by Jeffrey T. Kirchner, DO, AAHIVS, AAHIVM Chief Medical Officer
September 10, 2019
The DHHS Guidelines for the Prevention and Treatment of Opportunistic Infections recently updated their recommendations on the use of the two FDA-approved vaccines – recombinant zoster vaccine Shingrix® [RZV] and older zoster live vaccine Zostavax® [ZVL] for prevention of herpes zoster in persons with HIV. This information specifically focuses on PLWH age 50 years and older. The guidelines now recommend using RZV instead of ZVL.The newer RZV is a subunit preparation containing recombinant VZV glycoprotein E (gE) and adjuvant AS01B that elicits a much stronger immune response than ZVL. The current schedule for RZV is one IM injection followed by a second “booster” at 2 to 6 months. The guidelines note that ZVL may still be used if RZV is not available or cannot be given due to allergy or intolerance. They also note that ZVL is contraindicated in persons with a CD4 count < 200 cells/mm3.
The 2017 approval and recommendations for RZV use were based on several phase 3 randomized, placebo-controlled clinical trials involving >30,000 participants. In these studies, vaccine efficacy against herpes zoster was 97% overall and 91% in those aged ≥70 years. The most common adverse reactions were pain (78%), myalgia (45%), and fatigue (45%). Grade 3 injection site reactions (pain, redness, and swelling) were reported in 9% of vaccine recipients and grade 3 systemic events (myalgia, fatigue, headache, fever, and gastrointestinal symptoms) in 11% of recipients. These reactions occurred more frequently after the second dose of RZV. There are some limited data on use of RZV in persons with HIV, and currently ACIP/CDC has not specifically recommended its use in persons with HIV. There are also no data regarding the optimal timing of vaccination for persons who have CD4 counts <200 cells/mm3 or who are not virologically suppressed on ART. It would be reasonable, as with other vaccines to give RZV following initiation of ART with viral suppression and subsequent CD4 count recovery.
Following the approval of the RZV in October of 2017 there was such great demand that a subsequent shortage occurred for about one year. The vaccine is again available and we have been recommending for our age-appropriate ( >50 years) HIV patients. A few caveats with RZV included: counseling patients about adverse reactions and reassuring them that is it recommended even if they have had shingles in the past. There are insurance reimbursement issues with payers including Medicare, so most of our patients are getting Shingrix® at their community pharmacy or hospital outpatient pharmacy to cover the cost, which is billed under their prescription benefits.
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