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Perinatal Antiretroviral Treatment Guidelines Updated

October 19, 2017: The Recommendations for the use of Antiretroviral Drugs in Pregnant Women with HIV Infection and Interventions to Reduce Perinatal HIV Transmission in the United States were recently updated. The following is a summary of what's changed in this revision:

Recommendations for Use of Antiretroviral Drugs during Pregnancy and Table 6: What to Start: Initial Combination Regimens for Antiretroviral-Naive Pregnant Women

This section was updated to include new data and publications where relevant.
After review of available study findings, the Panel continues to recommend tenofovir as a component of first-line therapy and zidovudine as a second-line agent for use in antiretroviral-naive pregnant women living with HIV in the United States.
Based on limited but increasing experience with use in pregnancy, dolutegravir is now classified as an Alternative agent for antiretroviral-naive pregnant women.
The Panel has changed its classification of elvitegravir/cobicistat to Not Recommended for Initial Use in Pregnancy based on data showing inadequate levels of both drugs during the 2nd and 3rd trimester as well as viral breakthroughs.
When a pregnant woman presents on elvitegravir/cobicistat regimens, providers should consider switching to a more effective regimen. If elvitegravir/cobicistat regimens are continued, viral load should be monitored frequently and therapeutic drug monitoring may be useful.
Maraviroc and enfuvirtide are not recommended for use in antiretroviral-naive pregnant women, in accordance with guidelines for non-pregnant adults and due to lack of pharmacokinetic and safety data in pregnancy.

Table 8: Antiretroviral Drug Use in Pregnant HIV-Infected Women: Pharmacokinetic and Toxicity Data in Human Pregnancy and Recommendations for Use in Pregnancy and Appendix B: Safety and Toxicity of Individual Antiretroviral Agents in Pregnancy

These sections were updated with new data about tenofovir disoproxil fumarate.

Adult and Adolescent Opportunistic Infections Guidelines Updated

October 19, 2017: The Candida
section of the Guidelines for the Prevention and Treatment of Opportunistic Infections in HIV-Infected Adults and Adolescents was recently updated. This section was updated a) to include isavuconazole as a treatment option for patients with uncomplicated esophageal candidiasis, b) to highlight the results of a study describing complications from fluconazole use during pregnancy, and c) to incorporate statements regarding the occurrence of infections by non-albicans Candida strains, the presence of drug-drug interactions and absorption considerations with posaconazole, and the importance of ART/immune restoration in preventing mucosal candidiasis.

Changes to the REYATAZ Label Approved

The REYATAZ (atazanavir) package insert was updated to include the following:

In Section 2 Dosage and Administration a new subsection was added regarding renal and hepatic laboratory testing before and during treatment with REYATAZ. This information is consistent with current labeling practice.

2.2 Testing Prior to Initiation and During Treatment with REYATAZ
Renal laboratory testing should be performed in all patients prior to initiation of REYATAZ and continued during treatment with REYATAZ. Renal laboratory testing should include serum creatinine, estimated creatinine clearance, and urinalysis with microscopic examination.
Section 4 Contraindications was updated to include elbasvir/grazoprevir because concomitant use may increase the risk of ALT elevations due to a significant increase in grazoprevir plasma concentrations.
Section 5 Warnings and Precautions, section 6 Adverse Reactions and section 17 Patient Counseling were updated to include information on chronic kidney disease based on post-marketing data.
5.5 Chronic Kidney Disease
Chronic kidney disease in HIV-infected patients treated with atazanavir, with or without ritonavir, has been reported during postmarketing surveillance. Reports included biopsy-proven cases of granulomatous interstitial nephritis associated with the deposition of atazanavir drug crystals in the renal parenchyma. Consider alternatives to REYATAZ in patients at high risk for renal disease or with preexisting renal disease. Renal laboratory testing (including serum creatinine, estimated creatinine clearance, and urinalysis with microscopic examination) should be conducted in all patients prior to initiating therapy with REYATAZ and continued during treatment with REYATAZ. Expert consultation is advised for patients who have confirmed renal laboratory abnormalities while taking REYATAZ. In patients with progressive kidney disease, discontinuation of REYATAZ may be considered.

Postmarketing Experience
Renal System: nephrolithiasis, interstitial nephritis, granulomatous interstitial nephritis, chronic kidney disease.

17 Patient Counseling Information
Chronic Kidney Disease
Inform patients that treatment with REYATAZ may lead to the development of chronic kidney disease, and to maintain adequate hydration while taking REYATAZ.

The update label will soon be available at [email protected]

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