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Safety in Lactation: HIV infection

23 September 2020Breastfeeding by HIV-positive mothers may cause HIV infection in the infant and should be avoided where possible. The use of HIV drugs during breastfeeding is…
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Lactation Safety Information

Specialist drug/complex disease area for which expert advice is recommended
22 September 2020

New Medicines

RekambysHIV infection in adults who are virologically suppressed (HIV-1 RNA < 50 copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with, agents of the NNRTI and INI class (for use alongside cabotegrevir injection).

Information

Rekambys
New formulation
Janssen
Johnson & Johnson

Development and Regulatory status

Launched
Approved (Licensed)
Not approved
October 2021
Oct 21Rekambys 900mg prolonged-release suspension for injection available in the UK. Price for 1 vial = £440.47[20].
Dec 20Approved in EU [18].
Oct 20Recommended for EU approval by CHMP - the full indication is "in combination with cabotegravir injection, for the treatment of human immunodeficiency virus type 1 (HIV‑1) infection in adults who are virologically suppressed (HIV-1 RNA < 50 copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with, agents of the NNRTI and INI class (see sections 4.2, 4.4 and 5.1). Rekambys should be prescribed by physicians experienced in the management of HIV infection.” [17]
Dec 19FDA issues a complete response letter, not approving rilpivirine [16].
Jul 19ViiV Healthcare has submitted a regulatory application to the EMA for investigational drug rilpivirine in combination with cabotegravir as a monthly, injectable treatment for HIV in adults whose viral load is suppressed and who are not resistant to these. The application also includes data for cabotegravir oral tablets, intended for use as oral lead-in therapy prior to the commencement of injectable therapy. The submission is based on the global ATLAS and FLAIR pivotal phase III studies. [13]
Apr 19Filed in US.[14]
Jan 19Company plans to file in US & EU in 2019 [12].
Jan 19Still on company pipeline, PIII studies.[9]
Feb 18On company pipeline, PIII studies.[7]

Category

NNRTI
Public Health England (PHE) and NHS estimated in 2017 that ~78,000 people in England were diagnosed with HIV and of these, 90% (70,000) were receiving treatment and 93% (65,000) were virally suppressed. [15]
HIV infection in adults who are virologically suppressed (HIV-1 RNA < 50 copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with, agents of the NNRTI and INI class (for use alongside cabotegrevir injection).
Intramuscular

Further information

Yes

Trial or other data

Apr 21Extension of PIII FLAIR RCT (n=566) found long-acting cabotegravir & rilpivirine continued to be non-inferior vs continuing a standard care regimen in adults with HIV-1 for the maintenance of viral suppression at 96 weeks (3% had >50 HIV RNA copies per mL in both groups) [19].
Aug 19Top line data announced from the PIII ATLAS-2M (NCT03299049) study. This isa a randomised, open-label, active-controlled, multicentre, parallel-group, non-inferiority study to assess the non-inferior antiviral activity and safety of long-acting cabotegravir and rilpivirine administered every 8 weeks vs. long-acting cabotegravir and rilpivirine administered every 4 weeks over 48-weeks in 1,045 adults living with HIV-1 who are virally supressed. The study met its primary endpoint, showing that long-acting cabotegravir and rilpivirine administered every 8 weeks was non-inferior to 4-weekly. Safety, virologic response and drug resistance results for the every-2-months regimen were consistent with results from the PIII ATLAS study.[15]
Mar 19Another PIII study is underway (NCT02938520). The First Long-Acting Injectable Regimen (FLAIR) study is being conducted to establish if HIV-1 infected adults whose virus is virologically suppressed on an integrase inhibitor single tablet regimen (INI STR) will remain suppressed after switching to a two-drug intramuscular (IM) long-acting (LA) regimen of cabotegravir (CAB) and rilpivirine (RPV). In this study, the INI STR will be limited to abacavir/dolutegravir/lamivudine (ABC/DTG/3TC). FLAIR is designed to demonstrate the non-inferior antiviral activity of switching to a two drug CAB LA 400 mg + RPV LA 600 mg regimen every 4 weeks (Q4W: monthly) compared to remaining on ABC/DTG/3TC over 48 weeks (4 weeks oral CAB + RPV, 44 weeks LA therapy). Participants who are HLA-B*5701 positive at Screening may enroll into the study and receive DTG plus a non-abacavir containing dual nucleoside reverse transcriptase inhibitor (NRTI) regimen. Eligible participants will enroll into the Induction Phase of the study and receive ABC/DTG/3TC for 20 weeks (Week [-20] to Day 1). Participants who have an HIV 1 ribose nucleic acid (RNA) <50 copies per milliliter (c/mL) at Week (-4) will be randomized (1:1) into the Maintenance Phase at Day 1 to either continue ABC/DTG/3TC or to discontinue ABC/DTG/3TC and begin oral therapy with CAB 30 mg + RPV 25 mg once daily for approximately 4 Weeks, followed by monthly CAB LA + RPV LA injections from visit Week 4b until study completion or withdrawal. Participants who successfully complete Week 100 (without meeting study defined withdrawal criteria and who remain virologically suppressed through Week 96: HIV-1 RNA <50 c/mL) will be given the option to switch to the LA arm in the Extension Phase (using an optional oral lead-in with CAB + RPV) or be withdrawn from the study. Participants will continue to receive injections every 4 weeks during the Extension Phase until CAB LA and RPV LA are either locally approved and commercially available, the participant no longer derives clinical benefit, the participant meets a protocol-defined reason for discontinuation, or until development of either CAB LA or RPV LA is terminated. Collection of primary outcome data was due to complete Aug 18. The study is expected to finish Jul 22 [11].
Jan 19PIII study completed in May 18, no results posted. [10]
Feb 18PIII study (NCT02951052) ongoing. Estimated primary completion date is June 2018.[5]
Oct 16PIII study (NCT02951052) starts. It is a non-inferiority, open-label study evaluating the efficacy, safety, and tolerability of switching to long-acting cabotegravir plus long-acting rilpivirine from current INI- NNRTI-, or PI-based antiretroviral regimen in 570 HIV-1-infected adults who are virologically suppressed. Study sites include US & EU (not UK). Primary outcome is proportion of participants with plasma HIV 1 Ribonucleic acid <50 copies/millilitre (c/mL) at Week 48; collection of these data is expected to complete Jul 18 [4].