ViiV HEALTHCARE ANNOUNCES NEW DATA AT AIDS 2022 FROM UNBLINDED PHASE OF HPTN 084 STUDY IN WOMEN IN SUB SAHARAN AFRICA SHOWING CONTINUED SUPERIOR EFFICACY OF INJECTABLE CABOTEGRAVIR LONG-ACTING FOR PREP OVER DAILY, ORAL TDF/FTC TABLETS 

London, July 28, 2022 – ViiV Healthcare, the global specialist HIV company majority-owned by GSK, with Pfizer and Shionogi as shareholders, today announced new efficacy and safety findings from the unblinded period of the HIV Prevention Trials Network (HPTN) 084 trial evaluating cabotegravir long-acting (LA) for pre-exposure prophylaxis (PrEP) in women in sub Saharan Africa. The findings showed that cabotegravir LA for PrEP continued to demonstrate superior efficacy in the prevention of new HIV infections among women when compared to daily oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) tablets, with an 89% lower rate of HIV acquisition (HR 0.11, 95% CI 0.05, 0.24). Results were presented today at the 24^th International AIDS Conference (AIDS 2022) in Montreal, Canada.

Participants were subsequently told which regimen they were taking (unblinded) and continued on their original randomised study regimen, pending a study amendment to offer open-label cabotegravir LA for PrEP to all participants who wished to take it. The data presented at AIDS 2022 include the 12-month period after HPTN 084 trial participants were unblinded, but prior to the amendment.

Kimberly Smith, M.D., MPH, Head of Research & Development at ViiV Healthcare, said: “These remarkable data reaffirm the potential use of long-acting cabotegravir as an effective HIV prevention option for women, particularly women in sub Saharan Africa who are disproportionately impacted by HIV. This study also continues to provide us with valuable information about women who become pregnant while receiving cabotegravir LA. Women tell us they need more choices for HIV prevention. We believe that having an alternative to a daily pill to prevent HIV that reduces dosing days from 365 to as few as six times per year can potentially have a significant impact on efforts to end the epidemic.”

New pregnancy safety data were also presented at AIDS 2022. During the unblinded phase of the HPTN 084 study, 83 confirmed pregnancies (43 on cabotegravir, 40 on TDF/FTC) occurred. Women with confirmed pregnancies while on long-acting cabotegravir for PrEP discontinued cabotegravir injections until cessation of breast feeding. No birth defects were reported in either arm of the study. The increased pregnancy incidence during the unblinded period of the study highlights the importance of ongoing studies to evaluate the safety and pharmacology of cabotegravir LA during pregnancy and lactation.

About cabotegravir extended-release injectable suspension
Cabotegravir LA for PrEP is an integrase strand transfer inhibitor (INSTI). INSTIs, like cabotegravir extended-release injectable suspension, inhibit HIV replication by preventing the viral DNA from integrating into the genetic material of human immune cells (T-cells). This step is essential in the HIV replication cycle and is also responsible for establishing chronic disease.

Cabotegravir LA for PrEP is provided as an injection given as few as six times per year and is initiated with a single 600 mg (3-ml) intramuscular injection given one month apart for two consecutive months. After the second initiation injection, the recommended continuation injection dose is a single 600 mg (3-ml) injection given every two months. Vocabria (cabotegravir oral tablets) may be administered for approximately one month before initiating the first injection to assess the tolerability of the medicine.

Trademarks are owned by or licensed to the ViiV Healthcare group of companies.

APRETUDE (cabotegravir) extended-release injectable suspensions

INDICATION

APRETUDE is indicated in at-risk adults and adolescents weighing at least 35 kg for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection. Individuals must have a negative HIV-1 test prior to initiating APRETUDE (with or without an oral lead-in with oral cabotegravir) for HIV-1 PrEP.

Individuals must be tested for HIV-1 infection prior to initiating APRETUDE or oral cabotegravir, and with each subsequent injection of APRETUDE, using a test approved or cleared by the FDA for the diagnosis of acute or primary HIV-1 infection. Drug-resistant HIV-1 variants have been identified with use of APRETUDE by individuals with undiagnosed HIV-1 infection. Do not initiate APRETUDE for HIV-1 PrEP unless negative infection status is confirmed. Individuals who become infected with HIV-1 while receiving APRETUDE for PrEP must transition to a complete HIV-1 treatment regimen.

WARNINGS AND PRECAUTIONS

Comprehensive Management to Reduce the Risk of HIV-1 Infection:

• Use APRETUDE as part of a comprehensive prevention strategy, including adherence to the administration schedule and safer sex practices, including condoms, to reduce the risk of sexually transmitted infections (STIs). APRETUDE is not always effective in preventing HIV-1 acquisition. Risk for HIV-1 acquisition includes, but is not limited to, condomless sex, past or current STIs, self-identified HIV risk, having sexual partners of unknown HIV-1 viremic status, or sexual activity in a high prevalence area or network. Inform, counsel, and support individuals on the use of other prevention measures (e.g., consistent and correct condom use; knowledge of partner[s] HIV-1 status, including viral suppression status; regular testing for STIs)
• Use APRETUDE only in individuals confirmed to be HIV-1 negative. HIV-1 resistance substitutions may emerge in individuals with undiagnosed HIV-1 infection who are taking only APRETUDE, because APRETUDE alone does not constitute a complete regimen for HIV-1 treatment. Prior to initiating APRETUDE, ask seronegative individuals about recent (in past month) potential exposure events and evaluate for current or recent signs or symptoms consistent with acute HIV-1 infection (e.g., fever, fatigue, myalgia, skin rash). If recent (<1 month) exposures to HIV-1 are suspected or clinical symptoms consistent with acute HIV-1 infection are present, use a test approved or cleared by the FDA as an aid in the diagnosis of acute HIV-1 infection
• When using APRETUDE, HIV-1 testing should be repeated prior to each injection and upon diagnosis of any other STIs
• Additional HIV testing to determine HIV status is needed if an HIV-1 test indicates possible HIV-1 infection or if symptoms consistent with acute HIV-1 infection develop following an exposure event. If HIV-1 infection is confirmed, then transition the individual to a complete HIV-1 treatment
• Counsel HIV-1 uninfected individuals to strictly adhere to the recommended dosing and testing schedule for APRETUDE

Long-Acting Properties and Potential Associated Risks with APRETUDE:

• Residual concentrations of cabotegravir may remain in the systemic circulation of individuals for prolonged periods (up to 12 months or longer). Take the prolonged-release characteristics of cabotegravir into consideration and carefully select individuals who agree to the required every-2-month injection dosing schedule because non-adherence or missed doses could lead to HIV-1 acquisition and development of resistance

Hepatotoxicity:

• Hepatotoxicity has been reported in a limited number of individuals receiving cabotegravir with or without known pre-existing hepatic disease or identifiable risk factors
• Clinical and laboratory monitoring should be considered and APRETUDE should be discontinued if hepatotoxicity is suspected and individuals managed as clinically indicated

Risk of Reduced Drug Concentration of APRETUDE Due to Drug Interactions:

• The concomitant use of APRETUDE and other drugs may result in reduced drug concentration of APRETUDE
• Refer to the full Prescribing Information for steps to prevent or manage these possible and known significant drug interactions, including dosing recommendations. Consider the potential for drug interactions prior to and during use of, and after discontinuation of APRETUDE; review concomitant medications during use of APRETUDE

DRUG INTERACTIONS

• Refer to the full Prescribing Information for important drug interactions with APRETUDE
• Drugs that induce UGT1A1 may significantly decrease the plasma concentrations of cabotegravir

Trademarks are owned by or licensed to the ViiV Healthcare group of companies

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