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to Section One | to Arts & Entertainment
posted Friday, July 25 2014 - Volume 42 Issue 30
PrEP gets seal of approval in new study - Adherence still the key factor
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PrEP gets seal of approval in new study - Adherence still the key factor

by Mike Andrew - SGN Staff Writer

A new study of PrEP medications by NIH (National Institutes of Health) scientists shows that the HIV prevention method remains effective even if users skip occasional doses.

The study, released at the International AIDS Conference in Melbourne, Australia, and simultaneously published in The Lancet medical journal, involved 1,600 HIV-negative men who have sex with men and Transgender women in 11 locations, including Chicago, San Francisco, Boston, Thailand, Rio de Janeiro, and Cape Town.

According to the findings, PrEP provided 100% protection among participants who took the pill four times or more every week. Those who took the pill two or three times a week registered a protection rate of about 84%. Those who took fewer than two tablets in the same period had no protection at all.

One of the worries about PrEP as an HIV preventative has always been adherence to the dosage regimen, but the latest study seems to indicate that even moderately good adherence to the medication schedule affords significant benefits.

There has also been some concern that PrEP meds like Truvada might not be safe to use long term, and that access to PrEP could either cause individuals to increase risky sexual behavior or be reluctant to use it.

However, the study found no evidence of so-called 'risk compensation' and it also found that there was an interest and willingness to use the preventative method by those at high risk of HIV-infection.

'The project provides critical insight into what happens as PrEP transitions from clinical trials to clinical practice. It is particularly compelling to see such strong interest in PrEp among young Gay and Bisexual men who are increasingly impacted by HIV,' lead researcher Robert Grant of the Gladstone Institute, University of California said.

The study had a flexible design whereby men could join the study but could elect to start PrEP at any time in the first 48 weeks. They could also stop taking PrEP whenever they liked.

Participants were followed for 72 weeks regardless of whether they were taking PrEP or not. All participants received sexual health counseling and participants taking PrEP received extra adherence counseling.

Everyone who started PrEP had a blood sample taken to assess drug levels at some point in the first twelve weeks after starting PrEP. Participants did not know exactly which blood sample was used for drug levels.

In addition, a randomly selected 27% of participants had drug levels measured at every visit, and anyone who became HIV-positive had drug levels at every visit assessed retrospectively. All participants were tested for HIV every three months and for sexually transmitted infections including syphilis, herpes, gonorrhea, and chlamydia every six months.

Sixty-two percent of participants came from Peru or Ecuador, 18% from the USA, 13% from Brazil, and smaller numbers from South Africa and Thailand. The proportion actually allocated to PrEP ranged from 67% of participants in Peru to 95% of participants in Ecuador.

Their average age was 31, with 20% being under 24, and 22% over 40. Seventy individuals (4%) were Transgender women - a higher proportion than in previous PrEP studies.

Forty-one people, or 2.6% of the participants became HIV-positive during the study. Thirteen of these were in the group that had elected not to take PrEP while 28 were in the majority who chose to take PrEP.

However, seven of these participants had actually stopped taking PrEP more than two months before they became HIV-positive, in five cases because of side effects.

This meant that HIV infection rates in people on PrEP were 36% lower than in people not on PrEP. However, people who chose not to take PrEP had, as one might expect, lower rates of HIV risk behavior at the start of the study than those who chose to take PrEP.

Adherence was higher in people with higher levels of education. It was 69% higher in participants reporting receptive anal sex without a condom, 57% higher in participants reporting more than five sexual partners in the previous three months, and 40% higher in participants with a known HIV-positive partner, indicating that people were adjusting their PrEP use according to their perceived risk of acquiring HIV.

'If people were at higher risk they took more PrEP and adhered to it better...it shows that people who are at risk can take reasonable and appropriate decisions on their own behalf,' Grant noted.

However, adherence tailed off gradually over time, and adherence that tailed off faster was associated with becoming infected with HIV.

The researchers noted a 'PrEP cascade' effect - 75% of those whose risk behavior indicated a need for PrEP actually chose to start taking it, but when they returned three months later, 93% of them were still being given PrEP meds but only 70% were actually taking it in significant amounts.

Adding in discontinuations for side effects or by patient choice, this meant that only 39% of study participants who were at high risk of HIV at the start of the study were taking clinically meaningful doses of PrEP three months later.

If people stopped, they tended to stop early, after what the researchers called 'a brief period of engagement with PrEP.' People were much less likely to discontinue PrEP later on in the study.

Interestingly, although taking PrEP was related to sexual risk, receiving it was not, indicating that a lot of people were stockpiling the meds at home, possibly for times they did feel at risk, though a pattern of intermittent use was rarer than simply stopping it altogether.

Age turned out to be the strongest determent of adherence. Participants in their 30s were twice as likely to have detectable drug levels in their blood as participants under 25, and over-40s three times as likely.

Rates of adherence were not associated with recreational drug use or alcohol.

One other big influence on adherence was whether people believed PrEP would work or not. News of the efficacy of PrEP was released about halfway through the follow-up period in the study, and after this there was a substantial improvement in adherence seen in the men in Peru, who also tended to be younger than men in the other groups.

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