PrEP: mostly given to white men; and decreases new HIV diagnoses (2 studies)

​2 articles: first a CDC report of the striking under-representation of women and minorities in getting pre-exposure prophylaxis (PrEP) to HIV when appropriate; the second on a dramatic decrease in new HIV infections where PrEP was aggressively promoted.

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The CDC just published an analysis of PrEP to prevent HIV infection, finding pretty dramatic deficiencies especially among women, and black and Hispanic people overall (see https://www.cdc.gov/mmwr/volumes/67/wr/mm6741a3.htm ).

Details:

--CDC analyzed 2014-16 data from the IQVIA Real World Data -- Longitudinal Prescriptions to estimate the number of people prescribed PrEP when indicated in the US, with information about sex and race/ethnicity

    --this database includes all third party payers, including Medicaid and prescription claims from medication assistance programs

--they employed an algorithm to discern whether the TDF/FTC  (tenofovir disoproxil fumarate 300mg plus emtricitabine 200mg, the only approved regimen) was prescribed for PrEP vs HIV treatment vs post-HIV exposure prophylaxis vs hep B treatment

--overall, PrEP prescriptions increased 470% over this time period: from 13,748 to 78,360 prescriptions

--PrEP users were:

    --95% males: 69% white, 11% African-American, 13% Hispanic, and 5% Asian.

    --55% were 25-44 yo

    --least often living in the Midwestern US (16%) vs other regions (27-30%)

--commercial insurer paid for 81% of prescriptions; Medicaid 12%

--of the estimated 1.1 million people who had indications for PrEP, only 7% of patients got the meds in 2016:

    --only 2.1% of women with PrEP indications got meds

    --though black men and women accounted for 40% of people with PrEP indications, six times as many white men and women got meds

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A population-level study found that more aggressive use of PrEP against HIV infection does in fact lead to short-term dramatic decreases in new cases of HIV infection in the community (see hiv pre-exp prophylaxis dec new hiv lancethiv2018 in dropbox, or doi.org/10.1016/S2352-3018(18)30215-77).

Details:

--the EPIC-NSW study (Expanded PrEP Implementation in Communities--New South Wales) in Australia recruited 3700 men who have sex with men (MSM) in 8 months in 2016 who were at high risk of getting HIV infection (4 criteria: though, 91% met the one criterion of "receptive condomless anal intercourse with casual partners who are HIV-positive or unknown status")

    ​--2.3% of men (38,872) self-identify as gay in New South Wales, Australia's most populous state

 --median age 36, 96% gay men/4% bisexual, 56% originally from Australia/11% from wealthy English-speaking nations/rest from around the world, 38% from Sydney living in "gay  postcodes"/50% other places in Sydney

--26% used crystal methamphetamine

--patients were given TDF/FTC as a single pill daily

--high medication adherence rate: 97.8% median medication possession ratio over first 12 months, with mean of 83%, though 30% had medication possession rate <80%

Results:

--over 4100 person-years, 2 men became infected with HIV (0.048 per 100 person-yrs): neither were adherent to PrEP therapy

--HIV diagnoses overall decreased 25.1% (10.5-37.4%), from 295 in 12 months prior to PrEP​ to 221 afterwards

--31.5% decline in recent infections (11.3-47.3%)

--18.5% decrease in other HIV diagnoses (4.5-36.6%); this reflects HIV infections more likely to have been present for >12 months (ie, these men had not been tested so regularly, or did not have indeterminate or negative western blots or seroconversion illness at the time of the HIV diagnosis)

--decline in HIV was seen in all ages but was greatest in men >45yo  (about 50% fewer recent infections), those born in Australia (about 50% fewer), and those in the "gay suburbs" of Sydney (also about 50% fewer)

--during this study, there was an increase in chlamydia and gonorrhea case reports in New South Wales.

Commentary:

--The overall data on PrEP in several studies is that it is incredibly effective in very high-risk patients (eg: the iPrEx study found NO cases in patients whose blood test revealed that they were taking at least 4 pills a week). other studies have found similar effectiveness in both daily and intermittent PrEP, with HIV cases confined to those non-adherent to the meds.  Eg see http://gmodestmedblogs.blogspot.com/2015/12/on-demand-hiv-pre-exposure-prophylaxis.html

--Australia has a long-established system to monitor HIV infections likely to have been acquired in the previous 12 months. since this was not a randomized control trial, the comparison is with the historical incidence of new HIV infections: there was a stable number of new infections in the prior 2 years before the study (143 and 146 cases)

--this study was pretty effective in achieving huge increases in PrEP ​usage: 3.9% of non HIV-positive gay men in Sydney reporting that they "ever used PrEP " in the year prior to the study, increasing to 13.9% because of the rapid recruitment in this study. also, they recruited 3700 men in 8 months (their goal), though​ by the end of the 12-month follow-up, there were 7261 participants enrolled (ie, 20% of the gay-identified men who were HIV negative or of unknown HIV status)

--this was the first study to look at the larger public-health effects of PrEP, finding dramatic effectiveness in the setting of more widespread use of aggressive antiretroviral therapies, which also decrease HIV transmission dramatically (the "treatment as prevention" approach)

--the incidence of HIV transmission in the 3700 men dispensed PrEP ​decreased from the expected 2 per 100 per year to 1 per 2000 per year!! (again, only in men not actually taking the PrEP)

--the increase in gonorrhea and chlamydia cases and increase in self-reported condomless sex suggested that the likely rate of HIV prevention would have been even higher than the predicted levels [and the benefit of PrEP was certainly not simply from increased awareness of HIV transmission or study-inspired attempts to decrease transmission in the community]

--the CDC estimates that 492,000 MSM, 25% of all sexually active MSM, meet the risk criteria for PrEP;  after sluggish initial uptake of PrEP, even now only 83,672 men are on it (though, this is really patchy: eg, much more in San Francisco, where new HIV diagnoses have declined 50% from 2012-2016)

so, some really important take-home messages here:

--there was a major reduction of new cases of HIV by PrEP (ie, PrEP really works at a community level)

--it is likely very notable that the above rapid acceptance of PrEP may well have been related to the promotion by the New South Wales' largest gay and lesbian health organization [ie, this was likely a very, very important ally: for any public health initiatives it is much more effective if involving respected community-based organizations in the design and implementation of the interventions]

--still, in this study, about 30% of PrEP users were considered suboptimally treated (<80% medication possession rate). [though it does seem that even with 4 pills/week, there is quite good effectiveness. so, the 80% cutpoint may be high]

--one potentially concerning finding in this study and also in San Francisco and in Victoria is that increased PrEP usage was associated with​ an increase in condomless sex and the potential for other really bad diseases: eg syphilis, or  gonorrhea (which is becoming more treatment-resistant over time: see http://gmodestmedblogs.blogspot.com/2016/07/gonorrhea-resistance-increasing.html and http://gmodestmedblogs.blogspot.com/2018/04/antibiotic-overuse-in-animals-and.html​ )

--there was much greater reduction in new HIV cases in those >35yo, those born in Australia, and those residing in the "gay suburbs", which probably is generalizable and gives us some not-so-unexpected public health focuses (foci??): really trying to reach out to younger MSM, and those less integrated into the gay communities (and, i suspect, those more newly arrived and less integrated into any communities)

--so, the imperative here is reaching out to the many groups of people who seem to have much lower rates of appropriate PrEP usage: and, as per the CDC article above, especially to women and African-American/other minorities in the US who are at high HIV transmission risk. and in communities and areas where being gay is less accepted

and, bottom line: PrEP really works, both at the individual and society-wide levels.

geoff

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