Most Read Articles
29 Jul 2020
Adjunctive perampanel appears to be safe and effective for long-term treatment of patients with tonic‐clonic seizures, according to a posthoc analysis.
11 Aug 2020
During the Allergic Rhinitis (AR) Boot Camp held in conjunction with the Bayer Pharmacist Congress 2020, Professor Dr Baharudin Abdullah discussed the management of AR in the primary care setting and the importance of using patient profiles to guide the choice of antihistamines.
Jairia Dela Cruz, 18 Feb 2020
Administering daily oral doses of adjunctive perampanel is safe and well tolerated in the treatment of young and older children with focal seizures or generalized tonic‐clonic seizures, in addition to yielding about 40–70 percent reduction in seizure frequency, according to data from the open-label 311 Core Study.
23 Apr 2018
Long‐term treatment with perampanel in the adjunctive setting appears to provide improved seizure control without raising new safety/tolerability signals in patients with epilepsy, particularly those with secondarily generalized seizures at baseline, according to the results of an open-label extension of phase III trials.

AS04-HPV-16/18 more protective against cervical cancer in women with HIV

Audrey Abella
24 Jun 2020
The AS04-HPV-16/18 vaccine demonstrated immunologic superiority over the HPV-6/11/16/18 (4vHPV) vaccine in asymptomatic young women living with HIV (WLWH), translating into longer lasting or more robust protection against cervical cancer, a phase IV study suggests.
 
Compared with HIV-negative women, WLWH have higher rates of persistent HPV infection and are at greater risk of developing cervical cancer. [http://www.who.int/wer/2017/wer9219/en, accessed June 18, 2020; J Infect Dis 2004;190:37-45] As most cervical cancers are attributable to high-risk HPV types 16 and 18, [Lancet Oncol 2010;11:1048-1056] HPV vaccination appears highly beneficial in this setting, noted the researchers.
 
A total of 546 women (mean age 19.8 years) were randomized 1:1 to receive at least one dose of AS04-HPV-16/18 or 4vHPV 0.5 mL. Of these, 257 were WLWH (stage 1), while the rest were HIV-negative. The study duration included an active phase up to month 7 and a follow up phase until month 24. [E Clinical Medicine 2020;doi.org/10.1016/j.eclinm.2020.100353]
 
The primary immunogenicity endpoint was met, as reflected by the noninferiority and immunologic superiority of AS04-HPV-16/18 over 4vHPV in WLWH at month 7 – the anti-HPV-16 and HPV-18 neutralizing antibody titres were 2.74- and 7.44-fold higher with the former than the latter (p<0.0001 for both).
 
“[These findings show] significantly higher anti-HPV-16 and HPV-18 neutralizing antibody titres [with AS04-HPV-16/18] … The AS04 adjuvant system in AS04-HPV-16/18 is likely to play a key role in the difference of immunogenicity and efficacy profiles between the two vaccines,” said the researchers.
 
Interestingly, a similar response among HIV-negative women was seen, given the 3.05- and 5.38-fold higher anti-HPV-16 and HPV-18 neutralizing antibody titres (p<0.0001 for both) with AS04-HPV-16/18 vs 4vHPV. This is remarkable, given the overall lower antibody responses among WLWH vs HIV-negative individuals, noted the researchers.
 
By month 24, WLWH who received AS04-HPV-16/18 maintained a high seroconversion rate for HPV-16 and HPV-18 (99 percent and 95 percent, respectively); among 4vHPV recipients however, the seroconversion rate for HPV-18 fell to 68 percent. This rapid decline underpins its probable diminishing protective effect against HPV-18 infection in the long term, the researchers pointed out.
 
Overall, more serious adverse events (SAEs) were observed in the WLWH vs the HIV-negative arm. Nonetheless, apart from one case of immune thrombocytopaenic purpura tied to AS04-HPV-16/18 use in the WLWH arm, no other SAEs were deemed related to vaccination. All nonfatal SAEs resolved without sequelae. No AE-related withdrawals were reported. These reflect the acceptable safety profiles of both vaccines.
 
The AS04 edge
Apart from aluminium hydroxide, AS04 contains monophosphoryl lipid A, a potent immune system stimulant that induces high antibody and T cell responses. [Vaccine 2013;31:5745-5753] AS04 appears to be a vital factor in the broader-than-expected efficacy beyond vaccine types HPV-16 and HPV-18. [Expert Rev Vaccines 2019;18:309-322; Lancet Infect Dis 2017;17:1293-1302]
 
However, the findings may have been limited by the interpretation of immunogenicity, as there is no accepted immune correlate of protection for HPV vaccines, noted the researchers. “[Nonetheless,] it is believed that antibodies play a key role in protection.”
 
Taken together, the difference in immune response observed with the two vaccines underlines the potential benefits of AS04 adjuvantation. “Previous and present studies suggest a potential for a more robust and longer lasting protection with the adjuvanted vaccine. [H]opefully, ongoing trials may help provide an answer to that question,” they said.
 
 
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Most Read Articles
29 Jul 2020
Adjunctive perampanel appears to be safe and effective for long-term treatment of patients with tonic‐clonic seizures, according to a posthoc analysis.
11 Aug 2020
During the Allergic Rhinitis (AR) Boot Camp held in conjunction with the Bayer Pharmacist Congress 2020, Professor Dr Baharudin Abdullah discussed the management of AR in the primary care setting and the importance of using patient profiles to guide the choice of antihistamines.
Jairia Dela Cruz, 18 Feb 2020
Administering daily oral doses of adjunctive perampanel is safe and well tolerated in the treatment of young and older children with focal seizures or generalized tonic‐clonic seizures, in addition to yielding about 40–70 percent reduction in seizure frequency, according to data from the open-label 311 Core Study.
23 Apr 2018
Long‐term treatment with perampanel in the adjunctive setting appears to provide improved seizure control without raising new safety/tolerability signals in patients with epilepsy, particularly those with secondarily generalized seizures at baseline, according to the results of an open-label extension of phase III trials.