3N2), novel A (H1N1), or B strains.

Other information providers should consider includes:

▸ Recommended neuraminidase inhibitors are not licensed for chemoprophylaxis of children aged less than 1 year (oseltamivir) or aged less than 5 years (zanamivir).

▸ A recent Emergency Use Authorization provides information on use of oseltamivir for children aged less than 1 year.

▸ Some experts prefer weight-based dosing for children who are less than 1 year of age, particularly for very young or premature infants.

▸ When weight-based dosing is used for chemoprophylaxis in infants aged less than 1 year, those 6 months or older should receive 3.5 mg/kg per dose twice daily, and those aged less than 6 months should receive 3.0 mg/kg per dose twice daily.

Rather than voting simultaneously on recommendations for chemoprophylaxis—as has been done previously with seasonal influenza—ACIP decided instead to include a short paragraph within the treatment guidelines about chemoprophylaxis that will include the address for the CDC's H1N1 Web page (www.cdc.gov/H1N1

All flu strains appear susceptible to zanamivir, Dr. Anthony J. Fiore said.

Source ©Parker Smith Photography

ATLANTA — The Centers for Disease Control and Prevention's vaccine advisory panel voted to update its guidelines on antiviral treatment of influenza to include new information about antiviral resistance of seasonal influenza and address influenza caused by the newly-emerging pandemic strain of H1N1.

At the time of the Advisory Committee on Immunization Practice's June meeting, all pandemic H1N1 viruses tested were sensitive to oseltamivir and zanamivir and resistant to adamantadines. In contrast, seasonal H1N1 influenza is resistant to oseltamivir but susceptible to the other two antivirals. As of now, all circulating seasonal influenza H3N2 and B strains are susceptible to zanamivir, Dr. Anthony J. Fiore of the CDC's Influenza Division said at the meeting.

Subsequent to the meeting, a patient with oseltamivir-resistant novel H1N1 was identified in Denmark. This does not change the recommendations the committee voted on, CDC spokesman Tom Skinner said in a interview.

Antiviral treatment should be started as soon as possible after illness onset. Persons for whom antiviral treatment should be considered include those with influenza viral pneumonia or influenza and complicating bacterial pneumonia. The treatment also should be considered for patients hospitalized with influenza and those at higher risk for influenza complications, regardless of illness severity.

Zanamivir is recommended if laboratory testing is not done or is negative but there is clinical suspicion of influenza. The antiviral also is recommended if a patient tests positive for influenza A, influenza A and B, or seasonal A (H1N1).

Combined treatment with oseltamivir plus rimantadine is an acceptable alternative if zanamivir is unavailable or can't be tolerated. Either oseltamivir or zanamivir is recommended for positive A (H3N2), novel A (H1N1), or B strains.

Other information providers should consider includes:

▸ Recommended neuraminidase inhibitors are not licensed for chemoprophylaxis of children aged less than 1 year (oseltamivir) or aged less than 5 years (zanamivir).

▸ A recent Emergency Use Authorization provides information on use of oseltamivir for children aged less than 1 year.

▸ Some experts prefer weight-based dosing for children who are less than 1 year of age, particularly for very young or premature infants.

▸ When weight-based dosing is used for chemoprophylaxis in infants aged less than 1 year, those 6 months or older should receive 3.5 mg/kg per dose twice daily, and those aged less than 6 months should receive 3.0 mg/kg per dose twice daily.

Rather than voting simultaneously on recommendations for chemoprophylaxis—as has been done previously with seasonal influenza—ACIP decided instead to include a short paragraph within the treatment guidelines about chemoprophylaxis that will include the address for the CDC's H1N1 Web page (www.cdc.gov/H1N1

All flu strains appear susceptible to zanamivir, Dr. Anthony J. Fiore said.

Source ©Parker Smith Photography

ATLANTA — The Centers for Disease Control and Prevention's vaccine advisory panel voted to update its guidelines on antiviral treatment of influenza to include new information about antiviral resistance of seasonal influenza and address influenza caused by the newly-emerging pandemic strain of H1N1.

At the time of the Advisory Committee on Immunization Practice's June meeting, all pandemic H1N1 viruses tested were sensitive to oseltamivir and zanamivir and resistant to adamantadines. In contrast, seasonal H1N1 influenza is resistant to oseltamivir but susceptible to the other two antivirals. As of now, all circulating seasonal influenza H3N2 and B strains are susceptible to zanamivir, Dr. Anthony J. Fiore of the CDC's Influenza Division said at the meeting.

Subsequent to the meeting, a patient with oseltamivir-resistant novel H1N1 was identified in Denmark. This does not change the recommendations the committee voted on, CDC spokesman Tom Skinner said in a interview.

Antiviral treatment should be started as soon as possible after illness onset. Persons for whom antiviral treatment should be considered include those with influenza viral pneumonia or influenza and complicating bacterial pneumonia. The treatment also should be considered for patients hospitalized with influenza and those at higher risk for influenza complications, regardless of illness severity.

Zanamivir is recommended if laboratory testing is not done or is negative but there is clinical suspicion of influenza. The antiviral also is recommended if a patient tests positive for influenza A, influenza A and B, or seasonal A (H1N1).

Combined treatment with oseltamivir plus rimantadine is an acceptable alternative if zanamivir is unavailable or can't be tolerated. Either oseltamivir or zanamivir is recommended for positive A (H3N2), novel A (H1N1), or B strains.

Other information providers should consider includes:

▸ Recommended neuraminidase inhibitors are not licensed for chemoprophylaxis of children aged less than 1 year (oseltamivir) or aged less than 5 years (zanamivir).

▸ A recent Emergency Use Authorization provides information on use of oseltamivir for children aged less than 1 year.

▸ Some experts prefer weight-based dosing for children who are less than 1 year of age, particularly for very young or premature infants.

▸ When weight-based dosing is used for chemoprophylaxis in infants aged less than 1 year, those 6 months or older should receive 3.5 mg/kg per dose twice daily, and those aged less than 6 months should receive 3.0 mg/kg per dose twice daily.

Rather than voting simultaneously on recommendations for chemoprophylaxis—as has been done previously with seasonal influenza—ACIP decided instead to include a short paragraph within the treatment guidelines about chemoprophylaxis that will include the address for the CDC's H1N1 Web page (www.cdc.gov/H1N1

All flu strains appear susceptible to zanamivir, Dr. Anthony J. Fiore said.

Source ©Parker Smith Photography

ATLANTA — Physicians should resume giving booster vaccinations for Haemophilus influenzae type b to children aged 12-15 months at routine visits, the Centers for Disease Control and Prevention recommended.

H. influenzae type b (Hib) vaccine supplies were severely reduced almost 2 years ago when Merck & Co. voluntarily recalled certain lots of its PedvaxHIB (monovalent Hib vaccine) and Comvax (Hib-HepB) vaccines; production of those vaccines has not resumed. Because of the resulting shortage, the CDC recommended at that time (December 2007) that physicians defer the 12- to 15-month Hib booster in healthy children (MMWR 2009;24:673-4).

Beginning July 1, 2009, Sanofi Pasteur, manufacturer of ActHIB (monovalent Hib vaccine) and Pentacel (DTaP-IPV/Hib vaccine), aimed to ramp up production of those vaccines, allowing enough supply to resume the 12- to 15-month booster dose, Dr. Abigail Shefer said at a meeting of the CDC's Advisory Committee on Immunization Practices.

However, vaccine supply still will be insufficient to support a mass notification process in which all children whose booster dose was deferred would be contacted. Instead, physicians should review records and administer any needed doses during routine visits and other medical encounters, said Dr. Shefer of the CDC's immunization services division, National Center for Immunization and Respiratory Diseases.

Whenever possible, providers should match the type of booster dose (monovalent or combination) to what the child received in the primary series. However, the child still should be vaccinated if the only available vaccine does not match the vaccine type received in the primary series.

Both public and private providers will be able to order some additional doses of Hib vaccine each month, with allotments based on previous purchasing patterns or the size of the practice's birth cohort and estimates of additional needs.

The Hib vaccine shortage does not appear to have resulted in an increase in the number of disease cases in children less than 5 years of age, said the CDC's Dr. Michael L. Jackson. Between May 2008 and April 2009, a total of 43 cases were identified, compared with an annual average of 31.4 cases prior to the shortage.

Moreover, 32 states reported several Hib cases at or below baseline and just 20 states were over baseline. No differences were seen in characteristics of the Hib cases during the shortage compared with prior cases in either the mean age (10.9 months during the shortage vs. 13.7 months before the shortage) or percentage of unvaccinated cases or undervaccinated cases (66% vs. 54%), said Dr. Jackson of the CDC's meningitis and vaccine preventable diseases branch.

Another Hib vaccine, GlaxoSmith-Kline's Hiberix, is forthcoming. The company submitted a biologic license application for Hiberix with the proposed indication as a booster dose at 15 months to less than 5 years of age for the prevention of invasive disease. Data submitted to the Food and Drug Administration come from seven studies (including six that assess immunogenicity) with “core” data involving a total of 1,008 subjects, and two studies with a total of 1,396 subjects providing “supportive” data, GSK's Dr. Remon Abu-Elyazeed said at the meeting.

Those studies show that a booster dose of Hiberix provides immune responses in children who were previously primed with Hib vaccine, and is immunogenic when coadministered with other pediatric vaccines, said Dr. Abu-Elyazeed, head of GSK's pediatric vaccines division.

Denise Fulton contributed to this report.

Supply still will be insufficient to support vaccinating all children whose booster dose was deferred.

Source DR. SHEFER

ATLANTA — Physicians should resume giving booster vaccinations for Haemophilus influenzae type b to children aged 12-15 months at routine visits, the Centers for Disease Control and Prevention recommended.

H. influenzae type b (Hib) vaccine supplies were severely reduced almost 2 years ago when Merck & Co. voluntarily recalled certain lots of its PedvaxHIB (monovalent Hib vaccine) and Comvax (Hib-HepB) vaccines; production of those vaccines has not resumed. Because of the resulting shortage, the CDC recommended at that time (December 2007) that physicians defer the 12- to 15-month Hib booster in healthy children (MMWR 2009;24:673-4).

Beginning July 1, 2009, Sanofi Pasteur, manufacturer of ActHIB (monovalent Hib vaccine) and Pentacel (DTaP-IPV/Hib vaccine), aimed to ramp up production of those vaccines, allowing enough supply to resume the 12- to 15-month booster dose, Dr. Abigail Shefer said at a meeting of the CDC's Advisory Committee on Immunization Practices.

However, vaccine supply still will be insufficient to support a mass notification process in which all children whose booster dose was deferred would be contacted. Instead, physicians should review records and administer any needed doses during routine visits and other medical encounters, said Dr. Shefer of the CDC's immunization services division, National Center for Immunization and Respiratory Diseases.

Whenever possible, providers should match the type of booster dose (monovalent or combination) to what the child received in the primary series. However, the child still should be vaccinated if the only available vaccine does not match the vaccine type received in the primary series.

Both public and private providers will be able to order some additional doses of Hib vaccine each month, with allotments based on previous purchasing patterns or the size of the practice's birth cohort and estimates of additional needs.

The Hib vaccine shortage does not appear to have resulted in an increase in the number of disease cases in children less than 5 years of age, said the CDC's Dr. Michael L. Jackson. Between May 2008 and April 2009, a total of 43 cases were identified, compared with an annual average of 31.4 cases prior to the shortage.

Moreover, 32 states reported several Hib cases at or below baseline and just 20 states were over baseline. No differences were seen in characteristics of the Hib cases during the shortage compared with prior cases in either the mean age (10.9 months during the shortage vs. 13.7 months before the shortage) or percentage of unvaccinated cases or undervaccinated cases (66% vs. 54%), said Dr. Jackson of the CDC's meningitis and vaccine preventable diseases branch.

Another Hib vaccine, GlaxoSmith-Kline's Hiberix, is forthcoming. The company submitted a biologic license application for Hiberix with the proposed indication as a booster dose at 15 months to less than 5 years of age for the prevention of invasive disease. Data submitted to the Food and Drug Administration come from seven studies (including six that assess immunogenicity) with “core” data involving a total of 1,008 subjects, and two studies with a total of 1,396 subjects providing “supportive” data, GSK's Dr. Remon Abu-Elyazeed said at the meeting.

Those studies show that a booster dose of Hiberix provides immune responses in children who were previously primed with Hib vaccine, and is immunogenic when coadministered with other pediatric vaccines, said Dr. Abu-Elyazeed, head of GSK's pediatric vaccines division.

Denise Fulton contributed to this report.

Supply still will be insufficient to support vaccinating all children whose booster dose was deferred.

Source DR. SHEFER

ATLANTA — Physicians should resume giving booster vaccinations for Haemophilus influenzae type b to children aged 12-15 months at routine visits, the Centers for Disease Control and Prevention recommended.

H. influenzae type b (Hib) vaccine supplies were severely reduced almost 2 years ago when Merck & Co. voluntarily recalled certain lots of its PedvaxHIB (monovalent Hib vaccine) and Comvax (Hib-HepB) vaccines; production of those vaccines has not resumed. Because of the resulting shortage, the CDC recommended at that time (December 2007) that physicians defer the 12- to 15-month Hib booster in healthy children (MMWR 2009;24:673-4).

Beginning July 1, 2009, Sanofi Pasteur, manufacturer of ActHIB (monovalent Hib vaccine) and Pentacel (DTaP-IPV/Hib vaccine), aimed to ramp up production of those vaccines, allowing enough supply to resume the 12- to 15-month booster dose, Dr. Abigail Shefer said at a meeting of the CDC's Advisory Committee on Immunization Practices.

However, vaccine supply still will be insufficient to support a mass notification process in which all children whose booster dose was deferred would be contacted. Instead, physicians should review records and administer any needed doses during routine visits and other medical encounters, said Dr. Shefer of the CDC's immunization services division, National Center for Immunization and Respiratory Diseases.

Whenever possible, providers should match the type of booster dose (monovalent or combination) to what the child received in the primary series. However, the child still should be vaccinated if the only available vaccine does not match the vaccine type received in the primary series.

Both public and private providers will be able to order some additional doses of Hib vaccine each month, with allotments based on previous purchasing patterns or the size of the practice's birth cohort and estimates of additional needs.

The Hib vaccine shortage does not appear to have resulted in an increase in the number of disease cases in children less than 5 years of age, said the CDC's Dr. Michael L. Jackson. Between May 2008 and April 2009, a total of 43 cases were identified, compared with an annual average of 31.4 cases prior to the shortage.

Moreover, 32 states reported several Hib cases at or below baseline and just 20 states were over baseline. No differences were seen in characteristics of the Hib cases during the shortage compared with prior cases in either the mean age (10.9 months during the shortage vs. 13.7 months before the shortage) or percentage of unvaccinated cases or undervaccinated cases (66% vs. 54%), said Dr. Jackson of the CDC's meningitis and vaccine preventable diseases branch.

Another Hib vaccine, GlaxoSmith-Kline's Hiberix, is forthcoming. The company submitted a biologic license application for Hiberix with the proposed indication as a booster dose at 15 months to less than 5 years of age for the prevention of invasive disease. Data submitted to the Food and Drug Administration come from seven studies (including six that assess immunogenicity) with “core” data involving a total of 1,008 subjects, and two studies with a total of 1,396 subjects providing “supportive” data, GSK's Dr. Remon Abu-Elyazeed said at the meeting.

Those studies show that a booster dose of Hiberix provides immune responses in children who were previously primed with Hib vaccine, and is immunogenic when coadministered with other pediatric vaccines, said Dr. Abu-Elyazeed, head of GSK's pediatric vaccines division.

Denise Fulton contributed to this report.

Supply still will be insufficient to support vaccinating all children whose booster dose was deferred.

Source DR. SHEFER

NATIONAL HARBOR, MD. – Nursing home residents with dementia or severe mental illness face excess risk of being hospitalized for conditions that could otherwise be prevented or treated within their nursing homes.

Despite growing interest in reducing avoidable hospitalizations, little research has examined when nursing home care could have made the difference. Neither have researchers studied the role of mental illness in such hospitalizations, said Marion Becker, Ph.D., R.N., in a poster presentation at the annual meeting of the Gerontological Society of America.

Dr. Becker and her associates at the University of South Florida, Tampa, analyzed Medicaid claims data for 72,251 residents from 647 Florida nursing homes that had a median of 63% Medicaid-enrolled residents. The study population was 69% female, 84% aged 65 or older, and 70% white. Just over 40% had a diagnosis of dementia, 26% had a serious mental illness, and 36% had a major comorbid physical condition.

Almost all the facilities had at least one occupant who was hospitalized for a condition that could have been addressed in the nursing home–called an ambulatory care-sensitive (ACS) condition–during the 3-year study. ACS conditions include urinary tract infections, pneumonia, and ear, nose, or throat infections. In all, there were 8,191 ACS hospitalizations among 6,872 residents, accounting for 15% of all resident hospitalizations.

Resident demographic factors that increased the risk for ACS hospitalization included age younger than 65 years (odds ratio 0.6), being female (OR 1.1), and being nonwhite (OR 1.3). Even higher risk was associated with diagnoses of dementia (OR, 1.3) and serious mental illness. Odds ratios were 1.5 for major psychotic disorder, 1.8 for bipolar disorder, and 1.45 for major depressive disorder. Alcohol- and drug-use disorders were not large predictors of hospitalization for ACS conditions.

Some facility characteristics correlated with more ACS hospitalizations. For-profit status increased the risk (OR 1.1), whereas belonging to a chain decreased it (OR 0.9). Having a number of beds below the median decreased risk (OR 0.8), while occupancy rate, number of quality-survey citations, and registered nurse staffing ratios had no significant impact, Dr. Becker and her associates reported.

The findings suggest that many ACS hospitalizations could be avoided by “targeted preventive interventions. Given the high cost of hospitalizations, such interventions could well be a cost-effective option,” the researchers concluded.

The study was funded in part by the Florida Agency for Health Care Administration.

Registered nurse staffing ratios had no significant impact on hospitalization of nursing home residents with dementia, but 'targeted preventive interventions' made a difference.

Source Rebecca Gardner/Elsevier Global Medical News

NATIONAL HARBOR, MD. – Nursing home residents with dementia or severe mental illness face excess risk of being hospitalized for conditions that could otherwise be prevented or treated within their nursing homes.

Despite growing interest in reducing avoidable hospitalizations, little research has examined when nursing home care could have made the difference. Neither have researchers studied the role of mental illness in such hospitalizations, said Marion Becker, Ph.D., R.N., in a poster presentation at the annual meeting of the Gerontological Society of America.

Dr. Becker and her associates at the University of South Florida, Tampa, analyzed Medicaid claims data for 72,251 residents from 647 Florida nursing homes that had a median of 63% Medicaid-enrolled residents. The study population was 69% female, 84% aged 65 or older, and 70% white. Just over 40% had a diagnosis of dementia, 26% had a serious mental illness, and 36% had a major comorbid physical condition.

Almost all the facilities had at least one occupant who was hospitalized for a condition that could have been addressed in the nursing home–called an ambulatory care-sensitive (ACS) condition–during the 3-year study. ACS conditions include urinary tract infections, pneumonia, and ear, nose, or throat infections. In all, there were 8,191 ACS hospitalizations among 6,872 residents, accounting for 15% of all resident hospitalizations.

Resident demographic factors that increased the risk for ACS hospitalization included age younger than 65 years (odds ratio 0.6), being female (OR 1.1), and being nonwhite (OR 1.3). Even higher risk was associated with diagnoses of dementia (OR, 1.3) and serious mental illness. Odds ratios were 1.5 for major psychotic disorder, 1.8 for bipolar disorder, and 1.45 for major depressive disorder. Alcohol- and drug-use disorders were not large predictors of hospitalization for ACS conditions.

Some facility characteristics correlated with more ACS hospitalizations. For-profit status increased the risk (OR 1.1), whereas belonging to a chain decreased it (OR 0.9). Having a number of beds below the median decreased risk (OR 0.8), while occupancy rate, number of quality-survey citations, and registered nurse staffing ratios had no significant impact, Dr. Becker and her associates reported.

The findings suggest that many ACS hospitalizations could be avoided by “targeted preventive interventions. Given the high cost of hospitalizations, such interventions could well be a cost-effective option,” the researchers concluded.

The study was funded in part by the Florida Agency for Health Care Administration.

Registered nurse staffing ratios had no significant impact on hospitalization of nursing home residents with dementia, but 'targeted preventive interventions' made a difference.

Source Rebecca Gardner/Elsevier Global Medical News

NATIONAL HARBOR, MD. – Nursing home residents with dementia or severe mental illness face excess risk of being hospitalized for conditions that could otherwise be prevented or treated within their nursing homes.

Despite growing interest in reducing avoidable hospitalizations, little research has examined when nursing home care could have made the difference. Neither have researchers studied the role of mental illness in such hospitalizations, said Marion Becker, Ph.D., R.N., in a poster presentation at the annual meeting of the Gerontological Society of America.

Dr. Becker and her associates at the University of South Florida, Tampa, analyzed Medicaid claims data for 72,251 residents from 647 Florida nursing homes that had a median of 63% Medicaid-enrolled residents. The study population was 69% female, 84% aged 65 or older, and 70% white. Just over 40% had a diagnosis of dementia, 26% had a serious mental illness, and 36% had a major comorbid physical condition.

Almost all the facilities had at least one occupant who was hospitalized for a condition that could have been addressed in the nursing home–called an ambulatory care-sensitive (ACS) condition–during the 3-year study. ACS conditions include urinary tract infections, pneumonia, and ear, nose, or throat infections. In all, there were 8,191 ACS hospitalizations among 6,872 residents, accounting for 15% of all resident hospitalizations.

Resident demographic factors that increased the risk for ACS hospitalization included age younger than 65 years (odds ratio 0.6), being female (OR 1.1), and being nonwhite (OR 1.3). Even higher risk was associated with diagnoses of dementia (OR, 1.3) and serious mental illness. Odds ratios were 1.5 for major psychotic disorder, 1.8 for bipolar disorder, and 1.45 for major depressive disorder. Alcohol- and drug-use disorders were not large predictors of hospitalization for ACS conditions.

Some facility characteristics correlated with more ACS hospitalizations. For-profit status increased the risk (OR 1.1), whereas belonging to a chain decreased it (OR 0.9). Having a number of beds below the median decreased risk (OR 0.8), while occupancy rate, number of quality-survey citations, and registered nurse staffing ratios had no significant impact, Dr. Becker and her associates reported.

The findings suggest that many ACS hospitalizations could be avoided by “targeted preventive interventions. Given the high cost of hospitalizations, such interventions could well be a cost-effective option,” the researchers concluded.

The study was funded in part by the Florida Agency for Health Care Administration.

Registered nurse staffing ratios had no significant impact on hospitalization of nursing home residents with dementia, but 'targeted preventive interventions' made a difference.

Source Rebecca Gardner/Elsevier Global Medical News

NEW ORLEANS — Prescription plans offered by large discount stores could save diabetes patients at least $85 per month in out-of-pocket expenses compared with local chain or independent pharmacies, a cost analysis found.

Previous data suggest that one in every five U.S. patients with diabetes cuts back on medications because of cost. Recently, large retail stores such as Wal-Mart, Target, and Kmart have launched programs that offer generic medications at much lower cost to customers than that of other types of pharmacies.

An analysis of medical and pharmaceutical claims from the PharMetrics patient-centric database on 52 million unique insured patients from 91 health plans across the United States confirms that these programs can save patients a significant amount of money out-of-pocket, Dr. Clifton M. Jackness and Dr. Ronald Tamler reported in a poster at the annual scientific sessions of the American Diabetes Association.

“The purpose of our study was to increase physician and patient awareness that there are significant price differences among pharmacies, and that cost is a significant barrier to patient compliance,” Dr. Jackness said in an interview.

“Doctors and patients should work together to find the best pharmacy that serves their needs, and some smaller pharmacies may be able to compete with Wal-Mart's prices. However, Wal-Mart, Target, and Kmart are full-service pharmacies that answer patient questions, ask about interactions, and keep computerized records on all drugs prescribed through their stores,” added Dr. Jackness, an internist at Mount Sinai School of Medicine, New York.

He and Dr. Tamler, an endocrinologist at Mount Sinai, analyzed claims for the 10 most commonly prescribed medications for all adults younger than age 65 years with a diagnosis of diabetes (ICD-9 code 250) prior to Jan. 1, 2005. The 10 drugs included in the analysis were metformin, atorvastatin, lisinopril, rosiglitazone, furosemide, pioglitazone, simvastatin, hydrochlorothiazide, insulin glargine, and amlodipine. The average number of medications taken by a patient with diabetes is 8.9, according to the investigators.

Some generic drugs offered by Wal-Mart, Target, and Kmart cost much less than the same drugs sold by other pharmacies, while other medications were similar in price. For nongeneric medications, those three discounters, www.drugstore.com

For example, the 30-day out-of-pocket cost for generic metformin (500 mg) ranged from $4.00 at Wal-Mart and Target to $39.99 at Rite-Aid. For lisinopril (10 mg), the range was $4.00 at the same two big retailers to $36.95 at a local pharmacy. But atorvastatin (10 mg)—not available generically as of August 2008—was expensive just about everywhere, ranging from Wal-Mart's low of $71.63 to a high of $107.10 at drugstore.com

The superstores and mail-order firms did not always have the lowest price for every medication, but a patient who bought all 10 prescriptions at one of these stores would save a minimum of $85 per month, compared with the local chain or independent pharmacy, neither of which had the lowest price for any of the medications included in the analysis, Dr. Jackness and Dr. Tamler said.

Physicians should find out if the medications they prescribe are available as generics and are on the formularies for the low-cost programs. “All the data suggest that [outcomes] would improve if patients could afford their medications,” Dr. Jackness said during the interview.

Neither Dr. Jackness nor Dr. Tamler had any disclosures or conflicts of interest. The PharMetrics prescribing data came from Eli Lilly & Co. representatives, but they did not request compensation for that database.

NEW ORLEANS — Prescription plans offered by large discount stores could save diabetes patients at least $85 per month in out-of-pocket expenses compared with local chain or independent pharmacies, a cost analysis found.

Previous data suggest that one in every five U.S. patients with diabetes cuts back on medications because of cost. Recently, large retail stores such as Wal-Mart, Target, and Kmart have launched programs that offer generic medications at much lower cost to customers than that of other types of pharmacies.

An analysis of medical and pharmaceutical claims from the PharMetrics patient-centric database on 52 million unique insured patients from 91 health plans across the United States confirms that these programs can save patients a significant amount of money out-of-pocket, Dr. Clifton M. Jackness and Dr. Ronald Tamler reported in a poster at the annual scientific sessions of the American Diabetes Association.

“The purpose of our study was to increase physician and patient awareness that there are significant price differences among pharmacies, and that cost is a significant barrier to patient compliance,” Dr. Jackness said in an interview.

“Doctors and patients should work together to find the best pharmacy that serves their needs, and some smaller pharmacies may be able to compete with Wal-Mart's prices. However, Wal-Mart, Target, and Kmart are full-service pharmacies that answer patient questions, ask about interactions, and keep computerized records on all drugs prescribed through their stores,” added Dr. Jackness, an internist at Mount Sinai School of Medicine, New York.

He and Dr. Tamler, an endocrinologist at Mount Sinai, analyzed claims for the 10 most commonly prescribed medications for all adults younger than age 65 years with a diagnosis of diabetes (ICD-9 code 250) prior to Jan. 1, 2005. The 10 drugs included in the analysis were metformin, atorvastatin, lisinopril, rosiglitazone, furosemide, pioglitazone, simvastatin, hydrochlorothiazide, insulin glargine, and amlodipine. The average number of medications taken by a patient with diabetes is 8.9, according to the investigators.

Some generic drugs offered by Wal-Mart, Target, and Kmart cost much less than the same drugs sold by other pharmacies, while other medications were similar in price. For nongeneric medications, those three discounters, www.drugstore.com

For example, the 30-day out-of-pocket cost for generic metformin (500 mg) ranged from $4.00 at Wal-Mart and Target to $39.99 at Rite-Aid. For lisinopril (10 mg), the range was $4.00 at the same two big retailers to $36.95 at a local pharmacy. But atorvastatin (10 mg)—not available generically as of August 2008—was expensive just about everywhere, ranging from Wal-Mart's low of $71.63 to a high of $107.10 at drugstore.com

The superstores and mail-order firms did not always have the lowest price for every medication, but a patient who bought all 10 prescriptions at one of these stores would save a minimum of $85 per month, compared with the local chain or independent pharmacy, neither of which had the lowest price for any of the medications included in the analysis, Dr. Jackness and Dr. Tamler said.

Physicians should find out if the medications they prescribe are available as generics and are on the formularies for the low-cost programs. “All the data suggest that [outcomes] would improve if patients could afford their medications,” Dr. Jackness said during the interview.

Neither Dr. Jackness nor Dr. Tamler had any disclosures or conflicts of interest. The PharMetrics prescribing data came from Eli Lilly & Co. representatives, but they did not request compensation for that database.

NEW ORLEANS — Prescription plans offered by large discount stores could save diabetes patients at least $85 per month in out-of-pocket expenses compared with local chain or independent pharmacies, a cost analysis found.

Previous data suggest that one in every five U.S. patients with diabetes cuts back on medications because of cost. Recently, large retail stores such as Wal-Mart, Target, and Kmart have launched programs that offer generic medications at much lower cost to customers than that of other types of pharmacies.

An analysis of medical and pharmaceutical claims from the PharMetrics patient-centric database on 52 million unique insured patients from 91 health plans across the United States confirms that these programs can save patients a significant amount of money out-of-pocket, Dr. Clifton M. Jackness and Dr. Ronald Tamler reported in a poster at the annual scientific sessions of the American Diabetes Association.

“The purpose of our study was to increase physician and patient awareness that there are significant price differences among pharmacies, and that cost is a significant barrier to patient compliance,” Dr. Jackness said in an interview.

“Doctors and patients should work together to find the best pharmacy that serves their needs, and some smaller pharmacies may be able to compete with Wal-Mart's prices. However, Wal-Mart, Target, and Kmart are full-service pharmacies that answer patient questions, ask about interactions, and keep computerized records on all drugs prescribed through their stores,” added Dr. Jackness, an internist at Mount Sinai School of Medicine, New York.

He and Dr. Tamler, an endocrinologist at Mount Sinai, analyzed claims for the 10 most commonly prescribed medications for all adults younger than age 65 years with a diagnosis of diabetes (ICD-9 code 250) prior to Jan. 1, 2005. The 10 drugs included in the analysis were metformin, atorvastatin, lisinopril, rosiglitazone, furosemide, pioglitazone, simvastatin, hydrochlorothiazide, insulin glargine, and amlodipine. The average number of medications taken by a patient with diabetes is 8.9, according to the investigators.

Some generic drugs offered by Wal-Mart, Target, and Kmart cost much less than the same drugs sold by other pharmacies, while other medications were similar in price. For nongeneric medications, those three discounters, www.drugstore.com

For example, the 30-day out-of-pocket cost for generic metformin (500 mg) ranged from $4.00 at Wal-Mart and Target to $39.99 at Rite-Aid. For lisinopril (10 mg), the range was $4.00 at the same two big retailers to $36.95 at a local pharmacy. But atorvastatin (10 mg)—not available generically as of August 2008—was expensive just about everywhere, ranging from Wal-Mart's low of $71.63 to a high of $107.10 at drugstore.com

The superstores and mail-order firms did not always have the lowest price for every medication, but a patient who bought all 10 prescriptions at one of these stores would save a minimum of $85 per month, compared with the local chain or independent pharmacy, neither of which had the lowest price for any of the medications included in the analysis, Dr. Jackness and Dr. Tamler said.

Physicians should find out if the medications they prescribe are available as generics and are on the formularies for the low-cost programs. “All the data suggest that [outcomes] would improve if patients could afford their medications,” Dr. Jackness said during the interview.

Neither Dr. Jackness nor Dr. Tamler had any disclosures or conflicts of interest. The PharMetrics prescribing data came from Eli Lilly & Co. representatives, but they did not request compensation for that database.

ATLANTA — The Centers for Disease Control and Prevention's vaccine advisory panel voted to update its guidelines on antiviral treatment of influenza to include new information about antiviral resistance of seasonal influenza and to address influenza that is caused by the newly emergent pandemic strain of H1N1.

At the time of the meeting of the Advisory Committee on Immunization Practice, all pandemic H1N1 viruses tested were sensitive to oseltamivir and zanamivir and were resistant to the adamantadines. In contrast, seasonal H1N1 influenza is resistant to oseltamivir but susceptible to the other two antivirals.

Currently, all circulating seasonal influenza H3N2 and B strains are susceptible to zanamivir, Dr. Anthony J. Fiore of the CDC's Influenza Division said at the meeting.

Subsequent to the meeting, a patient with oseltamivir-resistant novel H1N1 was identified in Denmark. This development does not change the committee's recommendations, CDC spokesman Tom Skinner said in a interview.

Antiviral treatment should be started as soon as possible after illness onset.

Persons for whom antiviral treatment should be considered include those who have influenza viral pneumonia, or influenza and complicating bacterial pneumonia.

The treatment also should be considered for patients hospitalized with influenza and those at higher risk for influenza complications, regardless of illness severity.

Zanamivir is recommended if laboratory testing is not done or is negative but there is clinical suspicion of influenza.

The antiviral also is recommended if a patient tests positive for influenza A, both influenza A and B, or seasonal A (H1N1).

Combined treatment with oseltamivir plus rimantadine is an acceptable alternative if zanamivir is not available or can't be tolerated.

Either oseltamivir or zanamivir is recommended for positive A (H3N2) and novel A (H1N1) or B strains.

Rather than voting simultaneously on recommendations for chemoprophylaxis—as has been done previously with seasonal influenza—ACIP decided instead to include a short paragraph within the treatment guidelines about chemoprophylaxis that will include the address for the CDC's H1N1 Web page (www.cdc.gov/H1N1

The information on that site is updated frequently, and will likely be the most current information available. The recommendations on the need for chemoprophylaxis are expected to change as more becomes known about transmission of the novel H1N1 virus and vaccine availability, ACIP member Dr. Kathleen Neuzil said in an interview. Dr. Neuzil is an associate professor of medicine in the Division of Allergy and Infectious Diseases at the University of Washington, Seattle.

Currently, all strains of influenza are susceptible to zanamivir, Dr. Anthony J. Fiore said.

Source ©Parker Smith Photography

ATLANTA — The Centers for Disease Control and Prevention's vaccine advisory panel voted to update its guidelines on antiviral treatment of influenza to include new information about antiviral resistance of seasonal influenza and to address influenza that is caused by the newly emergent pandemic strain of H1N1.

At the time of the meeting of the Advisory Committee on Immunization Practice, all pandemic H1N1 viruses tested were sensitive to oseltamivir and zanamivir and were resistant to the adamantadines. In contrast, seasonal H1N1 influenza is resistant to oseltamivir but susceptible to the other two antivirals.

Currently, all circulating seasonal influenza H3N2 and B strains are susceptible to zanamivir, Dr. Anthony J. Fiore of the CDC's Influenza Division said at the meeting.

Subsequent to the meeting, a patient with oseltamivir-resistant novel H1N1 was identified in Denmark. This development does not change the committee's recommendations, CDC spokesman Tom Skinner said in a interview.

Antiviral treatment should be started as soon as possible after illness onset.

Persons for whom antiviral treatment should be considered include those who have influenza viral pneumonia, or influenza and complicating bacterial pneumonia.

The treatment also should be considered for patients hospitalized with influenza and those at higher risk for influenza complications, regardless of illness severity.

Zanamivir is recommended if laboratory testing is not done or is negative but there is clinical suspicion of influenza.

The antiviral also is recommended if a patient tests positive for influenza A, both influenza A and B, or seasonal A (H1N1).

Combined treatment with oseltamivir plus rimantadine is an acceptable alternative if zanamivir is not available or can't be tolerated.

Either oseltamivir or zanamivir is recommended for positive A (H3N2) and novel A (H1N1) or B strains.

Rather than voting simultaneously on recommendations for chemoprophylaxis—as has been done previously with seasonal influenza—ACIP decided instead to include a short paragraph within the treatment guidelines about chemoprophylaxis that will include the address for the CDC's H1N1 Web page (www.cdc.gov/H1N1

The information on that site is updated frequently, and will likely be the most current information available. The recommendations on the need for chemoprophylaxis are expected to change as more becomes known about transmission of the novel H1N1 virus and vaccine availability, ACIP member Dr. Kathleen Neuzil said in an interview. Dr. Neuzil is an associate professor of medicine in the Division of Allergy and Infectious Diseases at the University of Washington, Seattle.

Currently, all strains of influenza are susceptible to zanamivir, Dr. Anthony J. Fiore said.

Source ©Parker Smith Photography

ATLANTA — The Centers for Disease Control and Prevention's vaccine advisory panel voted to update its guidelines on antiviral treatment of influenza to include new information about antiviral resistance of seasonal influenza and to address influenza that is caused by the newly emergent pandemic strain of H1N1.

At the time of the meeting of the Advisory Committee on Immunization Practice, all pandemic H1N1 viruses tested were sensitive to oseltamivir and zanamivir and were resistant to the adamantadines. In contrast, seasonal H1N1 influenza is resistant to oseltamivir but susceptible to the other two antivirals.

Currently, all circulating seasonal influenza H3N2 and B strains are susceptible to zanamivir, Dr. Anthony J. Fiore of the CDC's Influenza Division said at the meeting.

Subsequent to the meeting, a patient with oseltamivir-resistant novel H1N1 was identified in Denmark. This development does not change the committee's recommendations, CDC spokesman Tom Skinner said in a interview.

Antiviral treatment should be started as soon as possible after illness onset.

Persons for whom antiviral treatment should be considered include those who have influenza viral pneumonia, or influenza and complicating bacterial pneumonia.

The treatment also should be considered for patients hospitalized with influenza and those at higher risk for influenza complications, regardless of illness severity.

Zanamivir is recommended if laboratory testing is not done or is negative but there is clinical suspicion of influenza.

The antiviral also is recommended if a patient tests positive for influenza A, both influenza A and B, or seasonal A (H1N1).

Combined treatment with oseltamivir plus rimantadine is an acceptable alternative if zanamivir is not available or can't be tolerated.

Either oseltamivir or zanamivir is recommended for positive A (H3N2) and novel A (H1N1) or B strains.

Rather than voting simultaneously on recommendations for chemoprophylaxis—as has been done previously with seasonal influenza—ACIP decided instead to include a short paragraph within the treatment guidelines about chemoprophylaxis that will include the address for the CDC's H1N1 Web page (www.cdc.gov/H1N1

The information on that site is updated frequently, and will likely be the most current information available. The recommendations on the need for chemoprophylaxis are expected to change as more becomes known about transmission of the novel H1N1 virus and vaccine availability, ACIP member Dr. Kathleen Neuzil said in an interview. Dr. Neuzil is an associate professor of medicine in the Division of Allergy and Infectious Diseases at the University of Washington, Seattle.

Currently, all strains of influenza are susceptible to zanamivir, Dr. Anthony J. Fiore said.

Source ©Parker Smith Photography

NEW ORLEANS — Prescription plans offered by large discount stores could save diabetes patients at least $85 per month in out-of-pocket expenses compared with local chain or independent pharmacies, a cost analysis found.

Previous data suggest that one in every five U.S. patients with diabetes cuts back on medications because of cost. Recently, large retail stores such as Wal-Mart, Target, and Kmart have launched programs that offer generic medications at much lower cost to customers than that of other types of pharmacies.

An analysis of medical and pharmaceutical claims from the PharMetrics patient-centric database on 52 million unique insured patients from 91 U.S. health plans confirms that these programs can save patients a significant amount of money out-of-pocket, Dr. Clifton M. Jackness and Dr. Ronald Tamler reported in a poster at the annual scientific sessions of the American Diabetes Association.

“Doctors and patients should work together to find the best pharmacy that serves their needs, and some smaller pharmacies may be able to compete with Wal-Mart's prices. However, Wal-Mart, Target, and Kmart are full-service pharmacies that answer patient questions, ask about interactions, and keep computerized records on all drugs prescribed through their stores,” Dr. Jackness, an internist at Mount Sinai School of Medicine, New York, said in an interview.

He and Dr. Tamler, an endocrinologist at Mt. Sinai, analyzed claims for the 10 most commonly prescribed medications for all adults younger than age 65 years with a diagnosis of diabetes (ICD-9 code 250) prior to Jan. 1, 2005. (See box.) Rosiglitazone is prescribed less often today, so it was removed and #11, atenolol (47,070 patients) was included in the analysis instead. The average number of medications taken by a patient with diabetes is 8.9, according to the investigators.

Some generic drugs offered by Wal-Mart, Target, and Kmart cost much less than the same drugs sold by other pharmacies, while other medications were similar in price. On the price of nongeneric medications, those three discounters, www.drugstore.com

When added up, the price of all 10 medications was lowest at Medco by Mail ($428.35), not including shipping and handling. Next lowest was Wal-Mart ($432.53), while the highest was a local pharmacy ($639.30).

The superstores and mail-order firms did not always have the lowest price for every medication, but a patient who bought all 10 prescriptions at one of these stores would save a minimum of $85 per month compared with the local chain or independent pharmacy, Dr. Jackness and Dr. Tamler said.

Neither Dr. Jackness nor Dr. Tamler had any disclosures or conflicts of interest. The PharMetrics prescribing data came from Eli Lilly & Co. representatives, but they did not request compensation for that database. There was no funding necessary for the study itself.

Source ELSEVIER GLOBAL MEDICAL NEWS

NEW ORLEANS — Prescription plans offered by large discount stores could save diabetes patients at least $85 per month in out-of-pocket expenses compared with local chain or independent pharmacies, a cost analysis found.

Previous data suggest that one in every five U.S. patients with diabetes cuts back on medications because of cost. Recently, large retail stores such as Wal-Mart, Target, and Kmart have launched programs that offer generic medications at much lower cost to customers than that of other types of pharmacies.

An analysis of medical and pharmaceutical claims from the PharMetrics patient-centric database on 52 million unique insured patients from 91 U.S. health plans confirms that these programs can save patients a significant amount of money out-of-pocket, Dr. Clifton M. Jackness and Dr. Ronald Tamler reported in a poster at the annual scientific sessions of the American Diabetes Association.

“Doctors and patients should work together to find the best pharmacy that serves their needs, and some smaller pharmacies may be able to compete with Wal-Mart's prices. However, Wal-Mart, Target, and Kmart are full-service pharmacies that answer patient questions, ask about interactions, and keep computerized records on all drugs prescribed through their stores,” Dr. Jackness, an internist at Mount Sinai School of Medicine, New York, said in an interview.

He and Dr. Tamler, an endocrinologist at Mt. Sinai, analyzed claims for the 10 most commonly prescribed medications for all adults younger than age 65 years with a diagnosis of diabetes (ICD-9 code 250) prior to Jan. 1, 2005. (See box.) Rosiglitazone is prescribed less often today, so it was removed and #11, atenolol (47,070 patients) was included in the analysis instead. The average number of medications taken by a patient with diabetes is 8.9, according to the investigators.

Some generic drugs offered by Wal-Mart, Target, and Kmart cost much less than the same drugs sold by other pharmacies, while other medications were similar in price. On the price of nongeneric medications, those three discounters, www.drugstore.com

When added up, the price of all 10 medications was lowest at Medco by Mail ($428.35), not including shipping and handling. Next lowest was Wal-Mart ($432.53), while the highest was a local pharmacy ($639.30).

The superstores and mail-order firms did not always have the lowest price for every medication, but a patient who bought all 10 prescriptions at one of these stores would save a minimum of $85 per month compared with the local chain or independent pharmacy, Dr. Jackness and Dr. Tamler said.

Neither Dr. Jackness nor Dr. Tamler had any disclosures or conflicts of interest. The PharMetrics prescribing data came from Eli Lilly & Co. representatives, but they did not request compensation for that database. There was no funding necessary for the study itself.

Source ELSEVIER GLOBAL MEDICAL NEWS

NEW ORLEANS — Prescription plans offered by large discount stores could save diabetes patients at least $85 per month in out-of-pocket expenses compared with local chain or independent pharmacies, a cost analysis found.

Previous data suggest that one in every five U.S. patients with diabetes cuts back on medications because of cost. Recently, large retail stores such as Wal-Mart, Target, and Kmart have launched programs that offer generic medications at much lower cost to customers than that of other types of pharmacies.

An analysis of medical and pharmaceutical claims from the PharMetrics patient-centric database on 52 million unique insured patients from 91 U.S. health plans confirms that these programs can save patients a significant amount of money out-of-pocket, Dr. Clifton M. Jackness and Dr. Ronald Tamler reported in a poster at the annual scientific sessions of the American Diabetes Association.

“Doctors and patients should work together to find the best pharmacy that serves their needs, and some smaller pharmacies may be able to compete with Wal-Mart's prices. However, Wal-Mart, Target, and Kmart are full-service pharmacies that answer patient questions, ask about interactions, and keep computerized records on all drugs prescribed through their stores,” Dr. Jackness, an internist at Mount Sinai School of Medicine, New York, said in an interview.

He and Dr. Tamler, an endocrinologist at Mt. Sinai, analyzed claims for the 10 most commonly prescribed medications for all adults younger than age 65 years with a diagnosis of diabetes (ICD-9 code 250) prior to Jan. 1, 2005. (See box.) Rosiglitazone is prescribed less often today, so it was removed and #11, atenolol (47,070 patients) was included in the analysis instead. The average number of medications taken by a patient with diabetes is 8.9, according to the investigators.

Some generic drugs offered by Wal-Mart, Target, and Kmart cost much less than the same drugs sold by other pharmacies, while other medications were similar in price. On the price of nongeneric medications, those three discounters, www.drugstore.com

When added up, the price of all 10 medications was lowest at Medco by Mail ($428.35), not including shipping and handling. Next lowest was Wal-Mart ($432.53), while the highest was a local pharmacy ($639.30).

The superstores and mail-order firms did not always have the lowest price for every medication, but a patient who bought all 10 prescriptions at one of these stores would save a minimum of $85 per month compared with the local chain or independent pharmacy, Dr. Jackness and Dr. Tamler said.

Neither Dr. Jackness nor Dr. Tamler had any disclosures or conflicts of interest. The PharMetrics prescribing data came from Eli Lilly & Co. representatives, but they did not request compensation for that database. There was no funding necessary for the study itself.

Source ELSEVIER GLOBAL MEDICAL NEWS

ATLANTA — Merck & Co.'s human papillomavirus vaccine Gardasil was efficacious against persistent infections and genital warts caused by the vaccine strains, in a randomized, double-blind, placebo-controlled study of more than 4,000 adolescent and young adult males.

The study, funded by Merck, was planned as a 36-month follow-up but was stopped early based on efficacy and safety data at a mean of 29 months, according to Dr. Richard M. Haupt, executive director of clinical research, Merck Research Laboratories, Whitehouse Station, N.J. The company submitted a biologics licensing application to the Food and Drug Administration in December 2008 for the use of Gardasil in males aged 9-26 years.

Of the four HPV strains in Gardasil, HPV-16 and HPV-18 are responsible for the majority of HPV-related penile, anal, and oropharyngeal cancers and their associated precancers in males. The other two strains, HPV-6 and HPV-11, cause more than 90% of genital warts and recurrent respiratory papillomatosis.

"Gardasil is highly efficacious against HPV-6/11/16/18-related persistent infections and genital warts in men. This efficacy may also translate to reduced transmission of vaccine type strains between sexual partners," Dr. Haupt said at a meeting of the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices.

The study included 3,463 heterosexual men aged 16-23 years and 602 men aged 16-26 years who have sex with men. Participants with more than five lifetime sexual partners were excluded. At baseline, just 17% of the total group was positive to at least one of the vaccine HPV strains by either serology or polymerase chain reaction testing, meaning that a large majority (83%) was susceptible.

The primary end point was vaccine efficacy against all external genital lesions.

In the per-protocol population, overall efficacy was 90%, driven primarily by the prevention of genital warts: 28 of 1,408 placebo subjects developed condyloma, compared with 3 of 1,397 who received Gardasil, for an efficacy of 89%. Efficacy against PIN 1/2/3 was 100%, but the numbers were small (3 vs. 0 cases).

Efficacy against persistent infection—defined as two or more consecutive positive samples with the same HPV strain 6 months apart—was 86% (101 placebo subjects vs. 15 who got Gardasil). The vaccine was highly immunogenic, with seroconversion rates at 7 months ranging from 97% for anti-HPV-18 antibodies to 99% for anti-HPV-6. At 24 months, seroconversion rates remained high for all strains except for anti-HPV-18, which dropped to 62%. However, efficacy remained high against all strains, he noted.

Adverse event rates did not differ significantly between groups. Injection site reactions were the most common adverse event. No serious vaccine-related adverse events were reported, and only two Gardasil and three placebo participants discontinued the study because of vaccine-related adverse events.

Because efficacy studies that include genital sampling and questions about sexual behavior are not feasible in sexually naive young adolescent boys, the FDA allowed Merck to use immunogenicity "bridging" data to represent vaccine efficacy in 9- to 15-year-old boys in order to gain approval for use in that age group.

Immune responses to each of the four vaccine strains were actually more than twice as high among 1,073 boys aged 9-15 years as they were among 2,025 boys 16-26 years old, while there were no significant differences in adverse events between the younger and older cohorts.

"We believe there is a real public health benefit to adding male vaccination to the already-recognized female vaccination," Dr. Haupt concluded.

'We believe there is a real … benefit to adding male vaccination to the already-recognized female vaccination.'

Source DR. HAUPT

ATLANTA — Merck & Co.'s human papillomavirus vaccine Gardasil was efficacious against persistent infections and genital warts caused by the vaccine strains, in a randomized, double-blind, placebo-controlled study of more than 4,000 adolescent and young adult males.

The study, funded by Merck, was planned as a 36-month follow-up but was stopped early based on efficacy and safety data at a mean of 29 months, according to Dr. Richard M. Haupt, executive director of clinical research, Merck Research Laboratories, Whitehouse Station, N.J. The company submitted a biologics licensing application to the Food and Drug Administration in December 2008 for the use of Gardasil in males aged 9-26 years.

Of the four HPV strains in Gardasil, HPV-16 and HPV-18 are responsible for the majority of HPV-related penile, anal, and oropharyngeal cancers and their associated precancers in males. The other two strains, HPV-6 and HPV-11, cause more than 90% of genital warts and recurrent respiratory papillomatosis.

"Gardasil is highly efficacious against HPV-6/11/16/18-related persistent infections and genital warts in men. This efficacy may also translate to reduced transmission of vaccine type strains between sexual partners," Dr. Haupt said at a meeting of the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices.

The study included 3,463 heterosexual men aged 16-23 years and 602 men aged 16-26 years who have sex with men. Participants with more than five lifetime sexual partners were excluded. At baseline, just 17% of the total group was positive to at least one of the vaccine HPV strains by either serology or polymerase chain reaction testing, meaning that a large majority (83%) was susceptible.

The primary end point was vaccine efficacy against all external genital lesions.

In the per-protocol population, overall efficacy was 90%, driven primarily by the prevention of genital warts: 28 of 1,408 placebo subjects developed condyloma, compared with 3 of 1,397 who received Gardasil, for an efficacy of 89%. Efficacy against PIN 1/2/3 was 100%, but the numbers were small (3 vs. 0 cases).

Efficacy against persistent infection—defined as two or more consecutive positive samples with the same HPV strain 6 months apart—was 86% (101 placebo subjects vs. 15 who got Gardasil). The vaccine was highly immunogenic, with seroconversion rates at 7 months ranging from 97% for anti-HPV-18 antibodies to 99% for anti-HPV-6. At 24 months, seroconversion rates remained high for all strains except for anti-HPV-18, which dropped to 62%. However, efficacy remained high against all strains, he noted.

Adverse event rates did not differ significantly between groups. Injection site reactions were the most common adverse event. No serious vaccine-related adverse events were reported, and only two Gardasil and three placebo participants discontinued the study because of vaccine-related adverse events.

Because efficacy studies that include genital sampling and questions about sexual behavior are not feasible in sexually naive young adolescent boys, the FDA allowed Merck to use immunogenicity "bridging" data to represent vaccine efficacy in 9- to 15-year-old boys in order to gain approval for use in that age group.

Immune responses to each of the four vaccine strains were actually more than twice as high among 1,073 boys aged 9-15 years as they were among 2,025 boys 16-26 years old, while there were no significant differences in adverse events between the younger and older cohorts.

"We believe there is a real public health benefit to adding male vaccination to the already-recognized female vaccination," Dr. Haupt concluded.

'We believe there is a real … benefit to adding male vaccination to the already-recognized female vaccination.'

Source DR. HAUPT

ATLANTA — Merck & Co.'s human papillomavirus vaccine Gardasil was efficacious against persistent infections and genital warts caused by the vaccine strains, in a randomized, double-blind, placebo-controlled study of more than 4,000 adolescent and young adult males.

The study, funded by Merck, was planned as a 36-month follow-up but was stopped early based on efficacy and safety data at a mean of 29 months, according to Dr. Richard M. Haupt, executive director of clinical research, Merck Research Laboratories, Whitehouse Station, N.J. The company submitted a biologics licensing application to the Food and Drug Administration in December 2008 for the use of Gardasil in males aged 9-26 years.

Of the four HPV strains in Gardasil, HPV-16 and HPV-18 are responsible for the majority of HPV-related penile, anal, and oropharyngeal cancers and their associated precancers in males. The other two strains, HPV-6 and HPV-11, cause more than 90% of genital warts and recurrent respiratory papillomatosis.

"Gardasil is highly efficacious against HPV-6/11/16/18-related persistent infections and genital warts in men. This efficacy may also translate to reduced transmission of vaccine type strains between sexual partners," Dr. Haupt said at a meeting of the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices.

The study included 3,463 heterosexual men aged 16-23 years and 602 men aged 16-26 years who have sex with men. Participants with more than five lifetime sexual partners were excluded. At baseline, just 17% of the total group was positive to at least one of the vaccine HPV strains by either serology or polymerase chain reaction testing, meaning that a large majority (83%) was susceptible.

The primary end point was vaccine efficacy against all external genital lesions.

In the per-protocol population, overall efficacy was 90%, driven primarily by the prevention of genital warts: 28 of 1,408 placebo subjects developed condyloma, compared with 3 of 1,397 who received Gardasil, for an efficacy of 89%. Efficacy against PIN 1/2/3 was 100%, but the numbers were small (3 vs. 0 cases).

Efficacy against persistent infection—defined as two or more consecutive positive samples with the same HPV strain 6 months apart—was 86% (101 placebo subjects vs. 15 who got Gardasil). The vaccine was highly immunogenic, with seroconversion rates at 7 months ranging from 97% for anti-HPV-18 antibodies to 99% for anti-HPV-6. At 24 months, seroconversion rates remained high for all strains except for anti-HPV-18, which dropped to 62%. However, efficacy remained high against all strains, he noted.

Adverse event rates did not differ significantly between groups. Injection site reactions were the most common adverse event. No serious vaccine-related adverse events were reported, and only two Gardasil and three placebo participants discontinued the study because of vaccine-related adverse events.

Because efficacy studies that include genital sampling and questions about sexual behavior are not feasible in sexually naive young adolescent boys, the FDA allowed Merck to use immunogenicity "bridging" data to represent vaccine efficacy in 9- to 15-year-old boys in order to gain approval for use in that age group.

Immune responses to each of the four vaccine strains were actually more than twice as high among 1,073 boys aged 9-15 years as they were among 2,025 boys 16-26 years old, while there were no significant differences in adverse events between the younger and older cohorts.

"We believe there is a real public health benefit to adding male vaccination to the already-recognized female vaccination," Dr. Haupt concluded.

'We believe there is a real … benefit to adding male vaccination to the already-recognized female vaccination.'

Source DR. HAUPT

ATLANTA — The efficacy of GlaxoSmithKline's human papillomavirus vaccine against cervical intraepithelial neoplasia grade 2 or higher was confirmed in a final analysis of phase III data from more than 18,000 women in 14 countries.

And in a separate head-to-head comparison involving a total of more than 1,100 women, immune responses to the oncogenic HPV strains 16 and 18 were significantly better with GSK's Cervarix than with Merck & Co.'s HPV vaccine Gardasil, Dr. Gary Dubin said at a meeting of the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices.

GlaxoSmithKline's phase III data on Cervarix were submitted to the Food and Drug Administration in March 2009 and are still under review. The vaccine is currently licensed in more than 95 countries, said Dr. Dubin, vice president, North American clinical development, GSK.

The final analysis enrolled 18,644 women aged 15-25 years in a double-blind, randomized, controlled trial using the hepatitis A vaccine as the control. Mean follow-up was 39 months following the first of three doses.

The primary objective was to assess efficacy against the development of cervical intraepithelial neoplasia-2 (CIN2+) associated with HPV-16 and HPV-18 in women who were DNA negative and seronegative at baseline and DNA negative at 6 months for the HPV type considered in the analysis.

Among the 14,656 seronegative women who had received all three doses of study vaccine, the overall efficacy of Cervarix against HPV-16/18 CIN2+ lesions was 93%. In total, 4/7,344 Cervarix recipients and 56/7,312 controls were found to have HPV-16/18 DNA in lesions during follow-up. Irrespective of baseline serostatus, vaccine efficacy was 91% for HPV-16/18.

In the subset of 11,641 totally vaccinated naive women, defined as those who at baseline had normal cytology, had no HPV DNA for 14 oncogenic types, and were seronegative for HPV-16 and HPV-18, Cervarix efficacy was 98% against HPV-16/18 CIN2+ lesions. For the total vaccinated cohort of 18,644 women, vaccine efficacy against HPV-16/18 CIN2+ lesions was 53%, reflecting the fact that many women in this cohort had preexisting lesions, he said.

A safety analysis showed identical rates of serious adverse events (7.5% with both Cervarix and hepatitis A vaccine) and of new-onset autoimmune disease (0.8% for both).

The head-to-head comparison was the first for the two licensed vaccines using the same methodology for immunogenicity and safety.

The primary objective was to compare the geometric mean titers of HPV-16 and HPV-18 serum neutralizing antibodies at month 7 following vaccination in women aged 18-26 years. The observer-blinded study was conducted at 40 U.S. centers in a total of 1,106 women randomized to receive Cervarix or Gardasil according to the recommended administration schedules. Placebo injections were given to the Gardasil group at 1 month and the Cervarix group at 2 months.

Cervarix induced significantly higher serum neutralizing antibody titers than did Gardasil. In women aged 18-26, titers for Cervarix were 3.7-fold higher against HPV-16 and 7.3-fold higher against HPV-18 compared with results for Gardasil. In women aged 27-35 years, those differences were 4.8-fold and 9.1-fold, and for 36- to 45-year-olds, 2.3-fold and 6.8-fold.

The frequency of circulating antigen-specific memory B cells at month 7 was 2.7-fold higher with Cervarix vs. Gardasil for HPV-16 and HPV-18, and the frequency of CD4+ T-cell responses at month 7 was also significantly higher with Cervarix compared with Gardasil for both HPV-16 and HPV-18.

ATLANTA — The efficacy of GlaxoSmithKline's human papillomavirus vaccine against cervical intraepithelial neoplasia grade 2 or higher was confirmed in a final analysis of phase III data from more than 18,000 women in 14 countries.

And in a separate head-to-head comparison involving a total of more than 1,100 women, immune responses to the oncogenic HPV strains 16 and 18 were significantly better with GSK's Cervarix than with Merck & Co.'s HPV vaccine Gardasil, Dr. Gary Dubin said at a meeting of the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices.

GlaxoSmithKline's phase III data on Cervarix were submitted to the Food and Drug Administration in March 2009 and are still under review. The vaccine is currently licensed in more than 95 countries, said Dr. Dubin, vice president, North American clinical development, GSK.

The final analysis enrolled 18,644 women aged 15-25 years in a double-blind, randomized, controlled trial using the hepatitis A vaccine as the control. Mean follow-up was 39 months following the first of three doses.

The primary objective was to assess efficacy against the development of cervical intraepithelial neoplasia-2 (CIN2+) associated with HPV-16 and HPV-18 in women who were DNA negative and seronegative at baseline and DNA negative at 6 months for the HPV type considered in the analysis.

Among the 14,656 seronegative women who had received all three doses of study vaccine, the overall efficacy of Cervarix against HPV-16/18 CIN2+ lesions was 93%. In total, 4/7,344 Cervarix recipients and 56/7,312 controls were found to have HPV-16/18 DNA in lesions during follow-up. Irrespective of baseline serostatus, vaccine efficacy was 91% for HPV-16/18.

In the subset of 11,641 totally vaccinated naive women, defined as those who at baseline had normal cytology, had no HPV DNA for 14 oncogenic types, and were seronegative for HPV-16 and HPV-18, Cervarix efficacy was 98% against HPV-16/18 CIN2+ lesions. For the total vaccinated cohort of 18,644 women, vaccine efficacy against HPV-16/18 CIN2+ lesions was 53%, reflecting the fact that many women in this cohort had preexisting lesions, he said.

A safety analysis showed identical rates of serious adverse events (7.5% with both Cervarix and hepatitis A vaccine) and of new-onset autoimmune disease (0.8% for both).

The head-to-head comparison was the first for the two licensed vaccines using the same methodology for immunogenicity and safety.

The primary objective was to compare the geometric mean titers of HPV-16 and HPV-18 serum neutralizing antibodies at month 7 following vaccination in women aged 18-26 years. The observer-blinded study was conducted at 40 U.S. centers in a total of 1,106 women randomized to receive Cervarix or Gardasil according to the recommended administration schedules. Placebo injections were given to the Gardasil group at 1 month and the Cervarix group at 2 months.

Cervarix induced significantly higher serum neutralizing antibody titers than did Gardasil. In women aged 18-26, titers for Cervarix were 3.7-fold higher against HPV-16 and 7.3-fold higher against HPV-18 compared with results for Gardasil. In women aged 27-35 years, those differences were 4.8-fold and 9.1-fold, and for 36- to 45-year-olds, 2.3-fold and 6.8-fold.

The frequency of circulating antigen-specific memory B cells at month 7 was 2.7-fold higher with Cervarix vs. Gardasil for HPV-16 and HPV-18, and the frequency of CD4+ T-cell responses at month 7 was also significantly higher with Cervarix compared with Gardasil for both HPV-16 and HPV-18.

ATLANTA — The efficacy of GlaxoSmithKline's human papillomavirus vaccine against cervical intraepithelial neoplasia grade 2 or higher was confirmed in a final analysis of phase III data from more than 18,000 women in 14 countries.

And in a separate head-to-head comparison involving a total of more than 1,100 women, immune responses to the oncogenic HPV strains 16 and 18 were significantly better with GSK's Cervarix than with Merck & Co.'s HPV vaccine Gardasil, Dr. Gary Dubin said at a meeting of the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices.

GlaxoSmithKline's phase III data on Cervarix were submitted to the Food and Drug Administration in March 2009 and are still under review. The vaccine is currently licensed in more than 95 countries, said Dr. Dubin, vice president, North American clinical development, GSK.

The final analysis enrolled 18,644 women aged 15-25 years in a double-blind, randomized, controlled trial using the hepatitis A vaccine as the control. Mean follow-up was 39 months following the first of three doses.

The primary objective was to assess efficacy against the development of cervical intraepithelial neoplasia-2 (CIN2+) associated with HPV-16 and HPV-18 in women who were DNA negative and seronegative at baseline and DNA negative at 6 months for the HPV type considered in the analysis.

Among the 14,656 seronegative women who had received all three doses of study vaccine, the overall efficacy of Cervarix against HPV-16/18 CIN2+ lesions was 93%. In total, 4/7,344 Cervarix recipients and 56/7,312 controls were found to have HPV-16/18 DNA in lesions during follow-up. Irrespective of baseline serostatus, vaccine efficacy was 91% for HPV-16/18.

In the subset of 11,641 totally vaccinated naive women, defined as those who at baseline had normal cytology, had no HPV DNA for 14 oncogenic types, and were seronegative for HPV-16 and HPV-18, Cervarix efficacy was 98% against HPV-16/18 CIN2+ lesions. For the total vaccinated cohort of 18,644 women, vaccine efficacy against HPV-16/18 CIN2+ lesions was 53%, reflecting the fact that many women in this cohort had preexisting lesions, he said.

A safety analysis showed identical rates of serious adverse events (7.5% with both Cervarix and hepatitis A vaccine) and of new-onset autoimmune disease (0.8% for both).

The head-to-head comparison was the first for the two licensed vaccines using the same methodology for immunogenicity and safety.

The primary objective was to compare the geometric mean titers of HPV-16 and HPV-18 serum neutralizing antibodies at month 7 following vaccination in women aged 18-26 years. The observer-blinded study was conducted at 40 U.S. centers in a total of 1,106 women randomized to receive Cervarix or Gardasil according to the recommended administration schedules. Placebo injections were given to the Gardasil group at 1 month and the Cervarix group at 2 months.

Cervarix induced significantly higher serum neutralizing antibody titers than did Gardasil. In women aged 18-26, titers for Cervarix were 3.7-fold higher against HPV-16 and 7.3-fold higher against HPV-18 compared with results for Gardasil. In women aged 27-35 years, those differences were 4.8-fold and 9.1-fold, and for 36- to 45-year-olds, 2.3-fold and 6.8-fold.

The frequency of circulating antigen-specific memory B cells at month 7 was 2.7-fold higher with Cervarix vs. Gardasil for HPV-16 and HPV-18, and the frequency of CD4+ T-cell responses at month 7 was also significantly higher with Cervarix compared with Gardasil for both HPV-16 and HPV-18.