Physician Views: How compelling is ViiV's new cabotegravir data?
Earlier this week, ViiV Healthcare reported new data showing that its experimental drug cabotegravir was 66% more effective at preventing HIV infection compared to Gilead Sciences' current standard-of-care therapy Truvada. Cabotegravir is further differentiated by administration with injection every two months versus once-daily oral dosing of Truvada.
In a note to investors, analysts at Jefferies argued that data from the Phase IIb/III HPTN 038 should strongly position cabotegravir, assuming it is approved by regulators. They believe that the US HIV pre-exposure prophylaxis (PrEP) market – currently worth around $2 billion a year – will be particularly important in shaping ViiV's commercial aspirations for cabotegravir. ViiV majority shareholder GlaxoSmithKline is projecting a minimum 15% to 20% share gain here, they add.
An expert we spoke to says that the outlook for cabotegravir is less certain, though he also argues that the size of the PrEP market could grow significantly in years to come.
To add another perspective, we are snap-polling infectious diseases specialists about the new data and how it could potentially influence their future utilisation of the therapy.
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Q. The Phase IIb/III HPTN 083 study is evaluating the safety and efficacy of long-acting, injectable cabotegravir for HIV pre-exposure prophylaxis (PrEP) among men who have sex with men (MSM) and transgender women who have sex with men.
Final data from HPTN 083 showed that cabotegravir – when administered every two months – is 66% more effective than daily oral Truvada (emtricitabine/tenofovir disoproxil fumarate) at preventing HIV infection. Fifty-two (52) documented cases of HIV were observed in the HPTN 083 trial, with 13 cases occurring in the long-acting cabotegravir arm and 39 cases occurring in the daily, oral FTC/TDF arm.
On a scale of 1 (not impressive) to 5 (very impressive), how impressive do you find these efficacy data?
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Q. On a scale of 1 (not compelling) to 5 (very compelling), how compelling is the potential of cabotegravir to offer effective HIV prevention with the convenience of dosing six times a year?
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Q. Eighty (80) percent of participants in the cabotegravir group reported pain or tenderness at the injection site, compared to 31% of those in the FTC/TDF arm, who received placebo injections. Discontinuation due to injection site reactions (ISRs) or injection intolerance in the cabotegravir arm of the study was 2.2% and there were no discontinuations due to ISRs in the FTC/TDF arm.
On a scale of 1 (not a barrier) to 5 (significant barrier), do you anticipate ISRs acting as a potential deterrent to your future use of cabotegravir?
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Q. Are these data for cabotegravir compelling enough to warrant 'widespread utilisation' versus the availability of generic Truvada?
Q. To approximately what percentage of HIV PrEP patients – who meet the criteria of patients enrolled in the HPTN 083 study – do you anticipate prescribing cabotegravir to, assuming it is approved by regulatory authorities?