Timely Topics in HIV

The latest advances in HIV treatment and care include new drug therapies, a new at-home test, and updates guidelines for antiretroviral therapy for pregnant women.

2012 marked the 31st year since the first cases of AIDS were reported in the United States. ¹ Extraordinary advances in understanding HIV and its treatment have been made in the last 3 decades—and that momentum continues with several recent advances and the development of best practices, new drugs, and new technologies. Some of the current HIV topics highlighted in this article include preexposure prophylaxis, a newly approved “quad” tablet, approval of an in-home HIV test, and updated guidelines for the treatment of perinatal HIV.

PREEXPOSURE PROPHYLAXIS (PREP) ^2-4

On July 16, 2012, the FDA approved Gilead’s Truvada (emtricitabine and tenofovir disoproxil fumarate) as the first drug to reduce the risk of HIV infection in uninfected individuals who are at high risk of HIV infection and who may engage in sexual activity with HIV-infected partners.

Truvada is to be used for preexposure prophylaxis (PrEP) in combination with safer sex practices to reduce the risk of sexually acquired HIV infection in adults at high risk. Truvada for PrEP was approved with a Risk Evaluation and Mitigation Strategy (REMS) to minimize the risk to uninfected individuals of acquiring HIV infection and to reduce the risk of developing HIV resistance. The REMS program aims to train and educate prescribers when counseling individuals who are taking or considering Truvada for PrEP.

The training and education program will not restrict distribution of the drug, but will provide information about the importance of adhering to the recommended dosing regimen and understanding the serious risks of becoming infected with HIV while taking Truvada for PrEP. It will also include an agreement form documenting the completion of patient education and an understanding of risks and responsibilities when initiating Truvada for PrEP.

The form will need to be signed by both the prescriber and uninfected individual and placed in the individual’s medical record. Furthermore, Gilead will be required to collect information from individuals who acquire HIV despite using Truvada for PrEP, in order to evaluate for resistance. Gilead will also be required to collect data on pregnancy outcomes, drug adherence, and the characteristics of patients using PrEP. At the FDA’s request, Gilead will be developing an adherence questionnaire that will help prescribers to identify individuals at risk for low adherence.

In response to the Truvada PrEP approval, the CDC issued an “Interim Guidance for Clinicians Considering the Use of Preexposure Prophylaxis for the Prevention of HIV Infection in Heterosexually Active Adults” on August 10, 2012. In addition, previous interim guidance was issued on January 28, 2011, to address “Preexposure Prophylaxis for the Prevention of HIV Infection in Men Who Have Sex with Men.”

The CDC and other public health agencies are developing a full set of guidelines on the use of PrEP as part of a comprehensive group of HIV prevention strategies. Those full guidelines are anticipated later this year.

NEW HIV TREATMENT OPTION^5,6

On August 27, 2012, the FDA approved Gilead’s Stribild, which contains 4 antiretroviral medications in 1 tablet (sometimes referred to as the “quad” pill) given once a day with food. Stribild contains the previously approved nucleoside reverse transcriptase inhibitors (NRTIs) emtricitabine and tenofovir disoproxil fumarate as well as the novel agents elvitegravir and cobicistat. Elvitegravir is an HIV integrase inhibitor and cobicistat inhibits an enzyme that metabolizes elvitegravir and thereby boosts elvitegravir’s effect.

Efficacy was evaluated in 1408 treatment-naïve patients who were randomized to receive Stribild (emtricitabine/ tenofovir/elvitegravir/cobicistat), Atripla (emtricitabine/tenofovir/efavirenz), or Truvada (emtricitabine/tenofovir) plus atazanavir and ritonavir. After 48 weeks of therapy, between 88% and 90% of patients treated with Stribild had an undetectable amount of HIV in their blood, compared with 84% treated with Atripla and 87% treated with Truvada plus atazanavir and ritonavir.

Common side effects of Stribild noted in clinical trials included nausea and diarrhea. A boxed warning states that there is a risk of lactic acidosis and the potential for severe liver problems. Additional warnings and precautions noted are renal impairment, decreases in bone mineral density, redistribution of body fat, and immune reconstitution syndrome.

FIRST OVER-THE-COUNTER AT HOME RAPID HIV TEST KIT ^7,8

In July 2012, the FDA approved the OraQuick In-Home HIV Test, which is the first over-the-counter rapid HIV test kit to be used at home. The OraQuick In-Home HIV Test detects antibodies to HIV-1 and HIV-2. Patients swab their upper and lower gums for an oral fluid sample with the testing device provided. The testing device is then placed in a tube with developing solution for 20 to 40 minutes. After that time, 1 line on the testing device indicates a negative test, while 2 lines indicate that HIV antibodies were detected and that a follow-up confirmation test performed by a health care professional is required. Clinical trials showed that approximately 1 false positive can be expected out of every 5000 test results in uninfected patients.

In addition, trials of the OraQuick test showed that approximately 1 false negative can be expected out of every 12 test results in HIV-infected patients. The test is not a reliable indicator of infection until at least 3 months after the initial HIV infection. The OraQuick customer support center has counselors available 24 hours a day to answer questions and provide local referrals for follow-up testing and HIV care.

It is anticipated by the FDA that the availability of the OraQuick In-Home HIV test will contribute to public health by offering another testing option to people who may not participate in standard HIV screenings. Helping more infected individuals become aware of their HIV status is a key in helping to reduce HIV transmission.

DEPARTMENT OF HEALTH AND HUMAN SERVICES PERINATAL ANTIRETROVIRAL GUIDELINES UPDATED ⁹

On July 31, 2012, the Health and Human Services Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission updated its guidelines, entitled “Recommendations for Use of Antiretroviral Drugs in Pregnant HIV-1- Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV Transmission in the United States.” Selected notable updates include:

• A preconception counseling and care section discussing reproductive options for HIV concordant and serodiscordant couples.
• An updated table of drug interactions between hormonal contraceptives and antiretroviral agents.
• An antepartum care section discussing general principles regarding the use of antiretroviral drugs during pregnancy and specific modified recommendations for preferred regimens, alternative regimens, or those regimens to use in special circumstances.
• An enhanced discussion of intrapartum and postpartum care, including infant antiretroviral prophylaxis and postnatal management of the HIV- exposed neonate

References

1. Valdiserri R. Commentary: thirty years of AIDS in America: a story of infinite hope. Office of HIV/AIDS and Infectious Disease Policy, US Department of Health and Human Services. http://aids.gov/news-and-events/thirty-years-of-aids/. Published June 2011. Accessed September 9, 2012.

2. FDA approves first drug for reducing the risk of sexually acquired HIV infection [press release]. US Food and Drug Administration website. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm312210.htm. Published July 16, 2012. Accessed September 9, 2012.

3. Truvada for PrEP fact sheet: ensuring safe and proper use. US Food and Drug Administration, US Department of Health and Human Services. www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM312290.pdf. Published July 2012. Accessed September 9, 2012.

4. Interim guidance for clinicians considering the use of preexposure prophylaxis for the prevention of HIV infection in heterosexually active adults. Centers for Disease Control and Prevention website. www.cdc.gov/Mmwr/preview/mmwrhtml/mm6131a2.htm. Published August 10, 2012. Accessed September 9, 2012.

5. FDA approves new combination pill for HIV treatment for some patients [press release]. US Food and Drug Administration website. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm317004.htm. Published August 27, 2012. Accessed September 9, 2012.

6. Stribild prescribing information, Gilead Sciences. www.stribild.com/Content/pdf/stribild_prescribing_information.pdf. Published August 2012. Accessed September 9, 2012.

7. FDA approves first over-the-counter home-use rapid HIV test [press release]. US Food and Drug Administration website. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm310542.htm. Published July 3, 2012. Accessed September 9, 2012.

8. First rapid home-use HIV kit approved for self-testing [press release]. US Food and Drug Administration website. www.fda.gov/ForConsumers/ConsumerUpdates/ucm310545.htm. Published July 2012. Accessed September 9, 2012.

9. Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission. Recommendations for Use of Antiretroviral Drugs in Pregnant HIV-1-Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV Transmission in the United States. http://aidsinfo.nih.gov/contentfiles/lvguidelines/PerinatalGL.pdf. Accessed September 9, 2012.

About the Author

Stacey Ness, PharmD, RPh, MSCS, is director of specialty clinical service, Managed Health Care Associates, Inc, and has worked in both national specialty pharmacy and payer organizations and has experience in clinical management, adherence, and persistency programs, as well as chronic disease cost optimization strategies. Dr. Ness is active in the Consortium of Multiple Sclerosis Centers, Academy of Managed Care Pharmacy, National Home Infusion Association, and Hematology and Oncology Pharmacy Association, and has served on the Minnesota Medicaid Drug Formulary Committee since 2008. She is a multiple sclerosis certified specialist and currently serves as the director of specialty clinical services at Managed Health Care Associates, Inc, a health care services organization based in Florham Park, New Jersey. Dr. Ness is an associate editor of Specialty Pharmacy Times.