Controversy Arises on Added Benefit of Rilpivirine for HIV-Positive Children and Adolescents

In a one-arm study examined by the German Institute for Quality and Efficiency in Health Care (IQWiG), the added benefit of rilpivirine for HIV-positive children and adolescents between the ages of 12 and 18, was not proven, contrary to the belief of the manufacturer.

The Centers for Disease Control and Prevention (CDC) reports that in 2014, around 9,731 individuals between the ages of 13 and 24 were diagnosed with HIV. In the United States, this age group has the highest rate of individuals living with undiagnosed HIV. Furthermore, those who are 13 to 24 years of age also have the lowest rate among any age group to be linked to care within 3 months of diagnosis. Eight percent of AIDS diagnoses (1,716) in 2014 were in the same age group. In 2013, 109 individuals between the ages of 15 and 24 died of HIV or AIDS.

The CDC attributes the high rate of HIV among young age groups in the United States to inadequate sex education. In its 2014 School Health Profiles, the CDC notes that less than one half of high schools nationwide include the 16 CDC-recommended topics in their curricula, and that none of the states met the CDC goals for middle school sex education. One important topic that most high schools do not include in their curricula is infection prevention methods for young gay and bisexual men, who, in 2014, accounted for 80% of HIV-positive cases between the ages of 13 to 24. In addition, the CDC reports that from 2000 to 2014 the percentage of schools teaching HIV-prevention decreased from 64% to 40%, respectively.

Rilpivirine was approved as a single agent for adult HIV-1 patients under the trade name Edurant in 2011. According to a recent press release, researchers saw the administration of the drug to children and adolescents (12 years of age or older) who had not received other antiretroviral therapy and had no more than a 100,000 viral load count (viral RNA copies/mL).

Results from a one-arm study (a study in where there is no randomized control group receiving placebo) on the added benefits of a drug are only to be considered in the case of dramatic effects, which uncover patient-relevant effects that are too large to be caused solely by a systematic bias.

The manufacturer studied the added benefits of rilpivirine in comparison to efavirenz in combination with abacavir plus lamivudine. However, Rilpivirine manufacturers claimed a non-quantifiable added benefit for the drug without examining studies for the appropriate comparator therapy.

In the press release, IQWiG confirmed that this study did not meet the requirements to be considered as a reliable one-arm study; therefore, all presented data is to be discounted. According to IQWiG, more English-language information will be available soon. If you would like to be informed when these documents are available, please send an e-mail to info@iqwig.de.