FDA Issues Safety Announcement with Updated Information on Drug Interactions Between Boceprevir (Victrelis) and Certain Ritonavir-Boosted HIV Protease Inhibitor Drugs

“The U.S. Food and Drug Administration (FDA) is notifying the public that co-administration of Victrelis (boceprevir), a hepatitis C virus (HCV) protease inhibitor, along with certain ritonavir-boosted human immunodeficiency virus (HIV) protease inhibitors, is not recommended at this time because of the possibility of reducing the effectiveness of the medicines, permitting the amount of HCV or HIV virus in the blood (viral load) to increase. Ritonavir-boosted HIV protease inhibitors include ritonavir-boosted Reyataz (atazanavir), ritonavir-boosted Prezista (darunavir), and Kaletra (lopinavir/ritonavir).

“Patients should not stop taking any of their hepatitis C or HIV medicines without talking to their healthcare professional.  Patients should contact their healthcare professional with any questions or concerns.

“Healthcare professionals who started patients infected with both chronic HCV and HIV on Victrelis while the patient was taking antiretroviral therapy containing one of these ritonavir-boosted protease inhibitors should closely monitor patients for treatment response (no HCV virus detected in the blood) and for potential HCV or HIV virologic rebound (HCV or HIV virus is detected in the blood again after becoming undetectable). …

“In light of both the findings of the drug-drug interaction study and the clinical trial, FDA has revised the Victrelis drug label to state that co-administration of Victrelis with ritonavir-boosted Reyataz (atazanavir), ritonavir-boosted Prezista (darunavir), or Kaletra (lopinavir/ritonavir) to patients infected with both chronic HCV and HIV is not recommended at this time.”

More information is available:

• FDA: Safety announcement
• FDA: Boceprevir (Victrelis) information

FDA Approves New Pediatric Dosing Recommendations for Fosamprenavir (Lexiva)

“On April 27, 2012, the Food and Drug Administration approved dosing recommendations for use of Lexiva (fosamprenavir) oral suspension in pediatric patients.

“Data submitted to FDA included three studies to support a new dosing regimen for Lexiva, with ritonavir, in combination with other antiretroviral drugs, for the treatment of HIV-1 infection in pediatric patients from at least 4 weeks to less than 6 years of age.

“The Lexiva label now includes dosing for pediatric patients aged at least 4 weeks to 18 years. The dosage of Lexiva should be calculated based on body weight (kg) and not exceed the recommended adult dose. …

“For pediatric patients, pharmacokinetic and clinical data:

• do not support once-daily dosing of LEXIVA alone or in combination with ritonavir
• do not support administration of LEXIVA alone or in combination with ritonavir for protease inhibitor-experienced children younger than 6 months of age
• do not support twice-daily dosing of LEXIVA without ritonavir in pediatric patients younger than 2 years of age”

The updated label will be available at the FDA website.

More information is available:

• FDA: Press release 
   

Join AIDSinfo in Observing National Asian and Pacific Islander HIV/AIDS Awareness Day

May 19, 2012, marks the eighth annual National Asian and Pacific Islander HIV/AIDS Awareness Day. It is a day that serves to increase awareness of the impact of HIV/AIDS among the Asian and Pacific Islander communities in the United States.

According to the 2010 HIV Surveillance Report from the Centers for Disease Control and Prevention (CDC), in the 46 states with confidential name-based HIV reporting, Native Hawaiians/Other Pacific Islanders had the third highest rate of new HIV diagnoses among racial and ethnic groups in 2010, following African Americans and Hispanics/Latinos. According to the HIV Surveillance by Race/Ethnicity slide set from CDC, Native Hawaiian/Other Pacific Islander males had a higher rate of HIV diagnoses than that of white males in 2010, and both Asian and Native Hawaiian/Other Pacific Islander females had a higher rate of HIV diagnoses than that of white females in 2010.

AIDSinfo has developed a webpage for this awareness day with information and resources about HIV/AIDS and the Asian and Pacific Islander communities.

More information is available:

• AIDSinfo: National Asian and Pacific Islander HIV/AIDS Awareness Day webpage [en español]

Join AIDSinfo in Observing HIV Vaccine Awareness Day

May 18, 2012, is the 15^th annual observance of HIV Vaccine Awareness Day. This day provides an opportunity to recognize the volunteers, community members, health professionals, and scientists working together toward finding an HIV vaccine. This day is also an opportunity to educate communities across the United States about the importance of HIV vaccine research.

Two types of experimental HIV vaccines are currently being studied in clinical trials. Therapeutic HIV vaccines are designed to treat HIV-infected people. Preventive HIV vaccines are designed to prevent HIV infection in people who do not already have HIV. Even though no HIV vaccines are currently available or approved by the Food and Drug Administration (FDA), significant research is under way to develop an effective vaccine.

There is scientific evidence that a safe and effective HIV vaccine may be possible. For the first time, in a research study in Thailand, an experimental vaccine demonstrated some ability to prevent HIV infection among vaccinated individuals. The 2009 research findings represent an important advance in HIV vaccine research. More research is needed but the study results bring researchers a step closer to developing a broadly protective HIV vaccine.

AIDSinfo has developed a webpage for this awareness day with information and resources about HIV vaccine research.

More information is available:

• AIDSinfo: HIV Vaccine Awareness Day webpage [en español]
• NIH: Official statement on HIV Vaccine Awareness Day [en español] 

Study Suggests HIV Infection Is an Independent Risk Factor for Incident Lung Cancer

• PubMed: Study abstract

NIH Study Suggests Tenofovir Use During Pregnancy Does Not Affect Infant Size or Birth Weight

“Infants born to women who used the anti-HIV drug tenofovir as part of an anti-HIV drug regimen during pregnancy do not weigh less at birth and are not of shorter length than infants born to women who used anti-HIV drug regimens that do not include tenofovir during pregnancy, according to findings from a National Institutes of Health network study. However, at 1 year of age, children born to the tenofovir-treated mothers were slightly shorter and had slightly smaller head circumference — about 1 centimeter each, on average — than were infants whose mothers did not take tenofovir.

“The study authors described the findings as reassuring, noting that the study did not identify any serious safety concerns during pregnancy for tenofovir. … The researchers called for additional studies to follow the children as they grow and develop, to identify any potential long term effects of the treatment. …

“The study included 2,000 U.S. infants born to HIV-positive mothers between 2003 and 2010. The researchers collected data for the infants’ size relative to their gestational age (time they had spent in the womb), their birth weight, length at birth, and the circumference of their head. The researchers recorded similar measurements when the child was 1 year old.

“They found that mothers taking tenofovir in combination with other anti-HIV medications and mothers on anti-HIV drug combinations that did not include tenofovir gave birth to infants who were smaller, on average, than infants born to HIV-negative mothers. However, they did not find significant differences between infants from the two groups of HIV-positive mothers.

“The tenofovir-exposed infant's smaller average size and head circumference at one year of age suggests tenofovir could have a delayed effect on growth.”

More information is available:

• NIH: Press release
   

Study Suggests Osteoporotic Fracture Risk Is Associated with Cumulative Exposure to Tenofovir and Other Antiretrovirals

• PubMed: Study abstract